Difference between revisions of "Mantle cell lymphoma"
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|[http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2961763-2/fulltext Rummel et al. 2013 (StiL NHL1)] | |[http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2961763-2/fulltext Rummel et al. 2013 (StiL NHL1)] | ||
− | | | + | |style="background-color:#00cd00"|Phase III |
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|[[Mantle_cell_lymphoma#R-CHOP|R-CHOP]] | |[[Mantle_cell_lymphoma#R-CHOP|R-CHOP]] | ||
− | | | + | |style="background-color:#00cd00"|Superior PFS |
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− | |[http://bloodjournal.org/content/123/19/2944.long Flinn et al. 2014 (BRIGHT)] | + | |[http://www.bloodjournal.org/content/123/19/2944.long Flinn et al. 2014 (BRIGHT)] |
− | | | + | |style="background-color:#00cd00"|Phase III |
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|[[Mantle_cell_lymphoma#R-CHOP|R-CHOP]]<br> [[Mantle_cell_lymphoma#R-CVP|R-CVP]] | |[[Mantle_cell_lymphoma#R-CHOP|R-CHOP]]<br> [[Mantle_cell_lymphoma#R-CVP|R-CVP]] | ||
− | | | + | |style="background-color:#eeee00"|Seems non-inferior |
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===References=== | ===References=== | ||
<!-- | <!-- | ||
− | # Mathias J Rummel, MD, PhD, Norbert Niederle, Georg Maschmeyer, Andre Banat, MD, MBA, Ulrich von Gruenhagen, MD, Christoph Losem, Gerhard Heil, Manfred Welslau, Christina Balser, Ulrich Kaiser, Harald Ballo, Eckhart Weidmann, Heinz A Duerk, Dorothea Kofahl-Krause, Fritz Roller, Juergen Barth, Dieter Hoelzer, MD, PhD, Axel Hinke and Wolfram Brugger. Bendamustine Plus Rituximab Is Superior in Respect of Progression Free Survival and CR Rate When Compared to CHOP Plus Rituximab as First-Line Treatment of Patients with Advanced Follicular, Indolent, and Mantle Cell Lymphomas: Final Results of a Randomized Phase III Study of the StiL (Study Group Indolent Lymphomas, Germany). 2009 ASH Annual Meeting abstract 405. [ | + | # Mathias J Rummel, MD, PhD, Norbert Niederle, Georg Maschmeyer, Andre Banat, MD, MBA, Ulrich von Gruenhagen, MD, Christoph Losem, Gerhard Heil, Manfred Welslau, Christina Balser, Ulrich Kaiser, Harald Ballo, Eckhart Weidmann, Heinz A Duerk, Dorothea Kofahl-Krause, Fritz Roller, Juergen Barth, Dieter Hoelzer, MD, PhD, Axel Hinke and Wolfram Brugger. Bendamustine Plus Rituximab Is Superior in Respect of Progression Free Survival and CR Rate When Compared to CHOP Plus Rituximab as First-Line Treatment of Patients with Advanced Follicular, Indolent, and Mantle Cell Lymphomas: Final Results of a Randomized Phase III Study of the StiL (Study Group Indolent Lymphomas, Germany). 2009 ASH Annual Meeting abstract 405. [http://www.bloodjournal.org/content/114/22/405 link to abstract] |
# Mathias J. Rummel, Norbert Niederle, Georg Maschmeyer, Andre G. Banat, Ulrich von Gruenhagen, Christoph Losem, Dorothea Kofahl-Krause, Gerhard Heil, Manfred Welslau, Christina Balser, Ulrich Kaiser, Eckhart Weidmann, Heinz A. Duerk, Harald Ballo, Martina Stauch, Juergen Barth, Axel Hinke, Wolfram Brugger, Study Group Indolent Lymphomas (StiL). Bendamustine plus rituximab (B-R) versus CHOP plus rituximab (CHOP-R) as first-line treatment in patients with indolent and mantle cell lymphomas (MCL): Updated results from the StiL NHL1 study. 2012 ASCO Annual Meeting abstract 3. [http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview==abst_detail_view&confID==114&abstractID==95807 link to abstract] [http://www.ascopost.com/issues/july-1-2012/german-study-finds-bendamustine-improves-progression-free-survival-in-patients-with-non-hodgkin-lymphoma.aspx ASCO Post article] [http://www.asco.org/ASCOv2/MultiMedia/Virtual%20Meeting?&vmview==vm_session_presentations_view&confID==114&sessionID==4807 ASCO plenary session video] --> | # Mathias J. Rummel, Norbert Niederle, Georg Maschmeyer, Andre G. Banat, Ulrich von Gruenhagen, Christoph Losem, Dorothea Kofahl-Krause, Gerhard Heil, Manfred Welslau, Christina Balser, Ulrich Kaiser, Eckhart Weidmann, Heinz A. Duerk, Harald Ballo, Martina Stauch, Juergen Barth, Axel Hinke, Wolfram Brugger, Study Group Indolent Lymphomas (StiL). Bendamustine plus rituximab (B-R) versus CHOP plus rituximab (CHOP-R) as first-line treatment in patients with indolent and mantle cell lymphomas (MCL): Updated results from the StiL NHL1 study. 2012 ASCO Annual Meeting abstract 3. [http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview==abst_detail_view&confID==114&abstractID==95807 link to abstract] [http://www.ascopost.com/issues/july-1-2012/german-study-finds-bendamustine-improves-progression-free-survival-in-patients-with-non-hodgkin-lymphoma.aspx ASCO Post article] [http://www.asco.org/ASCOv2/MultiMedia/Virtual%20Meeting?&vmview==vm_session_presentations_view&confID==114&sessionID==4807 ASCO plenary session video] --> | ||
− | # Rummel MJ, Niederle N, Maschmeyer G, Banat GA, von Grünhagen U, Losem C, Kofahl-Krause D, Heil G, Welslau M, Balser C, Kaiser U, Weidmann E, Dürk H, Ballo H, Stauch M, Roller F, Barth J, Hoelzer D, Hinke A, Brugger W; on behalf of the Study group indolent Lymphomas (StiL). Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial. Lancet. 2013 Apr 6;381(9873):1203-10. Epub 2013 Feb 20. Erratum in: Lancet. 2013 Apr 6;381(9873):1184. [http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2961763-2/fulltext link to original article] '''contains verified protocol''' [ | + | # Rummel MJ, Niederle N, Maschmeyer G, Banat GA, von Grünhagen U, Losem C, Kofahl-Krause D, Heil G, Welslau M, Balser C, Kaiser U, Weidmann E, Dürk H, Ballo H, Stauch M, Roller F, Barth J, Hoelzer D, Hinke A, Brugger W; on behalf of the Study group indolent Lymphomas (StiL). Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial. Lancet. 2013 Apr 6;381(9873):1203-10. Epub 2013 Feb 20. Erratum in: Lancet. 2013 Apr 6;381(9873):1184. [http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2961763-2/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23433739 PubMed] |
− | ## '''Update: Abstract:''' Mathias J. Rummel, MD, Georg Maschmeyer, MD, Arnold Ganser, Andrea Heider, PhD, Ulrich von Grünhagen, MD, PhD5, Christoph Losem, Gerhard Heil, MD, Manfred Welslau, Christina Balser, MD, Ulrich Kaiser, MD, Eckhart Weidmann, Heinz Dürk, MD, Hans Peter Böck, Martina Beate Stauch, MD, Jürgen Barth, Wolfgang Blau, MD, Alexander Burchardt, MD, Frank Kauff, PhD, Axel Hinke, PhD and Wolfram Brugger, MD. Bendamustine Plus Rituximab (B-R) Versus CHOP Plus Rituximab (CHOP-R) As First-Line Treatment in Patients with Indolent and Mantle Cell Lymphomas (MCL) – 7 Year Updated Results from the StiL NHL1 Study. | + | ## '''Update: Abstract:''' Mathias J. Rummel, MD, Georg Maschmeyer, MD, Arnold Ganser, Andrea Heider, PhD, Ulrich von Grünhagen, MD, PhD5, Christoph Losem, Gerhard Heil, MD, Manfred Welslau, Christina Balser, MD, Ulrich Kaiser, MD, Eckhart Weidmann, Heinz Dürk, MD, Hans Peter Böck, Martina Beate Stauch, MD, Jürgen Barth, Wolfgang Blau, MD, Alexander Burchardt, MD, Frank Kauff, PhD, Axel Hinke, PhD and Wolfram Brugger, MD. Bendamustine Plus Rituximab (B-R) Versus CHOP Plus Rituximab (CHOP-R) As First-Line Treatment in Patients with Indolent and Mantle Cell Lymphomas (MCL) – 7 Year Updated Results from the StiL NHL1 Study. Blood 2014 124:4407. [http://www.bloodjournal.org/content/124/21/4407 link to abstract] |
<!-- # Ian Flinn et al. An Open-Label, Randomized Study of Bendamustine and Rituximab (BR) Compared with Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in First-Line Treatment of Patients with Advanced Indolent Non-Hodgkin’s Lymphoma (NHL) or Mantle Cell Lymphoma (MCL): The Bright Study. 2012 ASH Annual Meeting abstract 902. [https://ash.confex.com/ash/2012/webprogram/Paper51442.html link to abstract] --> | <!-- # Ian Flinn et al. An Open-Label, Randomized Study of Bendamustine and Rituximab (BR) Compared with Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in First-Line Treatment of Patients with Advanced Indolent Non-Hodgkin’s Lymphoma (NHL) or Mantle Cell Lymphoma (MCL): The Bright Study. 2012 ASH Annual Meeting abstract 902. [https://ash.confex.com/ash/2012/webprogram/Paper51442.html link to abstract] --> | ||
− | # Flinn IW, van der Jagt R, Kahl BS, Wood P, Hawkins TE, Macdonald D, Hertzberg M, Kwan YL, Simpson D, Craig M, Kolibaba K, Issa S, Clementi R, Hallman DM, Munteanu M, Chen L, Burke JM. Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study. Blood. 2014 May 8;123(19):2944-52. Epub 2014 Mar 3. [http://bloodjournal.org/content/123/19/2944.long link to original article] '''contains verified protocol''' [ | + | # Flinn IW, van der Jagt R, Kahl BS, Wood P, Hawkins TE, Macdonald D, Hertzberg M, Kwan YL, Simpson D, Craig M, Kolibaba K, Issa S, Clementi R, Hallman DM, Munteanu M, Chen L, Burke JM. Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study. Blood. 2014 May 8;123(19):2944-52. Epub 2014 Mar 3. [http://www.bloodjournal.org/content/123/19/2944.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/24591201 PubMed] |
==CHOP {{#subobject:d6600|Regimen=1}}== | ==CHOP {{#subobject:d6600|Regimen=1}}== | ||
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|style="background-color:#00cd00"|Phase III | |style="background-color:#00cd00"|Phase III | ||
|[[Mantle_cell_lymphoma#MCP|MCP]] | |[[Mantle_cell_lymphoma#MCP|MCP]] | ||
− | |style="background-color:# | + | |style="background-color:#00cd00"|Might have superior ORR |
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===References=== | ===References=== | ||
− | # Lenz G, Dreyling M, Hoster E, Wörmann B, Dührsen U, Metzner B, Eimermacher H, Neubauer A, Wandt H, Steinhauer H, Martin S, Heidemann E, Aldaoud A, Parwaresch R, Hasford J, Unterhalt M, Hiddemann W. Immunochemotherapy with rituximab and cyclophosphamide, doxorubicin, vincristine, and prednisone significantly improves response and time to treatment failure, but not long-term outcome in patients with previously untreated mantle cell lymphoma: results of a prospective randomized trial of the German Low Grade Lymphoma Study Group (GLSG). J Clin Oncol. 2005 Mar 20;23(9):1984-92. Epub 2005 Jan 24. [http://jco.ascopubs.org/content/23/9/1984.long link to original article] [ | + | # Lenz G, Dreyling M, Hoster E, Wörmann B, Dührsen U, Metzner B, Eimermacher H, Neubauer A, Wandt H, Steinhauer H, Martin S, Heidemann E, Aldaoud A, Parwaresch R, Hasford J, Unterhalt M, Hiddemann W. Immunochemotherapy with rituximab and cyclophosphamide, doxorubicin, vincristine, and prednisone significantly improves response and time to treatment failure, but not long-term outcome in patients with previously untreated mantle cell lymphoma: results of a prospective randomized trial of the German Low Grade Lymphoma Study Group (GLSG). J Clin Oncol. 2005 Mar 20;23(9):1984-92. Epub 2005 Jan 24. [http://jco.ascopubs.org/content/23/9/1984.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/15668467 PubMed] |
− | # Nickenig C, Dreyling M, Hoster E, Pfreundschuh M, Trumper L, Reiser M, Wandt H, Lengfelder E, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. Combined cyclophosphamide, vincristine, doxorubicin, and prednisone (CHOP) improves response rates but not survival and has lower hematologic toxicity compared with combined mitoxantrone, chlorambucil, and prednisone (MCP) in follicular and mantle cell lymphomas: results of a prospective randomized trial of the German Low-Grade Lymphoma Study Group. Cancer. 2006 Sep 1;107(5):1014-22. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.22093/full link to original article] '''contains verified protocol''' [ | + | # Nickenig C, Dreyling M, Hoster E, Pfreundschuh M, Trumper L, Reiser M, Wandt H, Lengfelder E, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. Combined cyclophosphamide, vincristine, doxorubicin, and prednisone (CHOP) improves response rates but not survival and has lower hematologic toxicity compared with combined mitoxantrone, chlorambucil, and prednisone (MCP) in follicular and mantle cell lymphomas: results of a prospective randomized trial of the German Low-Grade Lymphoma Study Group. Cancer. 2006 Sep 1;107(5):1014-22. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.22093/full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/16878325 PubMed] |
==FC {{#subobject:c122ba|Regimen=1}}== | ==FC {{#subobject:c122ba|Regimen=1}}== | ||
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|[http://www.haematologica.org/content/101/2/235.long Rule et al. 2015 (CRUK-UCL-MCLIII)] | |[http://www.haematologica.org/content/101/2/235.long Rule et al. 2015 (CRUK-UCL-MCLIII)] | ||
− | | | + | |style="background-color:#00cd00"|Phase III |
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|[[#FCR|FCR]] | |[[#FCR|FCR]] | ||
− | | | + | |style="background-color:#ff0000"|Inferior OS |
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===References=== | ===References=== | ||
− | # Rule S, Smith P, Johnson PW, Bolam S, Follows G, Gambell J, Hillmen P, Jack A, Johnson S, Kirkwood AA, Kruger A, Pocock C, Seymour JF, Toncheva M, Walewski J, Linch D. The addition of rituximab to fludarabine and cyclophosphamide chemotherapy results in a significant improvement in overall survival in patients with newly diagnosed mantle cell lymphoma: results of a randomized UK National Cancer Research Institute trial. Haematologica. 2016 Feb;101(2):235-40. Epub 2015 Nov 26. [http://www.haematologica.org/content/101/2/235.long link to original article] '''contains verified protocol''' [ | + | # Rule S, Smith P, Johnson PW, Bolam S, Follows G, Gambell J, Hillmen P, Jack A, Johnson S, Kirkwood AA, Kruger A, Pocock C, Seymour JF, Toncheva M, Walewski J, Linch D. The addition of rituximab to fludarabine and cyclophosphamide chemotherapy results in a significant improvement in overall survival in patients with newly diagnosed mantle cell lymphoma: results of a randomized UK National Cancer Research Institute trial. Haematologica. 2016 Feb;101(2):235-40. Epub 2015 Nov 26. [http://www.haematologica.org/content/101/2/235.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/26611473 PubMed] |
==FCR {{#subobject:957676|Regimen=1}}== | ==FCR {{#subobject:957676|Regimen=1}}== | ||
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|} | |} | ||
FCR: '''<u>F</u>'''ludarabine, '''<u>C</u>'''yclophosphamide, '''<u>R</u>'''ituximab | FCR: '''<u>F</u>'''ludarabine, '''<u>C</u>'''yclophosphamide, '''<u>R</u>'''ituximab | ||
− | + | <br> R-FCR: '''<u>R</u>'''ituximab, '''<u>F</u>'''ludarabine, '''<u>C</u>'''yclophosphamide | |
− | ===Regimen {{#subobject:9ecbf7|Variant=1}}=== | + | ===Regimen #1 {{#subobject:9ecbf7|Variant=1}}=== |
{| border="1" style="text-align:center;" !align="left" | {| border="1" style="text-align:center;" !align="left" | ||
|'''Study''' | |'''Study''' | ||
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|[http://www.haematologica.org/content/101/2/235.long Rule et al. 2015 (CRUK-UCL-MCLIII)] | |[http://www.haematologica.org/content/101/2/235.long Rule et al. 2015 (CRUK-UCL-MCLIII)] | ||
− | | | + | |style="background-color:#00cd00"|Phase III |
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|[[#FC|FC]] | |[[#FC|FC]] | ||
− | | | + | |style="background-color:#00cd00"|Superior OS |
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'''28-day cycle for up to 8 cycles''' | '''28-day cycle for up to 8 cycles''' | ||
+ | |||
+ | ===Regimen #2, "R-FC" {{#subobject:839caa|Variant=1}}=== | ||
+ | {| border="1" style="text-align:center;" !align="left" | ||
+ | |'''Study''' | ||
+ | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
+ | |'''Comparator''' | ||
+ | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
+ | |- | ||
+ | |[http://www.nejm.org/doi/full/10.1056/NEJMoa1200920 Kluin-Nelemans et al. 2012] | ||
+ | |style="background-color:#00cd00"|Phase III | ||
+ | |[[#R-CHOP|R-CHOP]] | ||
+ | |style="background-color:#ff0000"|Inferior OS | ||
+ | |- | ||
+ | |} | ||
+ | ====Chemotherapy==== | ||
+ | *[[Rituximab (Rituxan)]] 375 mg/m<sup>2</sup> (maximum dose: 750 mg/m<sup>2</sup>) IV once on day 1 | ||
+ | *[[Fludarabine (Fludara)]] 30 mg/m<sup>2</sup> IV once per day on days 1 to 3 | ||
+ | *[[Cyclophosphamide (Cytoxan)]] 250 mg/m<sup>2</sup> IV once per day on days 1 to 3 | ||
+ | |||
+ | '''28-day cycle for 6 cycles''' | ||
+ | |||
+ | ''Responding patients were randomized to receive [[Mantle_cell_lymphoma#Rituximab_.28Rituxan.29|rituximab maintenance]] versus interferon alfa maintenance.'' | ||
===References=== | ===References=== | ||
− | # Kluin-Nelemans HC, Hoster E, Hermine O, Walewski J, Trneny M, Geisler CH, Stilgenbauer S, Thieblemont C, Vehling-Kaiser U, Doorduijn JK, Coiffier B, Forstpointner R, Tilly H, Kanz L, Feugier P, Szymczyk M, Hallek M, Kremers S, Lepeu G, Sanhes L, Zijlstra JM, Bouabdallah R, Lugtenburg PJ, Macro M, Pfreundschuh M, Procházka V, Di Raimondo F, Ribrag V, Uppenkamp M, André M, Klapper W, Hiddemann W, Unterhalt M, Dreyling MH. Treatment of older patients with mantle-cell lymphoma. N Engl J Med. 2012 Aug 9;367(6):520-31. [http://www.nejm.org/doi/full/10.1056/NEJMoa1200920 link to original article] [ | + | # Kluin-Nelemans HC, Hoster E, Hermine O, Walewski J, Trneny M, Geisler CH, Stilgenbauer S, Thieblemont C, Vehling-Kaiser U, Doorduijn JK, Coiffier B, Forstpointner R, Tilly H, Kanz L, Feugier P, Szymczyk M, Hallek M, Kremers S, Lepeu G, Sanhes L, Zijlstra JM, Bouabdallah R, Lugtenburg PJ, Macro M, Pfreundschuh M, Procházka V, Di Raimondo F, Ribrag V, Uppenkamp M, André M, Klapper W, Hiddemann W, Unterhalt M, Dreyling MH. Treatment of older patients with mantle-cell lymphoma. N Engl J Med. 2012 Aug 9;367(6):520-31. [http://www.nejm.org/doi/full/10.1056/NEJMoa1200920 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/22873532 PubMed] |
− | # Rule S, Smith P, Johnson PW, Bolam S, Follows G, Gambell J, Hillmen P, Jack A, Johnson S, Kirkwood AA, Kruger A, Pocock C, Seymour JF, Toncheva M, Walewski J, Linch D. The addition of rituximab to fludarabine and cyclophosphamide chemotherapy results in a significant improvement in overall survival in patients with newly diagnosed mantle cell lymphoma: results of a randomized UK National Cancer Research Institute trial. Haematologica. 2016 Feb;101(2):235-40. Epub 2015 Nov 26. [http://www.haematologica.org/content/101/2/235.long link to original article] '''contains verified protocol''' [ | + | # Rule S, Smith P, Johnson PW, Bolam S, Follows G, Gambell J, Hillmen P, Jack A, Johnson S, Kirkwood AA, Kruger A, Pocock C, Seymour JF, Toncheva M, Walewski J, Linch D. The addition of rituximab to fludarabine and cyclophosphamide chemotherapy results in a significant improvement in overall survival in patients with newly diagnosed mantle cell lymphoma: results of a randomized UK National Cancer Research Institute trial. Haematologica. 2016 Feb;101(2):235-40. Epub 2015 Nov 26. [http://www.haematologica.org/content/101/2/235.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/26611473 PubMed] |
==MCP {{#subobject:a84c0e|Regimen=1}}== | ==MCP {{#subobject:a84c0e|Regimen=1}}== | ||
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|[http://onlinelibrary.wiley.com/doi/10.1002/cncr.22093/full Nickenig et al. 2006] | |[http://onlinelibrary.wiley.com/doi/10.1002/cncr.22093/full Nickenig et al. 2006] | ||
− | | | + | |style="background-color:#00cd00"|Phase III |
− | style="background | ||
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− | |||
|[[Mantle_cell_lymphoma#CHOP|CHOP]] | |[[Mantle_cell_lymphoma#CHOP|CHOP]] | ||
− | | | + | |style="background-color:#ff0000"|Might have inferior ORR |
− | style="background | ||
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|} | |} | ||
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===References=== | ===References=== | ||
− | # Nickenig C, Dreyling M, Hoster E, Pfreundschuh M, Trumper L, Reiser M, Wandt H, Lengfelder E, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. Combined cyclophosphamide, vincristine, doxorubicin, and prednisone (CHOP) improves response rates but not survival and has lower hematologic toxicity compared with combined mitoxantrone, chlorambucil, and prednisone (MCP) in follicular and mantle cell lymphomas: results of a prospective randomized trial of the German Low-Grade Lymphoma Study Group. Cancer. 2006 Sep 1;107(5):1014-22. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.22093/full link to original article] '''contains verified protocol''' [ | + | # Nickenig C, Dreyling M, Hoster E, Pfreundschuh M, Trumper L, Reiser M, Wandt H, Lengfelder E, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. Combined cyclophosphamide, vincristine, doxorubicin, and prednisone (CHOP) improves response rates but not survival and has lower hematologic toxicity compared with combined mitoxantrone, chlorambucil, and prednisone (MCP) in follicular and mantle cell lymphomas: results of a prospective randomized trial of the German Low-Grade Lymphoma Study Group. Cancer. 2006 Sep 1;107(5):1014-22. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.22093/full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/16878325 PubMed] |
==R-CHOP {{#subobject:ca52ab|Regimen=1}}== | ==R-CHOP {{#subobject:ca52ab|Regimen=1}}== | ||
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|style="background-color:#00cd00"|Phase III | |style="background-color:#00cd00"|Phase III | ||
|[[#FCR|R-FC]] | |[[#FCR|R-FC]] | ||
− | |style="background-color:# | + | |style="background-color:#00cd00"|Superior OS |
|- | |- | ||
− | + | |[http://www.bloodjournal.org/content/123/19/2944.long Flinn et al. 2014 (BRIGHT)] | |
− | | | + | |style="background-color:#00cd00"|Phase III |
|[[Mantle_cell_lymphoma#BR|BR]] | |[[Mantle_cell_lymphoma#BR|BR]] | ||
|style="background-color:#eeee00"|Seems non-inferior | |style="background-color:#eeee00"|Seems non-inferior | ||
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|} | |} | ||
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|style="background-color:#00cd00"|Phase III | |style="background-color:#00cd00"|Phase III | ||
|[[Mantle_cell_lymphoma#BR|BR]] | |[[Mantle_cell_lymphoma#BR|BR]] | ||
− | |style="background-color:#ff0000"| | + | |style="background-color:#ff0000"|Inferior PFS |
|- | |- | ||
|} | |} | ||
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===References=== | ===References=== | ||
− | # Lenz G, Dreyling M, Hoster E, Wörmann B, Dührsen U, Metzner B, Eimermacher H, Neubauer A, Wandt H, Steinhauer H, Martin S, Heidemann E, Aldaoud A, Parwaresch R, Hasford J, Unterhalt M, Hiddemann W. Immunochemotherapy with rituximab and cyclophosphamide, doxorubicin, vincristine, and prednisone significantly improves response and time to treatment failure, but not long-term outcome in patients with previously untreated mantle cell lymphoma: results of a prospective randomized trial of the German Low Grade Lymphoma Study Group (GLSG). J Clin Oncol. 2005 Mar 20;23(9):1984-92. Epub 2005 Jan 24. [http://jco.ascopubs.org/content/23/9/1984.long link to original article] [ | + | # Lenz G, Dreyling M, Hoster E, Wörmann B, Dührsen U, Metzner B, Eimermacher H, Neubauer A, Wandt H, Steinhauer H, Martin S, Heidemann E, Aldaoud A, Parwaresch R, Hasford J, Unterhalt M, Hiddemann W. Immunochemotherapy with rituximab and cyclophosphamide, doxorubicin, vincristine, and prednisone significantly improves response and time to treatment failure, but not long-term outcome in patients with previously untreated mantle cell lymphoma: results of a prospective randomized trial of the German Low Grade Lymphoma Study Group (GLSG). J Clin Oncol. 2005 Mar 20;23(9):1984-92. Epub 2005 Jan 24. [http://jco.ascopubs.org/content/23/9/1984.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/15668467 PubMed] |
− | # Kluin-Nelemans HC, Hoster E, Hermine O, Walewski J, Trneny M, Geisler CH, Stilgenbauer S, Thieblemont C, Vehling-Kaiser U, Doorduijn JK, Coiffier B, Forstpointner R, Tilly H, Kanz L, Feugier P, Szymczyk M, Hallek M, Kremers S, Lepeu G, Sanhes L, Zijlstra JM, Bouabdallah R, Lugtenburg PJ, Macro M, Pfreundschuh M, Procházka V, Di Raimondo F, Ribrag V, Uppenkamp M, André M, Klapper W, Hiddemann W, Unterhalt M, Dreyling MH. Treatment of older patients with mantle-cell lymphoma. N Engl J Med. 2012 Aug 9;367(6):520-31. [http://www.nejm.org/doi/full/10.1056/NEJMoa1200920 link to original article] '''contains verified protocol''' [ | + | # Kluin-Nelemans HC, Hoster E, Hermine O, Walewski J, Trneny M, Geisler CH, Stilgenbauer S, Thieblemont C, Vehling-Kaiser U, Doorduijn JK, Coiffier B, Forstpointner R, Tilly H, Kanz L, Feugier P, Szymczyk M, Hallek M, Kremers S, Lepeu G, Sanhes L, Zijlstra JM, Bouabdallah R, Lugtenburg PJ, Macro M, Pfreundschuh M, Procházka V, Di Raimondo F, Ribrag V, Uppenkamp M, André M, Klapper W, Hiddemann W, Unterhalt M, Dreyling MH. Treatment of older patients with mantle-cell lymphoma. N Engl J Med. 2012 Aug 9;367(6):520-31. [http://www.nejm.org/doi/full/10.1056/NEJMoa1200920 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/22873532 PubMed] |
<!-- | <!-- | ||
# Mathias J Rummel, MD, PhD, Norbert Niederle, Georg Maschmeyer, Andre Banat, MD, MBA, Ulrich von Gruenhagen, MD, Christoph Losem, Gerhard Heil, Manfred Welslau, Christina Balser, Ulrich Kaiser, Harald Ballo, Eckhart Weidmann, Heinz A Duerk, Dorothea Kofahl-Krause, Fritz Roller, Juergen Barth, Dieter Hoelzer, MD, PhD, Axel Hinke and Wolfram Brugger. Bendamustine Plus Rituximab Is Superior in Respect of Progression Free Survival and CR Rate When Compared to CHOP Plus Rituximab as First-Line Treatment of Patients with Advanced Follicular, Indolent, and Mantle Cell Lymphomas: Final Results of a Randomized Phase III Study of the StiL (Study Group Indolent Lymphomas, Germany). 2009 ASH Annual Meeting abstract 405. [https://ash.confex.com/ash/2009/webprogram/Paper20178.html link to abstract] | # Mathias J Rummel, MD, PhD, Norbert Niederle, Georg Maschmeyer, Andre Banat, MD, MBA, Ulrich von Gruenhagen, MD, Christoph Losem, Gerhard Heil, Manfred Welslau, Christina Balser, Ulrich Kaiser, Harald Ballo, Eckhart Weidmann, Heinz A Duerk, Dorothea Kofahl-Krause, Fritz Roller, Juergen Barth, Dieter Hoelzer, MD, PhD, Axel Hinke and Wolfram Brugger. Bendamustine Plus Rituximab Is Superior in Respect of Progression Free Survival and CR Rate When Compared to CHOP Plus Rituximab as First-Line Treatment of Patients with Advanced Follicular, Indolent, and Mantle Cell Lymphomas: Final Results of a Randomized Phase III Study of the StiL (Study Group Indolent Lymphomas, Germany). 2009 ASH Annual Meeting abstract 405. [https://ash.confex.com/ash/2009/webprogram/Paper20178.html link to abstract] | ||
# Mathias J. Rummel, Norbert Niederle, Georg Maschmeyer, Andre G. Banat, Ulrich von Gruenhagen, Christoph Losem, Dorothea Kofahl-Krause, Gerhard Heil, Manfred Welslau, Christina Balser, Ulrich Kaiser, Eckhart Weidmann, Heinz A. Duerk, Harald Ballo, Martina Stauch, Juergen Barth, Axel Hinke, Wolfram Brugger, Study Group Indolent Lymphomas (StiL). Bendamustine plus rituximab (B-R) versus CHOP plus rituximab (CHOP-R) as first-line treatment in patients with indolent and mantle cell lymphomas (MCL): Updated results from the StiL NHL1 study. 2012 ASCO Annual Meeting abstract 3. [http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview==abst_detail_view&confID==114&abstractID==95807 link to abstract] [http://www.ascopost.com/issues/july-1-2012/german-study-finds-bendamustine-improves-progression-free-survival-in-patients-with-non-hodgkin-lymphoma.aspx ASCO Post article] [http://www.asco.org/ASCOv2/MultiMedia/Virtual%20Meeting?&vmview==vm_session_presentations_view&confID==114&sessionID==4807 ASCO plenary session video] --> | # Mathias J. Rummel, Norbert Niederle, Georg Maschmeyer, Andre G. Banat, Ulrich von Gruenhagen, Christoph Losem, Dorothea Kofahl-Krause, Gerhard Heil, Manfred Welslau, Christina Balser, Ulrich Kaiser, Eckhart Weidmann, Heinz A. Duerk, Harald Ballo, Martina Stauch, Juergen Barth, Axel Hinke, Wolfram Brugger, Study Group Indolent Lymphomas (StiL). Bendamustine plus rituximab (B-R) versus CHOP plus rituximab (CHOP-R) as first-line treatment in patients with indolent and mantle cell lymphomas (MCL): Updated results from the StiL NHL1 study. 2012 ASCO Annual Meeting abstract 3. [http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview==abst_detail_view&confID==114&abstractID==95807 link to abstract] [http://www.ascopost.com/issues/july-1-2012/german-study-finds-bendamustine-improves-progression-free-survival-in-patients-with-non-hodgkin-lymphoma.aspx ASCO Post article] [http://www.asco.org/ASCOv2/MultiMedia/Virtual%20Meeting?&vmview==vm_session_presentations_view&confID==114&sessionID==4807 ASCO plenary session video] --> | ||
− | # Rummel MJ, Niederle N, Maschmeyer G, Banat GA, von Grünhagen U, Losem C, Kofahl-Krause D, Heil G, Welslau M, Balser C, Kaiser U, Weidmann E, Dürk H, Ballo H, Stauch M, Roller F, Barth J, Hoelzer D, Hinke A, Brugger W; on behalf of the Study group indolent Lymphomas (StiL). Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial. Lancet. 2013 Apr 6;381(9873):1203-10. Epub 2013 Feb 20. Erratum in: Lancet. 2013 Apr 6;381(9873):1184. [http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2961763-2/fulltext link to original article] '''contains verified protocol''' [ | + | # Rummel MJ, Niederle N, Maschmeyer G, Banat GA, von Grünhagen U, Losem C, Kofahl-Krause D, Heil G, Welslau M, Balser C, Kaiser U, Weidmann E, Dürk H, Ballo H, Stauch M, Roller F, Barth J, Hoelzer D, Hinke A, Brugger W; on behalf of the Study group indolent Lymphomas (StiL). Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial. Lancet. 2013 Apr 6;381(9873):1203-10. Epub 2013 Feb 20. Erratum in: Lancet. 2013 Apr 6;381(9873):1184. [http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2961763-2/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23433739 PubMed] |
− | ## '''Update: Abstract:''' Mathias J. Rummel, MD, Georg Maschmeyer, MD, Arnold Ganser, Andrea Heider, PhD, Ulrich von Grünhagen, MD, PhD5, Christoph Losem, Gerhard Heil, MD, Manfred Welslau, Christina Balser, MD, Ulrich Kaiser, MD, Eckhart Weidmann, Heinz Dürk, MD, Hans Peter Böck, Martina Beate Stauch, MD, Jürgen Barth, Wolfgang Blau, MD, Alexander Burchardt, MD, Frank Kauff, PhD, Axel Hinke, PhD and Wolfram Brugger, MD. Bendamustine Plus Rituximab (B-R) Versus CHOP Plus Rituximab (CHOP-R) As First-Line Treatment in Patients with Indolent and Mantle Cell Lymphomas (MCL) – 7 Year Updated Results from the StiL NHL1 Study. | + | ## '''Update: Abstract:''' Mathias J. Rummel, MD, Georg Maschmeyer, MD, Arnold Ganser, Andrea Heider, PhD, Ulrich von Grünhagen, MD, PhD5, Christoph Losem, Gerhard Heil, MD, Manfred Welslau, Christina Balser, MD, Ulrich Kaiser, MD, Eckhart Weidmann, Heinz Dürk, MD, Hans Peter Böck, Martina Beate Stauch, MD, Jürgen Barth, Wolfgang Blau, MD, Alexander Burchardt, MD, Frank Kauff, PhD, Axel Hinke, PhD and Wolfram Brugger, MD. Bendamustine Plus Rituximab (B-R) Versus CHOP Plus Rituximab (CHOP-R) As First-Line Treatment in Patients with Indolent and Mantle Cell Lymphomas (MCL) – 7 Year Updated Results from the StiL NHL1 Study. Blood 2014 124:4407. [http://www.bloodjournal.org/content/124/21/4407 link to abstract] |
<!-- # Ian Flinn et al. An Open-Label, Randomized Study of Bendamustine and Rituximab (BR) Compared with Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in First-Line Treatment of Patients with Advanced Indolent Non-Hodgkin’s Lymphoma (NHL) or Mantle Cell Lymphoma (MCL): The Bright Study. 2012 ASH Annual Meeting abstract 902. [https://ash.confex.com/ash/2012/webprogram/Paper51442.html link to abstract] --> | <!-- # Ian Flinn et al. An Open-Label, Randomized Study of Bendamustine and Rituximab (BR) Compared with Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in First-Line Treatment of Patients with Advanced Indolent Non-Hodgkin’s Lymphoma (NHL) or Mantle Cell Lymphoma (MCL): The Bright Study. 2012 ASH Annual Meeting abstract 902. [https://ash.confex.com/ash/2012/webprogram/Paper51442.html link to abstract] --> | ||
− | # Flinn IW, van der Jagt R, Kahl BS, Wood P, Hawkins TE, Macdonald D, Hertzberg M, Kwan YL, Simpson D, Craig M, Kolibaba K, Issa S, Clementi R, Hallman DM, Munteanu M, Chen L, Burke JM. Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study. Blood. 2014 May 8;123(19):2944-52. Epub 2014 Mar 3. [http://bloodjournal.org/content/123/19/2944.long link to original article] '''contains verified protocol''' [ | + | # Flinn IW, van der Jagt R, Kahl BS, Wood P, Hawkins TE, Macdonald D, Hertzberg M, Kwan YL, Simpson D, Craig M, Kolibaba K, Issa S, Clementi R, Hallman DM, Munteanu M, Chen L, Burke JM. Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study. Blood. 2014 May 8;123(19):2944-52. Epub 2014 Mar 3. [http://www.bloodjournal.org/content/123/19/2944.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/24591201 PubMed] |
<!-- # '''Abstract:''' Franco Cavalli, Brendan Rooney, Lixia Pei, Helgi Van De Velde, Tadeusz Robak, on behalf of the LYM-3002 Investigators. Randomized phase 3 study of rituximab, cyclophosphamide, doxorubicin, and prednisone plus vincristine (R-CHOP) or bortezomib (VR-CAP) in newly diagnosed mantle cell lymphoma (MCL) patients (pts) ineligible for bone marrow transplantation (BMT). 2014 ASCO Annual Meeting abstract 8500. [http://meetinglibrary.asco.org/content/129206-144 link to abstract] --> | <!-- # '''Abstract:''' Franco Cavalli, Brendan Rooney, Lixia Pei, Helgi Van De Velde, Tadeusz Robak, on behalf of the LYM-3002 Investigators. Randomized phase 3 study of rituximab, cyclophosphamide, doxorubicin, and prednisone plus vincristine (R-CHOP) or bortezomib (VR-CAP) in newly diagnosed mantle cell lymphoma (MCL) patients (pts) ineligible for bone marrow transplantation (BMT). 2014 ASCO Annual Meeting abstract 8500. [http://meetinglibrary.asco.org/content/129206-144 link to abstract] --> | ||
− | # Robak T, Huang H, Jin J, Zhu J, Liu T, Samoilova O, Pylypenko H, Verhoef G, Siritanaratkul N, Osmanov E, Alexeeva J, Pereira J, Drach J, Mayer J, Hong X, Okamoto R, Pei L, Rooney B, van de Velde H, Cavalli F; the LYM-3002 Investigators. Bortezomib-Based Therapy for Newly Diagnosed Mantle-Cell Lymphoma. N Engl J Med. 2015 Mar 5;372(10):944-953. [http://www.nejm.org/doi/full/10.1056/NEJMoa1412096 link to original article] '''contains verified protocol''' [ | + | # Robak T, Huang H, Jin J, Zhu J, Liu T, Samoilova O, Pylypenko H, Verhoef G, Siritanaratkul N, Osmanov E, Alexeeva J, Pereira J, Drach J, Mayer J, Hong X, Okamoto R, Pei L, Rooney B, van de Velde H, Cavalli F; the LYM-3002 Investigators. Bortezomib-Based Therapy for Newly Diagnosed Mantle-Cell Lymphoma. N Engl J Med. 2015 Mar 5;372(10):944-953. [http://www.nejm.org/doi/full/10.1056/NEJMoa1412096 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/25738670 PubMed] |
# Hermine O, Hoster E, Walewski J, Bosly A, Stilgenbauer S, Thieblemont C, Szymczyk M, Bouabdallah R, Kneba M, Hallek M, Salles G, Feugier P, Ribrag V, Birkmann J, Forstpointner R, Haioun C, Hänel M, Casasnovas RO, Finke J, Peter N, Bouabdallah K, Sebban C, Fischer T, Dührsen U, Metzner B, Maschmeyer G, Kanz L, Schmidt C, Delarue R, Brousse N, Klapper W, Macintyre E, Delfau-Larue MH, Pott C, Hiddemann W, Unterhalt M, Dreyling M; European Mantle Cell Lymphoma Network. Addition of high-dose cytarabine to immunochemotherapy before autologous stem-cell transplantation in patients aged 65 years or younger with mantle cell lymphoma (MCL Younger): a randomised, open-label, phase 3 trial of the European Mantle Cell Lymphoma Network. Lancet. 2016 Aug 6;388(10044):565-75. Epub 2016 Jun 14. [http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)00739-X/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/27313086 PubMed] | # Hermine O, Hoster E, Walewski J, Bosly A, Stilgenbauer S, Thieblemont C, Szymczyk M, Bouabdallah R, Kneba M, Hallek M, Salles G, Feugier P, Ribrag V, Birkmann J, Forstpointner R, Haioun C, Hänel M, Casasnovas RO, Finke J, Peter N, Bouabdallah K, Sebban C, Fischer T, Dührsen U, Metzner B, Maschmeyer G, Kanz L, Schmidt C, Delarue R, Brousse N, Klapper W, Macintyre E, Delfau-Larue MH, Pott C, Hiddemann W, Unterhalt M, Dreyling M; European Mantle Cell Lymphoma Network. Addition of high-dose cytarabine to immunochemotherapy before autologous stem-cell transplantation in patients aged 65 years or younger with mantle cell lymphoma (MCL Younger): a randomised, open-label, phase 3 trial of the European Mantle Cell Lymphoma Network. Lancet. 2016 Aug 6;388(10044):565-75. Epub 2016 Jun 14. [http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)00739-X/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/27313086 PubMed] | ||
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|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|'''Comparator''' | |'''Comparator''' | ||
+ | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
|[http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)00739-X/fulltext Hermine et al. 2016 (MCL Younger)] | |[http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)00739-X/fulltext Hermine et al. 2016 (MCL Younger)] | ||
|style="background-color:#00cd00"|Phase III | |style="background-color:#00cd00"|Phase III | ||
|[[#R-CHOP|R-CHOP]] | |[[#R-CHOP|R-CHOP]] | ||
+ | |style="background-color:#00cd00"|Seems to have superior TTTF | ||
|- | |- | ||
|} | |} | ||
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|[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
− | + | |[http://www.bloodjournal.org/content/123/19/2944.long Flinn et al. 2014 (BRIGHT)] | |
− | | | + | |style="background-color:#00cd00"|Phase III |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|[[Mantle_cell_lymphoma#BR|BR]] | |[[Mantle_cell_lymphoma#BR|BR]] | ||
− | | | + | |style="background-color:#eeee00"|Seems non-inferior |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
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|} | |} | ||
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===References=== | ===References=== | ||
<!-- # '''Abstract:''' Ian Flinn et al. An Open-Label, Randomized Study of Bendamustine and Rituximab (BR) Compared with Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in First-Line Treatment of Patients with Advanced Indolent Non-Hodgkin’s Lymphoma (NHL) or Mantle Cell Lymphoma (MCL): The Bright Study. 2012 ASH Annual Meeting abstract 902. [https://ash.confex.com/ash/2012/webprogram/Paper51442.html link to abstract] --> | <!-- # '''Abstract:''' Ian Flinn et al. An Open-Label, Randomized Study of Bendamustine and Rituximab (BR) Compared with Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in First-Line Treatment of Patients with Advanced Indolent Non-Hodgkin’s Lymphoma (NHL) or Mantle Cell Lymphoma (MCL): The Bright Study. 2012 ASH Annual Meeting abstract 902. [https://ash.confex.com/ash/2012/webprogram/Paper51442.html link to abstract] --> | ||
− | # Flinn IW, van der Jagt R, Kahl BS, Wood P, Hawkins TE, Macdonald D, Hertzberg M, Kwan YL, Simpson D, Craig M, Kolibaba K, Issa S, Clementi R, Hallman DM, Munteanu M, Chen L, Burke JM. Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study. Blood. 2014 May 8;123(19):2944-52. Epub 2014 Mar 3. [http://bloodjournal.org/content/123/19/2944.long link to original article] '''contains verified protocol''' [ | + | # Flinn IW, van der Jagt R, Kahl BS, Wood P, Hawkins TE, Macdonald D, Hertzberg M, Kwan YL, Simpson D, Craig M, Kolibaba K, Issa S, Clementi R, Hallman DM, Munteanu M, Chen L, Burke JM. Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study. Blood. 2014 May 8;123(19):2944-52. Epub 2014 Mar 3. [http://www.bloodjournal.org/content/123/19/2944.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/24591201 PubMed] |
==VR-CAP {{#subobject:de09c8|Regimen=1}}== | ==VR-CAP {{#subobject:de09c8|Regimen=1}}== | ||
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|- | |- | ||
|[http://www.nejm.org/doi/full/10.1056/NEJMoa1412096 Robak et al. 2015 (LYM-3002)] | |[http://www.nejm.org/doi/full/10.1056/NEJMoa1412096 Robak et al. 2015 (LYM-3002)] | ||
− | | | + | |style="background-color:#00cd00"|Phase III |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|[[Mantle_cell_lymphoma#R-CHOP|R-CHOP]] | |[[Mantle_cell_lymphoma#R-CHOP|R-CHOP]] | ||
− | | | + | |style="background-color:#00cd00"|Superior PFS |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
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===References=== | ===References=== | ||
