Difference between revisions of "Diffuse large B-cell lymphoma - null regimens"
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[[#top|Back to Top]] | [[#top|Back to Top]] | ||
</div> | </div> | ||
| − | The purpose of this page is to provide references to "null therapy" such as placebo and observation. | + | The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the [[Diffuse large B-cell lymphoma|main DLBCL page]] for regimens that include active anticancer treatment. |
{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
| Line 9: | Line 9: | ||
=Consolidation after upfront therapy= | =Consolidation after upfront therapy= | ||
==Observation== | ==Observation== | ||
| − | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
| − | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
| Line 42: | Line 42: | ||
| style="background-color:#fee08b" |Might have inferior EFS | | style="background-color:#fee08b" |Might have inferior EFS | ||
|- | |- | ||
| − | |[https:// | + | |[https://doi.org/10.1111/bjh.13652 Witzens-Harig et al. 2015 (HD2002)] |
|2002-2011 | |2002-2011 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
| Line 61: | Line 61: | ||
|- | |- | ||
|} | |} | ||
| − | ''No further treatment, also variously termed "observation" and "watchful waiting". Note: in ECOG E4494, a statistically signficant disadvantage to observation was seen in the group receiving [[Diffuse_large_B-cell_lymphoma_-_historical#CHOP|CHOP | + | ''No further treatment, also variously termed "observation" and "watchful waiting". Note: in ECOG E4494, a statistically signficant disadvantage to observation was seen in the group receiving [[Diffuse_large_B-cell_lymphoma_-_historical#CHOP|CHOP]] induction, which is no longer standard of care.'' |
| + | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
| − | *ECOG E1484: [[Diffuse_large_B-cell_lymphoma_-_historical#CHOP|CHOP]] x 8, with CR | + | *ECOG E1484: Induction [[Diffuse_large_B-cell_lymphoma_-_historical#CHOP|CHOP]] x 8, with CR |
*ECOG E4494: [[Diffuse_large_B-cell_lymphoma#R-CHOP|R-CHOP]] versus [[Diffuse_large_B-cell_lymphoma_-_historical#CHOP|CHOP]] induction | *ECOG E4494: [[Diffuse_large_B-cell_lymphoma#R-CHOP|R-CHOP]] versus [[Diffuse_large_B-cell_lymphoma_-_historical#CHOP|CHOP]] induction | ||
| − | *Bonnet et al. 2007: [[Diffuse_large_B-cell_lymphoma_-_historical#CHOP|CHOP]] x 4 | + | *Bonnet et al. 2007: Induction [[Diffuse_large_B-cell_lymphoma_-_historical#CHOP|CHOP]] x 4 |
| − | *LNH 98-3: [[Diffuse_large_B-cell_lymphoma#CBVM.2C_then_auto_HSCT|CBVM, then auto HSCT | + | *LNH 98-3: [[Diffuse_large_B-cell_lymphoma#CBVM.2C_then_auto_HSCT|CBVM, then auto HSCT]] consolidation |
*HD2002: "Standard treatment" | *HD2002: "Standard treatment" | ||
| − | *LYSA/GOELAMS 02-03: [[Diffuse_large_B-cell_lymphoma#R-CHOP-14|R-CHOP-14]] x 4 to 6 | + | *LYSA/GOELAMS 02-03: Induction [[Diffuse_large_B-cell_lymphoma#R-CHOP-14|R-CHOP-14]] x 4 to 6 |
| − | + | </div></div> | |
===References=== | ===References=== | ||