<!-- # '''Abstract:''' Franco Cavalli, Brendan Rooney, Lixia Pei, Helgi Van De Velde, Tadeusz Robak, on behalf of the LYM-3002 Investigators. Randomized phase 3 study of rituximab, cyclophosphamide, doxorubicin, and prednisone plus vincristine (R-CHOP) or bortezomib (VR-CAP) in newly diagnosed mantle cell lymphoma (MCL) patients (pts) ineligible for bone marrow transplantation (BMT). 2014 ASCO Annual Meeting abstract 8500. [http://meetinglibrary.asco.org/content/129206-144 link to abstract] --> | <!-- # '''Abstract:''' Franco Cavalli, Brendan Rooney, Lixia Pei, Helgi Van De Velde, Tadeusz Robak, on behalf of the LYM-3002 Investigators. Randomized phase 3 study of rituximab, cyclophosphamide, doxorubicin, and prednisone plus vincristine (R-CHOP) or bortezomib (VR-CAP) in newly diagnosed mantle cell lymphoma (MCL) patients (pts) ineligible for bone marrow transplantation (BMT). 2014 ASCO Annual Meeting abstract 8500. [http://meetinglibrary.asco.org/content/129206-144 link to abstract] --> | ||
− | # Robak T, Huang H, Jin J, Zhu J, Liu T, Samoilova O, Pylypenko H, Verhoef G, Siritanaratkul N, Osmanov E, Alexeeva J, Pereira J, Drach J, Mayer J, Hong X, Okamoto R, Pei L, Rooney B, van de Velde H, Cavalli F; the LYM-3002 Investigators. Bortezomib-Based Therapy for Newly Diagnosed Mantle-Cell Lymphoma. N Engl J Med. 2015 Mar 5;372(10):944-953. [http://www.nejm.org/doi/full/10.1056/NEJMoa1412096 link to original article] '''contains verified protocol''' [ | + | # Robak T, Huang H, Jin J, Zhu J, Liu T, Samoilova O, Pylypenko H, Verhoef G, Siritanaratkul N, Osmanov E, Alexeeva J, Pereira J, Drach J, Mayer J, Hong X, Okamoto R, Pei L, Rooney B, van de Velde H, Cavalli F; the LYM-3002 Investigators. Bortezomib-Based Therapy for Newly Diagnosed Mantle-Cell Lymphoma. N Engl J Med. 2015 Mar 5;372(10):944-953. [http://www.nejm.org/doi/full/10.1056/NEJMoa1412096 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/25738670 PubMed] |
=Untreated, non-randomized or retrospective data= | =Untreated, non-randomized or retrospective data= | ||
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|- | |- | ||
|[http://jco.ascopubs.org/content/27/36/6101.long Damon et al. 2009] | |[http://jco.ascopubs.org/content/27/36/6101.long Damon et al. 2009] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
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===References=== | ===References=== | ||
− | # Damon LE, Johnson JL, Niedzwiecki D, Cheson BD, Hurd DD, Bartlett NL, Lacasce AS, Blum KA, Byrd JC, Kelly M, Stock W, Linker CA, Canellos GP. Immunochemotherapy and autologous stem-cell transplantation for untreated patients with mantle-cell lymphoma: CALGB 59909. J Clin Oncol. 2009 Dec 20;27(36):6101-8. Epub 2009 Nov 16. [http://jco.ascopubs.org/content/27/36/6101.long link to original article] '''contains protocol''' [ | + | # Damon LE, Johnson JL, Niedzwiecki D, Cheson BD, Hurd DD, Bartlett NL, Lacasce AS, Blum KA, Byrd JC, Kelly M, Stock W, Linker CA, Canellos GP. Immunochemotherapy and autologous stem-cell transplantation for untreated patients with mantle-cell lymphoma: CALGB 59909. J Clin Oncol. 2009 Dec 20;27(36):6101-8. Epub 2009 Nov 16. [http://jco.ascopubs.org/content/27/36/6101.long link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/19917845 PubMed] |
==Chlorambucil & Rituximab {{#subobject:f5fb55|Regimen=1}}== | ==Chlorambucil & Rituximab {{#subobject:f5fb55|Regimen=1}}== | ||
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|- | |- | ||
|[http://informahealthcare.com/doi/full/10.3109/10428194.2010.534518 Sachanas et al. 2011] | |[http://informahealthcare.com/doi/full/10.3109/10428194.2010.534518 Sachanas et al. 2011] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
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|} | |} | ||
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===References=== | ===References=== | ||
− | # Sachanas S, Pangalis GA, Vassilakopoulos TP, Korkolopoulou P, Kontopidou FN, Athanasoulia M, Yiakoumis X, Kalpadakis C, Georgiou G, Masouridis S, Moschogiannis M, Tsirkinidis P, Pappis V, Kokoris SI, Siakantaris MP, Panayiotidis P, Angelopoulou MK. Combination of rituximab with chlorambucil as first line treatment in patients with mantle cell lymphoma: a highly effective regimen. Leuk Lymphoma. 2011 Mar;52(3):387-93. Epub 2010 Dec 6. [http://informahealthcare.com/doi/full/10.3109/10428194.2010.534518 link to original article] '''contains verified protocol''' [ | + | # Sachanas S, Pangalis GA, Vassilakopoulos TP, Korkolopoulou P, Kontopidou FN, Athanasoulia M, Yiakoumis X, Kalpadakis C, Georgiou G, Masouridis S, Moschogiannis M, Tsirkinidis P, Pappis V, Kokoris SI, Siakantaris MP, Panayiotidis P, Angelopoulou MK. Combination of rituximab with chlorambucil as first line treatment in patients with mantle cell lymphoma: a highly effective regimen. Leuk Lymphoma. 2011 Mar;52(3):387-93. Epub 2010 Dec 6. [http://informahealthcare.com/doi/full/10.3109/10428194.2010.534518 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/21133713 PubMed] |
==Cladribine (Leustatin) {{#subobject:f729d6|Regimen=1}}== | ==Cladribine (Leustatin) {{#subobject:f729d6|Regimen=1}}== | ||
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|- | |- | ||
|[http://onlinelibrary.wiley.com/doi/10.1002/cncr.23537/full Inwards et al. 2008 (NCCTG 95-80-53)] | |[http://onlinelibrary.wiley.com/doi/10.1002/cncr.23537/full Inwards et al. 2008 (NCCTG 95-80-53)] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
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|} | |} | ||
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===References=== | ===References=== | ||
− | # Inwards DJ, Fishkin PA, Hillman DW, Brown DW, Ansell SM, Kurtin PJ, Fonseca R, Morton RF, Veeder MH, Witzig TE. Long-term results of the treatment of patients with mantle cell lymphoma with cladribine (2-CDA) alone (95-80-53) or 2-CDA and rituximab (N0189) in the North Central Cancer Treatment Group. Cancer. 2008 Jul 1;113(1):108-16. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.23537/full link to original article] '''contains verified protocol''' [ | + | # Inwards DJ, Fishkin PA, Hillman DW, Brown DW, Ansell SM, Kurtin PJ, Fonseca R, Morton RF, Veeder MH, Witzig TE. Long-term results of the treatment of patients with mantle cell lymphoma with cladribine (2-CDA) alone (95-80-53) or 2-CDA and rituximab (N0189) in the North Central Cancer Treatment Group. Cancer. 2008 Jul 1;113(1):108-16. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.23537/full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/18470909 PubMed] |
==Cladribine & Rituximab {{#subobject:9dabc7|Regimen=1}}== | ==Cladribine & Rituximab {{#subobject:9dabc7|Regimen=1}}== | ||
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|- | |- | ||
|[http://onlinelibrary.wiley.com/doi/10.1002/cncr.23537/full Inwards et al. 2008 (NCCTG N0189)] | |[http://onlinelibrary.wiley.com/doi/10.1002/cncr.23537/full Inwards et al. 2008 (NCCTG N0189)] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
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|} | |} | ||
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===References=== | ===References=== | ||
− | # Inwards DJ, Fishkin PA, Hillman DW, Brown DW, Ansell SM, Kurtin PJ, Fonseca R, Morton RF, Veeder MH, Witzig TE. Long-term results of the treatment of patients with mantle cell lymphoma with cladribine (2-CDA) alone (95-80-53) or 2-CDA and rituximab (N0189) in the North Central Cancer Treatment Group. Cancer. 2008 Jul 1;113(1):108-16. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.23537/full link to original article] '''contains verified protocol''' [ | + | # Inwards DJ, Fishkin PA, Hillman DW, Brown DW, Ansell SM, Kurtin PJ, Fonseca R, Morton RF, Veeder MH, Witzig TE. Long-term results of the treatment of patients with mantle cell lymphoma with cladribine (2-CDA) alone (95-80-53) or 2-CDA and rituximab (N0189) in the North Central Cancer Treatment Group. Cancer. 2008 Jul 1;113(1):108-16. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.23537/full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/18470909 PubMed] |
==Lenalidomide & Rituximab {{#subobject:517896|Regimen=1}}== | ==Lenalidomide & Rituximab {{#subobject:517896|Regimen=1}}== | ||
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|[http://www.nejm.org/doi/full/10.1056/NEJMoa1505237 Ruan et al. 2015] | |[http://www.nejm.org/doi/full/10.1056/NEJMoa1505237 Ruan et al. 2015] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
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|} | |} | ||
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===References=== | ===References=== | ||
− | <!-- # '''Abstract:''' Jia Ruan, Peter Martin, Bijal D. Shah, Stephen J. Schuster, Sonali M. Smith, Richard R. Furman, Paul Christos, Amelyn Rodriguez, Paige Wolstencroft, Jakub Svoboda, Alison Bender, Jessica Lewis, Morton Coleman, John P. Leonard. Combination Biologic Therapy Without Chemotherapy As Initial Treatment For Mantle Cell Lymphoma: Multi-Center Phase II Study Of Lenalidomide Plus Rituximab. Blood Nov 2013,122(21)247 [http://bloodjournal | + | <!-- # '''Abstract:''' Jia Ruan, Peter Martin, Bijal D. Shah, Stephen J. Schuster, Sonali M. Smith, Richard R. Furman, Paul Christos, Amelyn Rodriguez, Paige Wolstencroft, Jakub Svoboda, Alison Bender, Jessica Lewis, Morton Coleman, John P. Leonard. Combination Biologic Therapy Without Chemotherapy As Initial Treatment For Mantle Cell Lymphoma: Multi-Center Phase II Study Of Lenalidomide Plus Rituximab. Blood Nov 2013,122(21)247 [http://www.bloodjournal.org/content/122/21/247 link to abstract] |
## '''Update Abstract:''' Jia Ruan, MD, PhD, Peter Martin, MD, Bijal D. Shah, MD, Stephen J. Schuster, MD, Sonali M. Smith, MD, Richard R Furman, MD, Paul Christos, DrPH, Amelyn Rodriguez, RN, Louisa Drake, Jakub Svoboda, MD, Jessica Lewis, PA-C, Orel Katz, PA-C, Morton Coleman, MD and John P. Leonard, MD. Sustained Remission with the Combination Biologic Doublet of Lenalidomide Plus Rituximab As Initial Treatment for Mantle Cell Lymphoma: A Multi-Center Phase II Study Report. ASH Annual Meeting 2014 Abstract 625 [https://ash.confex.com/ash/2014/webprogram/Paper73280.html link to abstract] --> | ## '''Update Abstract:''' Jia Ruan, MD, PhD, Peter Martin, MD, Bijal D. Shah, MD, Stephen J. Schuster, MD, Sonali M. Smith, MD, Richard R Furman, MD, Paul Christos, DrPH, Amelyn Rodriguez, RN, Louisa Drake, Jakub Svoboda, MD, Jessica Lewis, PA-C, Orel Katz, PA-C, Morton Coleman, MD and John P. Leonard, MD. Sustained Remission with the Combination Biologic Doublet of Lenalidomide Plus Rituximab As Initial Treatment for Mantle Cell Lymphoma: A Multi-Center Phase II Study Report. ASH Annual Meeting 2014 Abstract 625 [https://ash.confex.com/ash/2014/webprogram/Paper73280.html link to abstract] --> | ||
− | # Ruan J, Martin P, Shah B, Schuster SJ, Smith SM, Furman RR, Christos P, Rodriguez A, Svoboda J, Lewis J, Katz O, Coleman M, Leonard JP. Lenalidomide plus Rituximab as Initial Treatment for Mantle-Cell Lymphoma. N Engl J Med. 2015 Nov 5;373(19):1835-44. [http://www.nejm.org/doi/full/10.1056/NEJMoa1505237 link to original article] '''contains verified protocol''' [ | + | # Ruan J, Martin P, Shah B, Schuster SJ, Smith SM, Furman RR, Christos P, Rodriguez A, Svoboda J, Lewis J, Katz O, Coleman M, Leonard JP. Lenalidomide plus Rituximab as Initial Treatment for Mantle-Cell Lymphoma. N Engl J Med. 2015 Nov 5;373(19):1835-44. [http://www.nejm.org/doi/full/10.1056/NEJMoa1505237 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/26535512 PubMed] |
==Nordic Regimen (maxi-CHOP, HiDAC, Rituximab) {{#subobject:360f9d|Regimen=1}}== | ==Nordic Regimen (maxi-CHOP, HiDAC, Rituximab) {{#subobject:360f9d|Regimen=1}}== | ||
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|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|- | |- | ||
− | |[http://bloodjournal | + | |[http://www.bloodjournal.org/content/112/7/2687.long Geisler et al. 2008] |
− | | | + | |style="background-color:#eeee00"|Phase II |
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|} | |} | ||
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===References=== | ===References=== | ||
− | # Geisler CH, Kolstad A, Laurell A, Andersen NS, Pedersen LB, Jerkeman M, Eriksson M, Nordström M, Kimby E, Boesen AM, Kuittinen O, Lauritzsen GF, Nilsson-Ehle H, Ralfkiaer E, Akerman M, Ehinger M, Sundström C, Langholm R, Delabie J, Karjalainen-Lindsberg ML, Brown P, Elonen E; Nordic Lymphoma Group. Long-term progression-free survival of mantle cell lymphoma after intensive front-line immunochemotherapy with in vivo-purged stem cell rescue: a nonrandomized phase 2 multicenter study by the Nordic Lymphoma Group. Blood. 2008 Oct 1;112(7):2687-93. Epub 2008 Jul 14. [http://bloodjournal | + | # Geisler CH, Kolstad A, Laurell A, Andersen NS, Pedersen LB, Jerkeman M, Eriksson M, Nordström M, Kimby E, Boesen AM, Kuittinen O, Lauritzsen GF, Nilsson-Ehle H, Ralfkiaer E, Akerman M, Ehinger M, Sundström C, Langholm R, Delabie J, Karjalainen-Lindsberg ML, Brown P, Elonen E; Nordic Lymphoma Group. Long-term progression-free survival of mantle cell lymphoma after intensive front-line immunochemotherapy with in vivo-purged stem cell rescue: a nonrandomized phase 2 multicenter study by the Nordic Lymphoma Group. Blood. 2008 Oct 1;112(7):2687-93. Epub 2008 Jul 14. [http://www.bloodjournal.org/content/112/7/2687.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/18625886 PubMed] |
==Observation== | ==Observation== | ||
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|- | |- | ||
|[http://jco.ascopubs.org/content/27/8/1209.long Martin et al. 2009] | |[http://jco.ascopubs.org/content/27/8/1209.long Martin et al. 2009] | ||
− | | | + | |style="background-color:#ff0000"|Retrospective |
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|} | |} | ||
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===References=== | ===References=== | ||
− | # '''Retrospective:''' Martin P, Chadburn A, Christos P, Weil K, Furman RR, Ruan J, Elstrom R, Niesvizky R, Ely S, Diliberto M, Melnick A, Knowles DM, Chen-Kiang S, Coleman M, Leonard JP. Outcome of deferred initial therapy in mantle-cell lymphoma. J Clin Oncol. 2009 Mar 10;27(8):1209-13. [http://jco.ascopubs.org/content/27/8/1209.long link to original article] [ | + | # '''Retrospective:''' Martin P, Chadburn A, Christos P, Weil K, Furman RR, Ruan J, Elstrom R, Niesvizky R, Ely S, Diliberto M, Melnick A, Knowles DM, Chen-Kiang S, Coleman M, Leonard JP. Outcome of deferred initial therapy in mantle-cell lymphoma. J Clin Oncol. 2009 Mar 10;27(8):1209-13. [http://jco.ascopubs.org/content/27/8/1209.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/19188674 PubMed] |
− | # '''Retrospective:''' Cohen JB, Han X, Jemal A, Ward EM, Flowers CR. Deferred therapy is associated with improved overall survival in patients with newly diagnosed mantle cell lymphoma. Cancer. 2016 Aug 1;122(15):2356-63. Epub 2016 May 6. [http://onlinelibrary.wiley.com/wol1/doi/10.1002/cncr.30068/full link to original article] [ | + | # '''Retrospective:''' Cohen JB, Han X, Jemal A, Ward EM, Flowers CR. Deferred therapy is associated with improved overall survival in patients with newly diagnosed mantle cell lymphoma. Cancer. 2016 Aug 1;122(15):2356-63. Epub 2016 May 6. [http://onlinelibrary.wiley.com/wol1/doi/10.1002/cncr.30068/full link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/27153197 PubMed] |
==R-BAC; RB/RC {{#subobject:3d5221|Regimen=1}}== | ==R-BAC; RB/RC {{#subobject:3d5221|Regimen=1}}== | ||
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|- | |- | ||
|[http://onlinelibrary.wiley.com/doi/10.1111/bjh.13929/full Armand et al. 2016] | |[http://onlinelibrary.wiley.com/doi/10.1111/bjh.13929/full Armand et al. 2016] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
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|[http://jco.ascopubs.org/content/31/11/1442.full Visco et al. 2013] | |[http://jco.ascopubs.org/content/31/11/1442.full Visco et al. 2013] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
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===References=== | ===References=== | ||
− | # Visco C, Finotto S, Zambello R, Paolini R, Menin A, Zanotti R, Zaja F, Semenzato G, Pizzolo G, D'Amore ES, Rodeghiero F. Combination of Rituximab, Bendamustine, and Cytarabine for Patients With Mantle-Cell Non-Hodgkin Lymphoma Ineligible for Intensive Regimens or Autologous Transplantation. J Clin Oncol. 2013 Apr 10;31(11):1442-9. Epub 2013 Feb 11. [http://jco.ascopubs.org/content/31/11/1442.full link to original article] '''contains verified protocol''' [ | + | # Visco C, Finotto S, Zambello R, Paolini R, Menin A, Zanotti R, Zaja F, Semenzato G, Pizzolo G, D'Amore ES, Rodeghiero F. Combination of Rituximab, Bendamustine, and Cytarabine for Patients With Mantle-Cell Non-Hodgkin Lymphoma Ineligible for Intensive Regimens or Autologous Transplantation. J Clin Oncol. 2013 Apr 10;31(11):1442-9. Epub 2013 Feb 11. [http://jco.ascopubs.org/content/31/11/1442.full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23401442 PubMed] |
− | # Armand P, Redd R, Bsat J, Mayuram S, Giardino A, Fisher DC, LaCasce AS, Jacobson C, Davids MS, Brown JR, Weng L, Wilkins J, Faham M, Freedman AS, Joyce R, Jacobsen ED. A phase 2 study of Rituximab-Bendamustine and Rituximab-Cytarabine for transplant-eligible patients with mantle cell lymphoma. Br J Haematol. 2016 Apr;173(1):89-95. Epub 2016 Jan 5. [http://onlinelibrary.wiley.com/doi/10.1111/bjh.13929/full link to original article] [ | + | # Armand P, Redd R, Bsat J, Mayuram S, Giardino A, Fisher DC, LaCasce AS, Jacobson C, Davids MS, Brown JR, Weng L, Wilkins J, Faham M, Freedman AS, Joyce R, Jacobsen ED. A phase 2 study of Rituximab-Bendamustine and Rituximab-Cytarabine for transplant-eligible patients with mantle cell lymphoma. Br J Haematol. 2016 Apr;173(1):89-95. Epub 2016 Jan 5. [http://onlinelibrary.wiley.com/doi/10.1111/bjh.13929/full link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/26729345 PubMed] |
==R-CHOP {{#subobject:69026f|Regimen=1}}== | ==R-CHOP {{#subobject:69026f|Regimen=1}}== | ||
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|[http://jco.ascopubs.org/content/30/25/3119.long Smith et al. 2012 (ECOG E1499)] | |[http://jco.ascopubs.org/content/30/25/3119.long Smith et al. 2012 (ECOG E1499)] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
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===References=== | ===References=== | ||
<!-- Presented in part at the 42nd Annual Meeting of the American Society of Clinical Oncology, Atlanta, GA, June 2-6, 2006; the 47th Annual Meeting of the American Society of Hematology, Atlanta, GA, December 8-11, 2007; and the 11th International Conference on Malignant Lymphoma, Lugano, Switzerland, June 15-18, 2011. --> | <!-- Presented in part at the 42nd Annual Meeting of the American Society of Clinical Oncology, Atlanta, GA, June 2-6, 2006; the 47th Annual Meeting of the American Society of Hematology, Atlanta, GA, December 8-11, 2007; and the 11th International Conference on Malignant Lymphoma, Lugano, Switzerland, June 15-18, 2011. --> | ||
− | # Smith MR, Li H, Gordon L, Gascoyne RD, Paietta E, Forero-Torres A, Kahl BS, Advani R, Hong F, Horning SJ. Phase II study of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone immunochemotherapy followed by yttrium-90-ibritumomab tiuxetan in untreated mantle-cell lymphoma: Eastern Cooperative Oncology Group Study E1499. J Clin Oncol. 2012 Sep 1;30(25):3119-26. Epub 2012 Jul 30. [http://jco.ascopubs.org/content/30/25/3119.long link to original article] '''contains verified protocol''' [ | + | # Smith MR, Li H, Gordon L, Gascoyne RD, Paietta E, Forero-Torres A, Kahl BS, Advani R, Hong F, Horning SJ. Phase II study of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone immunochemotherapy followed by yttrium-90-ibritumomab tiuxetan in untreated mantle-cell lymphoma: Eastern Cooperative Oncology Group Study E1499. J Clin Oncol. 2012 Sep 1;30(25):3119-26. Epub 2012 Jul 30. [http://jco.ascopubs.org/content/30/25/3119.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/22851557 PubMed] |
==R-CHOP -> HiDAC-R {{#subobject:3a58eb|Regimen=1}}== | ==R-CHOP -> HiDAC-R {{#subobject:3a58eb|Regimen=1}}== | ||
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|[http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2008.07498.x/full Van't Veer et al. 2008 (HOVON 45)] | |[http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2008.07498.x/full Van't Veer et al. 2008 (HOVON 45)] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
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===References=== | ===References=== | ||
− | # Van't Veer MB, de Jong D, MacKenzie M, Kluin-Nelemans HC, van Oers MH, Zijlstra J, Hagenbeek A, van Putten WL. High-dose Ara-C and beam with autograft rescue in R-CHOP responsive mantle cell lymphoma patients. Br J Haematol. 2009 Feb;144(4):524-30. Epub 2008 Nov 26. [http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2008.07498.x/full link to original article] '''contains verified protocol''' [ | + | # Van't Veer MB, de Jong D, MacKenzie M, Kluin-Nelemans HC, van Oers MH, Zijlstra J, Hagenbeek A, van Putten WL. High-dose Ara-C and beam with autograft rescue in R-CHOP responsive mantle cell lymphoma patients. Br J Haematol. 2009 Feb;144(4):524-30. Epub 2008 Nov 26. [http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2008.07498.x/full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/19036081 PubMed] |
==R-CHOP -> R-DHAP {{#subobject:ae6015|Regimen=1}}== | ==R-CHOP -> R-DHAP {{#subobject:ae6015|Regimen=1}}== | ||
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|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|- | |- | ||
− | |[http://bloodjournal | + | |[http://www.bloodjournal.org/content/121/1/48.full Delarue et al. 2012] |
− | | | + | |style="background-color:#eeee00"|Phase II |
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===References=== | ===References=== | ||
− | # Delarue R, Haioun C, Ribrag V, Brice P, Delmer A, Tilly H, Salles G, Van Hoof A, Casasnovas O, Brousse N, Lefrere F, Hermine O; for the Groupe d'Etude des Lymphomes de l'Adulte (GELA). CHOP and DHAP plus rituximab followed by autologous stem cell transplantation in mantle cell lymphoma: a phase 2 study from the Groupe d'Etude des Lymphomes de l'Adulte. Blood. 2013 Jan 3;121(1):48-53. Epub 2012 Jun 20. [http://bloodjournal | + | # Delarue R, Haioun C, Ribrag V, Brice P, Delmer A, Tilly H, Salles G, Van Hoof A, Casasnovas O, Brousse N, Lefrere F, Hermine O; for the Groupe d'Etude des Lymphomes de l'Adulte (GELA). CHOP and DHAP plus rituximab followed by autologous stem cell transplantation in mantle cell lymphoma: a phase 2 study from the Groupe d'Etude des Lymphomes de l'Adulte. Blood. 2013 Jan 3;121(1):48-53. Epub 2012 Jun 20. [http://www.bloodjournal.org/content/121/1/48.full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/22718839 PubMed] |
==R-DHAP {{#subobject:7bb19f|Regimen=1}}== | ==R-DHAP {{#subobject:7bb19f|Regimen=1}}== | ||
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|- | |- | ||
|[http://www.haematologica.org/content/91/3/425 de Guibert et al. 2006] | |[http://www.haematologica.org/content/91/3/425 de Guibert et al. 2006] | ||
− | | | + | |style="background-color:#ff0000"|Non-randomized, <20 pts |
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|- | |- | ||
− | |[ | + | |[http://www.bloodjournal.org/content/124/21/146 Le Gouill et al. 2014 (LyMa)] |
− | | | + | |style="background-color:#eeee00"|Non-randomized |
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===References=== | ===References=== | ||
− | # de Guibert S, Jaccard A, Bernard M, Turlure P, Bordessoule D, Lamy T. Rituximab and DHAP followed by intensive therapy with autologous stem-cell transplantation as first-line therapy for mantle cell lymphoma. Haematologica. 2006 Mar;91(3):425-6. [http://www.haematologica.org/content/91/3/425 link to original article] '''does not contain protocol''' [ | + | # de Guibert S, Jaccard A, Bernard M, Turlure P, Bordessoule D, Lamy T. Rituximab and DHAP followed by intensive therapy with autologous stem-cell transplantation as first-line therapy for mantle cell lymphoma. Haematologica. 2006 Mar;91(3):425-6. [http://www.haematologica.org/content/91/3/425 link to original article] '''does not contain protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/16531272 PubMed] |
− | # '''Abstract:''' Steven Le Gouill, MD, PhD, Catherine Thieblemont, MD, PhD, Lucie Oberic, Krimo Bouabdallah, MD, Emmanuel Gyan, MD, PhD, Gandhi Damaj, MD, Vincent Ribrag, MD, Serge Bologna, MD, Remy Gressin, MD, Olivier Casasnovas, MD, Corinne Haioun, MD, PhD, Philippe Solal-Celigny, MD, Herve Maisonneuve, MD, Eric Van Den Neste, MD, PhD, Anne Moreau, MD, Marie C Bene, Gilles Salles, MD PhD, Hervé Tilly, MD, PhD, Thierry Lamy, MD, PhD and Olivier Hermine, MD, PhD. Rituximab Maintenance Versus Wait and Watch after Four Courses of R-DHAP Followed By Autologous Stem Cell transplantation in Previously Untreated Young Patients with Mantle Cell Lymphoma: First Interim Analysis of the Phase III Prospective Lyma Trial, a Lysa Study. | + | # '''Abstract:''' Steven Le Gouill, MD, PhD, Catherine Thieblemont, MD, PhD, Lucie Oberic, Krimo Bouabdallah, MD, Emmanuel Gyan, MD, PhD, Gandhi Damaj, MD, Vincent Ribrag, MD, Serge Bologna, MD, Remy Gressin, MD, Olivier Casasnovas, MD, Corinne Haioun, MD, PhD, Philippe Solal-Celigny, MD, Herve Maisonneuve, MD, Eric Van Den Neste, MD, PhD, Anne Moreau, MD, Marie C Bene, Gilles Salles, MD PhD, Hervé Tilly, MD, PhD, Thierry Lamy, MD, PhD and Olivier Hermine, MD, PhD. Rituximab Maintenance Versus Wait and Watch after Four Courses of R-DHAP Followed By Autologous Stem Cell transplantation in Previously Untreated Young Patients with Mantle Cell Lymphoma: First Interim Analysis of the Phase III Prospective Lyma Trial, a Lysa Study. Blood 2014 124:146. [http://www.bloodjournal.org/content/124/21/146 link to abstract] |
==R-HyperCVAD/R-MA {{#subobject:a76238|Regimen=1}}== | ==R-HyperCVAD/R-MA {{#subobject:a76238|Regimen=1}}== | ||
Line 1,045: | Line 918: | ||
|- | |- | ||
|[http://jco.ascopubs.org/content/23/28/7013.long Romaguera et al. 2005] | |[http://jco.ascopubs.org/content/23/28/7013.long Romaguera et al. 2005] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|[http://onlinelibrary.wiley.com/doi/10.1002/cncr.23880/full Wang et al. 2008] | |[http://onlinelibrary.wiley.com/doi/10.1002/cncr.23880/full Wang et al. 2008] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|[http://annonc.oxfordjournals.org/content/24/6/1587.long Bernstein et al. 2013 (SWOG 0213)] | |[http://annonc.oxfordjournals.org/content/24/6/1587.long Bernstein et al. 2013 (SWOG 0213)] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background | ||
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|} | |} | ||
Line 1,113: | Line 971: | ||
===References=== | ===References=== | ||
− | # Romaguera JE, Fayad L, Rodriguez MA, Broglio KR, Hagemeister FB, Pro B, McLaughlin P, Younes A, Samaniego F, Goy A, Sarris AH, Dang NH, Wang M, Beasley V, Medeiros LJ, Katz RL, Gagneja H, Samuels BI, Smith TL, Cabanillas FF. High rate of durable remissions after treatment of newly diagnosed aggressive mantle-cell lymphoma with rituximab plus hyper-CVAD alternating with rituximab plus high-dose methotrexate and cytarabine. J Clin Oncol. 2005 Oct 1;23(28):7013-23. Epub 2005 Sep 6. [http://jco.ascopubs.org/content/23/28/7013.long link to original article] '''contains verified protocol''' [ | + | # Romaguera JE, Fayad L, Rodriguez MA, Broglio KR, Hagemeister FB, Pro B, McLaughlin P, Younes A, Samaniego F, Goy A, Sarris AH, Dang NH, Wang M, Beasley V, Medeiros LJ, Katz RL, Gagneja H, Samuels BI, Smith TL, Cabanillas FF. High rate of durable remissions after treatment of newly diagnosed aggressive mantle-cell lymphoma with rituximab plus hyper-CVAD alternating with rituximab plus high-dose methotrexate and cytarabine. J Clin Oncol. 2005 Oct 1;23(28):7013-23. Epub 2005 Sep 6. [http://jco.ascopubs.org/content/23/28/7013.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/16145068 PubMed] |
− | ## '''Update:''' Romaguera JE, Fayad LE, Feng L, Hartig K, Weaver P, Rodriguez MA, Hagemeister FB, Pro B, McLaughlin P, Younes A, Samaniego F, Goy A, Cabanillas F, Kantarjian H, Kwak L, Wang M. Ten-year follow-up after intense chemoimmunotherapy with Rituximab-HyperCVAD alternating with Rituximab-high dose methotrexate/cytarabine (R-MA) and without stem cell transplantation in patients with untreated aggressive mantle cell lymphoma. Br J Haematol. 2010 Jul;150(2):200-8. Epub 2010 May 26. Review. Erratum in: Br J Haematol.n 2010 Oct;151(1):111. [http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2010.08228.x/full link to original article] [ | + | ## '''Update:''' Romaguera JE, Fayad LE, Feng L, Hartig K, Weaver P, Rodriguez MA, Hagemeister FB, Pro B, McLaughlin P, Younes A, Samaniego F, Goy A, Cabanillas F, Kantarjian H, Kwak L, Wang M. Ten-year follow-up after intense chemoimmunotherapy with Rituximab-HyperCVAD alternating with Rituximab-high dose methotrexate/cytarabine (R-MA) and without stem cell transplantation in patients with untreated aggressive mantle cell lymphoma. Br J Haematol. 2010 Jul;150(2):200-8. Epub 2010 May 26. Review. Erratum in: Br J Haematol.n 2010 Oct;151(1):111. [http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2010.08228.x/full link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/20528872 PubMed] |
− | ## '''Update:''' Chihara D, Cheah CY, Westin JR, Fayad LE, Rodriguez MA, Hagemeister FB, Pro B, McLaughlin P, Younes A, Samaniego F, Goy A, Cabanillas F, Kantarjian H, Kwak LW, Wang ML, Romaguera JE. Rituximab plus hyper-CVAD alternating with MTX/Ara-C in patients with newly diagnosed mantle cell lymphoma: 15-year follow-up of a phase II study from the MD Anderson Cancer Center. Br J Haematol. 2016 Jan;172(1):80-8. Epub 2015 Dec 9. [http://onlinelibrary.wiley.com/doi/10.1111/bjh.13796/full link to original article] [ | + | ## '''Update:''' Chihara D, Cheah CY, Westin JR, Fayad LE, Rodriguez MA, Hagemeister FB, Pro B, McLaughlin P, Younes A, Samaniego F, Goy A, Cabanillas F, Kantarjian H, Kwak LW, Wang ML, Romaguera JE. Rituximab plus hyper-CVAD alternating with MTX/Ara-C in patients with newly diagnosed mantle cell lymphoma: 15-year follow-up of a phase II study from the MD Anderson Cancer Center. Br J Haematol. 2016 Jan;172(1):80-8. Epub 2015 Dec 9. [http://onlinelibrary.wiley.com/doi/10.1111/bjh.13796/full link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/26648336 PubMed] |
− | # Wang M, Fayad L, Cabanillas F, Hagemeister F, McLaughlin P, Rodriguez MA, Kwak LW, Zhou Y, Kantarjian H, Romaguera J. Phase 2 trial of rituximab plus hyper-CVAD alternating with rituximab plus methotrexate-cytarabine for relapsed or refractory aggressive mantle cell lymphoma. Cancer. 2008 Nov 15;113(10):2734-41.[http://onlinelibrary.wiley.com/doi/10.1002/cncr.23880/full link to original article] '''contains verified protocol''' [ | + | # Wang M, Fayad L, Cabanillas F, Hagemeister F, McLaughlin P, Rodriguez MA, Kwak LW, Zhou Y, Kantarjian H, Romaguera J. Phase 2 trial of rituximab plus hyper-CVAD alternating with rituximab plus methotrexate-cytarabine for relapsed or refractory aggressive mantle cell lymphoma. Cancer. 2008 Nov 15;113(10):2734-41.[http://onlinelibrary.wiley.com/doi/10.1002/cncr.23880/full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/18973182 PubMed] |
− | # Bernstein SH, Epner E, Unger JM, Leblanc M, Cebula E, Burack R, Rimsza L, Miller TP, Fisher RI. A phase II multicenter trial of hyperCVAD MTX/Ara-C and rituximab in patients with previously untreated mantle cell lymphoma; SWOG 0213. Ann Oncol. 2013 Jun;24(6):1587-93. Epub 2013 Mar 15. [http://annonc.oxfordjournals.org/content/24/6/1587.long link to original article] [ | + | # Bernstein SH, Epner E, Unger JM, Leblanc M, Cebula E, Burack R, Rimsza L, Miller TP, Fisher RI. A phase II multicenter trial of hyperCVAD MTX/Ara-C and rituximab in patients with previously untreated mantle cell lymphoma; SWOG 0213. Ann Oncol. 2013 Jun;24(6):1587-93. Epub 2013 Mar 15. [http://annonc.oxfordjournals.org/content/24/6/1587.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/23504948 PubMed] |
==R-MACLO/R-IVAM {{#subobject:51391f|Regimen=1}}== | ==R-MACLO/R-IVAM {{#subobject:51391f|Regimen=1}}== | ||
Line 1,133: | Line 991: | ||
|- | |- | ||
|[http://www.tandfonline.com/doi/full/10.3109/10428190903518345 Lossos et al. 2010 (UM-MCL1)] | |[http://www.tandfonline.com/doi/full/10.3109/10428190903518345 Lossos et al. 2010 (UM-MCL1)] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
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|} | |} | ||
Line 1,177: | Line 1,030: | ||
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|[http://onlinelibrary.wiley.com/doi/10.1002/ajh.23996/full Hosein et al. 2015 (UM-MCL2)] | |[http://onlinelibrary.wiley.com/doi/10.1002/ajh.23996/full Hosein et al. 2015 (UM-MCL2)] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background | ||
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− | |||
|- | |- | ||
|} | |} | ||
Line 1,218: | Line 1,066: | ||
===References=== | ===References=== | ||
− | # Lossos IS, Hosein PJ, Morgensztern D, Coleman F, Escalón MP, Byrne GE Jr, Rosenblatt JD, Walker GR. High rate and prolonged duration of complete remissions induced by rituximab, methotrexate, doxorubicin, cyclophosphamide, vincristine, ifosfamide, etoposide, cytarabine, and thalidomide (R-MACLO-IVAM-T), a modification of the National Cancer Institute 89-C-41 regimen, in patients with newly diagnosed mantle cell lymphoma. Leuk Lymphoma. 2010 Mar;51(3):406-14. [http://www.tandfonline.com/doi/full/10.3109/10428190903518345 link to original article] '''contains verified protocol''' [ | + | # Lossos IS, Hosein PJ, Morgensztern D, Coleman F, Escalón MP, Byrne GE Jr, Rosenblatt JD, Walker GR. High rate and prolonged duration of complete remissions induced by rituximab, methotrexate, doxorubicin, cyclophosphamide, vincristine, ifosfamide, etoposide, cytarabine, and thalidomide (R-MACLO-IVAM-T), a modification of the National Cancer Institute 89-C-41 regimen, in patients with newly diagnosed mantle cell lymphoma. Leuk Lymphoma. 2010 Mar;51(3):406-14. [http://www.tandfonline.com/doi/full/10.3109/10428190903518345 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20038221 PubMed] |
− | ## '''Update:''' Hosein PJ, Sandoval-Sus JD, Goodman D, Arteaga AG, Reis I, Hoffman J, Stefanovic A, Rosenblatt JD, Lossos IS. Updated survival analysis of two sequential prospective trials of R-MACLO-IVAM followed by maintenance for newly diagnosed mantle cell lymphoma. Am J Hematol. 2015 Jun;90(6):E111-6. Epub 2015 Apr 2. [http://onlinelibrary.wiley.com/doi/10.1002/ajh.23996/full link to original article] [ | + | ## '''Update:''' Hosein PJ, Sandoval-Sus JD, Goodman D, Arteaga AG, Reis I, Hoffman J, Stefanovic A, Rosenblatt JD, Lossos IS. Updated survival analysis of two sequential prospective trials of R-MACLO-IVAM followed by maintenance for newly diagnosed mantle cell lymphoma. Am J Hematol. 2015 Jun;90(6):E111-6. Epub 2015 Apr 2. [http://onlinelibrary.wiley.com/doi/10.1002/ajh.23996/full link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/25737247 PubMed] |
==RiPAD+C {{#subobject:438664|Regimen=1}}== | ==RiPAD+C {{#subobject:438664|Regimen=1}}== | ||
Line 1,234: | Line 1,082: | ||
|- | |- | ||
|[http://annonc.oxfordjournals.org/content/23/6/1555.long Houot et al. 2011] | |[http://annonc.oxfordjournals.org/content/23/6/1555.long Houot et al. 2011] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background | ||
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|- | |- | ||
|} | |} | ||
Line 1,254: | Line 1,097: | ||
===References=== | ===References=== | ||
− | # Houot R, Le Gouill S, Ojeda Uribe M, Mounier C, Courby S, Dartigeas C, Bouabdallah K, Alexis Vigier M, Moles MP, Tournilhac O, Arakelyan N, Rodon P, El Yamani A, Sutton L, Fornecker L, Assouline D, Harousseau JL, Maisonneuve H, Caulet-Maugendre S, Gressin R; French GOELAMS group. Combination of rituximab, bortezomib, doxorubicin, dexamethasone and chlorambucil (RiPAD+C) as first-line therapy for elderly mantle cell lymphoma patients: results of a phase II trial from the GOELAMS. Ann Oncol. 2012 Jun;23(6):1555-61. Epub 2011 Oct 19. [http://annonc.oxfordjournals.org/content/23/6/1555.long link to original article] '''contains verified protocol''' [ | + | # Houot R, Le Gouill S, Ojeda Uribe M, Mounier C, Courby S, Dartigeas C, Bouabdallah K, Alexis Vigier M, Moles MP, Tournilhac O, Arakelyan N, Rodon P, El Yamani A, Sutton L, Fornecker L, Assouline D, Harousseau JL, Maisonneuve H, Caulet-Maugendre S, Gressin R; French GOELAMS group. Combination of rituximab, bortezomib, doxorubicin, dexamethasone and chlorambucil (RiPAD+C) as first-line therapy for elderly mantle cell lymphoma patients: results of a phase II trial from the GOELAMS. Ann Oncol. 2012 Jun;23(6):1555-61. Epub 2011 Oct 19. [http://annonc.oxfordjournals.org/content/23/6/1555.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/22012966 PubMed] |
==(R)VAD+C {{#subobject:456435|Regimen=1}}== | ==(R)VAD+C {{#subobject:456435|Regimen=1}}== | ||
Line 1,269: | Line 1,112: | ||
|- | |- | ||
|[http://www.haematologica.org/content/95/8/1350.full Gressin et al. 2010 (GOELAMS LM1996, Lm<sup>2</sup>001)] | |[http://www.haematologica.org/content/95/8/1350.full Gressin et al. 2010 (GOELAMS LM1996, Lm<sup>2</sup>001)] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
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|} | |} | ||
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===References=== | ===References=== | ||
− | # Gressin R, Caulet-Maugendre S, Deconinck E, Tournilhac O, Gyan E, Moles MP, El Yamani A, Cornillon J, Rossi JF, Le Gouill S, Lepeu G, Damaj G, Celigny PS, Maisonneuve H, Corront B, Vilque JP, Casassus P, Lamy T, Colonna M, Colombat P; French GOELAMS Group. Evaluation of the (R)VAD+C regimen for the treatment of newly diagnosed mantle cell lymphoma. Combined results of two prospective phase II trials from the French GOELAMS group. Haematologica. 2010 Aug;95(8):1350-7. Epub 2010 Mar 10. [ | + | # Gressin R, Caulet-Maugendre S, Deconinck E, Tournilhac O, Gyan E, Moles MP, El Yamani A, Cornillon J, Rossi JF, Le Gouill S, Lepeu G, Damaj G, Celigny PS, Maisonneuve H, Corront B, Vilque JP, Casassus P, Lamy T, Colonna M, Colombat P; French GOELAMS Group. Evaluation of the (R)VAD+C regimen for the treatment of newly diagnosed mantle cell lymphoma. Combined results of two prospective phase II trials from the French GOELAMS group. Haematologica. 2010 Aug;95(8):1350-7. Epub 2010 Mar 10. [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2913084/ link to PMC article] [http://www.haematologica.org/content/95/8/1350.full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20220059 PubMed] |
==VcR-CVAD {{#subobject:2494f3|Regimen=1}}== | ==VcR-CVAD {{#subobject:2494f3|Regimen=1}}== | ||
Line 1,306: | Line 1,144: | ||
|- | |- | ||
|[http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2011.08820.x/full Chang et al. 2011] | |[http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2011.08820.x/full Chang et al. 2011] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
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− | |[http://bloodjournal | + | |[http://www.bloodjournal.org/content/123/11/1665.full Chang et al. 2014 (E1405)] |
− | | | + | |style="background-color:#eeee00"|Phase II |
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|} | |} | ||
Line 1,339: | Line 1,167: | ||
===References=== | ===References=== | ||
− | # Chang JE, Peterson C, Choi S, Eickhoff JC, Kim K, Yang DT, Gilbert LA, Rogers ES, Werndli JE, Huie MS, McFarland TA, Volk M, Blank J, Callander NS, Longo WL, Kahl BS. VcR-CVAD induction chemotherapy followed by maintenance rituximab in mantle cell lymphoma: a Wisconsin Oncology Network study. Br J Haematol. 2011 Oct;155(2):190-7. Epub 2011 Aug 16. [http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2011.08820.x/full link to original article] '''contains verified protocol''' [ | + | # Chang JE, Peterson C, Choi S, Eickhoff JC, Kim K, Yang DT, Gilbert LA, Rogers ES, Werndli JE, Huie MS, McFarland TA, Volk M, Blank J, Callander NS, Longo WL, Kahl BS. VcR-CVAD induction chemotherapy followed by maintenance rituximab in mantle cell lymphoma: a Wisconsin Oncology Network study. Br J Haematol. 2011 Oct;155(2):190-7. Epub 2011 Aug 16. [http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2011.08820.x/full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/21848883 PubMed] |
− | # Chang JE, Li H, Smith MR, Gascoyne RD, Paietta EM, Yang DT, Advani RH, Horning SJ, Kahl BS. Phase 2 study of VcR-CVAD with maintenance rituximab for untreated mantle cell lymphoma: an Eastern Cooperative Oncology Group study (E1405). Blood. 2014 Mar 13;123(11):1665-73. Epub 2014 Jan 23. [http://bloodjournal | + | # Chang JE, Li H, Smith MR, Gascoyne RD, Paietta EM, Yang DT, Advani RH, Horning SJ, Kahl BS. Phase 2 study of VcR-CVAD with maintenance rituximab for untreated mantle cell lymphoma: an Eastern Cooperative Oncology Group study (E1405). Blood. 2014 Mar 13;123(11):1665-73. Epub 2014 Jan 23. [http://www.bloodjournal.org/content/123/11/1665.full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/24458437 PubMed] |
==VR-CHOP {{#subobject:f5739b|Regimen=1}}== | ==VR-CHOP {{#subobject:f5739b|Regimen=1}}== | ||
Line 1,355: | Line 1,183: | ||
|- | |- | ||
|[http://jco.ascopubs.org/content/29/6/690.long Ruan et al. 2010] | |[http://jco.ascopubs.org/content/29/6/690.long Ruan et al. 2010] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background | ||
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− | |||
|- | |- | ||
|[http://onlinelibrary.wiley.com/doi/10.1111/bjh.13818/full Till et al. 2015 (SWOG S0601)] | |[http://onlinelibrary.wiley.com/doi/10.1111/bjh.13818/full Till et al. 2015 (SWOG S0601)] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
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|} | |} | ||
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===References=== | ===References=== | ||
− | # Ruan J, Martin P, Furman RR, Lee SM, Cheung K, Vose JM, Lacasce A, Morrison J, Elstrom R, Ely S, Chadburn A, Cesarman E, Coleman M, Leonard JP. Bortezomib plus CHOP-rituximab for previously untreated diffuse large B-cell lymphoma and mantle cell lymphoma. J Clin Oncol. 2011 Feb 20;29(6):690-7. Epub 2010 Dec 28. [http://jco.ascopubs.org/content/29/6/690.long link to original article] '''contains verified protocol''' [ | + | # Ruan J, Martin P, Furman RR, Lee SM, Cheung K, Vose JM, Lacasce A, Morrison J, Elstrom R, Ely S, Chadburn A, Cesarman E, Coleman M, Leonard JP. Bortezomib plus CHOP-rituximab for previously untreated diffuse large B-cell lymphoma and mantle cell lymphoma. J Clin Oncol. 2011 Feb 20;29(6):690-7. Epub 2010 Dec 28. [http://jco.ascopubs.org/content/29/6/690.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/21189393 PubMed] |
− | # Till BG, Li H, Bernstein SH, Fisher RI, Burack WR, Rimsza LM, Floyd JD, DaSilva MA, Moore DF Jr, Pozdnyakova O, Smith SM, LeBlanc M, Friedberg JW. Phase II trial of R-CHOP plus bortezomib induction therapy followed by bortezomib maintenance for newly diagnosed mantle cell lymphoma: SWOG S0601. Br J Haematol. 2016 Jan;172(2):208-18. Epub 2015 Oct 22. [http://onlinelibrary.wiley.com/doi/10.1111/bjh.13818/full link to original article] '''contains protocol''' [ | + | # Till BG, Li H, Bernstein SH, Fisher RI, Burack WR, Rimsza LM, Floyd JD, DaSilva MA, Moore DF Jr, Pozdnyakova O, Smith SM, LeBlanc M, Friedberg JW. Phase II trial of R-CHOP plus bortezomib induction therapy followed by bortezomib maintenance for newly diagnosed mantle cell lymphoma: SWOG S0601. Br J Haematol. 2016 Jan;172(2):208-18. Epub 2015 Oct 22. [http://onlinelibrary.wiley.com/doi/10.1111/bjh.13818/full link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/26492567 PubMed] |
=Consolidation and/or maintenance after upfront therapy= | =Consolidation and/or maintenance after upfront therapy= | ||
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|[http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2008.07498.x/full Van't Veer et al. 2008 (HOVON 45)] | |[http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2008.07498.x/full Van't Veer et al. 2008 (HOVON 45)] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
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|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|- | |- | ||
− | |[http://bloodjournal | + | |[http://www.bloodjournal.org/content/112/7/2687.long Geisler et al. 2008] |
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background | ||
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===References=== | ===References=== | ||
− | # Geisler CH, Kolstad A, Laurell A, Andersen NS, Pedersen LB, Jerkeman M, Eriksson M, Nordström M, Kimby E, Boesen AM, Kuittinen O, Lauritzsen GF, Nilsson-Ehle H, Ralfkiaer E, Akerman M, Ehinger M, Sundström C, Langholm R, Delabie J, Karjalainen-Lindsberg ML, Brown P, Elonen E; Nordic Lymphoma Group. Long-term progression-free survival of mantle cell lymphoma after intensive front-line immunochemotherapy with in vivo-purged stem cell rescue: a nonrandomized phase 2 multicenter study by the Nordic Lymphoma Group. Blood. 2008 Oct 1;112(7):2687-93. Epub 2008 Jul 14. [http://bloodjournal | + | # Geisler CH, Kolstad A, Laurell A, Andersen NS, Pedersen LB, Jerkeman M, Eriksson M, Nordström M, Kimby E, Boesen AM, Kuittinen O, Lauritzsen GF, Nilsson-Ehle H, Ralfkiaer E, Akerman M, Ehinger M, Sundström C, Langholm R, Delabie J, Karjalainen-Lindsberg ML, Brown P, Elonen E; Nordic Lymphoma Group. Long-term progression-free survival of mantle cell lymphoma after intensive front-line immunochemotherapy with in vivo-purged stem cell rescue: a nonrandomized phase 2 multicenter study by the Nordic Lymphoma Group. Blood. 2008 Oct 1;112(7):2687-93. Epub 2008 Jul 14. [http://www.bloodjournal.org/content/112/7/2687.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/18625886 PubMed] |
− | # Van't Veer MB, de Jong D, MacKenzie M, Kluin-Nelemans HC, van Oers MH, Zijlstra J, Hagenbeek A, van Putten WL. High-dose Ara-C and beam with autograft rescue in R-CHOP responsive mantle cell lymphoma patients. Br J Haematol. 2009 Feb;144(4):524-30. Epub 2008 Nov 26. [http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2008.07498.x/full link to original article] '''contains verified protocol''' [ | + | # Van't Veer MB, de Jong D, MacKenzie M, Kluin-Nelemans HC, van Oers MH, Zijlstra J, Hagenbeek A, van Putten WL. High-dose Ara-C and beam with autograft rescue in R-CHOP responsive mantle cell lymphoma patients. Br J Haematol. 2009 Feb;144(4):524-30. Epub 2008 Nov 26. [http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2008.07498.x/full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/19036081 PubMed] |
− | # Gressin R, Caulet-Maugendre S, Deconinck E, Tournilhac O, Gyan E, Moles MP, El Yamani A, Cornillon J, Rossi JF, Le Gouill S, Lepeu G, Damaj G, Celigny PS, Maisonneuve H, Corront B, Vilque JP, Casassus P, Lamy T, Colonna M, Colombat P; French GOELAMS Group. Evaluation of the (R)VAD+C regimen for the treatment of newly diagnosed mantle cell lymphoma. Combined results of two prospective phase II trials from the French GOELAMS group. Haematologica. 2010 Aug;95(8):1350-7. Epub 2010 Mar 10. [http://www.haematologica.org/content/95/8/1350.full link to original article] [ | + | # Gressin R, Caulet-Maugendre S, Deconinck E, Tournilhac O, Gyan E, Moles MP, El Yamani A, Cornillon J, Rossi JF, Le Gouill S, Lepeu G, Damaj G, Celigny PS, Maisonneuve H, Corront B, Vilque JP, Casassus P, Lamy T, Colonna M, Colombat P; French GOELAMS Group. Evaluation of the (R)VAD+C regimen for the treatment of newly diagnosed mantle cell lymphoma. Combined results of two prospective phase II trials from the French GOELAMS group. Haematologica. 2010 Aug;95(8):1350-7. Epub 2010 Mar 10. [http://www.haematologica.org/content/95/8/1350.full link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/20220059 PubMed] |
− | # Chang JE, Li H, Smith MR, Gascoyne RD, Paietta EM, Yang DT, Advani RH, Horning SJ, Kahl BS. Phase 2 study of VcR-CVAD with maintenance rituximab for untreated mantle cell lymphoma: an Eastern Cooperative Oncology Group study (E1405). Blood. 2014 Mar 13;123(11):1665-73. Epub 2014 Jan 23. [http://bloodjournal | + | # Chang JE, Li H, Smith MR, Gascoyne RD, Paietta EM, Yang DT, Advani RH, Horning SJ, Kahl BS. Phase 2 study of VcR-CVAD with maintenance rituximab for untreated mantle cell lymphoma: an Eastern Cooperative Oncology Group study (E1405). Blood. 2014 Mar 13;123(11):1665-73. Epub 2014 Jan 23. [http://www.bloodjournal.org/content/123/11/1665.full link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/24458437 PubMed] |
==Bortezomib (Velcade) {{#subobject:018719|Regimen=1}}== | ==Bortezomib (Velcade) {{#subobject:018719|Regimen=1}}== | ||
Line 1,462: | Line 1,270: | ||
|- | |- | ||
|[http://onlinelibrary.wiley.com/doi/10.1111/bjh.13818/full Till et al. 2015 (SWOG S0601)] | |[http://onlinelibrary.wiley.com/doi/10.1111/bjh.13818/full Till et al. 2015 (SWOG S0601)] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
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===References=== | ===References=== | ||
− | # Till BG, Li H, Bernstein SH, Fisher RI, Burack WR, Rimsza LM, Floyd JD, DaSilva MA, Moore DF Jr, Pozdnyakova O, Smith SM, LeBlanc M, Friedberg JW. Phase II trial of R-CHOP plus bortezomib induction therapy followed by bortezomib maintenance for newly diagnosed mantle cell lymphoma: SWOG S0601. Br J Haematol. 2016 Jan;172(2):208-18. Epub 2015 Oct 22. [http://onlinelibrary.wiley.com/doi/10.1111/bjh.13818/full link to original article] '''contains protocol''' [ | + | # Till BG, Li H, Bernstein SH, Fisher RI, Burack WR, Rimsza LM, Floyd JD, DaSilva MA, Moore DF Jr, Pozdnyakova O, Smith SM, LeBlanc M, Friedberg JW. Phase II trial of R-CHOP plus bortezomib induction therapy followed by bortezomib maintenance for newly diagnosed mantle cell lymphoma: SWOG S0601. Br J Haematol. 2016 Jan;172(2):208-18. Epub 2015 Oct 22. [http://onlinelibrary.wiley.com/doi/10.1111/bjh.13818/full link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/26492567 PubMed] |
==Ibritumomab tiuxetan (Zevalin) {{#subobject:165cb4|Regimen=1}}== | ==Ibritumomab tiuxetan (Zevalin) {{#subobject:165cb4|Regimen=1}}== | ||
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|- | |- | ||
|[http://jco.ascopubs.org/content/30/25/3119.long Smith et al. 2012 (ECOG E1499)] | |[http://jco.ascopubs.org/content/30/25/3119.long Smith et al. 2012 (ECOG E1499)] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
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===References=== | ===References=== | ||
<!-- Presented in part at the 42nd Annual Meeting of the American Society of Clinical Oncology, Atlanta, GA, June 2-6, 2006; the 47th Annual Meeting of the American Society of Hematology, Atlanta, GA, December 8-11, 2007; and the 11th International Conference on Malignant Lymphoma, Lugano, Switzerland, June 15-18, 2011. --> | <!-- Presented in part at the 42nd Annual Meeting of the American Society of Clinical Oncology, Atlanta, GA, June 2-6, 2006; the 47th Annual Meeting of the American Society of Hematology, Atlanta, GA, December 8-11, 2007; and the 11th International Conference on Malignant Lymphoma, Lugano, Switzerland, June 15-18, 2011. --> | ||
− | # Smith MR, Li H, Gordon L, Gascoyne RD, Paietta E, Forero-Torres A, Kahl BS, Advani R, Hong F, Horning SJ. Phase II study of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone immunochemotherapy followed by yttrium-90-ibritumomab tiuxetan in untreated mantle-cell lymphoma: Eastern Cooperative Oncology Group Study E1499. J Clin Oncol. 2012 Sep 1;30(25):3119-26. Epub 2012 Jul 30. [http://jco.ascopubs.org/content/30/25/3119.long link to original article] '''contains verified protocol''' [ | + | # Smith MR, Li H, Gordon L, Gascoyne RD, Paietta E, Forero-Torres A, Kahl BS, Advani R, Hong F, Horning SJ. Phase II study of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone immunochemotherapy followed by yttrium-90-ibritumomab tiuxetan in untreated mantle-cell lymphoma: Eastern Cooperative Oncology Group Study E1499. J Clin Oncol. 2012 Sep 1;30(25):3119-26. Epub 2012 Jul 30. [http://jco.ascopubs.org/content/30/25/3119.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/22851557 PubMed] |
==Lenalidomide & Rituximab {{#subobject:6bd100|Regimen=1}}== | ==Lenalidomide & Rituximab {{#subobject:6bd100|Regimen=1}}== | ||
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|- | |- | ||
|[http://www.nejm.org/doi/full/10.1056/NEJMoa1505237 Ruan et al. 2015] | |[http://www.nejm.org/doi/full/10.1056/NEJMoa1505237 Ruan et al. 2015] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
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− | |||
|- | |- | ||
|} | |} | ||
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===References=== | ===References=== | ||
− | <!-- # '''Abstract:''' Jia Ruan, Peter Martin, Bijal D. Shah, Stephen J. Schuster, Sonali M. Smith, Richard R. Furman, Paul Christos, Amelyn Rodriguez, Paige Wolstencroft, Jakub Svoboda, Alison Bender, Jessica Lewis, Morton Coleman, John P. Leonard. Combination Biologic Therapy Without Chemotherapy As Initial Treatment For Mantle Cell Lymphoma: Multi-Center Phase II Study Of Lenalidomide Plus Rituximab. Blood Nov 2013,122(21)247 [http://bloodjournal | + | <!-- # '''Abstract:''' Jia Ruan, Peter Martin, Bijal D. Shah, Stephen J. Schuster, Sonali M. Smith, Richard R. Furman, Paul Christos, Amelyn Rodriguez, Paige Wolstencroft, Jakub Svoboda, Alison Bender, Jessica Lewis, Morton Coleman, John P. Leonard. Combination Biologic Therapy Without Chemotherapy As Initial Treatment For Mantle Cell Lymphoma: Multi-Center Phase II Study Of Lenalidomide Plus Rituximab. Blood Nov 2013,122(21)247 [http://www.bloodjournal.org/content/122/21/247 link to abstract] |
## '''Update Abstract:''' Jia Ruan, MD, PhD, Peter Martin, MD, Bijal D. Shah, MD, Stephen J. Schuster, MD, Sonali M. Smith, MD, Richard R Furman, MD, Paul Christos, DrPH, Amelyn Rodriguez, RN, Louisa Drake, Jakub Svoboda, MD, Jessica Lewis, PA-C, Orel Katz, PA-C, Morton Coleman, MD and John P. Leonard, MD. Sustained Remission with the Combination Biologic Doublet of Lenalidomide Plus Rituximab As Initial Treatment for Mantle Cell Lymphoma: A Multi-Center Phase II Study Report. ASH Annual Meeting 2014 Abstract 625 [https://ash.confex.com/ash/2014/webprogram/Paper73280.html link to abstract] --> | ## '''Update Abstract:''' Jia Ruan, MD, PhD, Peter Martin, MD, Bijal D. Shah, MD, Stephen J. Schuster, MD, Sonali M. Smith, MD, Richard R Furman, MD, Paul Christos, DrPH, Amelyn Rodriguez, RN, Louisa Drake, Jakub Svoboda, MD, Jessica Lewis, PA-C, Orel Katz, PA-C, Morton Coleman, MD and John P. Leonard, MD. Sustained Remission with the Combination Biologic Doublet of Lenalidomide Plus Rituximab As Initial Treatment for Mantle Cell Lymphoma: A Multi-Center Phase II Study Report. ASH Annual Meeting 2014 Abstract 625 [https://ash.confex.com/ash/2014/webprogram/Paper73280.html link to abstract] --> | ||
− | # Ruan J, Martin P, Shah B, Schuster SJ, Smith SM, Furman RR, Christos P, Rodriguez A, Svoboda J, Lewis J, Katz O, Coleman M, Leonard JP. Lenalidomide plus Rituximab as Initial Treatment for Mantle-Cell Lymphoma. N Engl J Med. 2015 Nov 5;373(19):1835-44. [http://www.nejm.org/doi/full/10.1056/NEJMoa1505237 link to original article] '''contains verified protocol''' [ | + | # Ruan J, Martin P, Shah B, Schuster SJ, Smith SM, Furman RR, Christos P, Rodriguez A, Svoboda J, Lewis J, Katz O, Coleman M, Leonard JP. Lenalidomide plus Rituximab as Initial Treatment for Mantle-Cell Lymphoma. N Engl J Med. 2015 Nov 5;373(19):1835-44. [http://www.nejm.org/doi/full/10.1056/NEJMoa1505237 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/26535512 PubMed] |
==Observation== | ==Observation== | ||
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|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|'''Comparator''' | |'''Comparator''' | ||
+ | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
− | |[ | + | |[http://www.bloodjournal.org/content/124/21/146 Le Gouill et al. 2014 (LyMa)] |
− | | | + | |style="background-color:#00cd00"|Phase III |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|[[Mantle_cell_lymphoma#Rituximab_.28Rituxan.29|Rituximab]] | |[[Mantle_cell_lymphoma#Rituximab_.28Rituxan.29|Rituximab]] | ||
+ | |style="background-color:#ff0000"|Seems to have inferior PFS | ||
|- | |- | ||
|} | |} | ||
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===References=== | ===References=== | ||
− | # '''Abstract:''' Steven Le Gouill, MD, PhD, Catherine Thieblemont, MD, PhD, Lucie Oberic, Krimo Bouabdallah, MD, Emmanuel Gyan, MD, PhD, Gandhi Damaj, MD, Vincent Ribrag, MD, Serge Bologna, MD, Remy Gressin, MD, Olivier Casasnovas, MD, Corinne Haioun, MD, PhD, Philippe Solal-Celigny, MD, Herve Maisonneuve, MD, Eric Van Den Neste, MD, PhD, Anne Moreau, MD, Marie C Bene, Gilles Salles, MD PhD, Hervé Tilly, MD, PhD, Thierry Lamy, MD, PhD and Olivier Hermine, MD, PhD. Rituximab Maintenance Versus Wait and Watch after Four Courses of R-DHAP Followed By Autologous Stem Cell transplantation in Previously Untreated Young Patients with Mantle Cell Lymphoma: First Interim Analysis of the Phase III Prospective Lyma Trial, a Lysa Study. | + | # '''Abstract:''' Steven Le Gouill, MD, PhD, Catherine Thieblemont, MD, PhD, Lucie Oberic, Krimo Bouabdallah, MD, Emmanuel Gyan, MD, PhD, Gandhi Damaj, MD, Vincent Ribrag, MD, Serge Bologna, MD, Remy Gressin, MD, Olivier Casasnovas, MD, Corinne Haioun, MD, PhD, Philippe Solal-Celigny, MD, Herve Maisonneuve, MD, Eric Van Den Neste, MD, PhD, Anne Moreau, MD, Marie C Bene, Gilles Salles, MD PhD, Hervé Tilly, MD, PhD, Thierry Lamy, MD, PhD and Olivier Hermine, MD, PhD. Rituximab Maintenance Versus Wait and Watch after Four Courses of R-DHAP Followed By Autologous Stem Cell transplantation in Previously Untreated Young Patients with Mantle Cell Lymphoma: First Interim Analysis of the Phase III Prospective Lyma Trial, a Lysa Study. Blood 2014 124:146. [http://www.bloodjournal.org/content/124/21/146 link to abstract] |
==Rituximab (Rituxan) {{#subobject:712b01|Regimen=1}}== | ==Rituximab (Rituxan) {{#subobject:712b01|Regimen=1}}== | ||
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|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|'''Comparator''' | |'''Comparator''' | ||
+ | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
− | |[ | + | |[http://www.bloodjournal.org/content/124/21/146 Le Gouill et al. 2014 (LyMa)] |
− | | | + | |style="background-color:#00cd00"|Phase III |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|[[Mantle_cell_lymphoma#Observation_2|Observation]] | |[[Mantle_cell_lymphoma#Observation_2|Observation]] | ||
+ | |style="background-color:#00cd00"|Seems to have superior PFS | ||
|- | |- | ||
|} | |} | ||
− | |||
''Treatment preceded by [[Mantle_cell_lymphoma#R-DHAP|R-DHAP x4]] and [[Transplant_conditioning_regimens#R-BEAM|R-BEAM autologous stem cell transplant]].'' | ''Treatment preceded by [[Mantle_cell_lymphoma#R-DHAP|R-DHAP x4]] and [[Transplant_conditioning_regimens#R-BEAM|R-BEAM autologous stem cell transplant]].'' | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
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|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|'''Comparator''' | |'''Comparator''' | ||
+ | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
|[http://www.nejm.org/doi/full/10.1056/NEJMoa1200920 Kluin-Nelemans et al. 2012] | |[http://www.nejm.org/doi/full/10.1056/NEJMoa1200920 Kluin-Nelemans et al. 2012] | ||
− | | | + | |style="background-color:#00cd00"|Phase III |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|Interferon alfa | |Interferon alfa | ||
+ | |style="background-color:#00cd00"|Seeems to have superior combined PFS/OS | ||
|- | |- | ||
|} | |} | ||
− | |||
''Treatment preceded by [[Mantle_cell_lymphoma#R-CHOP|R-CHOP]] x 8 versus [[#FCR|R-FC]] x 6.'' | ''Treatment preceded by [[Mantle_cell_lymphoma#R-CHOP|R-CHOP]] x 8 versus [[#FCR|R-FC]] x 6.'' | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
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|- | |- | ||
|[http://onlinelibrary.wiley.com/doi/10.1002/ajh.23996/full Hosein et al. 2015 (UM-MCL2)] | |[http://onlinelibrary.wiley.com/doi/10.1002/ajh.23996/full Hosein et al. 2015 (UM-MCL2)] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
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|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|- | |- | ||
− | |[http://bloodjournal | + | |[http://www.bloodjournal.org/content/123/11/1665.full Chang et al. 2014 (ECOG E1405)] |
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
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|[http://informahealthcare.com/doi/full/10.3109/10428194.2010.534518 Sachanas et al. 2011] | |[http://informahealthcare.com/doi/full/10.3109/10428194.2010.534518 Sachanas et al. 2011] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
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===References=== | ===References=== | ||
− | # Sachanas S, Pangalis GA, Vassilakopoulos TP, Korkolopoulou P, Kontopidou FN, Athanasoulia M, Yiakoumis X, Kalpadakis C, Georgiou G, Masouridis S, Moschogiannis M, Tsirkinidis P, Pappis V, Kokoris SI, Siakantaris MP, Panayiotidis P, Angelopoulou MK. Combination of rituximab with chlorambucil as first line treatment in patients with mantle cell lymphoma: a highly effective regimen. Leuk Lymphoma. 2011 Mar;52(3):387-93. Epub 2010 Dec 6. [http://informahealthcare.com/doi/full/10.3109/10428194.2010.534518 link to original article] '''contains verified protocol''' [ | + | # Sachanas S, Pangalis GA, Vassilakopoulos TP, Korkolopoulou P, Kontopidou FN, Athanasoulia M, Yiakoumis X, Kalpadakis C, Georgiou G, Masouridis S, Moschogiannis M, Tsirkinidis P, Pappis V, Kokoris SI, Siakantaris MP, Panayiotidis P, Angelopoulou MK. Combination of rituximab with chlorambucil as first line treatment in patients with mantle cell lymphoma: a highly effective regimen. Leuk Lymphoma. 2011 Mar;52(3):387-93. Epub 2010 Dec 6. [http://informahealthcare.com/doi/full/10.3109/10428194.2010.534518 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/21133713 PubMed] |
− | # Kluin-Nelemans HC, Hoster E, Hermine O, Walewski J, Trneny M, Geisler CH, Stilgenbauer S, Thieblemont C, Vehling-Kaiser U, Doorduijn JK, Coiffier B, Forstpointner R, Tilly H, Kanz L, Feugier P, Szymczyk M, Hallek M, Kremers S, Lepeu G, Sanhes L, Zijlstra JM, Bouabdallah R, Lugtenburg PJ, Macro M, Pfreundschuh M, Procházka V, Di Raimondo F, Ribrag V, Uppenkamp M, André M, Klapper W, Hiddemann W, Unterhalt M, Dreyling MH. Treatment of older patients with mantle-cell lymphoma. N Engl J Med. 2012 Aug 9;367(6):520-31. [http://www.nejm.org/doi/full/10.1056/NEJMoa1200920 link to original article] '''contains verified protocol''' [ | + | # Kluin-Nelemans HC, Hoster E, Hermine O, Walewski J, Trneny M, Geisler CH, Stilgenbauer S, Thieblemont C, Vehling-Kaiser U, Doorduijn JK, Coiffier B, Forstpointner R, Tilly H, Kanz L, Feugier P, Szymczyk M, Hallek M, Kremers S, Lepeu G, Sanhes L, Zijlstra JM, Bouabdallah R, Lugtenburg PJ, Macro M, Pfreundschuh M, Procházka V, Di Raimondo F, Ribrag V, Uppenkamp M, André M, Klapper W, Hiddemann W, Unterhalt M, Dreyling MH. Treatment of older patients with mantle-cell lymphoma. N Engl J Med. 2012 Aug 9;367(6):520-31. [http://www.nejm.org/doi/full/10.1056/NEJMoa1200920 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/22873532 PubMed] |
− | # Räty R, Honkanen T, Jantunen E, Jyrkkiö S, Karjalainen-Lindsberg ML, Kuittinen O, Lehto M, Mikkola M, Poikonen E, Rauhala A, Rimpiläinen J, Räsänen A, Siitonen S, Suominen M, Vapaatalo M, Elonen E. Prolonged immunochemotherapy with rituximab, cytarabine and fludarabine added to cyclophosphamide, doxorubicin, vincristine and prednisolone and followed by rituximab maintenance in untreated elderly patients with mantle cell lymphoma: a prospective study by the Finnish Lymphoma Group. Leuk Lymphoma. 2012 Oct;53(10):1920-8. Epub 2012 Apr 23. [ | + | # Räty R, Honkanen T, Jantunen E, Jyrkkiö S, Karjalainen-Lindsberg ML, Kuittinen O, Lehto M, Mikkola M, Poikonen E, Rauhala A, Rimpiläinen J, Räsänen A, Siitonen S, Suominen M, Vapaatalo M, Elonen E. Prolonged immunochemotherapy with rituximab, cytarabine and fludarabine added to cyclophosphamide, doxorubicin, vincristine and prednisolone and followed by rituximab maintenance in untreated elderly patients with mantle cell lymphoma: a prospective study by the Finnish Lymphoma Group. Leuk Lymphoma. 2012 Oct;53(10):1920-8. Epub 2012 Apr 23. [https://www.ncbi.nlm.nih.gov/pubmed/22397313 PubMed] |
− | ## '''Update: Abstract:''' Riikka Räty, Tuomo Honkanen, Esa Jantunen, MD, PhD, Sirkku Jyrkkiö, Marja-Liisa Karjalainen-Lindsberg, MD, PhD, Outi Kuittinen, Minna Lehto, Maija Mikkola, Eira Poikonen, Auvo Rauhala, Johanna Rimpiläinen, Anu Räsänen, MD, Sanna Siitonen, Merja Suominen, MD, Mirja Vapaatalo and Erkki Elonen. Rituximab Maintenance Bimonthly for Two Years after Prolonged Immunochemotherapy in Elderly Patients with Mantle Cell Lymphoma (MCL) Results in Long Remissions: Update with Six-Year Follow-up of a Prospective Study By the Finnish Lymphoma Group. | + | ## '''Update: Abstract:''' Riikka Räty, Tuomo Honkanen, Esa Jantunen, MD, PhD, Sirkku Jyrkkiö, Marja-Liisa Karjalainen-Lindsberg, MD, PhD, Outi Kuittinen, Minna Lehto, Maija Mikkola, Eira Poikonen, Auvo Rauhala, Johanna Rimpiläinen, Anu Räsänen, MD, Sanna Siitonen, Merja Suominen, MD, Mirja Vapaatalo and Erkki Elonen. Rituximab Maintenance Bimonthly for Two Years after Prolonged Immunochemotherapy in Elderly Patients with Mantle Cell Lymphoma (MCL) Results in Long Remissions: Update with Six-Year Follow-up of a Prospective Study By the Finnish Lymphoma Group. Blood 2014 124:1749. [http://www.bloodjournal.org/content/124/21/1749 link to abstract] |
− | # Chang JE, Li H, Smith MR, Gascoyne RD, Paietta EM, Yang DT, Advani RH, Horning SJ, Kahl BS. Phase 2 study of VcR-CVAD with maintenance rituximab for untreated mantle cell lymphoma: an Eastern Cooperative Oncology Group study (E1405). Blood. 2014 Mar 13;123(11):1665-73. Epub 2014 Jan 23. [http://bloodjournal | + | # Chang JE, Li H, Smith MR, Gascoyne RD, Paietta EM, Yang DT, Advani RH, Horning SJ, Kahl BS. Phase 2 study of VcR-CVAD with maintenance rituximab for untreated mantle cell lymphoma: an Eastern Cooperative Oncology Group study (E1405). Blood. 2014 Mar 13;123(11):1665-73. Epub 2014 Jan 23. [http://www.bloodjournal.org/content/123/11/1665.full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/24458437 PubMed] |
− | # '''Abstract:''' Steven Le Gouill, MD, PhD, Catherine Thieblemont, MD, PhD, Lucie Oberic, Krimo Bouabdallah, MD, Emmanuel Gyan, MD, PhD, Gandhi Damaj, MD, Vincent Ribrag, MD, Serge Bologna, MD, Remy Gressin, MD, Olivier Casasnovas, MD, Corinne Haioun, MD, PhD, Philippe Solal-Celigny, MD, Herve Maisonneuve, MD, Eric Van Den Neste, MD, PhD, Anne Moreau, MD, Marie C Bene, Gilles Salles, MD PhD, Hervé Tilly, MD, PhD, Thierry Lamy, MD, PhD and Olivier Hermine, MD, PhD. Rituximab Maintenance Versus Wait and Watch after Four Courses of R-DHAP Followed By Autologous Stem Cell transplantation in Previously Untreated Young Patients with Mantle Cell Lymphoma: First Interim Analysis of the Phase III Prospective Lyma Trial, a Lysa Study. | + | # '''Abstract:''' Steven Le Gouill, MD, PhD, Catherine Thieblemont, MD, PhD, Lucie Oberic, Krimo Bouabdallah, MD, Emmanuel Gyan, MD, PhD, Gandhi Damaj, MD, Vincent Ribrag, MD, Serge Bologna, MD, Remy Gressin, MD, Olivier Casasnovas, MD, Corinne Haioun, MD, PhD, Philippe Solal-Celigny, MD, Herve Maisonneuve, MD, Eric Van Den Neste, MD, PhD, Anne Moreau, MD, Marie C Bene, Gilles Salles, MD PhD, Hervé Tilly, MD, PhD, Thierry Lamy, MD, PhD and Olivier Hermine, MD, PhD. Rituximab Maintenance Versus Wait and Watch after Four Courses of R-DHAP Followed By Autologous Stem Cell transplantation in Previously Untreated Young Patients with Mantle Cell Lymphoma: First Interim Analysis of the Phase III Prospective Lyma Trial, a Lysa Study. Blood 2014 124:146. [http://www.bloodjournal.org/content/124/21/146 link to abstract] |
− | # Hosein PJ, Sandoval-Sus JD, Goodman D, Arteaga AG, Reis I, Hoffman J, Stefanovic A, Rosenblatt JD, Lossos IS. Updated survival analysis of two sequential prospective trials of R-MACLO-IVAM followed by maintenance for newly diagnosed mantle cell lymphoma. Am J Hematol. 2015 Jun;90(6):E111-6. Epub 2015 Apr 2. [http://onlinelibrary.wiley.com/doi/10.1002/ajh.23996/full link to original article] [ | + | # Hosein PJ, Sandoval-Sus JD, Goodman D, Arteaga AG, Reis I, Hoffman J, Stefanovic A, Rosenblatt JD, Lossos IS. Updated survival analysis of two sequential prospective trials of R-MACLO-IVAM followed by maintenance for newly diagnosed mantle cell lymphoma. Am J Hematol. 2015 Jun;90(6):E111-6. Epub 2015 Apr 2. [http://onlinelibrary.wiley.com/doi/10.1002/ajh.23996/full link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/25737247 PubMed] |
=Relapsed/refractory, randomized data= | =Relapsed/refractory, randomized data= | ||
Line 1,715: | Line 1,482: | ||
|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|'''Comparator''' | |'''Comparator''' | ||
+ | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
|[http://onlinelibrary.wiley.com/doi/10.1111/bjh.13101/full Furtado et al. 2014] | |[http://onlinelibrary.wiley.com/doi/10.1111/bjh.13101/full Furtado et al. 2014] | ||
− | | | + | |style="background-color:#00cd00"|Randomized Phase II |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|[[Mantle_cell_lymphoma#CHOP_2|CHOP]] | |[[Mantle_cell_lymphoma#CHOP_2|CHOP]] | ||
+ | |style="background-color:#00cd00"|Seems to have superior OS | ||
|- | |- | ||
|} | |} | ||
Line 1,740: | Line 1,504: | ||
===References=== | ===References=== | ||
<!-- Previously presented in part (in poster form) at the 17th Congress of the European Haematology Association, June 2012 and orally at the BSH annual scientific meeting 2013. --> | <!-- Previously presented in part (in poster form) at the 17th Congress of the European Haematology Association, June 2012 and orally at the BSH annual scientific meeting 2013. --> | ||
− | # Furtado M, Johnson R, Kruger A, Turner D, Rule S. Addition of bortezomib to standard dose chop chemotherapy improves response and survival in relapsed mantle cell lymphoma. Br J Haematol. 2015 Jan;168(1):55-62. Epub 2014 Aug 22. [http://onlinelibrary.wiley.com/doi/10.1111/bjh.13101/full link to original article] '''contains verified protocol''' [ | + | # Furtado M, Johnson R, Kruger A, Turner D, Rule S. Addition of bortezomib to standard dose chop chemotherapy improves response and survival in relapsed mantle cell lymphoma. Br J Haematol. 2015 Jan;168(1):55-62. Epub 2014 Aug 22. [http://onlinelibrary.wiley.com/doi/10.1111/bjh.13101/full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/25146720 PubMed] |
==BR {{#subobject:3a2a8c|Regimen=1}}== | ==BR {{#subobject:3a2a8c|Regimen=1}}== | ||
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|- | |- | ||
|[http://link.springer.com/article/10.1007/s00277-015-2478-9/fulltext.html Czuczman et al. 2015] | |[http://link.springer.com/article/10.1007/s00277-015-2478-9/fulltext.html Czuczman et al. 2015] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background:#eeee00 | + | |style="background-color:#d3d3d3"| |
− | + | |style="background-color:#d3d3d3"| | |
− | |||
− | |||
− | |||
− | |||
− | | | ||
|- | |- | ||
|[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00447-7/fulltext Rummel et al. 2015 (StiL NHL 2-2003)] | |[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00447-7/fulltext Rummel et al. 2015 (StiL NHL 2-2003)] | ||
− | | | + | |style="background-color:#00cd00"|Phase III |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|[[Mantle_cell_lymphoma#FR|FR]] | |[[Mantle_cell_lymphoma#FR|FR]] | ||
− | | | + | |style="background-color:#00cd00"|Seems to have superior OS |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
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===References=== | ===References=== | ||
− | # Czuczman MS, Goy A, Lamonica D, Graf DA, Munteanu MC, van der Jagt RH. Phase II study of bendamustine combined with rituximab in relapsed/refractory mantle cell lymphoma: efficacy, tolerability, and safety findings. Ann Hematol. 2015 Dec;94(12):2025-32. Epub 2015 Sep 28. [http://link.springer.com/article/10.1007/s00277-015-2478-9/fulltext.html link to original article] '''contains verified protocol''' [ | + | # Czuczman MS, Goy A, Lamonica D, Graf DA, Munteanu MC, van der Jagt RH. Phase II study of bendamustine combined with rituximab in relapsed/refractory mantle cell lymphoma: efficacy, tolerability, and safety findings. Ann Hematol. 2015 Dec;94(12):2025-32. Epub 2015 Sep 28. [http://link.springer.com/article/10.1007/s00277-015-2478-9/fulltext.html link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/26411584 PubMed] |
<!-- # '''Abstract:''' Mathias J. Rummel, MD, PhD, Ulrich Kaiser, MD, Christina Balser, Martina Beate Stauch, Wolfram Brugger, MD, PhD, Manfred Welslau, Norbert Niederle, Christoph Losem, Harald Ballo, Eckhart Weidmann, Ulrich von Gruenhagen, Lothar Mueller, Michael Sandherr, MD, Julia Vereschagina, Axel Hinke and Juergen Barth. Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab In Patients with Relapsed Follicular, Indolent and Mantle Cell Lymphomas – Final Results of the Randomized Phase III Study NHL 2-2003 on Behalf of the StiL (Study Group Indolent Lymphomas, Germany). ASH Annual Meeting 2010, Abstract 856 [https://ash.confex.com/ash/2010/webprogram/Paper26917.html link to abstract] | <!-- # '''Abstract:''' Mathias J. Rummel, MD, PhD, Ulrich Kaiser, MD, Christina Balser, Martina Beate Stauch, Wolfram Brugger, MD, PhD, Manfred Welslau, Norbert Niederle, Christoph Losem, Harald Ballo, Eckhart Weidmann, Ulrich von Gruenhagen, Lothar Mueller, Michael Sandherr, MD, Julia Vereschagina, Axel Hinke and Juergen Barth. Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab In Patients with Relapsed Follicular, Indolent and Mantle Cell Lymphomas – Final Results of the Randomized Phase III Study NHL 2-2003 on Behalf of the StiL (Study Group Indolent Lymphomas, Germany). ASH Annual Meeting 2010, Abstract 856 [https://ash.confex.com/ash/2010/webprogram/Paper26917.html link to abstract] | ||
## '''Update:''' '''Abstract:''' Mathias J. Rummel, MD, Christina Balser, MD, Ulrich Kaiser, MD, Hans Peter Böck, Martina Beate Stauch, MD, Andrea Heider, PhD, Manfred Welslau, Christoph Losem, Eckhart Weidmann, Wolfgang Blau, MD, Alexander Burchardt, MD, Jürgen Barth, Frank Kauff, PhD, Axel Hinke, PhD and Wolfram Brugger, MD. Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab in Patients with Relapsed Follicular, Indolent, or Mantle Cell Lymphomas – 8-Year Follow-up Results of the Randomized Phase III Study NHL 2-2003 on Behalf of the StiL (Study Group Indolent Lymphomas, Germany). ASH Annual Meeting 2014, Abstract 145 [https://ash.confex.com/ash/2014/webprogram/Paper69154.html link to abstract] --> | ## '''Update:''' '''Abstract:''' Mathias J. Rummel, MD, Christina Balser, MD, Ulrich Kaiser, MD, Hans Peter Böck, Martina Beate Stauch, MD, Andrea Heider, PhD, Manfred Welslau, Christoph Losem, Eckhart Weidmann, Wolfgang Blau, MD, Alexander Burchardt, MD, Jürgen Barth, Frank Kauff, PhD, Axel Hinke, PhD and Wolfram Brugger, MD. Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab in Patients with Relapsed Follicular, Indolent, or Mantle Cell Lymphomas – 8-Year Follow-up Results of the Randomized Phase III Study NHL 2-2003 on Behalf of the StiL (Study Group Indolent Lymphomas, Germany). ASH Annual Meeting 2014, Abstract 145 [https://ash.confex.com/ash/2014/webprogram/Paper69154.html link to abstract] --> | ||
− | # Rummel M, Kaiser U, Balser C, Stauch M, Brugger W, Welslau M, Niederle N, Losem C, Boeck HP, Weidmann E, von Gruenhagen U, Mueller L, Sandherr M, Hahn L, Vereshchagina J, Kauff F, Blau W, Hinke A, Barth J; Study group indolent Lymphomas (StiL). Bendamustine plus rituximab versus fludarabine plus rituximab for patients with relapsed indolent and mantle-cell lymphomas: a multicentre, randomised, open-label, non-inferiority phase 3 trial. Lancet Oncol. 2016 Jan;17(1):57-66. Epub 2015 Dec 5. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00447-7/fulltext link to original article] '''contains protocol''' [ | + | # Rummel M, Kaiser U, Balser C, Stauch M, Brugger W, Welslau M, Niederle N, Losem C, Boeck HP, Weidmann E, von Gruenhagen U, Mueller L, Sandherr M, Hahn L, Vereshchagina J, Kauff F, Blau W, Hinke A, Barth J; Study group indolent Lymphomas (StiL). Bendamustine plus rituximab versus fludarabine plus rituximab for patients with relapsed indolent and mantle-cell lymphomas: a multicentre, randomised, open-label, non-inferiority phase 3 trial. Lancet Oncol. 2016 Jan;17(1):57-66. Epub 2015 Dec 5. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00447-7/fulltext link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/26655425 PubMed] |
==CHOP {{#subobject:a01b9f|Regimen=1}}== | ==CHOP {{#subobject:a01b9f|Regimen=1}}== | ||
Line 1,810: | Line 1,559: | ||
|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|'''Comparator''' | |'''Comparator''' | ||
+ | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
|[http://onlinelibrary.wiley.com/doi/10.1111/bjh.13101/full Furtado et al. 2014] | |[http://onlinelibrary.wiley.com/doi/10.1111/bjh.13101/full Furtado et al. 2014] | ||
− | | | + | |style="background-color:#00cd00"|Randomized Phase II |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|[[Mantle_cell_lymphoma#BCHOP|BCHOP]] | |[[Mantle_cell_lymphoma#BCHOP|BCHOP]] | ||
+ | |style="background-color:#ff0000"|Seems to have inferior OS | ||
|- | |- | ||
|} | |} | ||
Line 1,831: | Line 1,577: | ||
===References=== | ===References=== | ||
<!-- Previously presented in part (in poster form) at the 17th Congress of the European Haematology Association, June 2012 and orally at the BSH annual scientific meeting 2013. --> | <!-- Previously presented in part (in poster form) at the 17th Congress of the European Haematology Association, June 2012 and orally at the BSH annual scientific meeting 2013. --> | ||
− | # Furtado M, Johnson R, Kruger A, Turner D, Rule S. Addition of bortezomib to standard dose chop chemotherapy improves response and survival in relapsed mantle cell lymphoma. Br J Haematol. 2015 Jan;168(1):55-62. Epub 2014 Aug 22. [http://onlinelibrary.wiley.com/doi/10.1111/bjh.13101/full link to original article] '''contains verified protocol''' [ | + | # Furtado M, Johnson R, Kruger A, Turner D, Rule S. Addition of bortezomib to standard dose chop chemotherapy improves response and survival in relapsed mantle cell lymphoma. Br J Haematol. 2015 Jan;168(1):55-62. Epub 2014 Aug 22. [http://onlinelibrary.wiley.com/doi/10.1111/bjh.13101/full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/25146720 PubMed] |
==FCM {{#subobject:ddc2e3|Regimen=1}}== | ==FCM {{#subobject:ddc2e3|Regimen=1}}== | ||
Line 1,846: | Line 1,592: | ||
|[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
− | |[http://bloodjournal | + | |[http://www.bloodjournal.org/content/104/10/3064.long Forstpointner et al. 2004] |
− | | | + | |style="background-color:#00cd00"|Phase III |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|[[Mantle_cell_lymphoma#R-FCM|R-FCM]] | |[[Mantle_cell_lymphoma#R-FCM|R-FCM]] | ||
− | | | + | |style="background-color:#ff0000"|Inferior OS |
− | style="background:#ff0000 | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
Line 1,869: | Line 1,605: | ||
'''28-day cycle for 4 cycles''' | '''28-day cycle for 4 cycles''' | ||
− | ''Responders (PR or CR) were randomized to maintenance [[Rituximab (Rituxan)]] versus no further treatment.'' | + | ''Responders (PR or CR) were randomized to maintenance [[Rituximab (Rituxan)]] versus [[#Observation_3|no further treatment]].'' |
===References=== | ===References=== | ||
− | # Forstpointner R, Dreyling M, Repp R, Hermann S, Hänel A, Metzner B, Pott C, Hartmann F, Rothmann F, Rohrberg R, Böck HP, Wandt H, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. The addition of rituximab to a combination of fludarabine, cyclophosphamide, mitoxantrone (FCM) significantly increases the response rate and prolongs survival as compared with FCM alone in patients with relapsed and refractory follicular and mantle cell lymphomas: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood. 2004 Nov 15;104(10):3064-71. Epub 2004 Jul 29. [http://bloodjournal | + | # Forstpointner R, Dreyling M, Repp R, Hermann S, Hänel A, Metzner B, Pott C, Hartmann F, Rothmann F, Rohrberg R, Böck HP, Wandt H, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. The addition of rituximab to a combination of fludarabine, cyclophosphamide, mitoxantrone (FCM) significantly increases the response rate and prolongs survival as compared with FCM alone in patients with relapsed and refractory follicular and mantle cell lymphomas: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood. 2004 Nov 15;104(10):3064-71. Epub 2004 Jul 29. [http://www.bloodjournal.org/content/104/10/3064.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/15284112 PubMed] content property of [http://hemonc.org HemOnc.org] |