| − | #'''ECOG E1484:''' Horning SJ, Weller E, Kim K, Earle JD, O'Connell MJ, Habermann TM, Glick JH. Chemotherapy with or without radiotherapy in limited-stage diffuse aggressive non-Hodgkin's lymphoma: Eastern Cooperative Oncology Group study 1484. J Clin Oncol. 2004 Aug 1;22(15):3032-8. Epub 2004 Jun 21. [https://doi.org/10.1200/jco.2004.06.088 link to original article] [https://pubmed.ncbi.nlm.nih.gov/15210738 PubMed] | + | #'''ECOG E1484:''' Horning SJ, Weller E, Kim K, Earle JD, O'Connell MJ, Habermann TM, Glick JH. Chemotherapy with or without radiotherapy in limited-stage diffuse aggressive non-Hodgkin's lymphoma: Eastern Cooperative Oncology Group study 1484. J Clin Oncol. 2004 Aug 1;22(15):3032-8. Epub 2004 Jun 21. [https://doi.org/10.1200/jco.2004.06.088 link to original article] [https://pubmed.ncbi.nlm.nih.gov/15210738/ PubMed] |
| − | #'''ECOG E4494:''' Habermann TM, Weller EA, Morrison VA, Gascoyne RD, Cassileth PA, Cohn JB, Dakhil SR, Woda B, Fisher RI, Peterson BA, Horning SJ. Rituximab-CHOP versus CHOP alone or with maintenance rituximab in older patients with diffuse large B-cell lymphoma. J Clin Oncol. 2006 Jul 1;24(19):3121-7. Epub 2006 Jun 5. [https://doi.org/10.1200/jco.2005.05.1003 link to original article] | + | #'''ECOG E4494:''' Habermann TM, Weller EA, Morrison VA, Gascoyne RD, Cassileth PA, Cohn JB, Dakhil SR, Woda B, Fisher RI, Peterson BA, Horning SJ. Rituximab-CHOP versus CHOP alone or with maintenance rituximab in older patients with diffuse large B-cell lymphoma. J Clin Oncol. 2006 Jul 1;24(19):3121-7. Epub 2006 Jun 5. [https://doi.org/10.1200/jco.2005.05.1003 link to original article] [https://pubmed.ncbi.nlm.nih.gov/16754935/ PubMed] [https://clinicaltrials.gov/study/NCT00003150 NCT00003150] |
| − | #Bonnet C, Fillet G, Mounier N, Ganem G, Molina TJ, Thiéblemont C, Fermé C, Quesnel B, Martin C, Gisselbrecht C, Tilly H, Reyes F; Groupe d'Etude des Lymphomes de l'Adulte. CHOP alone compared with CHOP plus radiotherapy for localized aggressive lymphoma in elderly patients: a study by the Groupe d'Etude des Lymphomes de l'Adulte. J Clin Oncol. 2007 Mar 1;25(7):787-92. Epub 2007 Jan 16. [https://doi.org/10.1200/JCO.2006.07.0722 link to original article] | + | #Bonnet C, Fillet G, Mounier N, Ganem G, Molina TJ, Thiéblemont C, Fermé C, Quesnel B, Martin C, Gisselbrecht C, Tilly H, Reyes F; Groupe d'Etude des Lymphomes de l'Adulte. CHOP alone compared with CHOP plus radiotherapy for localized aggressive lymphoma in elderly patients: a study by the Groupe d'Etude des Lymphomes de l'Adulte. J Clin Oncol. 2007 Mar 1;25(7):787-92. Epub 2007 Jan 16. [https://doi.org/10.1200/JCO.2006.07.0722 link to original article] [https://pubmed.ncbi.nlm.nih.gov/17228021/ PubMed] |
| − | #'''LNH 98-3:''' Haioun C, Mounier N, Emile JF, Ranta D, Coiffier B, Tilly H, Récher C, Fermé C, Gabarre J, Herbrecht R, Morchhauser F, Gisselbrecht C. Rituximab versus observation after high-dose consolidative first-line chemotherapy with autologous stem-cell transplantation in patients with poor-risk diffuse large B-cell lymphoma. Ann Oncol. 2009 Dec;20(12):1985-92. Epub 2009 Jun 30. [https://doi.org/10.1093/annonc/mdp237 link to original article] [https://pubmed.ncbi.nlm.nih.gov/19567453 PubMed] | + | #'''LNH 98-3:''' Haioun C, Mounier N, Emile JF, Ranta D, Coiffier B, Tilly H, Récher C, Fermé C, Gabarre J, Herbrecht R, Morchhauser F, Gisselbrecht C. Rituximab versus observation after high-dose consolidative first-line chemotherapy with autologous stem-cell transplantation in patients with poor-risk diffuse large B-cell lymphoma. Ann Oncol. 2009 Dec;20(12):1985-92. Epub 2009 Jun 30. [https://doi.org/10.1093/annonc/mdp237 link to original article] [https://pubmed.ncbi.nlm.nih.gov/19567453/ PubMed] [https://clinicaltrials.gov/study/NCT00169169 NCT00169169] |