− | ## '''Update:''' Forstpointner R, Unterhalt M, Dreyling M, Böck HP, Repp R, Wandt H, Pott C, Seymour JF, Metzner B, Hänel A, Lehmann T, Hartmann F, Einsele H, Hiddemann W; German Low Grade Lymphoma Study Group (GLSG). Maintenance therapy with rituximab leads to a significant prolongation of response duration after salvage therapy with a combination of rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) in patients with recurring and refractory follicular and mantle cell lymphomas: Results of a prospective randomized study of the German Low Grade Lymphoma Study Group (GLSG). Blood. 2006 Dec 15;108(13):4003-8. Epub 2006 Aug 31. [http://bloodjournal | + | ## '''Update:''' Forstpointner R, Unterhalt M, Dreyling M, Böck HP, Repp R, Wandt H, Pott C, Seymour JF, Metzner B, Hänel A, Lehmann T, Hartmann F, Einsele H, Hiddemann W; German Low Grade Lymphoma Study Group (GLSG). Maintenance therapy with rituximab leads to a significant prolongation of response duration after salvage therapy with a combination of rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) in patients with recurring and refractory follicular and mantle cell lymphomas: Results of a prospective randomized study of the German Low Grade Lymphoma Study Group (GLSG). Blood. 2006 Dec 15;108(13):4003-8. Epub 2006 Aug 31. [http://www.bloodjournal.org/content/108/13/4003.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/16946304 PubMed] |
==FR {{#subobject:d61742|Regimen=1}}== | ==FR {{#subobject:d61742|Regimen=1}}== | ||
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|- | |- | ||
|[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00447-7/fulltext Rummel et al. 2015 (StiL NHL 2-2003)] | |[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00447-7/fulltext Rummel et al. 2015 (StiL NHL 2-2003)] | ||
− | | | + | |style="background-color:#00cd00"|Phase III |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|[[Mantle_cell_lymphoma#BR_2|BR]] | |[[Mantle_cell_lymphoma#BR_2|BR]] | ||
− | | | + | |style="background-color:#ff0000"|Seems to have inferior OS |
− | style="background:#ff0000 | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
Line 1,915: | Line 1,641: | ||
<!-- # '''Abstract:''' Mathias J. Rummel, MD, PhD, Ulrich Kaiser, MD, Christina Balser, Martina Beate Stauch, Wolfram Brugger, MD, PhD, Manfred Welslau, Norbert Niederle, Christoph Losem, Harald Ballo, Eckhart Weidmann, Ulrich von Gruenhagen, Lothar Mueller, Michael Sandherr, MD, Julia Vereschagina, Axel Hinke and Juergen Barth. Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab In Patients with Relapsed Follicular, Indolent and Mantle Cell Lymphomas – Final Results of the Randomized Phase III Study NHL 2-2003 on Behalf of the StiL (Study Group Indolent Lymphomas, Germany). ASH Annual Meeting 2010, Abstract 856 [https://ash.confex.com/ash/2010/webprogram/Paper26917.html link to abstract] | <!-- # '''Abstract:''' Mathias J. Rummel, MD, PhD, Ulrich Kaiser, MD, Christina Balser, Martina Beate Stauch, Wolfram Brugger, MD, PhD, Manfred Welslau, Norbert Niederle, Christoph Losem, Harald Ballo, Eckhart Weidmann, Ulrich von Gruenhagen, Lothar Mueller, Michael Sandherr, MD, Julia Vereschagina, Axel Hinke and Juergen Barth. Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab In Patients with Relapsed Follicular, Indolent and Mantle Cell Lymphomas – Final Results of the Randomized Phase III Study NHL 2-2003 on Behalf of the StiL (Study Group Indolent Lymphomas, Germany). ASH Annual Meeting 2010, Abstract 856 [https://ash.confex.com/ash/2010/webprogram/Paper26917.html link to abstract] | ||
## '''Update:''' '''Abstract:''' Mathias J. Rummel, MD, Christina Balser, MD, Ulrich Kaiser, MD, Hans Peter Böck, Martina Beate Stauch, MD, Andrea Heider, PhD, Manfred Welslau, Christoph Losem, Eckhart Weidmann, Wolfgang Blau, MD, Alexander Burchardt, MD, Jürgen Barth, Frank Kauff, PhD, Axel Hinke, PhD and Wolfram Brugger, MD. Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab in Patients with Relapsed Follicular, Indolent, or Mantle Cell Lymphomas – 8-Year Follow-up Results of the Randomized Phase III Study NHL 2-2003 on Behalf of the StiL (Study Group Indolent Lymphomas, Germany). ASH Annual Meeting 2014, Abstract 145 [https://ash.confex.com/ash/2014/webprogram/Paper69154.html link to abstract] --> | ## '''Update:''' '''Abstract:''' Mathias J. Rummel, MD, Christina Balser, MD, Ulrich Kaiser, MD, Hans Peter Böck, Martina Beate Stauch, MD, Andrea Heider, PhD, Manfred Welslau, Christoph Losem, Eckhart Weidmann, Wolfgang Blau, MD, Alexander Burchardt, MD, Jürgen Barth, Frank Kauff, PhD, Axel Hinke, PhD and Wolfram Brugger, MD. Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab in Patients with Relapsed Follicular, Indolent, or Mantle Cell Lymphomas – 8-Year Follow-up Results of the Randomized Phase III Study NHL 2-2003 on Behalf of the StiL (Study Group Indolent Lymphomas, Germany). ASH Annual Meeting 2014, Abstract 145 [https://ash.confex.com/ash/2014/webprogram/Paper69154.html link to abstract] --> | ||
− | # Rummel M, Kaiser U, Balser C, Stauch M, Brugger W, Welslau M, Niederle N, Losem C, Boeck HP, Weidmann E, von Gruenhagen U, Mueller L, Sandherr M, Hahn L, Vereshchagina J, Kauff F, Blau W, Hinke A, Barth J; Study group indolent Lymphomas (StiL). Bendamustine plus rituximab versus fludarabine plus rituximab for patients with relapsed indolent and mantle-cell lymphomas: a multicentre, randomised, open-label, non-inferiority phase 3 trial. Lancet Oncol. 2016 Jan;17(1):57-66. Epub 2015 Dec 5. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00447-7/fulltext link to original article] '''contains protocol''' [ | + | # Rummel M, Kaiser U, Balser C, Stauch M, Brugger W, Welslau M, Niederle N, Losem C, Boeck HP, Weidmann E, von Gruenhagen U, Mueller L, Sandherr M, Hahn L, Vereshchagina J, Kauff F, Blau W, Hinke A, Barth J; Study group indolent Lymphomas (StiL). Bendamustine plus rituximab versus fludarabine plus rituximab for patients with relapsed indolent and mantle-cell lymphomas: a multicentre, randomised, open-label, non-inferiority phase 3 trial. Lancet Oncol. 2016 Jan;17(1):57-66. Epub 2015 Dec 5. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00447-7/fulltext link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/26655425 PubMed] |
==Ibrutinib (Imbruvica) {{#subobject:1e0d5c|Regimen=1}}== | ==Ibrutinib (Imbruvica) {{#subobject:1e0d5c|Regimen=1}}== | ||
Line 1,930: | Line 1,656: | ||
|- | |- | ||
|[http://www.nejm.org/doi/full/10.1056/NEJMoa1306220 Wang et al. 2013 (PCYC-1104-CA)] | |[http://www.nejm.org/doi/full/10.1056/NEJMoa1306220 Wang et al. 2013 (PCYC-1104-CA)] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background:# | + | |style="background-color:#d3d3d3"| |
− | + | |style="background-color:#d3d3d3"| | |
− | |||
− | |||
− | |||
− | |||
− | | | ||
|- | |- | ||
|[http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00667-4/fulltext Dreyling et al. 2015] | |[http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00667-4/fulltext Dreyling et al. 2015] | ||
− | | | + | |style="background-color:#00cd00"|Phase III |
− | style="background:#00cd00 | ||
− | |||
− | |||
− | |||
− | |||
|[[#Temsirolimus_.28Torisel.29|Temsirolimus]] | |[[#Temsirolimus_.28Torisel.29|Temsirolimus]] | ||
− | | | + | |style="background-color:#00cd00"|Superior PFS |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
Line 1,961: | Line 1,672: | ||
===References=== | ===References=== | ||
− | # Wang ML, Rule S, Martin P, Goy A, Auer R, Kahl BS, Jurczak W, Advani RH, Romaguera JE, Williams ME, Barrientos JC, Chmielowska E, Radford J, Stilgenbauer S, Dreyling M, Jedrzejczak WW, Johnson P, Spurgeon SE, Li L, Zhang L, Newberry K, Ou Z, Cheng N, Fang B, McGreivy J, Clow F, Buggy JJ, Chang BY, Beaupre DM, Kunkel LA, Blum KA. Targeting BTK with Ibrutinib in Relapsed or Refractory Mantle-Cell Lymphoma. N Engl J Med. 2013 Aug 8;369(6):507-16. Epub 2013 Jun 19. [http://www.nejm.org/doi/full/10.1056/NEJMoa1306220 link to original article] '''contains verified protocol''' [ | + | # Wang ML, Rule S, Martin P, Goy A, Auer R, Kahl BS, Jurczak W, Advani RH, Romaguera JE, Williams ME, Barrientos JC, Chmielowska E, Radford J, Stilgenbauer S, Dreyling M, Jedrzejczak WW, Johnson P, Spurgeon SE, Li L, Zhang L, Newberry K, Ou Z, Cheng N, Fang B, McGreivy J, Clow F, Buggy JJ, Chang BY, Beaupre DM, Kunkel LA, Blum KA. Targeting BTK with Ibrutinib in Relapsed or Refractory Mantle-Cell Lymphoma. N Engl J Med. 2013 Aug 8;369(6):507-16. Epub 2013 Jun 19. [http://www.nejm.org/doi/full/10.1056/NEJMoa1306220 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23782157 PubMed] |
− | ## '''Update: Abstract:''' Michael Wang, MD, Simon Rule, MD, Peter Martin, MD, Andre Goy, MD, Rebecca Auer, MD, PhD, Brad S. Kahl, MD, Wojciech Jurczak, Ranjana Advani, MD, Jorge E. Romaguera, MD, Michael E. Williams, MD, Jacqueline C. Barrientos, M.D., Ewa Chmielowska, MD, John Radford, Stephan Stilgenbauer, MD, Martin Dreyling, Wieslaw Wiktor Jedrzejczak, MD, Peter W Johnson, MD, Stephen E. Spurgeon, MD, Liang Zhang, MD, PhD, Linda Baher, Mei Cheng, PhD, Darrin M. Beaupre, MD and Kristie A. Blum, MD. Single-Agent Ibrutinib Demonstrates Safety and Durability of Response at 2 Years Follow-up in Patients with Relapsed or Refractory Mantle Cell Lymphoma: Updated Results of an International, Multicenter, Open-Label Phase 2 Study. | + | ## '''Update: Abstract:''' Michael Wang, MD, Simon Rule, MD, Peter Martin, MD, Andre Goy, MD, Rebecca Auer, MD, PhD, Brad S. Kahl, MD, Wojciech Jurczak, Ranjana Advani, MD, Jorge E. Romaguera, MD, Michael E. Williams, MD, Jacqueline C. Barrientos, M.D., Ewa Chmielowska, MD, John Radford, Stephan Stilgenbauer, MD, Martin Dreyling, Wieslaw Wiktor Jedrzejczak, MD, Peter W Johnson, MD, Stephen E. Spurgeon, MD, Liang Zhang, MD, PhD, Linda Baher, Mei Cheng, PhD, Darrin M. Beaupre, MD and Kristie A. Blum, MD. Single-Agent Ibrutinib Demonstrates Safety and Durability of Response at 2 Years Follow-up in Patients with Relapsed or Refractory Mantle Cell Lymphoma: Updated Results of an International, Multicenter, Open-Label Phase 2 Study. Blood 2014 124:4453. [http://www.bloodjournal.org/content/124/21/4453 link to abstract] |
− | ## '''Update:''' Wang ML, Blum KA, Martin P, Goy A, Auer R, Kahl BS, Jurczak W, Advani RH, Romaguera JE, Williams ME, Barrientos JC, Chmielowska E, Radford J, Stilgenbauer S, Dreyling M, Jedrzejczak WW, Johnson P, Spurgeon SE, Zhang L, Baher L, Cheng M, Lee D, Beaupre DM, Rule S. Long-term follow-up of MCL patients treated with single-agent ibrutinib: Updated safety and efficacy results. Blood. 2015 Aug 6;126(6):739-45. Epub 2015 Jun 9. [http://www.bloodjournal.org/content/126/6/739 link to original article] [ | + | ## '''Update:''' Wang ML, Blum KA, Martin P, Goy A, Auer R, Kahl BS, Jurczak W, Advani RH, Romaguera JE, Williams ME, Barrientos JC, Chmielowska E, Radford J, Stilgenbauer S, Dreyling M, Jedrzejczak WW, Johnson P, Spurgeon SE, Zhang L, Baher L, Cheng M, Lee D, Beaupre DM, Rule S. Long-term follow-up of MCL patients treated with single-agent ibrutinib: Updated safety and efficacy results. Blood. 2015 Aug 6;126(6):739-45. Epub 2015 Jun 9. [http://www.bloodjournal.org/content/126/6/739 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/26059948 PubMed] |
− | # Dreyling M, Jurczak W, Jerkeman M, Silva RS, Rusconi C, Trneny M, Offner F, Caballero D, Joao C, Witzens-Harig M, Hess G, Bence-Bruckler I, Cho SG, Bothos J, Goldberg JD, Enny C, Traina S, Balasubramanian S, Bandyopadhyay N, Sun S, Vermeulen J, Rizo A, Rule S. Ibrutinib versus temsirolimus in patients with relapsed or refractory mantle-cell lymphoma: an international, randomised, open-label, phase 3 study. Lancet. 2016 Feb 20;387(10020):770-8. Epub 2015 Dec 4. [http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00667-4/fulltext link to original article] '''contains verified protocol''' [ | + | # Dreyling M, Jurczak W, Jerkeman M, Silva RS, Rusconi C, Trneny M, Offner F, Caballero D, Joao C, Witzens-Harig M, Hess G, Bence-Bruckler I, Cho SG, Bothos J, Goldberg JD, Enny C, Traina S, Balasubramanian S, Bandyopadhyay N, Sun S, Vermeulen J, Rizo A, Rule S. Ibrutinib versus temsirolimus in patients with relapsed or refractory mantle-cell lymphoma: an international, randomised, open-label, phase 3 study. Lancet. 2016 Feb 20;387(10020):770-8. Epub 2015 Dec 4. [http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00667-4/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/26673811 PubMed] |
==Lenalidomide (Revlimid) {{#subobject:b5de78|Regimen=1}}== | ==Lenalidomide (Revlimid) {{#subobject:b5de78|Regimen=1}}== | ||
Line 1,977: | Line 1,688: | ||
|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|'''Comparator''' | |'''Comparator''' | ||
+ | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
|[http://jco.ascopubs.org/content/26/30/4952.long Wiernik et al. 2008 (NHL-002)] | |[http://jco.ascopubs.org/content/26/30/4952.long Wiernik et al. 2008 (NHL-002)] | ||
− | | | + | |style="background-color:#ff0000"|Phase II, <20 pts in subgroup |
− | style="background:#ff0000 | + | |style="background-color:#d3d3d3"| |
− | + | |style="background-color:#d3d3d3"| | |
− | |||
− | |||
− | |||
− | | | ||
|- | |- | ||
|[http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2009.07626.x/full Habermann et al. 2009] | |[http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2009.07626.x/full Habermann et al. 2009] | ||
− | | | + | |style="background-color:#ff0000"|Phase II, <20 pts in subgroup |
− | style="background:#ff0000 | + | |style="background-color:#d3d3d3"| |
− | + | |style="background-color:#d3d3d3"| | |
− | |||
− | |||
− | |||
− | | | ||
|- | |- | ||
|[http://annonc.oxfordjournals.org/content/22/7/1622.long Witzig et al. 2011 (NHL-003)] | |[http://annonc.oxfordjournals.org/content/22/7/1622.long Witzig et al. 2011 (NHL-003)] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background:#eeee00 | + | |style="background-color:#d3d3d3"| |
− | + | |style="background-color:#d3d3d3"| | |
− | |||
− | |||
− | |||
− | | | ||
|- | |- | ||
|[http://onlinelibrary.wiley.com/doi/10.1111/bjh.12008/full Eve et al. 2012] | |[http://onlinelibrary.wiley.com/doi/10.1111/bjh.12008/full Eve et al. 2012] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background:#eeee00 | + | |style="background-color:#d3d3d3"| |
− | + | |style="background-color:#d3d3d3"| | |
− | |||
− | |||
− | |||
− | | | ||
|- | |- | ||
|[http://jco.ascopubs.org/content/31/29/3688.long Goy et al. 2013 (MCL-001, EMERGE)] | |[http://jco.ascopubs.org/content/31/29/3688.long Goy et al. 2013 (MCL-001, EMERGE)] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background:#eeee00 | + | |style="background-color:#d3d3d3"| |
− | + | |style="background-color:#d3d3d3"| | |
− | |||
− | |||
− | |||
− | | | ||
|- | |- | ||
|[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00559-8/fulltext Trněný et al. 2016 (MCL-002, SPRINT)] | |[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00559-8/fulltext Trněný et al. 2016 (MCL-002, SPRINT)] | ||
− | | | + | |style="background-color:#00cd00"|Randomized Phase II |
− | style="background:#00cd00 | ||
− | |||
− | |||
− | |||
− | |||
|Investigator's choice | |Investigator's choice | ||
+ | |style="background-color:#00cd00"|Superior PFS | ||
|- | |- | ||
|} | |} | ||
Line 2,044: | Line 1,732: | ||
===References=== | ===References=== | ||
<!-- Presented in part as oral presentations at the 48th Annual Meeting of the American Society of Hematology, December 9-12, 2006, Orlando, FL, and the 3rd International Conference of Innovative Therapies for Lymphoid Malignancies, September 28, 2006, Palermo, Italy; and as poster presentations at the 48th Annual Meeting of the American Society of Hematology, December 9-12, 2006, Orlando, FL, the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL; and the Pan Pacific Lymphoma Conference, June 11-15, 2007, Maui, HI. --> | <!-- Presented in part as oral presentations at the 48th Annual Meeting of the American Society of Hematology, December 9-12, 2006, Orlando, FL, and the 3rd International Conference of Innovative Therapies for Lymphoid Malignancies, September 28, 2006, Palermo, Italy; and as poster presentations at the 48th Annual Meeting of the American Society of Hematology, December 9-12, 2006, Orlando, FL, the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL; and the Pan Pacific Lymphoma Conference, June 11-15, 2007, Maui, HI. --> | ||
− | # Wiernik PH, Lossos IS, Tuscano JM, Justice G, Vose JM, Cole CE, Lam W, McBride K, Wride K, Pietronigro D, Takeshita K, Ervin-Haynes A, Zeldis JB, Habermann TM. Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma. J Clin Oncol. 2008 Oct 20;26(30):4952-7. Epub 2008 Jul 7. [http://jco.ascopubs.org/content/26/30/4952.long link to original article] '''contains verified protocol''' [ | + | # Wiernik PH, Lossos IS, Tuscano JM, Justice G, Vose JM, Cole CE, Lam W, McBride K, Wride K, Pietronigro D, Takeshita K, Ervin-Haynes A, Zeldis JB, Habermann TM. Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma. J Clin Oncol. 2008 Oct 20;26(30):4952-7. Epub 2008 Jul 7. [http://jco.ascopubs.org/content/26/30/4952.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/18606983 PubMed] |
− | # Habermann TM, Lossos IS, Justice G, Vose JM, Wiernik PH, McBride K, Wride K, Ervin-Haynes A, Takeshita K, Pietronigro D, Zeldis JB, Tuscano JM. Lenalidomide oral monotherapy produces a high response rate in patients with relapsed or refractory mantle cell lymphoma. Br J Haematol. 2009 May;145(3):344-9. Epub 2009 Feb 24. [http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2009.07626.x/full link to original article] '''contains verified protocol''' [ | + | # Habermann TM, Lossos IS, Justice G, Vose JM, Wiernik PH, McBride K, Wride K, Ervin-Haynes A, Takeshita K, Pietronigro D, Zeldis JB, Tuscano JM. Lenalidomide oral monotherapy produces a high response rate in patients with relapsed or refractory mantle cell lymphoma. Br J Haematol. 2009 May;145(3):344-9. Epub 2009 Feb 24. [http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2009.07626.x/full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/19245430 PubMed] |
− | # Witzig TE, Vose JM, Zinzani PL, Reeder CB, Buckstein R, Polikoff JA, Bouabdallah R, Haioun C, Tilly H, Guo P, Pietronigro D, Ervin-Haynes AL, Czuczman MS. An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. Ann Oncol. 2011 Jul;22(7):1622-7. Epub 2011 Jan 12. [http://annonc.oxfordjournals.org/content/22/7/1622.long link to original article] '''contains verified protocol''' [ | + | # Witzig TE, Vose JM, Zinzani PL, Reeder CB, Buckstein R, Polikoff JA, Bouabdallah R, Haioun C, Tilly H, Guo P, Pietronigro D, Ervin-Haynes AL, Czuczman MS. An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. Ann Oncol. 2011 Jul;22(7):1622-7. Epub 2011 Jan 12. [http://annonc.oxfordjournals.org/content/22/7/1622.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/21228334 PubMed] |
− | ## '''Update:''' Zinzani PL, Vose JM, Czuczman MS, Reeder CB, Haioun C, Polikoff J, Tilly H, Zhang L, Prandi K, Li J, Witzig TE. Long-term follow-up of lenalidomide in relapsed/refractory mantle cell lymphoma: subset analysis of the NHL-003 study. Ann Oncol. 2013 Nov;24(11):2892-7. Epub 2013 Sep 12. [http://annonc.oxfordjournals.org/content/24/11/2892.long link to original article] [ | + | ## '''Update:''' Zinzani PL, Vose JM, Czuczman MS, Reeder CB, Haioun C, Polikoff J, Tilly H, Zhang L, Prandi K, Li J, Witzig TE. Long-term follow-up of lenalidomide in relapsed/refractory mantle cell lymphoma: subset analysis of the NHL-003 study. Ann Oncol. 2013 Nov;24(11):2892-7. Epub 2013 Sep 12. [http://annonc.oxfordjournals.org/content/24/11/2892.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/24030098 PubMed] |
− | # Eve HE, Carey S, Richardson SJ, Heise CC, Mamidipudi V, Shi T, Radford JA, Auer RL, Bullard SH, Rule SA. Single-agent lenalidomide in relapsed/refractory mantle cell lymphoma: results from a UK phase II study suggest activity and possible gender differences. Br J Haematol. 2012 Oct;159(2):154-63. Epub 2012 Aug 9. [http://onlinelibrary.wiley.com/doi/10.1111/bjh.12008/full link to original article] '''contains verified protocol''' [ | + | # Eve HE, Carey S, Richardson SJ, Heise CC, Mamidipudi V, Shi T, Radford JA, Auer RL, Bullard SH, Rule SA. Single-agent lenalidomide in relapsed/refractory mantle cell lymphoma: results from a UK phase II study suggest activity and possible gender differences. Br J Haematol. 2012 Oct;159(2):154-63. Epub 2012 Aug 9. [http://onlinelibrary.wiley.com/doi/10.1111/bjh.12008/full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/22881386 PubMed] |
<!-- Presented in part at the 54th American Society of Hematology Meeting and Exposition, Atlanta, GA, December 8-11, 2012. --> | <!-- Presented in part at the 54th American Society of Hematology Meeting and Exposition, Atlanta, GA, December 8-11, 2012. --> | ||
− | # Goy A, Sinha R, Williams ME, Kalayoglu Besisik S, Drach J, Ramchandren R, Zhang L, Cicero S, Fu T, Witzig TE. Single-Agent Lenalidomide in Patients With Mantle-Cell Lymphoma Who Relapsed or Progressed After or Were Refractory to Bortezomib: Phase II MCL-001 (EMERGE) Study. J Clin Oncol. 2013 Oct 10;31(29):3688-95. Epub 2013 Sep 3. [http://jco.ascopubs.org/content/31/29/3688.long link to original article] '''contains verified protocol''' [ | + | # Goy A, Sinha R, Williams ME, Kalayoglu Besisik S, Drach J, Ramchandren R, Zhang L, Cicero S, Fu T, Witzig TE. Single-Agent Lenalidomide in Patients With Mantle-Cell Lymphoma Who Relapsed or Progressed After or Were Refractory to Bortezomib: Phase II MCL-001 (EMERGE) Study. J Clin Oncol. 2013 Oct 10;31(29):3688-95. Epub 2013 Sep 3. [http://jco.ascopubs.org/content/31/29/3688.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/24002500 PubMed] |
− | ## '''Update:''' Goy A, Kalayoglu Besisik S, Drach J, Ramchandren R, Robertson MJ, Avivi I, Rowe JM, Herbrecht R, Van Hoof A, Zhang L, Cicero S, Fu T, Witzig T. Longer-term follow-up and outcome by tumour cell proliferation rate (Ki-67) in patients with relapsed/refractory mantle cell lymphoma treated with lenalidomide on MCL-001(EMERGE) pivotal trial. Br J Haematol. 2015 Aug;170(4):496-503. Epub 2015 Apr 28. [http://onlinelibrary.wiley.com/doi/10.1111/bjh.13456/full link to original article] [ | + | ## '''Update:''' Goy A, Kalayoglu Besisik S, Drach J, Ramchandren R, Robertson MJ, Avivi I, Rowe JM, Herbrecht R, Van Hoof A, Zhang L, Cicero S, Fu T, Witzig T. Longer-term follow-up and outcome by tumour cell proliferation rate (Ki-67) in patients with relapsed/refractory mantle cell lymphoma treated with lenalidomide on MCL-001(EMERGE) pivotal trial. Br J Haematol. 2015 Aug;170(4):496-503. Epub 2015 Apr 28. [http://onlinelibrary.wiley.com/doi/10.1111/bjh.13456/full link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/25921098 PubMed] |
<!-- # '''Abstract:''' Marek Trneny, Thierry Lamy, Jan Walewski, Wojciech Jurczak, David Belada, MD, Jiri Mayer, Prof., MD, Ph.D., John Radford, Julia Alexeeva, Dzhelil Osmanov, Tsvetan Biyukov, Meera Patturajan, Marie-Laure Casadebaig Bravo and Luca Arcaini. Phase II Randomized, Multicenter Study of Lenalidomide Vs Best Investigator’s Choice in Relapsed/Refractory Mantle Cell Lymphoma: Results of the MCL-002 (SPRINT) Study. ASH Annual Meeting 2014 Abstract 627 [https://ash.confex.com/ash/2014/webprogram/Paper69212.html link to abstract] --> | <!-- # '''Abstract:''' Marek Trneny, Thierry Lamy, Jan Walewski, Wojciech Jurczak, David Belada, MD, Jiri Mayer, Prof., MD, Ph.D., John Radford, Julia Alexeeva, Dzhelil Osmanov, Tsvetan Biyukov, Meera Patturajan, Marie-Laure Casadebaig Bravo and Luca Arcaini. Phase II Randomized, Multicenter Study of Lenalidomide Vs Best Investigator’s Choice in Relapsed/Refractory Mantle Cell Lymphoma: Results of the MCL-002 (SPRINT) Study. ASH Annual Meeting 2014 Abstract 627 [https://ash.confex.com/ash/2014/webprogram/Paper69212.html link to abstract] --> | ||
− | # Trněný M, Lamy T, Walewski J, Belada D, Mayer J, Radford J, Jurczak W, Morschhauser F, Alexeeva J, Rule S, Afanasyev B, Kaplanov K, Thyss A, Kuzmin A, Voloshin S, Kuliczkowski K, Giza A, Milpied N, Stelitano C, Marks R, Trümper L, Biyukov T, Patturajan M, Bravo MC, Arcaini L; SPRINT trial investigators and in collaboration with the European Mantle Cell Lymphoma Network. Lenalidomide versus investigator's choice in relapsed or refractory mantle cell lymphoma (MCL-002; SPRINT): a phase 2, randomised, multicentre trial. Lancet Oncol. 2016 Mar;17(3):319-31. Epub 2016 Feb 15. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00559-8/fulltext link to original article] [ | + | # Trněný M, Lamy T, Walewski J, Belada D, Mayer J, Radford J, Jurczak W, Morschhauser F, Alexeeva J, Rule S, Afanasyev B, Kaplanov K, Thyss A, Kuzmin A, Voloshin S, Kuliczkowski K, Giza A, Milpied N, Stelitano C, Marks R, Trümper L, Biyukov T, Patturajan M, Bravo MC, Arcaini L; SPRINT trial investigators and in collaboration with the European Mantle Cell Lymphoma Network. Lenalidomide versus investigator's choice in relapsed or refractory mantle cell lymphoma (MCL-002; SPRINT): a phase 2, randomised, multicentre trial. Lancet Oncol. 2016 Mar;17(3):319-31. Epub 2016 Feb 15. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00559-8/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/26899778 PubMed] |
==R-FCM {{#subobject:4f239|Regimen=1}}== | ==R-FCM {{#subobject:4f239|Regimen=1}}== | ||
Line 2,069: | Line 1,757: | ||
|[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
− | |[http://bloodjournal | + | |[http://www.bloodjournal.org/content/104/10/3064.long Forstpointner et al. 2004] |
− | | | + | |style="background-color:#00cd00"|Phase III |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|[[Mantle_cell_lymphoma#FCM|FCM]] | |[[Mantle_cell_lymphoma#FCM|FCM]] | ||
− | | | + | |style="background-color:#00cd00"|Superior OS |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
Line 2,096: | Line 1,774: | ||
===References=== | ===References=== | ||
− | # Forstpointner R, Dreyling M, Repp R, Hermann S, Hänel A, Metzner B, Pott C, Hartmann F, Rothmann F, Rohrberg R, Böck HP, Wandt H, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. The addition of rituximab to a combination of fludarabine, cyclophosphamide, mitoxantrone (FCM) significantly increases the response rate and prolongs survival as compared with FCM alone in patients with relapsed and refractory follicular and mantle cell lymphomas: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood. 2004 Nov 15;104(10):3064-71. Epub 2004 Jul 29. [http://bloodjournal | + | # Forstpointner R, Dreyling M, Repp R, Hermann S, Hänel A, Metzner B, Pott C, Hartmann F, Rothmann F, Rohrberg R, Böck HP, Wandt H, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. The addition of rituximab to a combination of fludarabine, cyclophosphamide, mitoxantrone (FCM) significantly increases the response rate and prolongs survival as compared with FCM alone in patients with relapsed and refractory follicular and mantle cell lymphomas: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood. 2004 Nov 15;104(10):3064-71. Epub 2004 Jul 29. [http://www.bloodjournal.org/content/104/10/3064.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/15284112 PubMed] |
− | ## '''Update:''' Forstpointner R, Unterhalt M, Dreyling M, Böck HP, Repp R, Wandt H, Pott C, Seymour JF, Metzner B, Hänel A, Lehmann T, Hartmann F, Einsele H, Hiddemann W; German Low Grade Lymphoma Study Group (GLSG). Maintenance therapy with rituximab leads to a significant prolongation of response duration after salvage therapy with a combination of rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) in patients with recurring and refractory follicular and mantle cell lymphomas: Results of a prospective randomized study of the German Low Grade Lymphoma Study Group (GLSG). Blood. 2006 Dec 15;108(13):4003-8. Epub 2006 Aug 31. [http://bloodjournal | + | ## '''Update:''' Forstpointner R, Unterhalt M, Dreyling M, Böck HP, Repp R, Wandt H, Pott C, Seymour JF, Metzner B, Hänel A, Lehmann T, Hartmann F, Einsele H, Hiddemann W; German Low Grade Lymphoma Study Group (GLSG). Maintenance therapy with rituximab leads to a significant prolongation of response duration after salvage therapy with a combination of rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) in patients with recurring and refractory follicular and mantle cell lymphomas: Results of a prospective randomized study of the German Low Grade Lymphoma Study Group (GLSG). Blood. 2006 Dec 15;108(13):4003-8. Epub 2006 Aug 31. [http://www.bloodjournal.org/content/108/13/4003.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/16946304 PubMed] |
==Temsirolimus (Torisel) {{#subobject:575bde|Regimen=1}}== | ==Temsirolimus (Torisel) {{#subobject:575bde|Regimen=1}}== | ||
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|- | |- | ||
|[http://jco.ascopubs.org/content/27/23/3822.long Hess et al. 2009] | |[http://jco.ascopubs.org/content/27/23/3822.long Hess et al. 2009] | ||
− | | | + | |style="background-color:#00cd00"|Phase III |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|Investigator's choice<br> Temsirolimus 175/25 | |Investigator's choice<br> Temsirolimus 175/25 | ||
− | | | + | |style="background-color:#00cd00"|Superior PFS |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|[http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00667-4/fulltext Dreyling et al. 2015] | |[http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00667-4/fulltext Dreyling et al. 2015] | ||
− | | | + | |style="background-color:#00cd00"|Phase III |
− | style="background:#00cd00 | ||
− | |||
− | |||
− | |||
− | |||
|[[#Ibrutinib_.28Imbruvica.29|Ibrutinib]] | |[[#Ibrutinib_.28Imbruvica.29|Ibrutinib]] | ||
− | | | + | |style="background-color:#ff0000"|Inferior PFS |
− | style="background:#ff0000 | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
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===References=== | ===References=== | ||
− | # Hess G, Herbrecht R, Romaguera J, Verhoef G, Crump M, Gisselbrecht C, Laurell A, Offner F, Strahs A, Berkenblit A, Hanushevsky O, Clancy J, Hewes B, Moore L, Coiffier B. Phase III study to evaluate temsirolimus compared with investigator's choice therapy for the treatment of relapsed or refractory mantle cell lymphoma. J Clin Oncol. 2009 Aug 10;27(23):3822-9. Epub 2009 Jul 6. [http://jco.ascopubs.org/content/27/23/3822.long link to original article] '''contains verified protocol''' [ | + | # Hess G, Herbrecht R, Romaguera J, Verhoef G, Crump M, Gisselbrecht C, Laurell A, Offner F, Strahs A, Berkenblit A, Hanushevsky O, Clancy J, Hewes B, Moore L, Coiffier B. Phase III study to evaluate temsirolimus compared with investigator's choice therapy for the treatment of relapsed or refractory mantle cell lymphoma. J Clin Oncol. 2009 Aug 10;27(23):3822-9. Epub 2009 Jul 6. [http://jco.ascopubs.org/content/27/23/3822.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/19581539 PubMed] |
− | # Dreyling M, Jurczak W, Jerkeman M, Silva RS, Rusconi C, Trneny M, Offner F, Caballero D, Joao C, Witzens-Harig M, Hess G, Bence-Bruckler I, Cho SG, Bothos J, Goldberg JD, Enny C, Traina S, Balasubramanian S, Bandyopadhyay N, Sun S, Vermeulen J, Rizo A, Rule S. Ibrutinib versus temsirolimus in patients with relapsed or refractory mantle-cell lymphoma: an international, randomised, open-label, phase 3 study. Lancet. 2016 Feb 20;387(10020):770-8. Epub 2015 Dec 4. [http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00667-4/fulltext link to original article] '''contains verified protocol''' [ | + | # Dreyling M, Jurczak W, Jerkeman M, Silva RS, Rusconi C, Trneny M, Offner F, Caballero D, Joao C, Witzens-Harig M, Hess G, Bence-Bruckler I, Cho SG, Bothos J, Goldberg JD, Enny C, Traina S, Balasubramanian S, Bandyopadhyay N, Sun S, Vermeulen J, Rizo A, Rule S. Ibrutinib versus temsirolimus in patients with relapsed or refractory mantle-cell lymphoma: an international, randomised, open-label, phase 3 study. Lancet. 2016 Feb 20;387(10020):770-8. Epub 2015 Dec 4. [http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00667-4/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/26673811 PubMed] |
=Relapsed/refractory, non-randomized or retrospective data= | =Relapsed/refractory, non-randomized or retrospective data= | ||
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|- | |- | ||
|[http://annonc.oxfordjournals.org/content/25/7/1391.full.html Gill et al. 2014] | |[http://annonc.oxfordjournals.org/content/25/7/1391.full.html Gill et al. 2014] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
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===References=== | ===References=== | ||
− | # Gill H, Au WY, Cheung WW, Lee EY, Kwong YL. Oral arsenic trioxide-based regimen as salvage treatment for relapsed or refractory mantle cell lymphoma. Ann Oncol. 2014 Jul;25(7):1391-7. Epub 2014 Apr 12. [http://annonc.oxfordjournals.org/content/25/7/1391.full.html link to original article] '''contains verified protocol''' [ | + | # Gill H, Au WY, Cheung WW, Lee EY, Kwong YL. Oral arsenic trioxide-based regimen as salvage treatment for relapsed or refractory mantle cell lymphoma. Ann Oncol. 2014 Jul;25(7):1391-7. Epub 2014 Apr 12. [http://annonc.oxfordjournals.org/content/25/7/1391.full.html link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/24728036 PubMed] |
==BeRT {{#subobject:37c30e|Regimen=1}}== | ==BeRT {{#subobject:37c30e|Regimen=1}}== | ||
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|- | |- | ||
|[http://www.nature.com/leu/journal/v29/n8/full/leu201560a.html Hess et al. 2015] | |[http://www.nature.com/leu/journal/v29/n8/full/leu201560a.html Hess et al. 2015] | ||
− | | | + | |style="background-color:#ff0000"|Phase I/II, <20 pts reported |
− | style="background:#ff0000 | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
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===References=== | ===References=== | ||
− | # Hess G, Keller U, Scholz CW, Witzens-Harig M, Atta J, Buske C, Kirschey S, Ruckes C, Medler C, van Oordt C, Klapper W, Theobald M, Dreyling M. Safety and efficacy of Temsirolimus in combination with Bendamustine and Rituximab in relapsed mantle cell and follicular lymphoma. Leukemia. 2015 Aug;29(8):1695-701. Epub 2015 Mar 13. [http://www.nature.com/leu/journal/v29/n8/full/leu201560a.html link to original article] '''contains verified protocol''' [ | + | # Hess G, Keller U, Scholz CW, Witzens-Harig M, Atta J, Buske C, Kirschey S, Ruckes C, Medler C, van Oordt C, Klapper W, Theobald M, Dreyling M. Safety and efficacy of Temsirolimus in combination with Bendamustine and Rituximab in relapsed mantle cell and follicular lymphoma. Leukemia. 2015 Aug;29(8):1695-701. Epub 2015 Mar 13. [http://www.nature.com/leu/journal/v29/n8/full/leu201560a.html link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/25765545 PubMed] |
==BORID {{#subobject:d29ebe|Regimen=1}}== | ==BORID {{#subobject:d29ebe|Regimen=1}}== | ||
Line 2,242: | Line 1,890: | ||
|- | |- | ||
|[http://onlinelibrary.wiley.com/doi/10.1002/cncr.25792/full Lamm et al. 2011] | |[http://onlinelibrary.wiley.com/doi/10.1002/cncr.25792/full Lamm et al. 2011] | ||
− | | | + | |style="background-color:#ff0000"|Phase II, <20 pts reported |
− | style="background:#ff0000 | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
Line 2,260: | Line 1,903: | ||
===References=== | ===References=== | ||
− | # Lamm W, Kaufmann H, Raderer M, Hoffmann M, Chott A, Zielinski C, Drach J. Bortezomib combined with rituximab and dexamethasone is an active regimen for patients with relapsed and chemotherapy-refractory mantle cell lymphoma. Haematologica. 2011 Jul;96(7):1008-14. Epub 2011 Apr 12. [http://www.haematologica.org/content/96/7/1008.long link to original article] '''contains verified protocol''' [ | + | # Lamm W, Kaufmann H, Raderer M, Hoffmann M, Chott A, Zielinski C, Drach J. Bortezomib combined with rituximab and dexamethasone is an active regimen for patients with relapsed and chemotherapy-refractory mantle cell lymphoma. Haematologica. 2011 Jul;96(7):1008-14. Epub 2011 Apr 12. [http://www.haematologica.org/content/96/7/1008.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/21486866 PubMed] |
==Bortezomib (Velcade) {{#subobject:3bc0e1|Regimen=1}}== | ==Bortezomib (Velcade) {{#subobject:3bc0e1|Regimen=1}}== | ||
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|- | |- | ||
|[http://jco.ascopubs.org/content/24/30/4867.long Fisher et al. 2006 (PINNACLE)] | |[http://jco.ascopubs.org/content/24/30/4867.long Fisher et al. 2006 (PINNACLE)] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
Line 2,293: | Line 1,931: | ||
|- | |- | ||
|[http://jco.ascopubs.org/content/23/4/676.long O'Connor et al. 2005] | |[http://jco.ascopubs.org/content/23/4/676.long O'Connor et al. 2005] | ||
− | | | + | |style="background-color:#ff0000"|Phase II, <20 pts reported |
− | style="background:#ff0000 | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
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===References=== | ===References=== | ||
− | # O'Connor OA, Wright J, Moskowitz C, Muzzy J, MacGregor-Cortelli B, Stubblefield M, Straus D, Portlock C, Hamlin P, Choi E, Dumetrescu O, Esseltine D, Trehu E, Adams J, Schenkein D, Zelenetz AD. Phase II clinical experience with the novel proteasome inhibitor bortezomib in patients with indolent non-Hodgkin's lymphoma and mantle cell lymphoma. J Clin Oncol. 2005 Feb 1;23(4):676-84. Epub 2004 Dec 21. [http://jco.ascopubs.org/content/23/4/676.long link to original article] '''contains verified protocol''' [ | + | # O'Connor OA, Wright J, Moskowitz C, Muzzy J, MacGregor-Cortelli B, Stubblefield M, Straus D, Portlock C, Hamlin P, Choi E, Dumetrescu O, Esseltine D, Trehu E, Adams J, Schenkein D, Zelenetz AD. Phase II clinical experience with the novel proteasome inhibitor bortezomib in patients with indolent non-Hodgkin's lymphoma and mantle cell lymphoma. J Clin Oncol. 2005 Feb 1;23(4):676-84. Epub 2004 Dec 21. [http://jco.ascopubs.org/content/23/4/676.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/15613699 PubMed] |
− | # Fisher RI, Bernstein SH, Kahl BS, Djulbegovic B, Robertson MJ, de Vos S, Epner E, Krishnan A, Leonard JP, Lonial S, Stadtmauer EA, O'Connor OA, Shi H, Boral AL, Goy A. Multicenter phase II study of bortezomib in patients with relapsed or refractory mantle cell lymphoma. J Clin Oncol. 2006 Oct 20;24(30):4867-74. Epub 2006 Sep 25. [http://jco.ascopubs.org/content/24/30/4867.long link to original article] '''contains verified protocol''' [ | + | # Fisher RI, Bernstein SH, Kahl BS, Djulbegovic B, Robertson MJ, de Vos S, Epner E, Krishnan A, Leonard JP, Lonial S, Stadtmauer EA, O'Connor OA, Shi H, Boral AL, Goy A. Multicenter phase II study of bortezomib in patients with relapsed or refractory mantle cell lymphoma. J Clin Oncol. 2006 Oct 20;24(30):4867-74. Epub 2006 Sep 25. [http://jco.ascopubs.org/content/24/30/4867.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/17001068 PubMed] |
− | ## '''Update:''' Goy A, Bernstein SH, Kahl BS, Djulbegovic B, Robertson MJ, de Vos S, Epner E, Krishnan A, Leonard JP, Lonial S, Nasta S, O'Connor OA, Shi H, Boral AL, Fisher RI. Bortezomib in patients with relapsed or refractory mantle cell lymphoma: updated time-to-event analyses of the multicenter phase 2 PINNACLE study. Ann Oncol. 2009 Mar;20(3):520-5. Epub 2008 Dec 12. [http://annonc.oxfordjournals.org/content/20/3/520.long link to original article] '''contains protocol''' [ | + | ## '''Update:''' Goy A, Bernstein SH, Kahl BS, Djulbegovic B, Robertson MJ, de Vos S, Epner E, Krishnan A, Leonard JP, Lonial S, Nasta S, O'Connor OA, Shi H, Boral AL, Fisher RI. Bortezomib in patients with relapsed or refractory mantle cell lymphoma: updated time-to-event analyses of the multicenter phase 2 PINNACLE study. Ann Oncol. 2009 Mar;20(3):520-5. Epub 2008 Dec 12. [http://annonc.oxfordjournals.org/content/20/3/520.long link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/19074748 PubMed] |
==BR {{#subobject:391f6|Regimen=1}}== | ==BR {{#subobject:391f6|Regimen=1}}== | ||
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|- | |- | ||
|[http://jco.ascopubs.org/content/26/27/4473.long Rummel et al. 2005] | |[http://jco.ascopubs.org/content/26/27/4473.long Rummel et al. 2005] | ||
− | | | + | |style="background-color:#ff0000"|Phase II, <20 pts in subgroup |
− | style="background:#ff0000 | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|[http://jco.ascopubs.org/content/26/27/4473.long Robinson et al. 2008] | |[http://jco.ascopubs.org/content/26/27/4473.long Robinson et al. 2008] | ||
− | | | + | |style="background-color:#ff0000"|Phase II, <20 pts in subgroup |
− | style="background:#ff0000 | ||
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− | |||
− | |||
|- | |- | ||
|} | |} | ||
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===References=== | ===References=== | ||
<!-- No prepublication disclosed --> | <!-- No prepublication disclosed --> | ||
− | # Rummel MJ, Al-Batran SE, Kim SZ, Welslau M, Hecker R, Kofahl-Krause D, Josten KM, Dürk H, Rost A, Neise M, von Grünhagen U, Chow KU, Hansmann ML, Hoelzer D, Mitrou PS. Bendamustine plus rituximab is effective and has a favorable toxicity profile in the treatment of mantle cell and low-grade non-Hodgkin's lymphoma. J Clin Oncol. 2005 May 20;23(15):3383-9. [http://jco.ascopubs.org/content/23/15/3383.long link to original article] '''contains verified protocol''' [ | + | # Rummel MJ, Al-Batran SE, Kim SZ, Welslau M, Hecker R, Kofahl-Krause D, Josten KM, Dürk H, Rost A, Neise M, von Grünhagen U, Chow KU, Hansmann ML, Hoelzer D, Mitrou PS. Bendamustine plus rituximab is effective and has a favorable toxicity profile in the treatment of mantle cell and low-grade non-Hodgkin's lymphoma. J Clin Oncol. 2005 May 20;23(15):3383-9. [http://jco.ascopubs.org/content/23/15/3383.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/15908650 PubMed] |
<!-- Preliminary results were presented at the 48th Annual Meeting of the American Society of Hematology, December 9-12, 2006, Orlando, FL. --> | <!-- Preliminary results were presented at the 48th Annual Meeting of the American Society of Hematology, December 9-12, 2006, Orlando, FL. --> | ||
− | # Robinson KS, Williams ME, van der Jagt RH, Cohen P, Herst JA, Tulpule A, Schwartzberg LS, Lemieux B, Cheson BD. Phase II multicenter study of bendamustine plus rituximab in patients with relapsed indolent B-cell and mantle cell non-Hodgkin's lymphoma. J Clin Oncol. 2008 Sep 20;26(27):4473-9. Epub 2008 Jul 14. [http://jco.ascopubs.org/content/26/27/4473.long link to original article] '''contains verified protocol''' [ | + | # Robinson KS, Williams ME, van der Jagt RH, Cohen P, Herst JA, Tulpule A, Schwartzberg LS, Lemieux B, Cheson BD. Phase II multicenter study of bendamustine plus rituximab in patients with relapsed indolent B-cell and mantle cell non-Hodgkin's lymphoma. J Clin Oncol. 2008 Sep 20;26(27):4473-9. Epub 2008 Jul 14. [http://jco.ascopubs.org/content/26/27/4473.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/18626004 PubMed] |
==Cladribine (Leustatin) {{#subobject:340f61|Regimen=1}}== | ==Cladribine (Leustatin) {{#subobject:340f61|Regimen=1}}== | ||
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|- | |- | ||
|[http://onlinelibrary.wiley.com/doi/10.1002/cncr.23537/full Inwards et al. 2008 (NCCTG 95-80-53)] | |[http://onlinelibrary.wiley.com/doi/10.1002/cncr.23537/full Inwards et al. 2008 (NCCTG 95-80-53)] | ||
− | | | + | |style="background-color:#ff0000"|Phase II, <20 pts |
− | style="background:#ff0000 | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
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===References=== | ===References=== | ||
− | # Inwards DJ, Fishkin PA, Hillman DW, Brown DW, Ansell SM, Kurtin PJ, Fonseca R, Morton RF, Veeder MH, Witzig TE. Long-term results of the treatment of patients with mantle cell lymphoma with cladribine (2-CDA) alone (95-80-53) or 2-CDA and rituximab (N0189) in the North Central Cancer Treatment Group. Cancer. 2008 Jul 1;113(1):108-16. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.23537/full link to original article] '''contains verified protocol''' [ | + | # Inwards DJ, Fishkin PA, Hillman DW, Brown DW, Ansell SM, Kurtin PJ, Fonseca R, Morton RF, Veeder MH, Witzig TE. Long-term results of the treatment of patients with mantle cell lymphoma with cladribine (2-CDA) alone (95-80-53) or 2-CDA and rituximab (N0189) in the North Central Cancer Treatment Group. Cancer. 2008 Jul 1;113(1):108-16. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.23537/full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/18470909 PubMed] |
==Everolimus (Afinitor) {{#subobject:ae5164|Regimen=1}}== | ==Everolimus (Afinitor) {{#subobject:ae5164|Regimen=1}}== | ||
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|- | |- | ||
|[http://www.haematologica.org/content/97/7/1085.long Renner et al. 2012 (SAKK 36/06)] | |[http://www.haematologica.org/content/97/7/1085.long Renner et al. 2012 (SAKK 36/06)] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background:#eeee00 | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|[http://onlinelibrary.wiley.com/doi/10.1111/bjh.12780/full Wang et al. 2014 (PILLAR-1)] | |[http://onlinelibrary.wiley.com/doi/10.1111/bjh.12780/full Wang et al. 2014 (PILLAR-1)] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background:#eeee00 | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
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===References=== | ===References=== | ||
− | # Renner C, Zinzani PL, Gressin R, Klingbiel D, Dietrich PY, Hitz F, Bargetzi M, Mingrone W, Martinelli G, Trojan A, Bouabdallah K, Lohri A, Gyan E, Biaggi C, Cogliatti S, Bertoni F, Ghielmini M, Brauchli P, Ketterer N; Swiss SAKK and French GOELAMS group from European Mantle Cell Lymphoma Network. A multicenter phase II trial (SAKK 36/06) of single-agent everolimus (RAD001) in patients with relapsed or refractory mantle cell lymphoma. Haematologica. 2012 Jul;97(7):1085-91. Epub 2012 Feb 7. [http://www.haematologica.org/content/97/7/1085.long link to original article] '''contains verified protocol''' [ | + | # Renner C, Zinzani PL, Gressin R, Klingbiel D, Dietrich PY, Hitz F, Bargetzi M, Mingrone W, Martinelli G, Trojan A, Bouabdallah K, Lohri A, Gyan E, Biaggi C, Cogliatti S, Bertoni F, Ghielmini M, Brauchli P, Ketterer N; Swiss SAKK and French GOELAMS group from European Mantle Cell Lymphoma Network. A multicenter phase II trial (SAKK 36/06) of single-agent everolimus (RAD001) in patients with relapsed or refractory mantle cell lymphoma. Haematologica. 2012 Jul;97(7):1085-91. Epub 2012 Feb 7. [http://www.haematologica.org/content/97/7/1085.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/22315486 PubMed] |
− | # Wang M, Popplewell LL, Collins RH Jr, Winter JN, Goy A, Kaminski MS, Bartlett NL, Johnston PB, Lister J, Fanning SR, Tuscano JM, Beck JT, Kaya H, Robeva A, Fan J, Klimovsky J, Cheung W, Cherfi A, O'Connor OA. Everolimus for patients with mantle cell lymphoma refractory to or intolerant of bortezomib: multicentre, single-arm, phase 2 study. Br J Haematol. 2014 May;165(4):510-8. Epub 2014 Mar 2. [http://onlinelibrary.wiley.com/doi/10.1111/bjh.12780/full link to original article] '''contains verified protocol''' [ | + | # Wang M, Popplewell LL, Collins RH Jr, Winter JN, Goy A, Kaminski MS, Bartlett NL, Johnston PB, Lister J, Fanning SR, Tuscano JM, Beck JT, Kaya H, Robeva A, Fan J, Klimovsky J, Cheung W, Cherfi A, O'Connor OA. Everolimus for patients with mantle cell lymphoma refractory to or intolerant of bortezomib: multicentre, single-arm, phase 2 study. Br J Haematol. 2014 May;165(4):510-8. Epub 2014 Mar 2. [http://onlinelibrary.wiley.com/doi/10.1111/bjh.12780/full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/24579926 PubMed] |
==Ibrutinib & Rituximab {{#subobject:5c125a|Regimen=1}}== | ==Ibrutinib & Rituximab {{#subobject:5c125a|Regimen=1}}== | ||
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|[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00438-6/fulltext Wang et al. 2015] | |[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00438-6/fulltext Wang et al. 2015] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
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− | |||
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|} | |} | ||
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===References=== | ===References=== | ||
<!-- # '''Abstract:''' Michael (Luhua) Wang, MD, Fredrick Hagemeister, MD, Jason R. Westin, MD, Luis Fayad, MD, Felipe Samaniego, MD, Francesco Turturro, MD, Wendy Chen, Liang Zhang, MD, PhD, Maria Badillo, BS, Maria DeLa Rosa, Alicia Addison, Larry W. Kwak, MD, PhD and Jorge E. Romaguera, MD. Ibrutinib and Rituximab Are an Efficacious and Safe Combination in Relapsed Mantle Cell Lymphoma: Preliminary Results from a Phase II Clinical Trial. ASH Annual Meeting 2014 Abstract 627 [https://ash.confex.com/ash/2014/webprogram/Paper69685.html link to abstract] --> | <!-- # '''Abstract:''' Michael (Luhua) Wang, MD, Fredrick Hagemeister, MD, Jason R. Westin, MD, Luis Fayad, MD, Felipe Samaniego, MD, Francesco Turturro, MD, Wendy Chen, Liang Zhang, MD, PhD, Maria Badillo, BS, Maria DeLa Rosa, Alicia Addison, Larry W. Kwak, MD, PhD and Jorge E. Romaguera, MD. Ibrutinib and Rituximab Are an Efficacious and Safe Combination in Relapsed Mantle Cell Lymphoma: Preliminary Results from a Phase II Clinical Trial. ASH Annual Meeting 2014 Abstract 627 [https://ash.confex.com/ash/2014/webprogram/Paper69685.html link to abstract] --> | ||
− | # Wang ML, Lee H, Chuang H, Wagner-Bartak N, Hagemeister F, Westin J, Fayad L, Samaniego F, Turturro F, Oki Y, Chen W, Badillo M, Nomie K, Rosa MD, Zhao D, Lam L, Addison A, Zhang H, Young KH, Li S, Santos D, Medeiros LJ, Champlin R, Romaguera J, Zhang L. Ibrutinib in combination with rituximab in relapsed or refractory mantle cell lymphoma: a single-centre, open-label, phase 2 trial. Lancet Oncol. 2016 Jan;17(1):48-56. Epub 2015 Nov 28. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00438-6/fulltext link to original article] '''contains verified protocol''' [ | + | # Wang ML, Lee H, Chuang H, Wagner-Bartak N, Hagemeister F, Westin J, Fayad L, Samaniego F, Turturro F, Oki Y, Chen W, Badillo M, Nomie K, Rosa MD, Zhao D, Lam L, Addison A, Zhang H, Young KH, Li S, Santos D, Medeiros LJ, Champlin R, Romaguera J, Zhang L. Ibrutinib in combination with rituximab in relapsed or refractory mantle cell lymphoma: a single-centre, open-label, phase 2 trial. Lancet Oncol. 2016 Jan;17(1):48-56. Epub 2015 Nov 28. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)00438-6/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/26640039 PubMed] |
==Lenalidomide & Rituximab {{#subobject:c6d2a9|Regimen=1}}== | ==Lenalidomide & Rituximab {{#subobject:c6d2a9|Regimen=1}}== | ||
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|[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(12)70200-0/fulltext Wang et al. 2012] | |[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(12)70200-0/fulltext Wang et al. 2012] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
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|} | |} | ||
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|[http://clincancerres.aacrjournals.org/content/21/8/1835.full Chong et al. 2015] | |[http://clincancerres.aacrjournals.org/content/21/8/1835.full Chong et al. 2015] | ||
− | | | + | |style="background-color:#ff0000"|Phase II, <20 pts in subgroup |
− | style="background:#ff0000 | ||
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− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
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===References=== | ===References=== | ||
− | # Wang M, Fayad L, Wagner-Bartak N, Zhang L, Hagemeister F, Neelapu SS, Samaniego F, McLaughlin P, Fanale M, Younes A, Cabanillas F, Fowler N, Newberry KJ, Sun L, Young KH, Champlin R, Kwak L, Feng L, Badillo M, Bejarano M, Hartig K, Chen W, Chen Y, Byrne C, Bell N, Zeldis J, Romaguera J. Lenalidomide in combination with rituximab for patients with relapsed or refractory mantle-cell lymphoma: a phase 1/2 clinical trial. Lancet Oncol. 2012 Jul;13(7):716-23. Epub 2012 Jun 6. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(12)70200-0/fulltext link to original article] '''contains protocol''' [ | + | # Wang M, Fayad L, Wagner-Bartak N, Zhang L, Hagemeister F, Neelapu SS, Samaniego F, McLaughlin P, Fanale M, Younes A, Cabanillas F, Fowler N, Newberry KJ, Sun L, Young KH, Champlin R, Kwak L, Feng L, Badillo M, Bejarano M, Hartig K, Chen W, Chen Y, Byrne C, Bell N, Zeldis J, Romaguera J. Lenalidomide in combination with rituximab for patients with relapsed or refractory mantle-cell lymphoma: a phase 1/2 clinical trial. Lancet Oncol. 2012 Jul;13(7):716-23. Epub 2012 Jun 6. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(12)70200-0/fulltext link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/22677155 PubMed] |
− | # Chong EA, Ahmadi T, Aqui NA, Svoboda J, Nasta SD, Mato AR, Walsh KM, Schuster SJ. Combination of Lenalidomide and Rituximab Overcomes Rituximab Resistance in Patients with Indolent B-cell and Mantle Cell Lymphomas. Clin Cancer Res. 2015 Apr 15;21(8):1835-42. Epub 2015 Jan 28. [http://clincancerres.aacrjournals.org/content/21/8/1835.full link to original article] '''contains verified protocol''' [ | + | # Chong EA, Ahmadi T, Aqui NA, Svoboda J, Nasta SD, Mato AR, Walsh KM, Schuster SJ. Combination of Lenalidomide and Rituximab Overcomes Rituximab Resistance in Patients with Indolent B-cell and Mantle Cell Lymphomas. Clin Cancer Res. 2015 Apr 15;21(8):1835-42. Epub 2015 Jan 28. [http://clincancerres.aacrjournals.org/content/21/8/1835.full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/25632047 PubMed] |
==Obinutuzumab (Gazyva) {{#subobject:7f1090|Regimen=1}}== | ==Obinutuzumab (Gazyva) {{#subobject:7f1090|Regimen=1}}== | ||
Line 2,521: | Line 2,114: | ||
|- | |- | ||
|[http://jco.ascopubs.org/content/31/23/2912.long Morschhauser et al. 2013 (GAUGUIN)] | |[http://jco.ascopubs.org/content/31/23/2912.long Morschhauser et al. 2013 (GAUGUIN)] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
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|- | |- | ||
|} | |} | ||
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===References=== | ===References=== | ||
− | # Morschhauser FA, Cartron G, Thieblemont C, Solal-Céligny P, Haioun C, Bouabdallah R, Feugier P, Bouabdallah K, Asikanius E, Lei G, Wenger M, Wassner-Fritsch E, Salles GA. Obinutuzumab (GA101) Monotherapy in Relapsed/Refractory Diffuse Large B-Cell Lymphoma or Mantle-Cell Lymphoma: Results From the Phase II GAUGUIN Study. J Clin Oncol. 2013 Aug 10;31(23):2912-9. Epub 2013 Jul 8. [http://jco.ascopubs.org/content/31/23/2912.long link to original article] '''contains verified protocol''' [ | + | # Morschhauser FA, Cartron G, Thieblemont C, Solal-Céligny P, Haioun C, Bouabdallah R, Feugier P, Bouabdallah K, Asikanius E, Lei G, Wenger M, Wassner-Fritsch E, Salles GA. Obinutuzumab (GA101) Monotherapy in Relapsed/Refractory Diffuse Large B-Cell Lymphoma or Mantle-Cell Lymphoma: Results From the Phase II GAUGUIN Study. J Clin Oncol. 2013 Aug 10;31(23):2912-9. Epub 2013 Jul 8. [http://jco.ascopubs.org/content/31/23/2912.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/23835718 PubMed] |
==PEP-C {{#subobject:e8f271|Regimen=1}}== | ==PEP-C {{#subobject:e8f271|Regimen=1}}== | ||
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|- | |- | ||
|[http://informahealthcare.com/doi/full/10.1080/10428190701837330 Coleman et al. 2008] | |[http://informahealthcare.com/doi/full/10.1080/10428190701837330 Coleman et al. 2008] | ||
− | | | + | |style="background-color:#eeee00"|Non-randomized |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
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===References=== | ===References=== | ||
− | # Coleman M, Martin P, Ruan J, Furman R, Niesvizky R, Elstrom R, George P, Leonard J, Kaufmann T. Low-dose metronomic, multidrug therapy with the PEP-C oral combination chemotherapy regimen for mantle cell lymphoma. Leuk Lymphoma. 2008 Mar;49(3):447-50. [http://informahealthcare.com/doi/full/10.1080/10428190701837330 link to original article] '''contains verified protocol''' [ | + | # Coleman M, Martin P, Ruan J, Furman R, Niesvizky R, Elstrom R, George P, Leonard J, Kaufmann T. Low-dose metronomic, multidrug therapy with the PEP-C oral combination chemotherapy regimen for mantle cell lymphoma. Leuk Lymphoma. 2008 Mar;49(3):447-50. [http://informahealthcare.com/doi/full/10.1080/10428190701837330 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/18297520 PubMed] |
==Rituximab & Temsirolimus {{#subobject:8a89c9|Regimen=1}}== | ==Rituximab & Temsirolimus {{#subobject:8a89c9|Regimen=1}}== | ||
Line 2,598: | Line 2,181: | ||
|- | |- | ||
|[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(11)70062-6/fulltext Ansell et al. 2011] | |[http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(11)70062-6/fulltext Ansell et al. 2011] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
− | style="background | ||
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− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
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===References=== | ===References=== | ||
− | # Ansell SM, Tang H, Kurtin PJ, Koenig PA, Inwards DJ, Shah K, Ziesmer SC, Feldman AL, Rao R, Gupta M, Erlichman C, Witzig TE. Temsirolimus and rituximab in patients with relapsed or refractory mantle cell lymphoma: a phase 2 study. Lancet Oncol. 2011 Apr;12(4):361-8. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(11)70062-6/fulltext link to original article] [ | + | # Ansell SM, Tang H, Kurtin PJ, Koenig PA, Inwards DJ, Shah K, Ziesmer SC, Feldman AL, Rao R, Gupta M, Erlichman C, Witzig TE. Temsirolimus and rituximab in patients with relapsed or refractory mantle cell lymphoma: a phase 2 study. Lancet Oncol. 2011 Apr;12(4):361-8. [http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(11)70062-6/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3106222/ link to PMC article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/21440503 PubMed] |
==RT-PEPC {{#subobject:bc6d27|Regimen=1}}== | ==RT-PEPC {{#subobject:bc6d27|Regimen=1}}== | ||
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|- | |- | ||
|[http://onlinelibrary.wiley.com/doi/10.1002/cncr.25055/full Ruan et al. 2010] | |[http://onlinelibrary.wiley.com/doi/10.1002/cncr.25055/full Ruan et al. 2010] | ||
− | | | + | |style="background-color:#eeee00"|Non-randomized |
− | style="background | ||
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− | |||
|- | |- | ||
|} | |} | ||
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===References=== | ===References=== | ||
− | # Ruan J, Martin P, Coleman M, Furman RR, Cheung K, Faye A, Elstrom R, Lachs M, Hajjar KA, Leonard JP. Durable responses with the metronomic rituximab and thalidomide plus prednisone, etoposide, procarbazine, and cyclophosphamide regimen in elderly patients with recurrent mantle cell lymphoma. Cancer. 2010 Jun 1;116(11):2655-64. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.25055/full link to original article] '''contains verified protocol''' [ | + | # Ruan J, Martin P, Coleman M, Furman RR, Cheung K, Faye A, Elstrom R, Lachs M, Hajjar KA, Leonard JP. Durable responses with the metronomic rituximab and thalidomide plus prednisone, etoposide, procarbazine, and cyclophosphamide regimen in elderly patients with recurrent mantle cell lymphoma. Cancer. 2010 Jun 1;116(11):2655-64. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.25055/full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20235190 PubMed] |
==Temsirolimus (Torisel) {{#subobject:575bde|Regimen=1}}== | ==Temsirolimus (Torisel) {{#subobject:575bde|Regimen=1}}== | ||
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|- | |- | ||
|[http://onlinelibrary.wiley.com/doi/10.1002/cncr.23580/full Ansell et al. 2008] | |[http://onlinelibrary.wiley.com/doi/10.1002/cncr.23580/full Ansell et al. 2008] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
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|} | |} | ||
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|[http://jco.ascopubs.org/content/23/23/5347.long Witzig et al. 2005] | |[http://jco.ascopubs.org/content/23/23/5347.long Witzig et al. 2005] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
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|} | |} | ||
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===References=== | ===References=== | ||
− | # Witzig TE, Geyer SM, Ghobrial I, Inwards DJ, Fonseca R, Kurtin P, Ansell SM, Luyun R, Flynn PJ, Morton RF, Dakhil SR, Gross H, Kaufmann SH. Phase II trial of single-agent temsirolimus (CCI-779) for relapsed mantle cell lymphoma. J Clin Oncol. 2005 Aug 10;23(23):5347-56. Epub 2005 Jun 27. [http://jco.ascopubs.org/content/23/23/5347.long link to original article] '''contains verified protocol''' [ | + | # Witzig TE, Geyer SM, Ghobrial I, Inwards DJ, Fonseca R, Kurtin P, Ansell SM, Luyun R, Flynn PJ, Morton RF, Dakhil SR, Gross H, Kaufmann SH. Phase II trial of single-agent temsirolimus (CCI-779) for relapsed mantle cell lymphoma. J Clin Oncol. 2005 Aug 10;23(23):5347-56. Epub 2005 Jun 27. [http://jco.ascopubs.org/content/23/23/5347.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/15983389 PubMed] |
− | # Ansell SM, Inwards DJ, Rowland KM Jr, Flynn PJ, Morton RF, Moore DF Jr, Kaufmann SH, Ghobrial I, Kurtin PJ, Maurer M, Allmer C, Witzig TE. Low-dose, single-agent temsirolimus for relapsed mantle cell lymphoma: a phase 2 trial in the North Central Cancer Treatment Group. Cancer. 2008 Aug 1;113(3):508-14. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.23580/full link to original article] '''contains verified protocol''' [ | + | # Ansell SM, Inwards DJ, Rowland KM Jr, Flynn PJ, Morton RF, Moore DF Jr, Kaufmann SH, Ghobrial I, Kurtin PJ, Maurer M, Allmer C, Witzig TE. Low-dose, single-agent temsirolimus for relapsed mantle cell lymphoma: a phase 2 trial in the North Central Cancer Treatment Group. Cancer. 2008 Aug 1;113(3):508-14. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.23580/full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/18543327 PubMed] |
==VR {{#subobject:ea40ed|Regimen=1}}== | ==VR {{#subobject:ea40ed|Regimen=1}}== | ||
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|[http://onlinelibrary.wiley.com/doi/10.1002/cncr.25792/full Baiocchi et al. 2011] | |[http://onlinelibrary.wiley.com/doi/10.1002/cncr.25792/full Baiocchi et al. 2011] | ||
− | | | + | |style="background-color:#ff0000"|Phase II, <20 pts |
− | style="background:#ff0000 | ||
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|} | |} | ||
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===References=== | ===References=== | ||
− | # Baiocchi RA, Alinari L, Lustberg ME, Lin TS, Porcu P, Li X, Johnston JS, Byrd JC, Blum KA. Phase 2 trial of rituximab and bortezomib in patients with relapsed or refractory mantle cell and follicular lymphoma. Cancer. 2011 Jun 1;117(11):2442-51. Epub 2010 Dec 14. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.25792/full link to original article] '''contains verified protocol''' [ | + | # Baiocchi RA, Alinari L, Lustberg ME, Lin TS, Porcu P, Li X, Johnston JS, Byrd JC, Blum KA. Phase 2 trial of rituximab and bortezomib in patients with relapsed or refractory mantle cell and follicular lymphoma. Cancer. 2011 Jun 1;117(11):2442-51. Epub 2010 Dec 14. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.25792/full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/24048792 PubMed] |
=Consolidation and/or maintenance after salvage therapy= | =Consolidation and/or maintenance after salvage therapy= | ||
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|[http://annonc.oxfordjournals.org/content/25/7/1391.full.html Gill et al. 2014] | |[http://annonc.oxfordjournals.org/content/25/7/1391.full.html Gill et al. 2014] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
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|} | |} | ||
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===References=== | ===References=== | ||
− | # Gill H, Au WY, Cheung WW, Lee EY, Kwong YL. Oral arsenic trioxide-based regimen as salvage treatment for relapsed or refractory mantle cell lymphoma. Ann Oncol. 2014 Jul;25(7):1391-7. Epub 2014 Apr 12. [http://annonc.oxfordjournals.org/content/25/7/1391.full.html link to original article] '''contains verified protocol''' [ | + | # Gill H, Au WY, Cheung WW, Lee EY, Kwong YL. Oral arsenic trioxide-based regimen as salvage treatment for relapsed or refractory mantle cell lymphoma. Ann Oncol. 2014 Jul;25(7):1391-7. Epub 2014 Apr 12. [http://annonc.oxfordjournals.org/content/25/7/1391.full.html link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/24728036 PubMed] |
==Autologous stem cell transplant {{#subobject:49287f|Regimen=1}}== | ==Autologous stem cell transplant {{#subobject:49287f|Regimen=1}}== | ||
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|[http://onlinelibrary.wiley.com/doi/10.1111/bjh.12008/full Eve et al. 2012] | |[http://onlinelibrary.wiley.com/doi/10.1111/bjh.12008/full Eve et al. 2012] | ||
− | | | + | |style="background-color:#eeee00"|Phase II |
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|} | |} | ||
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===References=== | ===References=== | ||
− | # Eve HE, Carey S, Richardson SJ, Heise CC, Mamidipudi V, Shi T, Radford JA, Auer RL, Bullard SH, Rule SA. Single-agent lenalidomide in relapsed/refractory mantle cell lymphoma: results from a UK phase II study suggest activity and possible gender differences. Br J Haematol. 2012 Oct;159(2):154-63. Epub 2012 Aug 9. [http://onlinelibrary.wiley.com/doi/10.1111/bjh.12008/full link to original article] '''contains verified protocol''' [ | + | # Eve HE, Carey S, Richardson SJ, Heise CC, Mamidipudi V, Shi T, Radford JA, Auer RL, Bullard SH, Rule SA. Single-agent lenalidomide in relapsed/refractory mantle cell lymphoma: results from a UK phase II study suggest activity and possible gender differences. Br J Haematol. 2012 Oct;159(2):154-63. Epub 2012 Aug 9. [http://onlinelibrary.wiley.com/doi/10.1111/bjh.12008/full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/22881386 PubMed] |
==Observation {{#subobject:7600b6|Regimen=1}}== | ==Observation {{#subobject:7600b6|Regimen=1}}== | ||
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|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|'''Comparator''' | |'''Comparator''' | ||
+ | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
− | |[http://bloodjournal | + | |[http://www.bloodjournal.org/content/104/10/3064.long Forstpointner et al. 2004] |
− | | | + | |style="background-color:#00cd00"|Phase III |
− | style="background | ||
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− | |||
− | |||
− | |||
|[[#Rituximab_.28Rituxan.29_2|Rituximab]] | |[[#Rituximab_.28Rituxan.29_2|Rituximab]] | ||
+ | |style="background-color:#ff0000"|Seems to have inferior response duration | ||
|- | |- | ||
|} | |} | ||
− | + | ''Preceded by [[#FCM|FCM]] versus [[#R-FCM|R-FCM]]; no further treatment was given.'' | |
− | ''Preceded by [[#R-FCM|R-FCM]] | ||
===References=== | ===References=== | ||
− | # Forstpointner R, Dreyling M, Repp R, Hermann S, Hänel A, Metzner B, Pott C, Hartmann F, Rothmann F, Rohrberg R, Böck HP, Wandt H, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. The addition of rituximab to a combination of fludarabine, cyclophosphamide, mitoxantrone (FCM) significantly increases the response rate and prolongs survival as compared with FCM alone in patients with relapsed and refractory follicular and mantle cell lymphomas: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood. 2004 Nov 15;104(10):3064-71. Epub 2004 Jul 29. [http://bloodjournal | + | # Forstpointner R, Dreyling M, Repp R, Hermann S, Hänel A, Metzner B, Pott C, Hartmann F, Rothmann F, Rohrberg R, Böck HP, Wandt H, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. The addition of rituximab to a combination of fludarabine, cyclophosphamide, mitoxantrone (FCM) significantly increases the response rate and prolongs survival as compared with FCM alone in patients with relapsed and refractory follicular and mantle cell lymphomas: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood. 2004 Nov 15;104(10):3064-71. Epub 2004 Jul 29. [http://www.bloodjournal.org/content/104/10/3064.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/15284112 PubMed] |
− | ## '''Update:''' Forstpointner R, Unterhalt M, Dreyling M, Böck HP, Repp R, Wandt H, Pott C, Seymour JF, Metzner B, Hänel A, Lehmann T, Hartmann F, Einsele H, Hiddemann W; German Low Grade Lymphoma Study Group (GLSG). Maintenance therapy with rituximab leads to a significant prolongation of response duration after salvage therapy with a combination of rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) in patients with recurring and refractory follicular and mantle cell lymphomas: Results of a prospective randomized study of the German Low Grade Lymphoma Study Group (GLSG). Blood. 2006 Dec 15;108(13):4003-8. Epub 2006 Aug 31. [http://bloodjournal | + | ## '''Update:''' Forstpointner R, Unterhalt M, Dreyling M, Böck HP, Repp R, Wandt H, Pott C, Seymour JF, Metzner B, Hänel A, Lehmann T, Hartmann F, Einsele H, Hiddemann W; German Low Grade Lymphoma Study Group (GLSG). Maintenance therapy with rituximab leads to a significant prolongation of response duration after salvage therapy with a combination of rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) in patients with recurring and refractory follicular and mantle cell lymphomas: Results of a prospective randomized study of the German Low Grade Lymphoma Study Group (GLSG). Blood. 2006 Dec 15;108(13):4003-8. Epub 2006 Aug 31. [http://www.bloodjournal.org/content/108/13/4003.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/16946304 PubMed] |
==Rituximab (Rituxan) {{#subobject:ea4966|Regimen=1}}== | ==Rituximab (Rituxan) {{#subobject:ea4966|Regimen=1}}== | ||
Line 2,863: | Line 2,407: | ||
|[[Levels_of_Evidence#Evidence|'''Evidence''']] | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
|'''Comparator''' | |'''Comparator''' | ||
+ | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
|- | |- | ||
− | |[http://bloodjournal | + | |[http://www.bloodjournal.org/content/104/10/3064.long Forstpointner et al. 2004] |
− | | | + | |style="background-color:#00cd00"|Phase III |
− | style="background | ||
− | |||
− | |||
− | |||
− | |||
|[[#Observation_3|Observation]] | |[[#Observation_3|Observation]] | ||
+ | |style="background-color:#00cd00"|Seems to have superior response duration | ||
|- | |- | ||
|} | |} | ||
− | + | ''Treatment preceded by [[#FCM|FCM]] versus [[#R-FCM|R-FCM]].'' | |
− | ''Treatment preceded by [[#R-FCM|R-FCM]] | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Rituximab (Rituxan)]] 375 mg/m<sup>2</sup> IV once per week on days 1, 8, 15, 22 | *[[Rituximab (Rituxan)]] 375 mg/m<sup>2</sup> IV once per week on days 1, 8, 15, 22 | ||
Line 2,887: | Line 2,427: | ||
|- | |- | ||
|[http://onlinelibrary.wiley.com/doi/10.1002/cncr.25792/full Lamm et al. 2011] | |[http://onlinelibrary.wiley.com/doi/10.1002/cncr.25792/full Lamm et al. 2011] | ||
− | | | + | |style="background-color:#ff0000"|Phase II, <20 pts |
− | style="background:#ff0000 | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
− | |||
''Treatment preceded by [[Mantle_cell_lymphoma#BORID|BORID]] x 6.'' | ''Treatment preceded by [[Mantle_cell_lymphoma#BORID|BORID]] x 6.'' | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
Line 2,903: | Line 2,437: | ||
===References=== | ===References=== | ||
− | # Forstpointner R, Dreyling M, Repp R, Hermann S, Hänel A, Metzner B, Pott C, Hartmann F, Rothmann F, Rohrberg R, Böck HP, Wandt H, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. The addition of rituximab to a combination of fludarabine, cyclophosphamide, mitoxantrone (FCM) significantly increases the response rate and prolongs survival as compared with FCM alone in patients with relapsed and refractory follicular and mantle cell lymphomas: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood. 2004 Nov 15;104(10):3064-71. Epub 2004 Jul 29. [http://bloodjournal | + | # Forstpointner R, Dreyling M, Repp R, Hermann S, Hänel A, Metzner B, Pott C, Hartmann F, Rothmann F, Rohrberg R, Böck HP, Wandt H, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. The addition of rituximab to a combination of fludarabine, cyclophosphamide, mitoxantrone (FCM) significantly increases the response rate and prolongs survival as compared with FCM alone in patients with relapsed and refractory follicular and mantle cell lymphomas: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood. 2004 Nov 15;104(10):3064-71. Epub 2004 Jul 29. [http://www.bloodjournal.org/content/104/10/3064.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/15284112 PubMed] |
− | ## '''Update:''' Forstpointner R, Unterhalt M, Dreyling M, Böck HP, Repp R, Wandt H, Pott C, Seymour JF, Metzner B, Hänel A, Lehmann T, Hartmann F, Einsele H, Hiddemann W; German Low Grade Lymphoma Study Group (GLSG). Maintenance therapy with rituximab leads to a significant prolongation of response duration after salvage therapy with a combination of rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) in patients with recurring and refractory follicular and mantle cell lymphomas: Results of a prospective randomized study of the German Low Grade Lymphoma Study Group (GLSG). Blood. 2006 Dec 15;108(13):4003-8. Epub 2006 Aug 31. [http://bloodjournal | + | ## '''Update:''' Forstpointner R, Unterhalt M, Dreyling M, Böck HP, Repp R, Wandt H, Pott C, Seymour JF, Metzner B, Hänel A, Lehmann T, Hartmann F, Einsele H, Hiddemann W; German Low Grade Lymphoma Study Group (GLSG). Maintenance therapy with rituximab leads to a significant prolongation of response duration after salvage therapy with a combination of rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) in patients with recurring and refractory follicular and mantle cell lymphomas: Results of a prospective randomized study of the German Low Grade Lymphoma Study Group (GLSG). Blood. 2006 Dec 15;108(13):4003-8. Epub 2006 Aug 31. [http://www.bloodjournal.org/content/108/13/4003.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/16946304 PubMed] |
− | # Lamm W, Kaufmann H, Raderer M, Hoffmann M, Chott A, Zielinski C, Drach J. Bortezomib combined with rituximab and dexamethasone is an active regimen for patients with relapsed and chemotherapy-refractory mantle cell lymphoma. Haematologica. 2011 Jul;96(7):1008-14. Epub 2011 Apr 12. [http://www.haematologica.org/content/96/7/1008.long link to original article] '''contains verified protocol''' [ | + | # Lamm W, Kaufmann H, Raderer M, Hoffmann M, Chott A, Zielinski C, Drach J. Bortezomib combined with rituximab and dexamethasone is an active regimen for patients with relapsed and chemotherapy-refractory mantle cell lymphoma. Haematologica. 2011 Jul;96(7):1008-14. Epub 2011 Apr 12. [http://www.haematologica.org/content/96/7/1008.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/21486866 PubMed] |
==VR {{#subobject:465914|Regimen=1}}== | ==VR {{#subobject:465914|Regimen=1}}== | ||
Line 2,920: | Line 2,454: | ||
|- | |- | ||
|[http://onlinelibrary.wiley.com/doi/10.1002/cncr.25792/full Baiocchi et al. 2011] | |[http://onlinelibrary.wiley.com/doi/10.1002/cncr.25792/full Baiocchi et al. 2011] | ||
− | | | + | |style="background-color:#ff0000"|Phase II, <20 pts |
− | style="background:#ff0000 | ||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
Line 2,937: | Line 2,466: | ||
===References=== | ===References=== | ||
− | # Baiocchi RA, Alinari L, Lustberg ME, Lin TS, Porcu P, Li X, Johnston JS, Byrd JC, Blum KA. Phase 2 trial of rituximab and bortezomib in patients with relapsed or refractory mantle cell and follicular lymphoma. Cancer. 2011 Jun 1;117(11):2442-51. Epub 2010 Dec 14. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.25792/full link to original article] '''contains verified protocol''' [ | + | # Baiocchi RA, Alinari L, Lustberg ME, Lin TS, Porcu P, Li X, Johnston JS, Byrd JC, Blum KA. Phase 2 trial of rituximab and bortezomib in patients with relapsed or refractory mantle cell and follicular lymphoma. Cancer. 2011 Jun 1;117(11):2442-51. Epub 2010 Dec 14. [http://onlinelibrary.wiley.com/doi/10.1002/cncr.25792/full link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/24048792 PubMed] |
=Investigational agents= | =Investigational agents= | ||
Line 2,968: | Line 2,497: | ||
===References=== | ===References=== | ||
− | # Hoster E, Dreyling M, Klapper W, Gisselbrecht C, van Hoof A, Kluin-Nelemans HC, Pfreundschuh M, Reiser M, Metzner B, Einsele H, Peter N, Jung W, Wörmann B, Ludwig WD, Dührsen U, Eimermacher H, Wandt H, Hasford J, Hiddemann W, Unterhalt M; German Low Grade Lymphoma Study Group (GLSG); European Mantle Cell Lymphoma Network. A new prognostic index (MIPI) for patients with advanced-stage mantle cell lymphoma. Blood. 2008 Jan 15;111(2):558-65. Epub 2007 Oct 25. Erratum in: Blood. 2008 Jun 15;111(12):5761. [http://www.bloodjournal.org/content/111/2/558.long link to original article] [ | + | # Hoster E, Dreyling M, Klapper W, Gisselbrecht C, van Hoof A, Kluin-Nelemans HC, Pfreundschuh M, Reiser M, Metzner B, Einsele H, Peter N, Jung W, Wörmann B, Ludwig WD, Dührsen U, Eimermacher H, Wandt H, Hasford J, Hiddemann W, Unterhalt M; German Low Grade Lymphoma Study Group (GLSG); European Mantle Cell Lymphoma Network. A new prognostic index (MIPI) for patients with advanced-stage mantle cell lymphoma. Blood. 2008 Jan 15;111(2):558-65. Epub 2007 Oct 25. Erratum in: Blood. 2008 Jun 15;111(12):5761. [http://www.bloodjournal.org/content/111/2/558.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/17962512 PubMed] |
− | # Hoster E, Klapper W, Hermine O, Kluin-Nelemans HC, Walewski J, van Hoof A, Trneny M, Geisler CH, Di Raimondo F, Szymczyk M, Stilgenbauer S, Thieblemont C, Hallek M, Forstpointner R, Pott C, Ribrag V, Doorduijn J, Hiddemann W, Dreyling MH, Unterhalt M. Confirmation of the mantle-cell lymphoma International Prognostic Index in randomized trials of the European Mantle-Cell Lymphoma Network. J Clin Oncol. 2014 May 1;32(13):1338-46. Epub 2014 Mar 31. [http://jco.ascopubs.org/content/32/13/1338.long link to original article] [ | + | # Hoster E, Klapper W, Hermine O, Kluin-Nelemans HC, Walewski J, van Hoof A, Trneny M, Geisler CH, Di Raimondo F, Szymczyk M, Stilgenbauer S, Thieblemont C, Hallek M, Forstpointner R, Pott C, Ribrag V, Doorduijn J, Hiddemann W, Dreyling MH, Unterhalt M. Confirmation of the mantle-cell lymphoma International Prognostic Index in randomized trials of the European Mantle-Cell Lymphoma Network. J Clin Oncol. 2014 May 1;32(13):1338-46. Epub 2014 Mar 31. [http://jco.ascopubs.org/content/32/13/1338.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/24687837 PubMed] |
=Response criteria= | =Response criteria= | ||
==NCI Sponsored International Working Group Criteria (1999)== | ==NCI Sponsored International Working Group Criteria (1999)== | ||
− | # Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, Lister TA, Vose J, Grillo-López A, Hagenbeek A, Cabanillas F, Klippensten D, Hiddemann W, Castellino R, Harris NL, Armitage JO, Carter W, Hoppe R, Canellos GP. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol. 1999 Apr;17(4):1244. Review. Erratum in: J Clin Oncol 2000 Jun;18(11):2351. [http://jco.ascopubs.org/content/17/4/1244.long link to original article] [ | + | # Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, Lister TA, Vose J, Grillo-López A, Hagenbeek A, Cabanillas F, Klippensten D, Hiddemann W, Castellino R, Harris NL, Armitage JO, Carter W, Hoppe R, Canellos GP. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol. 1999 Apr;17(4):1244. Review. Erratum in: J Clin Oncol 2000 Jun;18(11):2351. [http://jco.ascopubs.org/content/17/4/1244.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/10561185 PubMed] |
[[Category:Chemotherapy regimens]] | [[Category:Chemotherapy regimens]] | ||
[[Category:Malignant hematology regimens]] | [[Category:Malignant hematology regimens]] | ||
[[Category:Lymphoma regimens]] | [[Category:Lymphoma regimens]] |
Revision as of 18:53, 9 October 2016
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Is there a regimen missing from this list? Would you like to share a different dosage/schedule or an additional reference for a regimen? Have you noticed an error? Do you have an idea that will help the site grow to better meet your needs and the needs of many others? You are invited to contribute to the site.
81 regimens on this page
105 variants on this page
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Untreated, randomized data
BR
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BR: Bendamustine, Rituximab
Regimen
Study | Evidence | Comparator | Efficacy |
Rummel et al. 2013 (StiL NHL1) | Phase III | R-CHOP | Superior PFS |
Flinn et al. 2014 (BRIGHT) | Phase III | R-CHOP R-CVP |
Seems non-inferior |
Chemotherapy
Note: the bendamustine infusion instructions are for the Treanda formulation, which was discontinued on 3/31/2016.
- Bendamustine 90 mg/m2 IV over 30 to 60 minutes once per day on days 1 & 2
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
Supportive medications
- Antiemetics, antipyretics, and antibiotics according to local standard of care
- Prophylactic use of G-CSF allowed according ASCO guidelines (2006)
28-day cycle for up to 6 cycles (StiL NHL1) or 8 cycles (BRIGHT)
References
- Rummel MJ, Niederle N, Maschmeyer G, Banat GA, von Grünhagen U, Losem C, Kofahl-Krause D, Heil G, Welslau M, Balser C, Kaiser U, Weidmann E, Dürk H, Ballo H, Stauch M, Roller F, Barth J, Hoelzer D, Hinke A, Brugger W; on behalf of the Study group indolent Lymphomas (StiL). Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial. Lancet. 2013 Apr 6;381(9873):1203-10. Epub 2013 Feb 20. Erratum in: Lancet. 2013 Apr 6;381(9873):1184. link to original article contains verified protocol PubMed
- Update: Abstract: Mathias J. Rummel, MD, Georg Maschmeyer, MD, Arnold Ganser, Andrea Heider, PhD, Ulrich von Grünhagen, MD, PhD5, Christoph Losem, Gerhard Heil, MD, Manfred Welslau, Christina Balser, MD, Ulrich Kaiser, MD, Eckhart Weidmann, Heinz Dürk, MD, Hans Peter Böck, Martina Beate Stauch, MD, Jürgen Barth, Wolfgang Blau, MD, Alexander Burchardt, MD, Frank Kauff, PhD, Axel Hinke, PhD and Wolfram Brugger, MD. Bendamustine Plus Rituximab (B-R) Versus CHOP Plus Rituximab (CHOP-R) As First-Line Treatment in Patients with Indolent and Mantle Cell Lymphomas (MCL) – 7 Year Updated Results from the StiL NHL1 Study. Blood 2014 124:4407. link to abstract
- Flinn IW, van der Jagt R, Kahl BS, Wood P, Hawkins TE, Macdonald D, Hertzberg M, Kwan YL, Simpson D, Craig M, Kolibaba K, Issa S, Clementi R, Hallman DM, Munteanu M, Chen L, Burke JM. Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study. Blood. 2014 May 8;123(19):2944-52. Epub 2014 Mar 3. link to original article contains verified protocol PubMed
CHOP
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CHOP: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone
Regimen
Study | Evidence | Comparator | Efficacy |
Lenz et al. 2005 | Phase III | R-CHOP | Inferior ORR |
Nickenig et al. 2006 | Phase III | MCP | Might have superior ORR |
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg per cycle) IV once on day 1
- Prednisone (Sterapred) 100 mg/m2 PO once per day on days 1 to 5
21-day cycle for 6 to 8 cycles
References
- Lenz G, Dreyling M, Hoster E, Wörmann B, Dührsen U, Metzner B, Eimermacher H, Neubauer A, Wandt H, Steinhauer H, Martin S, Heidemann E, Aldaoud A, Parwaresch R, Hasford J, Unterhalt M, Hiddemann W. Immunochemotherapy with rituximab and cyclophosphamide, doxorubicin, vincristine, and prednisone significantly improves response and time to treatment failure, but not long-term outcome in patients with previously untreated mantle cell lymphoma: results of a prospective randomized trial of the German Low Grade Lymphoma Study Group (GLSG). J Clin Oncol. 2005 Mar 20;23(9):1984-92. Epub 2005 Jan 24. link to original article PubMed
- Nickenig C, Dreyling M, Hoster E, Pfreundschuh M, Trumper L, Reiser M, Wandt H, Lengfelder E, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. Combined cyclophosphamide, vincristine, doxorubicin, and prednisone (CHOP) improves response rates but not survival and has lower hematologic toxicity compared with combined mitoxantrone, chlorambucil, and prednisone (MCP) in follicular and mantle cell lymphomas: results of a prospective randomized trial of the German Low-Grade Lymphoma Study Group. Cancer. 2006 Sep 1;107(5):1014-22. link to original article contains verified protocol PubMed
FC
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FC: Fludarabine, Cyclophosphamide
Regimen
Study | Evidence | Comparator | Efficacy |
Rule et al. 2015 (CRUK-UCL-MCLIII) | Phase III | FCR | Inferior OS |
Chemotherapy
- Fludarabine (Fludara) 40 mg/m2 PO once per day on days 1 to 3
- Patients intolerant of the oral route received 25 mg/m2 IV once per day on days 1 to 3
- Cyclophosphamide (Cytoxan) 250 mg/m2 PO once per day on days 1 to 3
- Patients intolerant of the oral route received 250 mg/m2 IV once per day on days 1 to 3
Supportive medications
- PJP prophylaxis was mandatory
28-day cycle for up to 8 cycles
References
- Rule S, Smith P, Johnson PW, Bolam S, Follows G, Gambell J, Hillmen P, Jack A, Johnson S, Kirkwood AA, Kruger A, Pocock C, Seymour JF, Toncheva M, Walewski J, Linch D. The addition of rituximab to fludarabine and cyclophosphamide chemotherapy results in a significant improvement in overall survival in patients with newly diagnosed mantle cell lymphoma: results of a randomized UK National Cancer Research Institute trial. Haematologica. 2016 Feb;101(2):235-40. Epub 2015 Nov 26. link to original article contains verified protocol PubMed
FCR
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FCR: Fludarabine, Cyclophosphamide, Rituximab
R-FCR: Rituximab, Fludarabine, Cyclophosphamide
Regimen #1
Study | Evidence | Comparator | Efficacy |
Rule et al. 2015 (CRUK-UCL-MCLIII) | Phase III | FC | Superior OS |
Chemotherapy
- Fludarabine (Fludara) 40 mg/m2 PO once per day on days 1 to 3
- Patients intolerant of the oral route received 25 mg/m2 IV once per day on days 1 to 3
- Cyclophosphamide (Cytoxan) 250 mg/m2 PO once per day on days 1 to 3
- Patients intolerant of the oral route received 250 mg/m2 IV once per day on days 1 to 3
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
Supportive medications
- PJP prophylaxis was mandatory
28-day cycle for up to 8 cycles
Regimen #2, "R-FC"
Study | Evidence | Comparator | Efficacy |
Kluin-Nelemans et al. 2012 | Phase III | R-CHOP | Inferior OS |
Chemotherapy
- Rituximab (Rituxan) 375 mg/m2 (maximum dose: 750 mg/m2) IV once on day 1
- Fludarabine (Fludara) 30 mg/m2 IV once per day on days 1 to 3
- Cyclophosphamide (Cytoxan) 250 mg/m2 IV once per day on days 1 to 3
28-day cycle for 6 cycles
Responding patients were randomized to receive rituximab maintenance versus interferon alfa maintenance.
References
- Kluin-Nelemans HC, Hoster E, Hermine O, Walewski J, Trneny M, Geisler CH, Stilgenbauer S, Thieblemont C, Vehling-Kaiser U, Doorduijn JK, Coiffier B, Forstpointner R, Tilly H, Kanz L, Feugier P, Szymczyk M, Hallek M, Kremers S, Lepeu G, Sanhes L, Zijlstra JM, Bouabdallah R, Lugtenburg PJ, Macro M, Pfreundschuh M, Procházka V, Di Raimondo F, Ribrag V, Uppenkamp M, André M, Klapper W, Hiddemann W, Unterhalt M, Dreyling MH. Treatment of older patients with mantle-cell lymphoma. N Engl J Med. 2012 Aug 9;367(6):520-31. link to original article contains verified protocol PubMed
- Rule S, Smith P, Johnson PW, Bolam S, Follows G, Gambell J, Hillmen P, Jack A, Johnson S, Kirkwood AA, Kruger A, Pocock C, Seymour JF, Toncheva M, Walewski J, Linch D. The addition of rituximab to fludarabine and cyclophosphamide chemotherapy results in a significant improvement in overall survival in patients with newly diagnosed mantle cell lymphoma: results of a randomized UK National Cancer Research Institute trial. Haematologica. 2016 Feb;101(2):235-40. Epub 2015 Nov 26. link to original article contains verified protocol PubMed
MCP
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MCP: Mitoxantrone, Chlorambucil, Prednisolone
Regimen
Study | Evidence | Comparator | Efficacy |
Nickenig et al. 2006 | Phase III | CHOP | Might have inferior ORR |
Chemotherapy
- Mitoxantrone (Novantrone) 8 mg/m2 IV once per day on days 1 & 2
- Chlorambucil (Leukeran) 3 mg/m2 PO TID (written in the reference as "3 x 3"; total daily dose is 9 mg/m2) on days 1 to 5
- Prednisone (Sterapred) 25 mg/m2 PO once per day on days 1 to 5
28-day cycle for 6 to 8 cycles
References
- Nickenig C, Dreyling M, Hoster E, Pfreundschuh M, Trumper L, Reiser M, Wandt H, Lengfelder E, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. Combined cyclophosphamide, vincristine, doxorubicin, and prednisone (CHOP) improves response rates but not survival and has lower hematologic toxicity compared with combined mitoxantrone, chlorambucil, and prednisone (MCP) in follicular and mantle cell lymphomas: results of a prospective randomized trial of the German Low-Grade Lymphoma Study Group. Cancer. 2006 Sep 1;107(5):1014-22. link to original article contains verified protocol PubMed
R-CHOP
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R-CHOP: Rituximab, Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone
Synonyms: R-CHOP-21, CHOP-R
Structured Concept: C9760 (NCI-T), C0393023 (NCI-MT/UMLS)
Example orders
Regimen #1
Study | Evidence | Comparator | Efficacy |
Lenz et al. 2005 | Phase III | CHOP | Superior ORR |
Robak et al. 2015 (LYM-3002) | Phase III | VR-CAP | Inferior PFS |
Note the slight differences between the two regimens.
Chemotherapy
- Rituximab (Rituxan) 375 mg/m2 IV once on day -1 (Lenz et al. 2005) or day 1 (LYM-3002)
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2mg per cycle) IV once on day 1
- Prednisone (Sterapred) 100 mg/m2 PO once per day on days 1 to 5
21-day cycle for 6 cycles (Lenz et al. 2005) or up to 8 cycles (LYM-3002)
Regimen #2
Study | Evidence | Comparator | Efficacy |
Kluin-Nelemans et al. 2012 | Phase III | R-FC | Superior OS |
Flinn et al. 2014 (BRIGHT) | Phase III | BR | Seems non-inferior |
Chemotherapy
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg per cycle) IV once on day 1
- Prednisone (Sterapred) 100 mg PO once per day on days 1 to 5
Supportive medications
- Antiemetics, antipyretics, and antibiotics per local standard of care
- G-CSF "according to the American Society of Clinical Oncology guidelines"
21-day cycle for up to 8 cycles
Patients responding after 8 cycles in Kluin-Nelemans et al. 2012 were randomized to receive rituximab maintenance versus interferon alfa maintenance.
Regimen #3
Study | Evidence | Comparator | Efficacy |
Rummel et al. 2013 (StiL NHL1) | Phase III | BR | Inferior PFS |
Chemotherapy
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 IV once on day 1
- Prednisone (Sterapred) 100 mg once per day on days 1 to 5
21-day cycle up to maximum of 6 cycles
References
- Lenz G, Dreyling M, Hoster E, Wörmann B, Dührsen U, Metzner B, Eimermacher H, Neubauer A, Wandt H, Steinhauer H, Martin S, Heidemann E, Aldaoud A, Parwaresch R, Hasford J, Unterhalt M, Hiddemann W. Immunochemotherapy with rituximab and cyclophosphamide, doxorubicin, vincristine, and prednisone significantly improves response and time to treatment failure, but not long-term outcome in patients with previously untreated mantle cell lymphoma: results of a prospective randomized trial of the German Low Grade Lymphoma Study Group (GLSG). J Clin Oncol. 2005 Mar 20;23(9):1984-92. Epub 2005 Jan 24. link to original article PubMed
- Kluin-Nelemans HC, Hoster E, Hermine O, Walewski J, Trneny M, Geisler CH, Stilgenbauer S, Thieblemont C, Vehling-Kaiser U, Doorduijn JK, Coiffier B, Forstpointner R, Tilly H, Kanz L, Feugier P, Szymczyk M, Hallek M, Kremers S, Lepeu G, Sanhes L, Zijlstra JM, Bouabdallah R, Lugtenburg PJ, Macro M, Pfreundschuh M, Procházka V, Di Raimondo F, Ribrag V, Uppenkamp M, André M, Klapper W, Hiddemann W, Unterhalt M, Dreyling MH. Treatment of older patients with mantle-cell lymphoma. N Engl J Med. 2012 Aug 9;367(6):520-31. link to original article contains verified protocol PubMed
- Rummel MJ, Niederle N, Maschmeyer G, Banat GA, von Grünhagen U, Losem C, Kofahl-Krause D, Heil G, Welslau M, Balser C, Kaiser U, Weidmann E, Dürk H, Ballo H, Stauch M, Roller F, Barth J, Hoelzer D, Hinke A, Brugger W; on behalf of the Study group indolent Lymphomas (StiL). Bendamustine plus rituximab versus CHOP plus rituximab as first-line treatment for patients with indolent and mantle-cell lymphomas: an open-label, multicentre, randomised, phase 3 non-inferiority trial. Lancet. 2013 Apr 6;381(9873):1203-10. Epub 2013 Feb 20. Erratum in: Lancet. 2013 Apr 6;381(9873):1184. link to original article contains verified protocol PubMed
- Update: Abstract: Mathias J. Rummel, MD, Georg Maschmeyer, MD, Arnold Ganser, Andrea Heider, PhD, Ulrich von Grünhagen, MD, PhD5, Christoph Losem, Gerhard Heil, MD, Manfred Welslau, Christina Balser, MD, Ulrich Kaiser, MD, Eckhart Weidmann, Heinz Dürk, MD, Hans Peter Böck, Martina Beate Stauch, MD, Jürgen Barth, Wolfgang Blau, MD, Alexander Burchardt, MD, Frank Kauff, PhD, Axel Hinke, PhD and Wolfram Brugger, MD. Bendamustine Plus Rituximab (B-R) Versus CHOP Plus Rituximab (CHOP-R) As First-Line Treatment in Patients with Indolent and Mantle Cell Lymphomas (MCL) – 7 Year Updated Results from the StiL NHL1 Study. Blood 2014 124:4407. link to abstract
- Flinn IW, van der Jagt R, Kahl BS, Wood P, Hawkins TE, Macdonald D, Hertzberg M, Kwan YL, Simpson D, Craig M, Kolibaba K, Issa S, Clementi R, Hallman DM, Munteanu M, Chen L, Burke JM. Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study. Blood. 2014 May 8;123(19):2944-52. Epub 2014 Mar 3. link to original article contains verified protocol PubMed
- Robak T, Huang H, Jin J, Zhu J, Liu T, Samoilova O, Pylypenko H, Verhoef G, Siritanaratkul N, Osmanov E, Alexeeva J, Pereira J, Drach J, Mayer J, Hong X, Okamoto R, Pei L, Rooney B, van de Velde H, Cavalli F; the LYM-3002 Investigators. Bortezomib-Based Therapy for Newly Diagnosed Mantle-Cell Lymphoma. N Engl J Med. 2015 Mar 5;372(10):944-953. link to original article contains verified protocol PubMed
- Hermine O, Hoster E, Walewski J, Bosly A, Stilgenbauer S, Thieblemont C, Szymczyk M, Bouabdallah R, Kneba M, Hallek M, Salles G, Feugier P, Ribrag V, Birkmann J, Forstpointner R, Haioun C, Hänel M, Casasnovas RO, Finke J, Peter N, Bouabdallah K, Sebban C, Fischer T, Dührsen U, Metzner B, Maschmeyer G, Kanz L, Schmidt C, Delarue R, Brousse N, Klapper W, Macintyre E, Delfau-Larue MH, Pott C, Hiddemann W, Unterhalt M, Dreyling M; European Mantle Cell Lymphoma Network. Addition of high-dose cytarabine to immunochemotherapy before autologous stem-cell transplantation in patients aged 65 years or younger with mantle cell lymphoma (MCL Younger): a randomised, open-label, phase 3 trial of the European Mantle Cell Lymphoma Network. Lancet. 2016 Aug 6;388(10044):565-75. Epub 2016 Jun 14. link to original article PubMed
R-CHOP/R-DHAP
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R-CHOP: Rituximab, Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone
R-DHAP: Rituximab, Dexamethasone, High-dose Ara-C (Cytarabine), Platinol (Cisplatin)
Regimen
Study | Evidence | Comparator | Efficacy |
Hermine et al. 2016 (MCL Younger) | Phase III | R-CHOP | Seems to have superior TTTF |
Note: dosing details were not available in the abstract. The doses here are similar to the regimen of R-CHOP followed by R-DHAP by Delarue et al. 2012; please see original paper for actual dosing details.
Chemotherapy, R-CHOP portion
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 IV once on day 1
- Prednisone (Sterapred) 40 mg/m2 PO once per day on days 1 to 5
21-day cycle for up to 3 cycles, alternating with R-DHAP
Chemotherapy, R-DHAP portion
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
- Dexamethasone (Decadron) 40 mg once per day on days 1 to 4
- Cytarabine (Cytosar) 2000 mg/m2 IV Q12H x 2 doses on day 2 (total dose is 4000 mg/m2)
- Cisplatin (Platinol) 100 mg/m2 IV continuous infusion over 24 hours on day 1
21-day cycle for 3 cycles, alternating with R-CHOP
Treatment followed by high-dose therapy with autologous hematopoietic cell transplant.
References
- Hermine O, Hoster E, Walewski J, Bosly A, Stilgenbauer S, Thieblemont C, Szymczyk M, Bouabdallah R, Kneba M, Hallek M, Salles G, Feugier P, Ribrag V, Birkmann J, Forstpointner R, Haioun C, Hänel M, Casasnovas RO, Finke J, Peter N, Bouabdallah K, Sebban C, Fischer T, Dührsen U, Metzner B, Maschmeyer G, Kanz L, Schmidt C, Delarue R, Brousse N, Klapper W, Macintyre E, Delfau-Larue MH, Pott C, Hiddemann W, Unterhalt M, Dreyling M; European Mantle Cell Lymphoma Network. Addition of high-dose cytarabine to immunochemotherapy before autologous stem-cell transplantation in patients aged 65 years or younger with mantle cell lymphoma (MCL Younger): a randomised, open-label, phase 3 trial of the European Mantle Cell Lymphoma Network. Lancet. 2016 Aug 6;388(10044):565-75. Epub 2016 Jun 14. link to original article PubMed
R-CVP
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R-CVP: Rituximab, Cyclophosphamide, Vincristine, Prednisone
Regimen
Study | Evidence | Comparator | Efficacy |
Flinn et al. 2014 (BRIGHT) | Phase III | BR | Seems non-inferior |
Chemotherapy
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
- Cyclophosphamide (Cytoxan) 750 mg/m2 or 1000 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg per cycle) IV once on day 1
- Prednisone (Sterapred) 100 mg PO once per day on days 1 to 5
Supportive medications
- Antiemetics, antipyretics, and antibiotics per local standard of care
- G-CSF "according to the American Society of Clinical Oncology guidelines"
21-day cycle for up to 8 cycles
References
- Flinn IW, van der Jagt R, Kahl BS, Wood P, Hawkins TE, Macdonald D, Hertzberg M, Kwan YL, Simpson D, Craig M, Kolibaba K, Issa S, Clementi R, Hallman DM, Munteanu M, Chen L, Burke JM. Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study. Blood. 2014 May 8;123(19):2944-52. Epub 2014 Mar 3. link to original article contains verified protocol PubMed
VR-CAP
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VR-CAP: Velcade (Bortezomib), Rituximab, Cyclophosphamide, Adriamycin (Doxorubicin), Prednisone
Regimen
Study | Evidence | Comparator | Efficacy |
Robak et al. 2015 (LYM-3002) | Phase III | R-CHOP | Superior PFS |
Chemotherapy
- Bortezomib (Velcade) 1.3 mg/m2 IV once per day on days 1, 4, 8, 11, given first
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1, given second
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Prednisone (Sterapred) 100 mg/m2 PO once per day on days 1 to 5
21-day cycle for up to 8 cycles
References
- Robak T, Huang H, Jin J, Zhu J, Liu T, Samoilova O, Pylypenko H, Verhoef G, Siritanaratkul N, Osmanov E, Alexeeva J, Pereira J, Drach J, Mayer J, Hong X, Okamoto R, Pei L, Rooney B, van de Velde H, Cavalli F; the LYM-3002 Investigators. Bortezomib-Based Therapy for Newly Diagnosed Mantle-Cell Lymphoma. N Engl J Med. 2015 Mar 5;372(10):944-953. link to original article contains verified protocol PubMed
Untreated, non-randomized or retrospective data
CALGB 59909 Regimen (R-M-CHOP, EAR, CBV auto SCT, Rituximab)
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Regimen
Study | Evidence |
Damon et al. 2009 | Phase II |
Treatments 1-2, R-M-CHOP
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1 (rituximab withheld if circulating mantle cells are >10,000 cells/uL)
- Methotrexate (MTX) 300 mg/m2 IV over 4 hours once on day 2
- Cyclophosphamide (Cytoxan) 2000 mg/m2 IV over 2 hours once on day 3
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 3
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg for patients >40 years old) IV once on day 3
- Prednisone (Sterapred) 100 mg/m2 PO once per day on days 3 to 7
Supportive medications
- Folinic acid (Leucovorin) 50 mg/m2 IV every 6 hours x 3 doses, starting 24 hours after completion of Methotrexate (MTX), then 10 mg/m2 IV/PO every 6 hours until serum methotrexate level <0.05 uM
- Filgrastim (Neupogen) 5 mcg/kg SC once per day starting on day 4, to continue until ANC >10000 once or >5000 twice
- Levofloxacin (Levaquin) 500 mg PO once per day, starting on day 6, to continue until ANC =1500
- Fluconazole (Diflucan) 200 mg PO once per day, starting on day 6, to continue until ANC =1500
Interval between treatment 1 & 2 based on count recovery. Median days between treatment 1 & 2 was 23 days, with a range of 16 to 41 days observed.
Patients with =15% involvement by disease in bone marrow biopsy after treatment 2 proceed to treatment 3. If bone marrow biopsy after treatment 2 has >15% involvement by disease, repeat treatment 2 (identified as "treatment 2.5"). Patients with >15% bone marrow involvement by disease after treatment 2.5 were removed from protocol.
Treatment 3, "EAR"
EAR: Etoposide, Ara-C, Rituximab
Treatment 3 begins 4 weeks after treatment 2, if ANC =1000, platelets =100,000/uL, Cr <2 mg/dL, total bilirubin <2x upper limit of normal, and AST <3x upper limit of normal.
- Etoposide (Vepesid) 10 mg/kg/day (40 mg/kg total dose) IV continuous infusion over 96 hours on days 1 to 4
- Cytarabine (Cytosar) 2000 mg/m2 IV over 2 hours BID on days 1 to 4 (8 total doses)
- Rituximab (Rituxan) 375 mg/m2 IV once per day on days 6 & 13
- Daily leukapheresis to start when WBC =5000/uL
Supportive medications
- Filgrastim (Neupogen) 10 mcg/kg SC once per day starting on day 14, to continue until peripheral blood stem cell collection is complete
- Levofloxacin (Levaquin) 500 mg PO once per day, starting on day 7, to continue until ANC =500
- Fluconazole (Diflucan) 200 mg PO once per day, starting on day 6, to continue until ANC =500
- Acyclovir (Zovirax) 200 mg PO TID, starting on day 6, to continue until 1 year after autologous stem cell transplant (ASCT)
- Note: Text specified that Trimethoprim/Sulfamethoxazole (Bactrim DS) prophylaxis started during treatment 3 (see dose/schedule in treatment 4)--although table 1 did not list it--to continue until 3 months after ASCT.
Treatment 4, CBV with autologous stem cell transplant
CBV: Cyclophosphamide, BiCNU, VP-16
See details of regimen at Transplant conditioning regimens#CBV
Treatment 5, Rituximab
- Rituximab (Rituxan) 375 mg/m2 IV once per week x 2 doses, during the sixth and seventh weeks after ASCT
Additional considerations
If cerebrospinal fluid (CSF) contained disease with CSF WBC =5 cells/uL:
- Methotrexate (MTX) 12 mg intrathecal x 10 total doses during treatments 1 to 3; not given concurrently with intrathecal methotrexate or cytarabine
If CSF contained >5 cells/uL:
- In addition to intrathecal chemotherapy above, patient also received 2 Gy x 12 fractions (total dose 24 Gy) cranial radiation
If any patient appeared to be experiencing carmustine-induced pneumonitis:
- Prednisone (Sterapred) 0.5 mg/kg PO BID x 2 weeks, then tapered over 4 weeks
References
- Damon LE, Johnson JL, Niedzwiecki D, Cheson BD, Hurd DD, Bartlett NL, Lacasce AS, Blum KA, Byrd JC, Kelly M, Stock W, Linker CA, Canellos GP. Immunochemotherapy and autologous stem-cell transplantation for untreated patients with mantle-cell lymphoma: CALGB 59909. J Clin Oncol. 2009 Dec 20;27(36):6101-8. Epub 2009 Nov 16. link to original article contains protocol PubMed
Chlorambucil & Rituximab
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Regimen
Study | Evidence |
Sachanas et al. 2011 | Phase II |
Chemotherapy
- Chlorambucil (Leukeran) 10 mg PO once per day on days 2 to 11 of cycles 1 to 8, then once per day on days 1 to 10 of cycles 9 to 12
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1 of cycles 1 to 8
28-day cycle for 12 cycles
Patients in PR/CR received maintenance rituximab.
References
- Sachanas S, Pangalis GA, Vassilakopoulos TP, Korkolopoulou P, Kontopidou FN, Athanasoulia M, Yiakoumis X, Kalpadakis C, Georgiou G, Masouridis S, Moschogiannis M, Tsirkinidis P, Pappis V, Kokoris SI, Siakantaris MP, Panayiotidis P, Angelopoulou MK. Combination of rituximab with chlorambucil as first line treatment in patients with mantle cell lymphoma: a highly effective regimen. Leuk Lymphoma. 2011 Mar;52(3):387-93. Epub 2010 Dec 6. link to original article contains verified protocol PubMed
Cladribine (Leustatin)
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Regimen
Study | Evidence |
Inwards et al. 2008 (NCCTG 95-80-53) | Phase II |
Chemotherapy
- Cladribine (Leustatin) 5 mg/m2 IV over 2 hours once per day on days 1 to 5
28-day cycle for up to 6 cycles
References
- Inwards DJ, Fishkin PA, Hillman DW, Brown DW, Ansell SM, Kurtin PJ, Fonseca R, Morton RF, Veeder MH, Witzig TE. Long-term results of the treatment of patients with mantle cell lymphoma with cladribine (2-CDA) alone (95-80-53) or 2-CDA and rituximab (N0189) in the North Central Cancer Treatment Group. Cancer. 2008 Jul 1;113(1):108-16. link to original article contains verified protocol PubMed
Cladribine & Rituximab
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Regimen
Study | Evidence |
Inwards et al. 2008 (NCCTG N0189) | Phase II |
Chemotherapy
- Cladribine (Leustatin) 5 mg/m2 IV over 2 hours once per day on days 1 to 5
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
Supportive medications
- Pegfilgrastim (Neulasta) 6 mg SC once on day 6
OR
- Filgrastim (Neupogen) (dose not specified) SC once per day on days 6 to 15
28-day cycle for up to 6 cycles
References
- Inwards DJ, Fishkin PA, Hillman DW, Brown DW, Ansell SM, Kurtin PJ, Fonseca R, Morton RF, Veeder MH, Witzig TE. Long-term results of the treatment of patients with mantle cell lymphoma with cladribine (2-CDA) alone (95-80-53) or 2-CDA and rituximab (N0189) in the North Central Cancer Treatment Group. Cancer. 2008 Jul 1;113(1):108-16. link to original article contains verified protocol PubMed
Lenalidomide & Rituximab
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Regimen
Study | Evidence |
Ruan et al. 2015 | Phase II |
Chemotherapy
- Lenalidomide (Revlimid) as follows:
- Cycle 1: 20 mg PO once per day on days 1 to 21
- Cycle 2 onwards (if no dose-limiting adverse events in cycle 1): 25 mg PO once per day on days 1 to 21
- Rituximab (Rituxan) 375 mg/m2 IV once per week on weeks 1 to 4, 13, 21, 29, 37, 45 (total of 9 doses)
Supportive medications
- Thromboprophylaxis with Aspirin or low molecular weight heparin unless on treatment for known thrombosis
28-day cycle for 12 cycles
Induction followed by maintenance lenalidomide & rituximab.
References
- Ruan J, Martin P, Shah B, Schuster SJ, Smith SM, Furman RR, Christos P, Rodriguez A, Svoboda J, Lewis J, Katz O, Coleman M, Leonard JP. Lenalidomide plus Rituximab as Initial Treatment for Mantle-Cell Lymphoma. N Engl J Med. 2015 Nov 5;373(19):1835-44. link to original article contains verified protocol PubMed
Nordic Regimen (maxi-CHOP, HiDAC, Rituximab)
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CHOP: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone
HiDAC: High Dose Ara-C
Regimen
Study | Evidence |
Geisler et al. 2008 | Phase II |
Protocol originally started rituximab during cycle 4, but the protocol was amended to start it on cycle 2.
Cycle 1 uses maxi-CHOP, cycle 2 uses HiDAC, cycle 3 uses maxi-CHOP, etc.
- Rituximab (Rituxan) as follows:
- Cycles 2 to 5: 375 mg/m2 IV once on day 1
- Cycle 6: 375 mg/m2 IV once per day on days 1 & 9
maxi-CHOP
- Cyclophosphamide (Cytoxan) 1200 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 75 mg/m2 IV once on day 1
- Vincristine (Oncovin) 2 mg IV once on day 1
- Prednisone (Sterapred) 100 mg PO once per day on days 1 to 5
21-day cycles, alternating with high-dose cytarabine, for a total of 3 cycles of maxi-CHOP and 3 cycles of high-dose cytarabine
HiDAC/HDAC, high-dose Cytarabine (Cytosar)
- Cytarabine (Cytosar) as follows:
- Patients ≤60 years old: 3000 mg/m2 IV over 3 hours Q12H on days 1 & 2 (4 total doses)
- Patients >60 years old: 2000 mg/m2 IV over 3 hours Q12H on days 1 & 2 (4 total doses)
Supportive medications
- Filgrastim (Neupogen) given during cycle 6 as part of stem cell mobilization, with at least 2 million CD34+ cells/kg harvested
21-day cycles, alternating with maxi-CHOP, for a total of 3 cycles of maxi-CHOP and 3 cycles of high-dose cytarabine
Followed in 1 to 2 weeks with autologous stem cell transplant. If transplant was delayed, an additional 1 to 2 cycles of chemotherapy with maxi-CHOP or HiDAC could be given.
References
- Geisler CH, Kolstad A, Laurell A, Andersen NS, Pedersen LB, Jerkeman M, Eriksson M, Nordström M, Kimby E, Boesen AM, Kuittinen O, Lauritzsen GF, Nilsson-Ehle H, Ralfkiaer E, Akerman M, Ehinger M, Sundström C, Langholm R, Delabie J, Karjalainen-Lindsberg ML, Brown P, Elonen E; Nordic Lymphoma Group. Long-term progression-free survival of mantle cell lymphoma after intensive front-line immunochemotherapy with in vivo-purged stem cell rescue: a nonrandomized phase 2 multicenter study by the Nordic Lymphoma Group. Blood. 2008 Oct 1;112(7):2687-93. Epub 2008 Jul 14. link to original article PubMed
Observation
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Regimen
Study | Evidence |
Martin et al. 2009 | Retrospective |
Also known as "watchful waiting".
References
- Retrospective: Martin P, Chadburn A, Christos P, Weil K, Furman RR, Ruan J, Elstrom R, Niesvizky R, Ely S, Diliberto M, Melnick A, Knowles DM, Chen-Kiang S, Coleman M, Leonard JP. Outcome of deferred initial therapy in mantle-cell lymphoma. J Clin Oncol. 2009 Mar 10;27(8):1209-13. link to original article PubMed
- Retrospective: Cohen JB, Han X, Jemal A, Ward EM, Flowers CR. Deferred therapy is associated with improved overall survival in patients with newly diagnosed mantle cell lymphoma. Cancer. 2016 Aug 1;122(15):2356-63. Epub 2016 May 6. link to original article PubMed
R-BAC; RB/RC
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R-BAC: Rituximab, Bendamustine, Ara-C (Cytarabine)
RB/RC: Rituximab, Bendamustine, Rituximab, Cytarabine
Regimen #1, RB/RC
Study | Evidence |
Armand et al. 2016 | Phase II |
Chemotherapy
Note: the bendamustine infusion instructions are for the Treanda formulation, which was discontinued on 3/31/2016.
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
- Bendamustine as follows:
- Cycles 1 to 3: (dose not specified) IV over 30 to 60 minutes once per day on days 1 & 2
- Cytarabine (Cytosar) as follows:
- Cycles 4 to 6: (dose not specified) IV q12h on days 1 & 2
28-day cycle for 6 cycles
Regimen #2, R-BAC
Study | Evidence |
Visco et al. 2013 | Phase II |
Chemotherapy
Note: the bendamustine infusion instructions are for the Treanda formulation, which was discontinued on 3/31/2016.
- Rituximab (Rituxan) as follows:
- Cycle 1: 375 mg/m2 IV once on day 1
- Cycle 2 onwards: 375 mg/m2 IV once on day 2
- Bendamustine 70 mg/m2 IV over 30 to 60 minutes once per day on days 2 & 3
- Cytarabine (Cytosar) 800 mg/m2 IV over 2 hours once per day on days 2 to 4, starting 2 hours after bendamustine on days 2 & 3
28-day cycle for 4 cycles (up to 6 for newly diagnosed patients under the age of 80, tolerated treatment, or had regression of disease between cycles 2 and 4)
References
- Visco C, Finotto S, Zambello R, Paolini R, Menin A, Zanotti R, Zaja F, Semenzato G, Pizzolo G, D'Amore ES, Rodeghiero F. Combination of Rituximab, Bendamustine, and Cytarabine for Patients With Mantle-Cell Non-Hodgkin Lymphoma Ineligible for Intensive Regimens or Autologous Transplantation. J Clin Oncol. 2013 Apr 10;31(11):1442-9. Epub 2013 Feb 11. link to original article contains verified protocol PubMed
- Armand P, Redd R, Bsat J, Mayuram S, Giardino A, Fisher DC, LaCasce AS, Jacobson C, Davids MS, Brown JR, Weng L, Wilkins J, Faham M, Freedman AS, Joyce R, Jacobsen ED. A phase 2 study of Rituximab-Bendamustine and Rituximab-Cytarabine for transplant-eligible patients with mantle cell lymphoma. Br J Haematol. 2016 Apr;173(1):89-95. Epub 2016 Jan 5. link to original article PubMed
R-CHOP
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R-CHOP: Rituximab, Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone
Synonyms: R-CHOP-21, CHOP-R
Structured Concept: C9760 (NCI-T), C0393023 (NCI-MT/UMLS)
Example orders
Regimen
Study | Evidence |
Smith et al. 2012 (ECOG E1499) | Phase II |
Chemotherapy
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg per cycle) IV once on day 1
- Prednisone (Sterapred) 100 mg PO once per day on days 1 to 5
3-week cycle for 4 cycles
Followed in 4 to 8 weeks by ibritumomab tiuxetan consolidation.
References
- Smith MR, Li H, Gordon L, Gascoyne RD, Paietta E, Forero-Torres A, Kahl BS, Advani R, Hong F, Horning SJ. Phase II study of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone immunochemotherapy followed by yttrium-90-ibritumomab tiuxetan in untreated mantle-cell lymphoma: Eastern Cooperative Oncology Group Study E1499. J Clin Oncol. 2012 Sep 1;30(25):3119-26. Epub 2012 Jul 30. link to original article contains verified protocol PubMed
R-CHOP -> HiDAC-R
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R-CHOP: Rituximab, Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone
HiDAC-R: High Dose Ara-C (Cytarabine) and Rituximab
Regimen
Study | Evidence |
Van't Veer et al. 2008 (HOVON 45) | Phase II |
R-CHOP portion
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 IV once on day 1
- Prednisolone (Millipred) 100 mg PO once per day on days 1 to 5
3-week cycle for 3 cycles
Patients with at least a partial response proceeded to received HiDAC-R:
HiDAC-R portion
- Cytarabine (Cytosar) 2000 mg/m2 IV q12h on days 1 to 4 (8 total doses)
- Rituximab (Rituxan) 375 mg/m2 IV once on day 11
One course
Stem cells were collected after this cycle with G-CSF given to "enhance" collection. Patients then proceeded to BEAM autologous stem cell transplant.
References
- Van't Veer MB, de Jong D, MacKenzie M, Kluin-Nelemans HC, van Oers MH, Zijlstra J, Hagenbeek A, van Putten WL. High-dose Ara-C and beam with autograft rescue in R-CHOP responsive mantle cell lymphoma patients. Br J Haematol. 2009 Feb;144(4):524-30. Epub 2008 Nov 26. link to original article contains verified protocol PubMed
R-CHOP -> R-DHAP
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R-CHOP: Rituximab, Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone
R-DHAP: Rituximab, Dexamethasone, High-dose Ara-C (Cytarabine), Platinol (Cisplatin)
Regimen
Study | Evidence |
Delarue et al. 2012 | Phase II |
Chemotherapy, R-CHOP portion
- Rituximab (Rituxan) as follows:
- Cycles 1 & 2: none
- Cycle 3: 375 mg/m2 IV once on day 1
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 IV once on day 1
- Prednisone (Sterapred) 40 mg/m2 PO once per day on days 1 to 5
21-day cycle for up to 3 cycles, +/- intrathecal therapy below; patients who progress after first 2 cycles go directly to R-DHAP
Chemotherapy, R-DHAP portion
Note: Delarue et al. 2013 did not clearly specify the total dose/schedule of cytarabine in this part of the regimen, but this is believed to be correct based on other documented DHAP protocols.
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
- Dexamethasone (Decadron) 40 mg once per day on days 1 to 4
- Cytarabine (Cytosar) 2000 mg/m2 IV Q12H x 2 doses on day 2 (total dose is 4000 mg/m2)
- Cisplatin (Platinol) 100 mg/m2 IV continuous infusion over 24 hours on day 1
21-day cycle for 3 cycles, +/- intrathecal therapy below, then proceed with stem cell collection and intensified therapy
Intrathecal therapy
Intrathecal prophylaxis with the following was given per physician discretion; no timeframe or total number of doses is described in Delarue et al. 2013:
- Methotrexate (MTX) 15 mg IT
- Cytarabine (Cytosar) 40 mg IT
- Corticosteroids
Treatment followed by TAM6 or BEAM regimen (see Transplant conditioning regimens).
References
- Delarue R, Haioun C, Ribrag V, Brice P, Delmer A, Tilly H, Salles G, Van Hoof A, Casasnovas O, Brousse N, Lefrere F, Hermine O; for the Groupe d'Etude des Lymphomes de l'Adulte (GELA). CHOP and DHAP plus rituximab followed by autologous stem cell transplantation in mantle cell lymphoma: a phase 2 study from the Groupe d'Etude des Lymphomes de l'Adulte. Blood. 2013 Jan 3;121(1):48-53. Epub 2012 Jun 20. link to original article contains verified protocol PubMed
R-DHAP
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R-DHAP: Rituximab, Dexamethasone, High-dose Ara-C (Cytarabine), Platinol (Cisplatin)
Regimen
Study | Evidence |
de Guibert et al. 2006 | Non-randomized, <20 pts |
Le Gouill et al. 2014 (LyMa) | Non-randomized |
Neither reference contains details about the R-DHAP dosing. The below is the dosing used in the NCIC-CTG LY.12 trial.
Chemotherapy
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
- Dexamethasone (Decadron) 40 mg PO once per day on days 1 to 4
- Cytarabine (Cytosar) 2000 mg/m2 IV over 3 hours Q12H x 2 doses on day 2 (total of 2 doses)
- Cisplatin (Platinol) 100 mg/m2 IV continuous infusion over 24 hours on day 1
4 to 6 cycles
Responding patients in de Guibert et al. 2006 received BEAM autologous transplant if older than 60, or TBI-based autologous transplant if younger than 60. Patients in LyMa who did not achieve at least a PR could go on to receive R-CHOP x4; all others proceeded to R-BEAM autologous stem cell transplant.
References
- de Guibert S, Jaccard A, Bernard M, Turlure P, Bordessoule D, Lamy T. Rituximab and DHAP followed by intensive therapy with autologous stem-cell transplantation as first-line therapy for mantle cell lymphoma. Haematologica. 2006 Mar;91(3):425-6. link to original article does not contain protocol PubMed
- Abstract: Steven Le Gouill, MD, PhD, Catherine Thieblemont, MD, PhD, Lucie Oberic, Krimo Bouabdallah, MD, Emmanuel Gyan, MD, PhD, Gandhi Damaj, MD, Vincent Ribrag, MD, Serge Bologna, MD, Remy Gressin, MD, Olivier Casasnovas, MD, Corinne Haioun, MD, PhD, Philippe Solal-Celigny, MD, Herve Maisonneuve, MD, Eric Van Den Neste, MD, PhD, Anne Moreau, MD, Marie C Bene, Gilles Salles, MD PhD, Hervé Tilly, MD, PhD, Thierry Lamy, MD, PhD and Olivier Hermine, MD, PhD. Rituximab Maintenance Versus Wait and Watch after Four Courses of R-DHAP Followed By Autologous Stem Cell transplantation in Previously Untreated Young Patients with Mantle Cell Lymphoma: First Interim Analysis of the Phase III Prospective Lyma Trial, a Lysa Study. Blood 2014 124:146. link to abstract
R-HyperCVAD/R-MA
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R-HyperCVAD: Rituximab, Hyperfractionated Cyclophosphamide, Vincristine, Adriamycin (Doxorubicin), Dexamethasone
R-MA: Rituximab, Methotrexate, Ara-C (Cytarabine)
R-MTX-Ara-C: Rituximab, MTX (Methotrexate), Ara-C (Cytarabine)
Regimen
Study | Evidence |
Romaguera et al. 2005 | Phase II |
Wang et al. 2008 | Phase II |
Bernstein et al. 2013 (SWOG 0213) | Phase II |
Bernstein et al. 2013 use the original protocol as specified in Romaguera et al. 2005.
Part A (cycles 1, 3, 5, 7)
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1, given first
- Patients with peripheral blood involvement could have the cycle 1 dose of rituximab delayed or omitted by clinician discretion
- Cyclophosphamide (Cytoxan) 300 mg/m2 IV over 3 hours Q12H x 6 doses on days 2 to 4, given second
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once per day on days 5 & 12; day 5 dose is given 12 hours after the last dose of Cyclophosphamide (Cytoxan)
- Doxorubicin (Adriamycin) 16.6 to 16.7 (note: Romaguera et al. 2005 had slightly different dosages in the text vs. table 1) mg/m2/day IV continuous infusion over 72 hours on days 5 to 7 (total dose per cycle: 49.8 to 50.1 mg/m2)
- Dexamethasone (Decadron) 40 mg PO/IV once per day on days 2 to 5, 12 to 15
Supportive medications
- Mesna (Mesnex) 600 mg/m2/day IV continuous infusion over 76 hours on days 2 to 4, starting 1 hour before Cyclophosphamide (Cytoxan) and completed 12 hours after the last dose of Cyclophosphamide (Cytoxan)
- "Over 76 hours" is not exactly specified in Romaguera et al. 2005; Wang et al. 2008. It is based on the assumption that "completed 12 hours after the last dose of cyclophosphamide" means that it would finish 12 hours after the last dose of cyclophosphamide completes.
All growth factors and antibiotics given for 10 days, starting 24 to 36 hours after doxorubicin infusion is complete
- Filgrastim (Neupogen) 5 mcg/kg SC once per day
- Valacyclovir (Valtrex) 500 mg PO once per day
- Fluconazole (Diflucan) 100 mg PO once per day
- Levofloxacin (Levaquin) 500 mg PO once per day or Ciprofloxacin (Cipro) 500 mg PO BID
- Erythropoietin was permitted throughout therapy
21-day cycles, alternating every 21 days with Part B, for a total of 4 cycles of Part A and 4 cycles of Part B
Part B (cycles 2, 4, 6, 8)
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1, given first
- Methotrexate (MTX) 200 mg/m2 IV over 2 hours, then 800 mg/m2 IV over 22 hours once on day 2, given second
- Urine alkalinized to pH of 6.8 or more prior to the start of methotrexate and kept within that range until methotrexate is cleared
- Patients with a Cr >1.5 mg/dL received a 50% reduced dose of methotrexate
- Cytarabine (Cytosar) 3000 mg/m2 IV over 2 hours Q12H on days 3 & 4 (4 doses total)
- Dose reduced to 1000 mg/m2 for patients >60 years old or with Cr >1.5
Supportive medications
- Folinic acid (Leucovorin) 50 mg PO x1 12 hours after Methotrexate (MTX) is complete, then 15 mg PO Q6H x 8 doses. If serum methotrexate level at 24 hours is >1 umol/L or at 48 hours is >0.1 umol/L, dose of folinic acid is increased to 100 mg IV Q3H.
- Prednisolone 1% ophthalmic solution 2 drops in each eye 4 times per day on days 3 to 9 was started on the day of the start of Cytarabine (Cytosar) infusion and was continued for 7 days to prevent chemical conjunctivitis.
The starting day of the following medications was not specified. All medications are given for 10 days.
- Filgrastim (Neupogen) 5 mcg/kg SC once per day
- Valacyclovir (Valtrex) 500 mg PO once per day
- Fluconazole (Diflucan) 100 mg PO once per day
- Levofloxacin (Levaquin) 500 mg PO once per day or Ciprofloxacin (Cipro) 500 mg PO BID
- Erythropoietin was permitted throughout therapy
21-day cycles, alternating every 21 days with Part A, for a total of 4 cycles of Part A and 4 cycles of Part B
References
- Romaguera JE, Fayad L, Rodriguez MA, Broglio KR, Hagemeister FB, Pro B, McLaughlin P, Younes A, Samaniego F, Goy A, Sarris AH, Dang NH, Wang M, Beasley V, Medeiros LJ, Katz RL, Gagneja H, Samuels BI, Smith TL, Cabanillas FF. High rate of durable remissions after treatment of newly diagnosed aggressive mantle-cell lymphoma with rituximab plus hyper-CVAD alternating with rituximab plus high-dose methotrexate and cytarabine. J Clin Oncol. 2005 Oct 1;23(28):7013-23. Epub 2005 Sep 6. link to original article contains verified protocol PubMed
- Update: Romaguera JE, Fayad LE, Feng L, Hartig K, Weaver P, Rodriguez MA, Hagemeister FB, Pro B, McLaughlin P, Younes A, Samaniego F, Goy A, Cabanillas F, Kantarjian H, Kwak L, Wang M. Ten-year follow-up after intense chemoimmunotherapy with Rituximab-HyperCVAD alternating with Rituximab-high dose methotrexate/cytarabine (R-MA) and without stem cell transplantation in patients with untreated aggressive mantle cell lymphoma. Br J Haematol. 2010 Jul;150(2):200-8. Epub 2010 May 26. Review. Erratum in: Br J Haematol.n 2010 Oct;151(1):111. link to original article PubMed
- Update: Chihara D, Cheah CY, Westin JR, Fayad LE, Rodriguez MA, Hagemeister FB, Pro B, McLaughlin P, Younes A, Samaniego F, Goy A, Cabanillas F, Kantarjian H, Kwak LW, Wang ML, Romaguera JE. Rituximab plus hyper-CVAD alternating with MTX/Ara-C in patients with newly diagnosed mantle cell lymphoma: 15-year follow-up of a phase II study from the MD Anderson Cancer Center. Br J Haematol. 2016 Jan;172(1):80-8. Epub 2015 Dec 9. link to original article PubMed
- Wang M, Fayad L, Cabanillas F, Hagemeister F, McLaughlin P, Rodriguez MA, Kwak LW, Zhou Y, Kantarjian H, Romaguera J. Phase 2 trial of rituximab plus hyper-CVAD alternating with rituximab plus methotrexate-cytarabine for relapsed or refractory aggressive mantle cell lymphoma. Cancer. 2008 Nov 15;113(10):2734-41.link to original article contains verified protocol PubMed
- Bernstein SH, Epner E, Unger JM, Leblanc M, Cebula E, Burack R, Rimsza L, Miller TP, Fisher RI. A phase II multicenter trial of hyperCVAD MTX/Ara-C and rituximab in patients with previously untreated mantle cell lymphoma; SWOG 0213. Ann Oncol. 2013 Jun;24(6):1587-93. Epub 2013 Mar 15. link to original article PubMed
R-MACLO/R-IVAM
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R-MACLO: Rituximab, MTX (Methotrexate), Adriamycin (Doxorubicin), Cyclophosphamide, Leucovorin (Folinic acid), Oncovin (Vincristine)
R-IVAM: Rituximab, VP-16 (Etoposide), Ara-C (Cytarabine), Mesna
Regimen #1
Study | Evidence |
Lossos et al. 2010 (UM-MCL1) | Phase II |
R-MACLO (Cycles 1 & 3)
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 45 mg/m2 IV once on day 1
- Cyclophosphamide (Cytoxan) 800 mg/m2 IV once on day 1, then 200 mg/m2 IV once per day on days 2 to 5
- Vincristine (Oncovin) 1.5 mg/m2 (maximum dose of 2 mg) IV once per day on days 1 & 8
- Methotrexate (MTX) 1200 mg/m2 IV over 1 hour, then 5520 mg/m2 IV over 23 hours on day 10
Supportive medications
- Folinic acid (Leucovorin) 180 mg/m2 IV once 12 hours after Methotrexate (MTX) is complete, then 12 mg/m2 IV Q6H for at least 10 doses or until serum methotrexate level is <0.05 umol/L
- G-CSF given starting on day 13, continued until ANC >1.5 x 10^9 for two consecutive days
Next cycle to start after count recovery
R-IVAM (Cycles 2 & 4)
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
- Cytarabine (Cytosar) 2000 mg/m2 IV Q12H on days 1 & 2 (4 doses total)
- Etoposide (Vepesid) 60 mg/m2 IV once per day on days 1 to 5
- Ifosfamide (Ifex) 1500 mg/m2 IV onc per day on days 1 to 5
Supportive medications
- Mesna (Mesnex) 360 mg/m2 IV starting "prior to Ifosfamide (Ifex)" and given Q3H through day 5 (total of 40 doses)
- G-CSF given starting on day 7, continued until ANC >1.5 x 10^9 for two consecutive days
Next cycle to start after count recovery + 2 weeks
Total of 4 cycles
Patients achieving a CR proceeded to thalidomide maintenance.
Regimen #2
Study | Evidence |
Hosein et al. 2015 (UM-MCL2) | Phase II |
The only difference between this regimen and regimen #1 above is the dose of the MTX and the maintenance portion. It is unclear from the text whether the total dose of MTX is reduced to 3000 mg/m2 or if the 23 hour infusional portion is reduced to 3000 mg/m2.
R-MACLO (Cycles 1 & 3)
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 45 mg/m2 IV once on day 1
- Cyclophosphamide (Cytoxan) 800 mg/m2 IV once on day 1, then 200 mg/m2 IV once per day on days 2 to 5
- Vincristine (Oncovin) 1.5 mg/m2 (maximum dose of 2 mg) IV once per day on days 1 & 8
- Methotrexate (MTX) 1200 mg/m2 IV over 1 hour, then 3000 mg/m2 IV over 23 hours on day 10
Supportive medications
- Folinic acid (Leucovorin) 180 mg/m2 IV once 12 hours after Methotrexate (MTX) is complete, then 12 mg/m2 IV Q6H for at least 10 doses or until serum methotrexate level is <0.05 umol/L
- G-CSF given starting on day 13, continued until ANC >1.5 x 10^9 for two consecutive days
Next cycle to start after count recovery
R-IVAM (Cycles 2 & 4)
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
- Cytarabine (Cytosar) 2000 mg/m2 IV Q12H on days 1 & 2 (4 doses total)
- Etoposide (Vepesid) 60 mg/m2 IV once per day on days 1 to 5
- Ifosfamide (Ifex) 1500 mg/m2 IV onc per day on days 1 to 5
Supportive medications
- Mesna (Mesnex) 360 mg/m2 IV starting "prior to Ifosfamide (Ifex)" and given Q3H through day 5 (total of 40 doses)
- G-CSF given starting on day 7, continued until ANC >1.5 x 10^9 for two consecutive days
Next cycle to start after count recovery + 2 weeks
Total of 4 cycles
Patients achieving a CR proceeded to rituximab maintenance.
References
- Lossos IS, Hosein PJ, Morgensztern D, Coleman F, Escalón MP, Byrne GE Jr, Rosenblatt JD, Walker GR. High rate and prolonged duration of complete remissions induced by rituximab, methotrexate, doxorubicin, cyclophosphamide, vincristine, ifosfamide, etoposide, cytarabine, and thalidomide (R-MACLO-IVAM-T), a modification of the National Cancer Institute 89-C-41 regimen, in patients with newly diagnosed mantle cell lymphoma. Leuk Lymphoma. 2010 Mar;51(3):406-14. link to original article contains verified protocol PubMed
- Update: Hosein PJ, Sandoval-Sus JD, Goodman D, Arteaga AG, Reis I, Hoffman J, Stefanovic A, Rosenblatt JD, Lossos IS. Updated survival analysis of two sequential prospective trials of R-MACLO-IVAM followed by maintenance for newly diagnosed mantle cell lymphoma. Am J Hematol. 2015 Jun;90(6):E111-6. Epub 2015 Apr 2. link to original article PubMed
RiPAD+C
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RiPAD+C: Rituximab, PS-341 (Bortezomib), Adriamycin (Doxorubicin), Dexamethasone, Chlorambucil
Regimen
Study | Evidence |
Houot et al. 2011 | Phase II |
Chemotherapy
- Rituximab (Rituxan) as follows:
- Cycle 1: 375 mg/m2 IV once per day on days 1 & 8
- Cycle 2 onwards: 375 mg/m2 IV once on day 1
- Bortezomib (Velcade) 1.3 mg/m2 (route not specified) once per day on days 1, 4, 8, 11
- Doxorubicin (Adriamycin) 9 mg/m2/day IV continuous infusion on days 1 to 4 (total dose = 36 mg/m2)
- Dexamethasone (Decadron) 20 mg (route not specified) BID on days 1 to 4
- Chlorambucil (Leukeran) 12 mg PO once per day on days 20 to 29
35-day cycle for up to 6 cycles
References
- Houot R, Le Gouill S, Ojeda Uribe M, Mounier C, Courby S, Dartigeas C, Bouabdallah K, Alexis Vigier M, Moles MP, Tournilhac O, Arakelyan N, Rodon P, El Yamani A, Sutton L, Fornecker L, Assouline D, Harousseau JL, Maisonneuve H, Caulet-Maugendre S, Gressin R; French GOELAMS group. Combination of rituximab, bortezomib, doxorubicin, dexamethasone and chlorambucil (RiPAD+C) as first-line therapy for elderly mantle cell lymphoma patients: results of a phase II trial from the GOELAMS. Ann Oncol. 2012 Jun;23(6):1555-61. Epub 2011 Oct 19. link to original article contains verified protocol PubMed
(R)VAD+C
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(R)VAD+C: Rituximab, Vincristine, Adriamycin (Doxorubicin), Dexamethasone, Chlorambucil
Regimen
Study | Evidence |
Gressin et al. 2010 (GOELAMS LM1996, Lm2001) | Phase II |
LM1996 did not incorporate rituximab, but these trials were pooled in the publication.
Chemotherapy
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
- Vincristine (Oncovin) 0.4 mg/m2/day IV continuous infusion on days 1 to 4 (total dose = 1.6 mg/m2)
- Doxorubicin (Adriamycin) 9 mg/m2/day IV continuous infusion on days 1 to 4 (total dose = 36 mg/m2)
- Dexamethasone (Decadron) 20 mg PO/IV BID on days 1 to 4
- Chlorambucil (Leukeran) 12 mg PO once per day on days 20 to 29
5-week cycle for 4 to 8 cycles
Transplant-eligible patients with more than partial response after 4 cycles proceed to high-dose melphalan & TBI -> autologous transplant 4 weeks after the 6th cycle.
References
- Gressin R, Caulet-Maugendre S, Deconinck E, Tournilhac O, Gyan E, Moles MP, El Yamani A, Cornillon J, Rossi JF, Le Gouill S, Lepeu G, Damaj G, Celigny PS, Maisonneuve H, Corront B, Vilque JP, Casassus P, Lamy T, Colonna M, Colombat P; French GOELAMS Group. Evaluation of the (R)VAD+C regimen for the treatment of newly diagnosed mantle cell lymphoma. Combined results of two prospective phase II trials from the French GOELAMS group. Haematologica. 2010 Aug;95(8):1350-7. Epub 2010 Mar 10. link to PMC article link to original article contains verified protocol PubMed
VcR-CVAD
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VcR-CVAD: Velcade (Bortezomib), Rituximab, Cyclophosphamide, Vincristine, Adriamycin (Doxorubicin), Dexamethasone
Regimen
Study | Evidence |
Chang et al. 2011 | Phase II |
Chang et al. 2014 (E1405) | Phase II |
Chemotherapy
- Bortezomib (Velcade) 1.3 mg/m2 IV once per day on days 1 & 4
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
- Cyclophosphamide (Cytoxan) 300 mg/m2 IV over 3 hours Q12H x 6 doses on days 1 to 3 (total dose per cycle: 1800 mg/m2)
- Vincristine (Oncovin) 1 mg IV once on day 3
- Doxorubicin (Adriamycin) 50 mg/m2 IV continuous infusion over 48 hours on days 1 & 2 (total dose per cycle: 100 mg/m2)
- Dexamethasone (Decadron) 40 mg PO once per day on days 1 to 4
Supportive medications
- Mesna (Mesnex) dose not specified Chang et al. 2011; not mentioned in Chang et al. 2014
- Filgrastim (Neupogen) 5 mcg/kg SC once per day or Pegfilgrastim (Neulasta) on day 5 or 6 of each cycle
21-day cycle for 6 cycles
Patients in E1405 with at least a PR proceeded to receive maintenance rituximab or autologous stem cell transplant, patient choice.
References
- Chang JE, Peterson C, Choi S, Eickhoff JC, Kim K, Yang DT, Gilbert LA, Rogers ES, Werndli JE, Huie MS, McFarland TA, Volk M, Blank J, Callander NS, Longo WL, Kahl BS. VcR-CVAD induction chemotherapy followed by maintenance rituximab in mantle cell lymphoma: a Wisconsin Oncology Network study. Br J Haematol. 2011 Oct;155(2):190-7. Epub 2011 Aug 16. link to original article contains verified protocol PubMed
- Chang JE, Li H, Smith MR, Gascoyne RD, Paietta EM, Yang DT, Advani RH, Horning SJ, Kahl BS. Phase 2 study of VcR-CVAD with maintenance rituximab for untreated mantle cell lymphoma: an Eastern Cooperative Oncology Group study (E1405). Blood. 2014 Mar 13;123(11):1665-73. Epub 2014 Jan 23. link to original article contains verified protocol PubMed
VR-CHOP
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VR-CHOP: Velcade (Bortezomib), Rituximab, Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone
Regimen
Study | Evidence |
Ruan et al. 2010 | Phase II |
Till et al. 2015 (SWOG S0601) | Phase II |
Doses here are the phase II dose of bortezomib and the R-CHOP protocol as specified in the phase I report by Furman et al. 2010
Chemotherapy
- Bortezomib (Velcade) 1.3 mg/m2 (route not specified) once per day on days 1 & 4 (day 1 given prior to R-CHOP)
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg per cycle) IV once on day 1
- Prednisone (Sterapred) 100 mg PO once per day on days 1 to 5
Supportive medications
- "Standard" Acetaminophen (Tylenol) and Diphenhydramine (Benadryl) prior to Rituximab (Rituxan)
21-day cycle for 6 cycles
Patients in SWOG S0601 proceeded to receive bortezomib maintenance.
References
- Ruan J, Martin P, Furman RR, Lee SM, Cheung K, Vose JM, Lacasce A, Morrison J, Elstrom R, Ely S, Chadburn A, Cesarman E, Coleman M, Leonard JP. Bortezomib plus CHOP-rituximab for previously untreated diffuse large B-cell lymphoma and mantle cell lymphoma. J Clin Oncol. 2011 Feb 20;29(6):690-7. Epub 2010 Dec 28. link to original article contains verified protocol PubMed
- Till BG, Li H, Bernstein SH, Fisher RI, Burack WR, Rimsza LM, Floyd JD, DaSilva MA, Moore DF Jr, Pozdnyakova O, Smith SM, LeBlanc M, Friedberg JW. Phase II trial of R-CHOP plus bortezomib induction therapy followed by bortezomib maintenance for newly diagnosed mantle cell lymphoma: SWOG S0601. Br J Haematol. 2016 Jan;172(2):208-18. Epub 2015 Oct 22. link to original article contains protocol PubMed
Consolidation and/or maintenance after upfront therapy
Autologous stem cell transplant
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To be completed. See details about preparative regimens.
Regimen #1, BEAM
Study | Evidence |
Van't Veer et al. 2008 (HOVON 45) | Phase II |
Treatment preceded by R-CHOP -> HiDAC-R.
Preparative regimen
- Carmustine (BiCNU) 300 mg/m2 IV once on day -7
- Etoposide (Vepesid) 100 mg/m2 IV Q12H on days -6 to -3
- Cytarabine (Cytosar) 100 mg/m2 IV Q12H on days -6 to -3
- Melphalan (Alkeran) 140 mg/m2 IV once on day -2
Stem cells re-infused on day 0
Regimen #2
Study | Evidence |
Geisler et al. 2008 | Phase II |
Treatment preceded by Nordic regimen.
High-dose chemotherapy with BEAM or BEAC
References
- Geisler CH, Kolstad A, Laurell A, Andersen NS, Pedersen LB, Jerkeman M, Eriksson M, Nordström M, Kimby E, Boesen AM, Kuittinen O, Lauritzsen GF, Nilsson-Ehle H, Ralfkiaer E, Akerman M, Ehinger M, Sundström C, Langholm R, Delabie J, Karjalainen-Lindsberg ML, Brown P, Elonen E; Nordic Lymphoma Group. Long-term progression-free survival of mantle cell lymphoma after intensive front-line immunochemotherapy with in vivo-purged stem cell rescue: a nonrandomized phase 2 multicenter study by the Nordic Lymphoma Group. Blood. 2008 Oct 1;112(7):2687-93. Epub 2008 Jul 14. link to original article PubMed
- Van't Veer MB, de Jong D, MacKenzie M, Kluin-Nelemans HC, van Oers MH, Zijlstra J, Hagenbeek A, van Putten WL. High-dose Ara-C and beam with autograft rescue in R-CHOP responsive mantle cell lymphoma patients. Br J Haematol. 2009 Feb;144(4):524-30. Epub 2008 Nov 26. link to original article contains verified protocol PubMed
- Gressin R, Caulet-Maugendre S, Deconinck E, Tournilhac O, Gyan E, Moles MP, El Yamani A, Cornillon J, Rossi JF, Le Gouill S, Lepeu G, Damaj G, Celigny PS, Maisonneuve H, Corront B, Vilque JP, Casassus P, Lamy T, Colonna M, Colombat P; French GOELAMS Group. Evaluation of the (R)VAD+C regimen for the treatment of newly diagnosed mantle cell lymphoma. Combined results of two prospective phase II trials from the French GOELAMS group. Haematologica. 2010 Aug;95(8):1350-7. Epub 2010 Mar 10. link to original article PubMed
- Chang JE, Li H, Smith MR, Gascoyne RD, Paietta EM, Yang DT, Advani RH, Horning SJ, Kahl BS. Phase 2 study of VcR-CVAD with maintenance rituximab for untreated mantle cell lymphoma: an Eastern Cooperative Oncology Group study (E1405). Blood. 2014 Mar 13;123(11):1665-73. Epub 2014 Jan 23. link to original article PubMed
Bortezomib (Velcade)
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Regimen
Study | Evidence |
Till et al. 2015 (SWOG S0601) | Phase II |
Treatment preceded by VR-CHOP x 6.
Chemotherapy
- Bortezomib (Velcade) 1.3 mg/m2 (route not specified) once per day on days 1, 4, 8, 11
3-month cycle for 2 years
References
- Till BG, Li H, Bernstein SH, Fisher RI, Burack WR, Rimsza LM, Floyd JD, DaSilva MA, Moore DF Jr, Pozdnyakova O, Smith SM, LeBlanc M, Friedberg JW. Phase II trial of R-CHOP plus bortezomib induction therapy followed by bortezomib maintenance for newly diagnosed mantle cell lymphoma: SWOG S0601. Br J Haematol. 2016 Jan;172(2):208-18. Epub 2015 Oct 22. link to original article contains protocol PubMed
Ibritumomab tiuxetan (Zevalin)
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Regimen
Study | Evidence |
Smith et al. 2012 (ECOG E1499) | Phase II |
Treatment preceded by R-CHOP x 4.
Chemotherapy
- Rituximab (Rituxan) 250 mg/m2 IV once on day 1, then another single dose on day 8
- Ibritumomab tiuxetan & Yttrium-90 (Zevalin) 0.4 mCi/kg (maximum dose of 32 mCi) IV once, given after second dose of Rituximab (Rituxan)
- Dose-reduced to 0.3 mCi/kg if platelet count between 100,000/µL and 149,000/µL
One course
References
- Smith MR, Li H, Gordon L, Gascoyne RD, Paietta E, Forero-Torres A, Kahl BS, Advani R, Hong F, Horning SJ. Phase II study of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone immunochemotherapy followed by yttrium-90-ibritumomab tiuxetan in untreated mantle-cell lymphoma: Eastern Cooperative Oncology Group Study E1499. J Clin Oncol. 2012 Sep 1;30(25):3119-26. Epub 2012 Jul 30. link to original article contains verified protocol PubMed
Lenalidomide & Rituximab
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Regimen
Study | Evidence |
Ruan et al. 2015 | Phase II |
Treatment preceded by lenalidomide & rituximab induction.
Chemotherapy
- Lenalidomide (Revlimid) 15 mg PO once per day on days 1 to 21
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1 every other cycle (every 8 weeks)
28-day cycles until progression of disease.
References
- Ruan J, Martin P, Shah B, Schuster SJ, Smith SM, Furman RR, Christos P, Rodriguez A, Svoboda J, Lewis J, Katz O, Coleman M, Leonard JP. Lenalidomide plus Rituximab as Initial Treatment for Mantle-Cell Lymphoma. N Engl J Med. 2015 Nov 5;373(19):1835-44. link to original article contains verified protocol PubMed
Observation
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Regimen
Study | Evidence | Comparator | Efficacy |
Le Gouill et al. 2014 (LyMa) | Phase III | Rituximab | Seems to have inferior PFS |
Preceded by R-DHAP x4 and R-BEAM autologous stem cell transplant. This arm received no further treatment.
References
- Abstract: Steven Le Gouill, MD, PhD, Catherine Thieblemont, MD, PhD, Lucie Oberic, Krimo Bouabdallah, MD, Emmanuel Gyan, MD, PhD, Gandhi Damaj, MD, Vincent Ribrag, MD, Serge Bologna, MD, Remy Gressin, MD, Olivier Casasnovas, MD, Corinne Haioun, MD, PhD, Philippe Solal-Celigny, MD, Herve Maisonneuve, MD, Eric Van Den Neste, MD, PhD, Anne Moreau, MD, Marie C Bene, Gilles Salles, MD PhD, Hervé Tilly, MD, PhD, Thierry Lamy, MD, PhD and Olivier Hermine, MD, PhD. Rituximab Maintenance Versus Wait and Watch after Four Courses of R-DHAP Followed By Autologous Stem Cell transplantation in Previously Untreated Young Patients with Mantle Cell Lymphoma: First Interim Analysis of the Phase III Prospective Lyma Trial, a Lysa Study. Blood 2014 124:146. link to abstract
Rituximab (Rituxan)
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Regimen #1
Study | Evidence | Comparator | Efficacy |
Le Gouill et al. 2014 (LyMa) | Phase III | Observation | Seems to have superior PFS |
Treatment preceded by R-DHAP x4 and R-BEAM autologous stem cell transplant.
Chemotherapy
- Rituximab (Rituxan) 375 mg/m2 IV once every 3 months
3-year course (12 total doses)
Regimen #2
Study | Evidence | Comparator | Efficacy |
Kluin-Nelemans et al. 2012 | Phase III | Interferon alfa | Seeems to have superior combined PFS/OS |
Treatment preceded by R-CHOP x 8 versus R-FC x 6.
Chemotherapy
- Rituximab (Rituxan) 375 mg/m2 IV once every 2 months
Continued until progression
Regimen #3, Räty et al. 2012
To be completed
Regimen #4
Study | Evidence |
Hosein et al. 2015 (UM-MCL2) | Phase II |
Treatment preceded by R-MACLO/R-IVAM.
Chemotherapy
- Rituximab (Rituxan) 375 mg/m2 IV once per week for four weeks
Course repeats every 6 months for 3 years (24 total doses)
Regimen #5
Study | Evidence |
Chang et al. 2014 (ECOG E1405) | Phase II |
Treatment preceded by VcR-CVAD.
Chemotherapy
- Rituximab (Rituxan) 375 mg/m2 IV once per week for four weeks
Course repeats every 6 months for 2 years (16 total doses)
Regimen #6
Study | Evidence |
Sachanas et al. 2011 | Phase II |
Treatment preceded by chlorambucil & rituximab.
Chemotherapy
- Rituximab (Rituxan) 375 mg/m2 IV once every 2 months
12-month course (6 total doses)
References
- Sachanas S, Pangalis GA, Vassilakopoulos TP, Korkolopoulou P, Kontopidou FN, Athanasoulia M, Yiakoumis X, Kalpadakis C, Georgiou G, Masouridis S, Moschogiannis M, Tsirkinidis P, Pappis V, Kokoris SI, Siakantaris MP, Panayiotidis P, Angelopoulou MK. Combination of rituximab with chlorambucil as first line treatment in patients with mantle cell lymphoma: a highly effective regimen. Leuk Lymphoma. 2011 Mar;52(3):387-93. Epub 2010 Dec 6. link to original article contains verified protocol PubMed
- Kluin-Nelemans HC, Hoster E, Hermine O, Walewski J, Trneny M, Geisler CH, Stilgenbauer S, Thieblemont C, Vehling-Kaiser U, Doorduijn JK, Coiffier B, Forstpointner R, Tilly H, Kanz L, Feugier P, Szymczyk M, Hallek M, Kremers S, Lepeu G, Sanhes L, Zijlstra JM, Bouabdallah R, Lugtenburg PJ, Macro M, Pfreundschuh M, Procházka V, Di Raimondo F, Ribrag V, Uppenkamp M, André M, Klapper W, Hiddemann W, Unterhalt M, Dreyling MH. Treatment of older patients with mantle-cell lymphoma. N Engl J Med. 2012 Aug 9;367(6):520-31. link to original article contains verified protocol PubMed
- Räty R, Honkanen T, Jantunen E, Jyrkkiö S, Karjalainen-Lindsberg ML, Kuittinen O, Lehto M, Mikkola M, Poikonen E, Rauhala A, Rimpiläinen J, Räsänen A, Siitonen S, Suominen M, Vapaatalo M, Elonen E. Prolonged immunochemotherapy with rituximab, cytarabine and fludarabine added to cyclophosphamide, doxorubicin, vincristine and prednisolone and followed by rituximab maintenance in untreated elderly patients with mantle cell lymphoma: a prospective study by the Finnish Lymphoma Group. Leuk Lymphoma. 2012 Oct;53(10):1920-8. Epub 2012 Apr 23. PubMed
- Update: Abstract: Riikka Räty, Tuomo Honkanen, Esa Jantunen, MD, PhD, Sirkku Jyrkkiö, Marja-Liisa Karjalainen-Lindsberg, MD, PhD, Outi Kuittinen, Minna Lehto, Maija Mikkola, Eira Poikonen, Auvo Rauhala, Johanna Rimpiläinen, Anu Räsänen, MD, Sanna Siitonen, Merja Suominen, MD, Mirja Vapaatalo and Erkki Elonen. Rituximab Maintenance Bimonthly for Two Years after Prolonged Immunochemotherapy in Elderly Patients with Mantle Cell Lymphoma (MCL) Results in Long Remissions: Update with Six-Year Follow-up of a Prospective Study By the Finnish Lymphoma Group. Blood 2014 124:1749. link to abstract
- Chang JE, Li H, Smith MR, Gascoyne RD, Paietta EM, Yang DT, Advani RH, Horning SJ, Kahl BS. Phase 2 study of VcR-CVAD with maintenance rituximab for untreated mantle cell lymphoma: an Eastern Cooperative Oncology Group study (E1405). Blood. 2014 Mar 13;123(11):1665-73. Epub 2014 Jan 23. link to original article contains verified protocol PubMed
- Abstract: Steven Le Gouill, MD, PhD, Catherine Thieblemont, MD, PhD, Lucie Oberic, Krimo Bouabdallah, MD, Emmanuel Gyan, MD, PhD, Gandhi Damaj, MD, Vincent Ribrag, MD, Serge Bologna, MD, Remy Gressin, MD, Olivier Casasnovas, MD, Corinne Haioun, MD, PhD, Philippe Solal-Celigny, MD, Herve Maisonneuve, MD, Eric Van Den Neste, MD, PhD, Anne Moreau, MD, Marie C Bene, Gilles Salles, MD PhD, Hervé Tilly, MD, PhD, Thierry Lamy, MD, PhD and Olivier Hermine, MD, PhD. Rituximab Maintenance Versus Wait and Watch after Four Courses of R-DHAP Followed By Autologous Stem Cell transplantation in Previously Untreated Young Patients with Mantle Cell Lymphoma: First Interim Analysis of the Phase III Prospective Lyma Trial, a Lysa Study. Blood 2014 124:146. link to abstract
- Hosein PJ, Sandoval-Sus JD, Goodman D, Arteaga AG, Reis I, Hoffman J, Stefanovic A, Rosenblatt JD, Lossos IS. Updated survival analysis of two sequential prospective trials of R-MACLO-IVAM followed by maintenance for newly diagnosed mantle cell lymphoma. Am J Hematol. 2015 Jun;90(6):E111-6. Epub 2015 Apr 2. link to original article PubMed
Relapsed/refractory, randomized data
BCHOP
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BCHOP: Bortezomib, Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisolone
Regimen
Study | Evidence | Comparator | Efficacy |
Furtado et al. 2014 | Randomized Phase II | CHOP | Seems to have superior OS |
Chemotherapy
- Bortezomib (Velcade) 1.6 mg/m2 (route not specified) once per day on days 1 & 8
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg per cycle) IV once on day 1
- Prednisolone (Millipred) 100 mg PO once per day on days 1 to 5
Supportive medications
- Acyclovir (Zovirax) 400 mg PO BID
21-day cycle for up to 8 cycles
References
- Furtado M, Johnson R, Kruger A, Turner D, Rule S. Addition of bortezomib to standard dose chop chemotherapy improves response and survival in relapsed mantle cell lymphoma. Br J Haematol. 2015 Jan;168(1):55-62. Epub 2014 Aug 22. link to original article contains verified protocol PubMed
BR
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BR: Bendamustine, Rituximab
Regimen
Study | Evidence | Comparator | Efficacy |
Czuczman et al. 2015 | Phase II | ||
Rummel et al. 2015 (StiL NHL 2-2003) | Phase III | FR | Seems to have superior OS |
Chemotherapy
- Bendamustine 90 mg/m2 IV once per day on days 1 & 2
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
Supportive medications
- Analgesics and antipyretics prior to each dose of Rituximab (Rituxan)
28-day cycle for 6 to 8 cycles
References
- Czuczman MS, Goy A, Lamonica D, Graf DA, Munteanu MC, van der Jagt RH. Phase II study of bendamustine combined with rituximab in relapsed/refractory mantle cell lymphoma: efficacy, tolerability, and safety findings. Ann Hematol. 2015 Dec;94(12):2025-32. Epub 2015 Sep 28. link to original article contains verified protocol PubMed
- Rummel M, Kaiser U, Balser C, Stauch M, Brugger W, Welslau M, Niederle N, Losem C, Boeck HP, Weidmann E, von Gruenhagen U, Mueller L, Sandherr M, Hahn L, Vereshchagina J, Kauff F, Blau W, Hinke A, Barth J; Study group indolent Lymphomas (StiL). Bendamustine plus rituximab versus fludarabine plus rituximab for patients with relapsed indolent and mantle-cell lymphomas: a multicentre, randomised, open-label, non-inferiority phase 3 trial. Lancet Oncol. 2016 Jan;17(1):57-66. Epub 2015 Dec 5. link to original article contains protocol PubMed
CHOP
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CHOP: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisolone
Regimen
Study | Evidence | Comparator | Efficacy |
Furtado et al. 2014 | Randomized Phase II | BCHOP | Seems to have inferior OS |
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
- Prednisolone (Millipred) 100 mg PO once per day on days 1 to 5
21-day cycle for 6 to 8 cycles
References
- Furtado M, Johnson R, Kruger A, Turner D, Rule S. Addition of bortezomib to standard dose chop chemotherapy improves response and survival in relapsed mantle cell lymphoma. Br J Haematol. 2015 Jan;168(1):55-62. Epub 2014 Aug 22. link to original article contains verified protocol PubMed
FCM
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FCM: Fludarabine, Cyclophosphamide, Mitoxantrone
Regimen
Study | Evidence | Comparator | Efficacy |
Forstpointner et al. 2004 | Phase III | R-FCM | Inferior OS |
Chemotherapy
- Fludarabine (Fludara) 25 mg/m2 IV over 30 minutes once per day on days 1 to 3
- Cyclophosphamide (Cytoxan) 200 mg/m2 IV over 4 hours on days 1 to 3
- Mitoxantrone (Novantrone) 8 mg/m2 IV over 30 minutes once on day 1
28-day cycle for 4 cycles
Responders (PR or CR) were randomized to maintenance Rituximab (Rituxan) versus no further treatment.
References
- Forstpointner R, Dreyling M, Repp R, Hermann S, Hänel A, Metzner B, Pott C, Hartmann F, Rothmann F, Rohrberg R, Böck HP, Wandt H, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. The addition of rituximab to a combination of fludarabine, cyclophosphamide, mitoxantrone (FCM) significantly increases the response rate and prolongs survival as compared with FCM alone in patients with relapsed and refractory follicular and mantle cell lymphomas: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood. 2004 Nov 15;104(10):3064-71. Epub 2004 Jul 29. link to original article contains verified protocol PubMed content property of HemOnc.org
- Update: Forstpointner R, Unterhalt M, Dreyling M, Böck HP, Repp R, Wandt H, Pott C, Seymour JF, Metzner B, Hänel A, Lehmann T, Hartmann F, Einsele H, Hiddemann W; German Low Grade Lymphoma Study Group (GLSG). Maintenance therapy with rituximab leads to a significant prolongation of response duration after salvage therapy with a combination of rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) in patients with recurring and refractory follicular and mantle cell lymphomas: Results of a prospective randomized study of the German Low Grade Lymphoma Study Group (GLSG). Blood. 2006 Dec 15;108(13):4003-8. Epub 2006 Aug 31. link to original article contains verified protocol PubMed
FR
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FR: Fludarabine, Rituximab
Regimen
Study | Evidence | Comparator | Efficacy |
Rummel et al. 2015 (StiL NHL 2-2003) | Phase III | BR | Seems to have inferior OS |
Chemotherapy
- Fludarabine (Fludara) 25 mg/m2 (route not specified) once per day on days 1 to 3
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
28-day cycle for up to 6 cycles
References
- Rummel M, Kaiser U, Balser C, Stauch M, Brugger W, Welslau M, Niederle N, Losem C, Boeck HP, Weidmann E, von Gruenhagen U, Mueller L, Sandherr M, Hahn L, Vereshchagina J, Kauff F, Blau W, Hinke A, Barth J; Study group indolent Lymphomas (StiL). Bendamustine plus rituximab versus fludarabine plus rituximab for patients with relapsed indolent and mantle-cell lymphomas: a multicentre, randomised, open-label, non-inferiority phase 3 trial. Lancet Oncol. 2016 Jan;17(1):57-66. Epub 2015 Dec 5. link to original article contains protocol PubMed
Ibrutinib (Imbruvica)
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Regimen
Study | Evidence | Comparator | Efficacy |
Wang et al. 2013 (PCYC-1104-CA) | Phase II | ||
Dreyling et al. 2015 | Phase III | Temsirolimus | Superior PFS |
Chemotherapy
- Ibrutinib (Imbruvica) 560 mg PO once per day
Given until progression of disease or unacceptable toxicity
References
- Wang ML, Rule S, Martin P, Goy A, Auer R, Kahl BS, Jurczak W, Advani RH, Romaguera JE, Williams ME, Barrientos JC, Chmielowska E, Radford J, Stilgenbauer S, Dreyling M, Jedrzejczak WW, Johnson P, Spurgeon SE, Li L, Zhang L, Newberry K, Ou Z, Cheng N, Fang B, McGreivy J, Clow F, Buggy JJ, Chang BY, Beaupre DM, Kunkel LA, Blum KA. Targeting BTK with Ibrutinib in Relapsed or Refractory Mantle-Cell Lymphoma. N Engl J Med. 2013 Aug 8;369(6):507-16. Epub 2013 Jun 19. link to original article contains verified protocol PubMed
- Update: Abstract: Michael Wang, MD, Simon Rule, MD, Peter Martin, MD, Andre Goy, MD, Rebecca Auer, MD, PhD, Brad S. Kahl, MD, Wojciech Jurczak, Ranjana Advani, MD, Jorge E. Romaguera, MD, Michael E. Williams, MD, Jacqueline C. Barrientos, M.D., Ewa Chmielowska, MD, John Radford, Stephan Stilgenbauer, MD, Martin Dreyling, Wieslaw Wiktor Jedrzejczak, MD, Peter W Johnson, MD, Stephen E. Spurgeon, MD, Liang Zhang, MD, PhD, Linda Baher, Mei Cheng, PhD, Darrin M. Beaupre, MD and Kristie A. Blum, MD. Single-Agent Ibrutinib Demonstrates Safety and Durability of Response at 2 Years Follow-up in Patients with Relapsed or Refractory Mantle Cell Lymphoma: Updated Results of an International, Multicenter, Open-Label Phase 2 Study. Blood 2014 124:4453. link to abstract
- Update: Wang ML, Blum KA, Martin P, Goy A, Auer R, Kahl BS, Jurczak W, Advani RH, Romaguera JE, Williams ME, Barrientos JC, Chmielowska E, Radford J, Stilgenbauer S, Dreyling M, Jedrzejczak WW, Johnson P, Spurgeon SE, Zhang L, Baher L, Cheng M, Lee D, Beaupre DM, Rule S. Long-term follow-up of MCL patients treated with single-agent ibrutinib: Updated safety and efficacy results. Blood. 2015 Aug 6;126(6):739-45. Epub 2015 Jun 9. link to original article PubMed
- Dreyling M, Jurczak W, Jerkeman M, Silva RS, Rusconi C, Trneny M, Offner F, Caballero D, Joao C, Witzens-Harig M, Hess G, Bence-Bruckler I, Cho SG, Bothos J, Goldberg JD, Enny C, Traina S, Balasubramanian S, Bandyopadhyay N, Sun S, Vermeulen J, Rizo A, Rule S. Ibrutinib versus temsirolimus in patients with relapsed or refractory mantle-cell lymphoma: an international, randomised, open-label, phase 3 study. Lancet. 2016 Feb 20;387(10020):770-8. Epub 2015 Dec 4. link to original article contains verified protocol PubMed
Lenalidomide (Revlimid)
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Regimen
Study | Evidence | Comparator | Efficacy |
Wiernik et al. 2008 (NHL-002) | Phase II, <20 pts in subgroup | ||
Habermann et al. 2009 | Phase II, <20 pts in subgroup | ||
Witzig et al. 2011 (NHL-003) | Phase II | ||
Eve et al. 2012 | Phase II | ||
Goy et al. 2013 (MCL-001, EMERGE) | Phase II | ||
Trněný et al. 2016 (MCL-002, SPRINT) | Randomized Phase II | Investigator's choice | Superior PFS |
Participants in EMERGE "were required to have had prior treatment with rituximab, cyclophosphamide and anthracycline (or mitoxantrone), and to have relapsed or progressed (<12 months) after or were refractory to bortezomib." Investigator's choice in the SPRINT trial was restricted to single-agent therapy with cytarabine, rituximab, gemcitabine, fludarabine, or chlorambucil.
Chemotherapy
- Lenalidomide (Revlimid) 25 mg PO once per day on days 1 to 21
28-day cycles, given until progression of disease, unacceptable toxicity, or voluntary withdrawal
Patients in Eve et al. 2012 proceeded to receive maintenance lenalidomide after 6 cycles.
References
- Wiernik PH, Lossos IS, Tuscano JM, Justice G, Vose JM, Cole CE, Lam W, McBride K, Wride K, Pietronigro D, Takeshita K, Ervin-Haynes A, Zeldis JB, Habermann TM. Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma. J Clin Oncol. 2008 Oct 20;26(30):4952-7. Epub 2008 Jul 7. link to original article contains verified protocol PubMed
- Habermann TM, Lossos IS, Justice G, Vose JM, Wiernik PH, McBride K, Wride K, Ervin-Haynes A, Takeshita K, Pietronigro D, Zeldis JB, Tuscano JM. Lenalidomide oral monotherapy produces a high response rate in patients with relapsed or refractory mantle cell lymphoma. Br J Haematol. 2009 May;145(3):344-9. Epub 2009 Feb 24. link to original article contains verified protocol PubMed
- Witzig TE, Vose JM, Zinzani PL, Reeder CB, Buckstein R, Polikoff JA, Bouabdallah R, Haioun C, Tilly H, Guo P, Pietronigro D, Ervin-Haynes AL, Czuczman MS. An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. Ann Oncol. 2011 Jul;22(7):1622-7. Epub 2011 Jan 12. link to original article contains verified protocol PubMed
- Update: Zinzani PL, Vose JM, Czuczman MS, Reeder CB, Haioun C, Polikoff J, Tilly H, Zhang L, Prandi K, Li J, Witzig TE. Long-term follow-up of lenalidomide in relapsed/refractory mantle cell lymphoma: subset analysis of the NHL-003 study. Ann Oncol. 2013 Nov;24(11):2892-7. Epub 2013 Sep 12. link to original article PubMed
- Eve HE, Carey S, Richardson SJ, Heise CC, Mamidipudi V, Shi T, Radford JA, Auer RL, Bullard SH, Rule SA. Single-agent lenalidomide in relapsed/refractory mantle cell lymphoma: results from a UK phase II study suggest activity and possible gender differences. Br J Haematol. 2012 Oct;159(2):154-63. Epub 2012 Aug 9. link to original article contains verified protocol PubMed
- Goy A, Sinha R, Williams ME, Kalayoglu Besisik S, Drach J, Ramchandren R, Zhang L, Cicero S, Fu T, Witzig TE. Single-Agent Lenalidomide in Patients With Mantle-Cell Lymphoma Who Relapsed or Progressed After or Were Refractory to Bortezomib: Phase II MCL-001 (EMERGE) Study. J Clin Oncol. 2013 Oct 10;31(29):3688-95. Epub 2013 Sep 3. link to original article contains verified protocol PubMed
- Update: Goy A, Kalayoglu Besisik S, Drach J, Ramchandren R, Robertson MJ, Avivi I, Rowe JM, Herbrecht R, Van Hoof A, Zhang L, Cicero S, Fu T, Witzig T. Longer-term follow-up and outcome by tumour cell proliferation rate (Ki-67) in patients with relapsed/refractory mantle cell lymphoma treated with lenalidomide on MCL-001(EMERGE) pivotal trial. Br J Haematol. 2015 Aug;170(4):496-503. Epub 2015 Apr 28. link to original article PubMed
- Trněný M, Lamy T, Walewski J, Belada D, Mayer J, Radford J, Jurczak W, Morschhauser F, Alexeeva J, Rule S, Afanasyev B, Kaplanov K, Thyss A, Kuzmin A, Voloshin S, Kuliczkowski K, Giza A, Milpied N, Stelitano C, Marks R, Trümper L, Biyukov T, Patturajan M, Bravo MC, Arcaini L; SPRINT trial investigators and in collaboration with the European Mantle Cell Lymphoma Network. Lenalidomide versus investigator's choice in relapsed or refractory mantle cell lymphoma (MCL-002; SPRINT): a phase 2, randomised, multicentre trial. Lancet Oncol. 2016 Mar;17(3):319-31. Epub 2016 Feb 15. link to original article PubMed
R-FCM
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R-FCM: Rituximab, Fludarabine, Cyclophosphamide, Mitoxantrone
Regimen
Study | Evidence | Comparator | Efficacy |
Forstpointner et al. 2004 | Phase III | FCM | Superior OS |
Chemotherapy
- Rituximab (Rituxan) 375 mg/m2 IV once on day -1 (the day before FCM)
- Fludarabine (Fludara) 25 mg/m2 IV over 30 minutes once per day on days 1 to 3
- Cyclophosphamide (Cytoxan) 200 mg/m2 IV over 4 hours once per day on days 1 to 3
- Mitoxantrone (Novantrone) 8 mg/m2 IV over 30 minutes once on day 1
28-day cycle for 4 cycles
Responders (PR or CR) were randomized to rituximab maintenance versus no further treatment.
References
- Forstpointner R, Dreyling M, Repp R, Hermann S, Hänel A, Metzner B, Pott C, Hartmann F, Rothmann F, Rohrberg R, Böck HP, Wandt H, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. The addition of rituximab to a combination of fludarabine, cyclophosphamide, mitoxantrone (FCM) significantly increases the response rate and prolongs survival as compared with FCM alone in patients with relapsed and refractory follicular and mantle cell lymphomas: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood. 2004 Nov 15;104(10):3064-71. Epub 2004 Jul 29. link to original article contains verified protocol PubMed
- Update: Forstpointner R, Unterhalt M, Dreyling M, Böck HP, Repp R, Wandt H, Pott C, Seymour JF, Metzner B, Hänel A, Lehmann T, Hartmann F, Einsele H, Hiddemann W; German Low Grade Lymphoma Study Group (GLSG). Maintenance therapy with rituximab leads to a significant prolongation of response duration after salvage therapy with a combination of rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) in patients with recurring and refractory follicular and mantle cell lymphomas: Results of a prospective randomized study of the German Low Grade Lymphoma Study Group (GLSG). Blood. 2006 Dec 15;108(13):4003-8. Epub 2006 Aug 31. link to original article contains verified protocol PubMed
Temsirolimus (Torisel)
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Regimen
Study | Evidence | Comparator | Efficacy |
Hess et al. 2009 | Phase III | Investigator's choice Temsirolimus 175/25 |
Superior PFS |
Dreyling et al. 2015 | Phase III | Ibrutinib | Inferior PFS |
The most commonly compared regimens in Hess et al. 2009 were single agent gemcitabine and single agent fludarabine.
Chemotherapy
- Temsirolimus (Torisel) as follows:
- Cycle 1: 175 mg IV over 30 to 60 minutes once per day on days 1, 8, 15
- Cycle 2 onwards: 75 mg IV over 30 to 60 minutes once per day on days 1, 8, 15
Supportive medications
- Antihistamine once 30 minutes prior to Temsirolimus (Torisel).
- Corticosteroid use was not allowed in Hess et al. 2009.
21-day cycles given until progression or unacceptable toxicity
References
- Hess G, Herbrecht R, Romaguera J, Verhoef G, Crump M, Gisselbrecht C, Laurell A, Offner F, Strahs A, Berkenblit A, Hanushevsky O, Clancy J, Hewes B, Moore L, Coiffier B. Phase III study to evaluate temsirolimus compared with investigator's choice therapy for the treatment of relapsed or refractory mantle cell lymphoma. J Clin Oncol. 2009 Aug 10;27(23):3822-9. Epub 2009 Jul 6. link to original article contains verified protocol PubMed
- Dreyling M, Jurczak W, Jerkeman M, Silva RS, Rusconi C, Trneny M, Offner F, Caballero D, Joao C, Witzens-Harig M, Hess G, Bence-Bruckler I, Cho SG, Bothos J, Goldberg JD, Enny C, Traina S, Balasubramanian S, Bandyopadhyay N, Sun S, Vermeulen J, Rizo A, Rule S. Ibrutinib versus temsirolimus in patients with relapsed or refractory mantle-cell lymphoma: an international, randomised, open-label, phase 3 study. Lancet. 2016 Feb 20;387(10020):770-8. Epub 2015 Dec 4. link to original article contains verified protocol PubMed
Relapsed/refractory, non-randomized or retrospective data
Arsenic trioxide & chlorambucil
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Regimen
Study | Evidence |
Gill et al. 2014 | Phase II |
Chemotherapy
- Arsenic trioxide (Trisenox) 10 mg PO once per day, reduced to 5 mg PO once per day after 4 weeks
- Chlorambucil (Leukeran) 4 mg PO once per day, increased to 8 mg PO once per day "if leukocyte count allowed"
Supportive medications
- Ascorbic acid (Vitamin C) 1000 mg PO once per day
6-week course
Patients with at least stable disease received maintenance arsenic trioxide and chlorambucil.
References
- Gill H, Au WY, Cheung WW, Lee EY, Kwong YL. Oral arsenic trioxide-based regimen as salvage treatment for relapsed or refractory mantle cell lymphoma. Ann Oncol. 2014 Jul;25(7):1391-7. Epub 2014 Apr 12. link to original article contains verified protocol PubMed
BeRT
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BeRT: Bendamustine, Rituximab, Temsirolimus
Regimen
Study | Evidence |
Hess et al. 2015 | Phase I/II, <20 pts reported |
The temsirolimus dose was the maximum dose used in the phase I portion of the trial; no DLT were observed.
Chemotherapy
- Bendamustine 90 mg/m2 IV once per day on days 1 & 2
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
- Temsirolimus (Torisel) 75 mg IV once per day on days 1, 8, 15
28-day cycle for up to 4 cycles
References
- Hess G, Keller U, Scholz CW, Witzens-Harig M, Atta J, Buske C, Kirschey S, Ruckes C, Medler C, van Oordt C, Klapper W, Theobald M, Dreyling M. Safety and efficacy of Temsirolimus in combination with Bendamustine and Rituximab in relapsed mantle cell and follicular lymphoma. Leukemia. 2015 Aug;29(8):1695-701. Epub 2015 Mar 13. link to original article contains verified protocol PubMed
BORID
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BORID: BOrtezomib, RItuximab, Dexamethasone
Regimen
Study | Evidence |
Lamm et al. 2011 | Phase II, <20 pts reported |
Chemotherapy
- Bortezomib (Velcade) 1.3 mg/m2 IV over 3 to 5 seconds once per day on days 1, 4, 8, 11
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
- Dexamethasone (Decadron) 40 mg PO once per day on days 1 to 4
21-day cycle for 6 cycles
Responding patients received rituximab consolidation.
References
- Lamm W, Kaufmann H, Raderer M, Hoffmann M, Chott A, Zielinski C, Drach J. Bortezomib combined with rituximab and dexamethasone is an active regimen for patients with relapsed and chemotherapy-refractory mantle cell lymphoma. Haematologica. 2011 Jul;96(7):1008-14. Epub 2011 Apr 12. link to original article contains verified protocol PubMed
Bortezomib (Velcade)
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Regimen #1
Study | Evidence |
Fisher et al. 2006 (PINNACLE) | Phase II |
Chemotherapy
- Bortezomib (Velcade) 1.3 mg/m2 IV once per day on days 1, 4, 8, 11
21-day cycles "up to 17 cycles or four cycles beyond initial reporting of CR/CRu, discontinuing for progressive disease (PD) or unacceptable toxicity, or by patient/investigator decision."
Regimen #2
Study | Evidence |
O'Connor et al. 2005 | Phase II, <20 pts reported |
Chemotherapy
- Bortezomib (Velcade) 1.5 mg/m2 IV once per day on days 1, 4, 8, 11
Supportive medications
- "Use of antiemetics, erythropoietin, and Filgrastim (Neupogen) was allowed if deemed necessary by the treating physician."
21-day cycles
References
- O'Connor OA, Wright J, Moskowitz C, Muzzy J, MacGregor-Cortelli B, Stubblefield M, Straus D, Portlock C, Hamlin P, Choi E, Dumetrescu O, Esseltine D, Trehu E, Adams J, Schenkein D, Zelenetz AD. Phase II clinical experience with the novel proteasome inhibitor bortezomib in patients with indolent non-Hodgkin's lymphoma and mantle cell lymphoma. J Clin Oncol. 2005 Feb 1;23(4):676-84. Epub 2004 Dec 21. link to original article contains verified protocol PubMed
- Fisher RI, Bernstein SH, Kahl BS, Djulbegovic B, Robertson MJ, de Vos S, Epner E, Krishnan A, Leonard JP, Lonial S, Stadtmauer EA, O'Connor OA, Shi H, Boral AL, Goy A. Multicenter phase II study of bortezomib in patients with relapsed or refractory mantle cell lymphoma. J Clin Oncol. 2006 Oct 20;24(30):4867-74. Epub 2006 Sep 25. link to original article contains verified protocol PubMed
- Update: Goy A, Bernstein SH, Kahl BS, Djulbegovic B, Robertson MJ, de Vos S, Epner E, Krishnan A, Leonard JP, Lonial S, Nasta S, O'Connor OA, Shi H, Boral AL, Fisher RI. Bortezomib in patients with relapsed or refractory mantle cell lymphoma: updated time-to-event analyses of the multicenter phase 2 PINNACLE study. Ann Oncol. 2009 Mar;20(3):520-5. Epub 2008 Dec 12. link to original article contains protocol PubMed
BR
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BR: Bendamustine, Rituximab
Regimen
Study | Evidence |
Rummel et al. 2005 | Phase II, <20 pts in subgroup |
Robinson et al. 2008 | Phase II, <20 pts in subgroup |
Chemotherapy
Note: the bendamustine infusion instructions are for the Treanda formulation, which was discontinued on 3/31/2016.
- Rituximab (Rituxan) as follows:
- One week prior to start of cycle 1: 375 mg/m2 IV once
- Cycles 1 to 4: 375 mg/m2 IV once on day 1
- 4 weeks after cycle 4: 375 mg/m2 IV once
- Bendamustine 90 mg/m2 IV over 30 to 60 minutes once per day on days 2 & 3
28-day cycle for 4 cycles
Robinson et al. 2008 said that patients "could receive up to six cycles if disease regression was evident between the second and fourth cycles".
References
- Rummel MJ, Al-Batran SE, Kim SZ, Welslau M, Hecker R, Kofahl-Krause D, Josten KM, Dürk H, Rost A, Neise M, von Grünhagen U, Chow KU, Hansmann ML, Hoelzer D, Mitrou PS. Bendamustine plus rituximab is effective and has a favorable toxicity profile in the treatment of mantle cell and low-grade non-Hodgkin's lymphoma. J Clin Oncol. 2005 May 20;23(15):3383-9. link to original article contains verified protocol PubMed
- Robinson KS, Williams ME, van der Jagt RH, Cohen P, Herst JA, Tulpule A, Schwartzberg LS, Lemieux B, Cheson BD. Phase II multicenter study of bendamustine plus rituximab in patients with relapsed indolent B-cell and mantle cell non-Hodgkin's lymphoma. J Clin Oncol. 2008 Sep 20;26(27):4473-9. Epub 2008 Jul 14. link to original article contains verified protocol PubMed
Cladribine (Leustatin)
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Regimen
Study | Evidence |
Inwards et al. 2008 (NCCTG 95-80-53) | Phase II, <20 pts |
Chemotherapy
- Cladribine (Leustatin) 5 mg/m2 IV over 2 hours once per day on days 1 to 5
28-day cycle for up to 6 cycles
References
- Inwards DJ, Fishkin PA, Hillman DW, Brown DW, Ansell SM, Kurtin PJ, Fonseca R, Morton RF, Veeder MH, Witzig TE. Long-term results of the treatment of patients with mantle cell lymphoma with cladribine (2-CDA) alone (95-80-53) or 2-CDA and rituximab (N0189) in the North Central Cancer Treatment Group. Cancer. 2008 Jul 1;113(1):108-16. link to original article contains verified protocol PubMed
Everolimus (Afinitor)
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Regimen
Study | Evidence |
Renner et al. 2012 (SAKK 36/06) | Phase II |
Wang et al. 2014 (PILLAR-1) | Phase II |
Chemotherapy
- Everolimus (Afinitor) 10 mg PO once per day "in a fasting state or with a light fat-free meal"
28-day cycles, given until progression or unacceptable toxicity
References
- Renner C, Zinzani PL, Gressin R, Klingbiel D, Dietrich PY, Hitz F, Bargetzi M, Mingrone W, Martinelli G, Trojan A, Bouabdallah K, Lohri A, Gyan E, Biaggi C, Cogliatti S, Bertoni F, Ghielmini M, Brauchli P, Ketterer N; Swiss SAKK and French GOELAMS group from European Mantle Cell Lymphoma Network. A multicenter phase II trial (SAKK 36/06) of single-agent everolimus (RAD001) in patients with relapsed or refractory mantle cell lymphoma. Haematologica. 2012 Jul;97(7):1085-91. Epub 2012 Feb 7. link to original article contains verified protocol PubMed
- Wang M, Popplewell LL, Collins RH Jr, Winter JN, Goy A, Kaminski MS, Bartlett NL, Johnston PB, Lister J, Fanning SR, Tuscano JM, Beck JT, Kaya H, Robeva A, Fan J, Klimovsky J, Cheung W, Cherfi A, O'Connor OA. Everolimus for patients with mantle cell lymphoma refractory to or intolerant of bortezomib: multicentre, single-arm, phase 2 study. Br J Haematol. 2014 May;165(4):510-8. Epub 2014 Mar 2. link to original article contains verified protocol PubMed
Ibrutinib & Rituximab
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Regimen
Study | Evidence |
Wang et al. 2015 | Phase II |
Chemotherapy
- Ibrutinib (Imbruvica) 560 mg PO once per day
- Rituximab (Rituxan) as follows:
- Cycle 1: 375 mg/m2 IV once per day on days 1, 8, 15, 22
- Cycle 2: no rituximab
- Cycles 3 to 8: 375 mg/m2 IV once on day 1
- Cycle 10 onwards: 375 mg/m2 IV once on day 1 of every other cycle, up to 2 years
28-day cycles, given until progression of disease or unacceptable toxicity
References
- Wang ML, Lee H, Chuang H, Wagner-Bartak N, Hagemeister F, Westin J, Fayad L, Samaniego F, Turturro F, Oki Y, Chen W, Badillo M, Nomie K, Rosa MD, Zhao D, Lam L, Addison A, Zhang H, Young KH, Li S, Santos D, Medeiros LJ, Champlin R, Romaguera J, Zhang L. Ibrutinib in combination with rituximab in relapsed or refractory mantle cell lymphoma: a single-centre, open-label, phase 2 trial. Lancet Oncol. 2016 Jan;17(1):48-56. Epub 2015 Nov 28. link to original article contains verified protocol PubMed
Lenalidomide & Rituximab
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Regimen #1
Study | Evidence |
Wang et al. 2012 | Phase II |
Chemotherapy
- Lenalidomide (Revlimid) 25 mg PO once per day on days 1 to 21
- Rituximab (Rituxan) 375 mg/m2 IV once per day on days 1, 8, 15, 22 of cycle 1 only
28-day cycles, given until until disease progression, stem-cell transplantation, or severe toxicity
Regimen #2
Study | Evidence |
Chong et al. 2015 | Phase II, <20 pts in subgroup |
Chemotherapy
- Lenalidomide (Revlimid) 10 mg PO once per day
- Rituximab (Rituxan) 375 mg/m2 IV once per week x 4 doses, given during the 3rd cycle
28-day cycles until progression or intolerance
References
- Wang M, Fayad L, Wagner-Bartak N, Zhang L, Hagemeister F, Neelapu SS, Samaniego F, McLaughlin P, Fanale M, Younes A, Cabanillas F, Fowler N, Newberry KJ, Sun L, Young KH, Champlin R, Kwak L, Feng L, Badillo M, Bejarano M, Hartig K, Chen W, Chen Y, Byrne C, Bell N, Zeldis J, Romaguera J. Lenalidomide in combination with rituximab for patients with relapsed or refractory mantle-cell lymphoma: a phase 1/2 clinical trial. Lancet Oncol. 2012 Jul;13(7):716-23. Epub 2012 Jun 6. link to original article contains protocol PubMed
- Chong EA, Ahmadi T, Aqui NA, Svoboda J, Nasta SD, Mato AR, Walsh KM, Schuster SJ. Combination of Lenalidomide and Rituximab Overcomes Rituximab Resistance in Patients with Indolent B-cell and Mantle Cell Lymphomas. Clin Cancer Res. 2015 Apr 15;21(8):1835-42. Epub 2015 Jan 28. link to original article contains verified protocol PubMed
Obinutuzumab (Gazyva)
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Regimen
Study | Evidence |
Morschhauser et al. 2013 (GAUGUIN) | Phase II |
Chemotherapy
- Obinutuzumab (Gazyva) as follows:
- Cycle 1: 1600 mg (diluted to 10 mg/mL) IV once per day on days 1 & 8
- Cycles 2 to 8: 800 mg IV once on day 1
- Initial infusion rate is 50 mg/hour. In the absence of infusion-related reactions (IRRs), the rate is then increased by 50 mg/hour every 30 minutes, up to a maximum of 400 mg/hour.
Supportive medications
- Acetaminophen (Tylenol) or paracetamol 650 to 1000 mg PO once 30 minutes prior to Obinutuzumab (Gazyva)
- An antihistamine 30 minutes prior to Obinutuzumab (Gazyva); if there were no infusion-related reactions (IRRs) requiring medication or infusion interruption, antihistamine could be omitted for subsequent infusions
- Premedication with corticosteroids recommended for patients at high risk of infusion-related reactions (IRRs)
- Use of G-CSF allowed for severe neutropenia
- Antibiotic prophylaxis allowed
21-day cycle for 8 cycles
References
- Morschhauser FA, Cartron G, Thieblemont C, Solal-Céligny P, Haioun C, Bouabdallah R, Feugier P, Bouabdallah K, Asikanius E, Lei G, Wenger M, Wassner-Fritsch E, Salles GA. Obinutuzumab (GA101) Monotherapy in Relapsed/Refractory Diffuse Large B-Cell Lymphoma or Mantle-Cell Lymphoma: Results From the Phase II GAUGUIN Study. J Clin Oncol. 2013 Aug 10;31(23):2912-9. Epub 2013 Jul 8. link to original article contains verified protocol PubMed
PEP-C
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PEP-C: Prednisone, Etoposide, Procarbazine, Cyclophosphamide
Regimen
Study | Evidence |
Coleman et al. 2008 | Non-randomized |
Induction phase
- Prednisone (Sterapred) 20 mg PO once per day after breakfast
- Etoposide (Vepesid) 50 mg PO once per day after dinner
- Procarbazine (Matulane) 50 mg PO once per day at bedtime
- Cyclophosphamide (Cytoxan) 50 mg PO once per day after lunch
Supportive medications
- Ondansetron (Zofran) (dose not specified) with each Procarbazine (Matulane) dose
Continue until WBC <3 x 109/L, hold until WBC recovery, then titrate in maintenance phase per paper (see publication for details)
Maintenance phase
- Same medications and doses given per day as used in the induction phase, but the number of days per week they are used is titrated to maintain a WBC of at least 3; for example, 5 out of 7 days, every other day, once per week, etc.
References
- Coleman M, Martin P, Ruan J, Furman R, Niesvizky R, Elstrom R, George P, Leonard J, Kaufmann T. Low-dose metronomic, multidrug therapy with the PEP-C oral combination chemotherapy regimen for mantle cell lymphoma. Leuk Lymphoma. 2008 Mar;49(3):447-50. link to original article contains verified protocol PubMed
Rituximab & Temsirolimus
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Regimen
Study | Evidence |
Ansell et al. 2011 | Phase II |
Chemotherapy
- Temsirolimus (Torisel) 25 mg IV once per week on weeks 1 to 4
- Rituximab (Rituxan) 375 mg/m2 IV once per week on weeks 1 to 4 of cycle 1, then once on day 1 of every other cycle (cycles 3, 5, 7, 9, 11)
28-day cycle up to 12 cycles
References
- Ansell SM, Tang H, Kurtin PJ, Koenig PA, Inwards DJ, Shah K, Ziesmer SC, Feldman AL, Rao R, Gupta M, Erlichman C, Witzig TE. Temsirolimus and rituximab in patients with relapsed or refractory mantle cell lymphoma: a phase 2 study. Lancet Oncol. 2011 Apr;12(4):361-8. link to original article link to PMC article contains verified protocol PubMed
RT-PEPC
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RT-PEPC: Rituximab, Thalidomide, Prednisone, Etoposide, Procarbazine, Cyclophosphamide
Regimen
Study | Evidence |
Ruan et al. 2010 | Non-randomized |
Induction phase
- Rituximab (Rituxan) (dose not specified) IV once per week on weeks 1 to 4 of month 1
- Thalidomide (Thalomid) 50 mg PO once per day during months 1 & 2, then 100 mg PO once per day for month 3
- Prednisone (Sterapred) 20 mg PO once per day after breakfast
- Etoposide (Vepesid) 50 mg PO once per day after dinner
- Procarbazine (Matulane) 50 mg PO once per day at bedtime
- Cyclophosphamide (Cytoxan) 50 mg PO once per day after lunch
Supportive medications
- Aspirin 81 mg PO once per day "after 2 episodes of DVT occurred."
3-month course
Maintenance phase
- Rituximab (Rituxan) (dose not specified) IV once per week on weeks 1 to 4 every 4 months
- Thalidomide (Thalomid) 100 mg PO once per day
- PEPC: Same medications and doses given per day as used in the induction phase, but titrated to maintain ANC of at least 2000 cells/µL.
Supportive medications
- Aspirin 81 mg PO once per day "after 2 episodes of DVT occurred."
Continued until progression
References
- Ruan J, Martin P, Coleman M, Furman RR, Cheung K, Faye A, Elstrom R, Lachs M, Hajjar KA, Leonard JP. Durable responses with the metronomic rituximab and thalidomide plus prednisone, etoposide, procarbazine, and cyclophosphamide regimen in elderly patients with recurrent mantle cell lymphoma. Cancer. 2010 Jun 1;116(11):2655-64. link to original article contains verified protocol PubMed
Temsirolimus (Torisel)
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Regimen #1
Study | Evidence |
Ansell et al. 2008 | Phase II |
Chemotherapy
- Temsirolimus (Torisel) 25 mg in 250 mL normal saline IV over 30 minutes once per day on days 1, 8, 15, 22
Supportive medications
- Diphenhydramine (Benadryl) 25 to 50 mg IV once prior to Temsirolimus (Torisel)
4-week cycle, stopped at various timepoints (see paper for details); maximum of 12 months
Regimen #2
Study | Evidence |
Witzig et al. 2005 | Phase II |
Chemotherapy
- Temsirolimus (Torisel) 250 mg in 250 mL normal saline IV over 30 minutes once per day on days 1, 8, 15, 22
Supportive medications
- Use of white blood cell growth factors at physician discretion if neutropenia occurred.
- Use of erythropoietin for anemia was allowed.
28-day cycles, given until progression, 2 cycles past CR, up to a total of 12 months
References
- Witzig TE, Geyer SM, Ghobrial I, Inwards DJ, Fonseca R, Kurtin P, Ansell SM, Luyun R, Flynn PJ, Morton RF, Dakhil SR, Gross H, Kaufmann SH. Phase II trial of single-agent temsirolimus (CCI-779) for relapsed mantle cell lymphoma. J Clin Oncol. 2005 Aug 10;23(23):5347-56. Epub 2005 Jun 27. link to original article contains verified protocol PubMed
- Ansell SM, Inwards DJ, Rowland KM Jr, Flynn PJ, Morton RF, Moore DF Jr, Kaufmann SH, Ghobrial I, Kurtin PJ, Maurer M, Allmer C, Witzig TE. Low-dose, single-agent temsirolimus for relapsed mantle cell lymphoma: a phase 2 trial in the North Central Cancer Treatment Group. Cancer. 2008 Aug 1;113(3):508-14. link to original article contains verified protocol PubMed
VR
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VR: Velcade (Bortezomib), Rituximab
Regimen
Study | Evidence |
Baiocchi et al. 2011 | Phase II, <20 pts |
Bortezomib dose was initially 1.5 mg/m2 but was reduced due to excess grade 3 neurotoxicity.
Chemotherapy
- Bortezomib (Velcade) 1.3 mg/m2 IV once on days 1, 4, 8, 11
- Rituximab (Rituxan) 375 mg/m2 IV once per day on days 1 & 8, starting with cycle 2 and thereafter
21-day cycle for up to 5 cycles
Patients without progression could receive maintenance VR.
References
- Baiocchi RA, Alinari L, Lustberg ME, Lin TS, Porcu P, Li X, Johnston JS, Byrd JC, Blum KA. Phase 2 trial of rituximab and bortezomib in patients with relapsed or refractory mantle cell and follicular lymphoma. Cancer. 2011 Jun 1;117(11):2442-51. Epub 2010 Dec 14. link to original article contains verified protocol PubMed
Consolidation and/or maintenance after salvage therapy
Allogeneic stem cell transplant
To be completed. Usually reserved for younger and very fit individuals; preceded by a high-intensity salvage chemotherapy such as those used for DLBCL. See details about preparative regimens.
Arsenic trioxide & chlorambucil
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Regimen
Study | Evidence |
Gill et al. 2014 | Phase II |
Treatment preceded by salvage arsenic trioxide and chlorambucil.
Chemotherapy
- Arsenic trioxide (Trisenox) 3 mg PO once per day
- Chlorambucil (Leukeran) 2 mg PO once per day
Supportive medications
- Ascorbic acid (Vitamin C) 300 mg PO once per day
Continuously until disease progression.
References
- Gill H, Au WY, Cheung WW, Lee EY, Kwong YL. Oral arsenic trioxide-based regimen as salvage treatment for relapsed or refractory mantle cell lymphoma. Ann Oncol. 2014 Jul;25(7):1391-7. Epub 2014 Apr 12. link to original article contains verified protocol PubMed
Autologous stem cell transplant
To be completed. Usually preceded by a high-intensity salvage chemotherapy such as those used for DLBCL. See details about preparative regimens.
Lenalidomide (Revlimid)
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Regimen
Study | Evidence |
Eve et al. 2012 | Phase II |
Treatment preceded by salvage lenalidomide.
Chemotherapy
- Lenalidomide (Revlimid) 15 mg PO once per day on days 1 to 21
28-day cycle to continue until progression of disease or intolerance
References
- Eve HE, Carey S, Richardson SJ, Heise CC, Mamidipudi V, Shi T, Radford JA, Auer RL, Bullard SH, Rule SA. Single-agent lenalidomide in relapsed/refractory mantle cell lymphoma: results from a UK phase II study suggest activity and possible gender differences. Br J Haematol. 2012 Oct;159(2):154-63. Epub 2012 Aug 9. link to original article contains verified protocol PubMed
Observation
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Regimen #1
Study | Evidence | Comparator | Efficacy |
Forstpointner et al. 2004 | Phase III | Rituximab | Seems to have inferior response duration |
Preceded by FCM versus R-FCM; no further treatment was given.
References
- Forstpointner R, Dreyling M, Repp R, Hermann S, Hänel A, Metzner B, Pott C, Hartmann F, Rothmann F, Rohrberg R, Böck HP, Wandt H, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. The addition of rituximab to a combination of fludarabine, cyclophosphamide, mitoxantrone (FCM) significantly increases the response rate and prolongs survival as compared with FCM alone in patients with relapsed and refractory follicular and mantle cell lymphomas: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood. 2004 Nov 15;104(10):3064-71. Epub 2004 Jul 29. link to original article contains verified protocol PubMed
- Update: Forstpointner R, Unterhalt M, Dreyling M, Böck HP, Repp R, Wandt H, Pott C, Seymour JF, Metzner B, Hänel A, Lehmann T, Hartmann F, Einsele H, Hiddemann W; German Low Grade Lymphoma Study Group (GLSG). Maintenance therapy with rituximab leads to a significant prolongation of response duration after salvage therapy with a combination of rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) in patients with recurring and refractory follicular and mantle cell lymphomas: Results of a prospective randomized study of the German Low Grade Lymphoma Study Group (GLSG). Blood. 2006 Dec 15;108(13):4003-8. Epub 2006 Aug 31. link to original article contains verified protocol PubMed
Rituximab (Rituxan)
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Regimen #1
Study | Evidence | Comparator | Efficacy |
Forstpointner et al. 2004 | Phase III | Observation | Seems to have superior response duration |
Treatment preceded by FCM versus R-FCM.
Chemotherapy
- Rituximab (Rituxan) 375 mg/m2 IV once per week on days 1, 8, 15, 22
Two courses, given 3 and 6 months after completion of salvage therapy
Regimen #2
Study | Evidence |
Lamm et al. 2011 | Phase II, <20 pts |
Treatment preceded by BORID x 6.
Chemotherapy
- Rituximab (Rituxan) 375 mg/m2 IV once every 8 weeks
4 doses
References
- Forstpointner R, Dreyling M, Repp R, Hermann S, Hänel A, Metzner B, Pott C, Hartmann F, Rothmann F, Rohrberg R, Böck HP, Wandt H, Unterhalt M, Hiddemann W; German Low-Grade Lymphoma Study Group. The addition of rituximab to a combination of fludarabine, cyclophosphamide, mitoxantrone (FCM) significantly increases the response rate and prolongs survival as compared with FCM alone in patients with relapsed and refractory follicular and mantle cell lymphomas: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood. 2004 Nov 15;104(10):3064-71. Epub 2004 Jul 29. link to original article contains verified protocol PubMed
- Update: Forstpointner R, Unterhalt M, Dreyling M, Böck HP, Repp R, Wandt H, Pott C, Seymour JF, Metzner B, Hänel A, Lehmann T, Hartmann F, Einsele H, Hiddemann W; German Low Grade Lymphoma Study Group (GLSG). Maintenance therapy with rituximab leads to a significant prolongation of response duration after salvage therapy with a combination of rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) in patients with recurring and refractory follicular and mantle cell lymphomas: Results of a prospective randomized study of the German Low Grade Lymphoma Study Group (GLSG). Blood. 2006 Dec 15;108(13):4003-8. Epub 2006 Aug 31. link to original article contains verified protocol PubMed
- Lamm W, Kaufmann H, Raderer M, Hoffmann M, Chott A, Zielinski C, Drach J. Bortezomib combined with rituximab and dexamethasone is an active regimen for patients with relapsed and chemotherapy-refractory mantle cell lymphoma. Haematologica. 2011 Jul;96(7):1008-14. Epub 2011 Apr 12. link to original article contains verified protocol PubMed
VR
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VR: Velcade (Bortezomib), Rituximab
Regimen
Study | Evidence |
Baiocchi et al. 2011 | Phase II, <20 pts |
Treatment preceded by VR x 5.
Chemotherapy
- Bortezomib (Velcade) 1.3 mg/m2 IV once per week for two weeks
- Rituximab (Rituxan) 375 mg/m2 IV once per week for four weeks
6-month cycle for up to 2 years
References
- Baiocchi RA, Alinari L, Lustberg ME, Lin TS, Porcu P, Li X, Johnston JS, Byrd JC, Blum KA. Phase 2 trial of rituximab and bortezomib in patients with relapsed or refractory mantle cell and follicular lymphoma. Cancer. 2011 Jun 1;117(11):2442-51. Epub 2010 Dec 14. link to original article contains verified protocol PubMed
Investigational agents
These are drugs under study with at least some promising results for this disease.
Prognosis
Mantle cell lymphoma international prognostic index (MIPI)
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Calculation generally require a calculator such as the one provided by BloodRef. The MIPI is calculated using the following formula: [0.03535 × age (in years)] + 0.6978 (if ECOG PS > 1) + [1.367 × log10(LDH/ULN)] + [0.9393 × log10(white cells per uL blood)]. Risk factors include:
- Age
- ECOG Performance Status
- Serum LDH level (note that reference ranges can vary widely!)
- Number of nodal sites
- WBC count
Risk stratification:
- <5.7 points: Low risk
- 5.7 to <6.2 points: Intermediate risk
- ≥ 6.2 points: High risk
References
- Hoster E, Dreyling M, Klapper W, Gisselbrecht C, van Hoof A, Kluin-Nelemans HC, Pfreundschuh M, Reiser M, Metzner B, Einsele H, Peter N, Jung W, Wörmann B, Ludwig WD, Dührsen U, Eimermacher H, Wandt H, Hasford J, Hiddemann W, Unterhalt M; German Low Grade Lymphoma Study Group (GLSG); European Mantle Cell Lymphoma Network. A new prognostic index (MIPI) for patients with advanced-stage mantle cell lymphoma. Blood. 2008 Jan 15;111(2):558-65. Epub 2007 Oct 25. Erratum in: Blood. 2008 Jun 15;111(12):5761. link to original article PubMed
- Hoster E, Klapper W, Hermine O, Kluin-Nelemans HC, Walewski J, van Hoof A, Trneny M, Geisler CH, Di Raimondo F, Szymczyk M, Stilgenbauer S, Thieblemont C, Hallek M, Forstpointner R, Pott C, Ribrag V, Doorduijn J, Hiddemann W, Dreyling MH, Unterhalt M. Confirmation of the mantle-cell lymphoma International Prognostic Index in randomized trials of the European Mantle-Cell Lymphoma Network. J Clin Oncol. 2014 May 1;32(13):1338-46. Epub 2014 Mar 31. link to original article PubMed
Response criteria
NCI Sponsored International Working Group Criteria (1999)
- Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, Lister TA, Vose J, Grillo-López A, Hagenbeek A, Cabanillas F, Klippensten D, Hiddemann W, Castellino R, Harris NL, Armitage JO, Carter W, Hoppe R, Canellos GP. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol. 1999 Apr;17(4):1244. Review. Erratum in: J Clin Oncol 2000 Jun;18(11):2351. link to original article PubMed