<!-- These data have been presented in part at the 55th Annual Meeting of the American Society of Hematology, New Orleans 2013, the 12th International Conference on Malignant Lymphoma 2013, Lugano, and the 18th Congress of the European Hematology Association, Stockholm 2013. --> | <!-- These data have been presented in part at the 55th Annual Meeting of the American Society of Hematology, New Orleans 2013, the 12th International Conference on Malignant Lymphoma 2013, Lugano, and the 18th Congress of the European Hematology Association, Stockholm 2013. --> | ||
| − | #'''NHL13:''' Jaeger U, Trneny M, Melzer H, Praxmarer M, Nawarawong W, Ben Yehuda D, Goldstein D, Mihaljevic B, Ilhan O, Ballova V, Hedenus M, Hsiao LT, Au WY, Burgstaller S, Weidinger G, Keil F, Dittrich C, Skrabs C, Klingler A, Chott A, Fridrik MA, Greil R. Rituximab maintenance for patients with aggressive B-cell lymphoma in first remission: results of the randomized NHL13 trial. Haematologica. 2015 Jul;100(7):955-63. Epub 2015 Apr 24. [http://www.haematologica.org/content/100/7/955 link to original article] | + | #'''NHL13:''' Jaeger U, Trneny M, Melzer H, Praxmarer M, Nawarawong W, Ben Yehuda D, Goldstein D, Mihaljevic B, Ilhan O, Ballova V, Hedenus M, Hsiao LT, Au WY, Burgstaller S, Weidinger G, Keil F, Dittrich C, Skrabs C, Klingler A, Chott A, Fridrik MA, Greil R. Rituximab maintenance for patients with aggressive B-cell lymphoma in first remission: results of the randomized NHL13 trial. Haematologica. 2015 Jul;100(7):955-63. Epub 2015 Apr 24. [http://www.haematologica.org/content/100/7/955 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4486230/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/25911553/ PubMed] [https://clinicaltrials.gov/study/NCT00400478 NCT00400478] |
| − | #'''HD2002:''' Witzens-Harig M, Benner A, McClanahan F, Klemmer J, Brandt J, Brants E, Rieger M, Meissner J, Hensel M, Neben K, Dreger P, Lengfelder E, Schmidt-Wolf I, Krämer A, Ho AD. Rituximab maintenance improves survival in male patients with diffuse large B-cell lymphoma: results of the HD2002 prospective multicentre randomized phase III trial. Br J Haematol. 2015 Dec;171(5):710-9. Epub 2015 Oct 9. [https:// | + | #'''HD2002:''' Witzens-Harig M, Benner A, McClanahan F, Klemmer J, Brandt J, Brants E, Rieger M, Meissner J, Hensel M, Neben K, Dreger P, Lengfelder E, Schmidt-Wolf I, Krämer A, Ho AD. Rituximab maintenance improves survival in male patients with diffuse large B-cell lymphoma: results of the HD2002 prospective multicentre randomized phase III trial. Br J Haematol. 2015 Dec;171(5):710-9. Epub 2015 Oct 9. [https://doi.org/10.1111/bjh.13652 link to original article] [https://pubmed.ncbi.nlm.nih.gov/26449739/ PubMed] [https://clinicaltrials.gov/study/NCT01933711 NCT01933711] |
| − | #'''LYSA/GOELAMS 02-03:''' Lamy T, Damaj G, Soubeyran P, Gyan E, Cartron G, Bouabdallah K, Gressin R, Cornillon J, Banos A, Le Du K, Benchalal M, Moles MP, Le Gouill S, Fleury J, Godmer P, Maisonneuve H, Deconinck E, Houot R, Laribi K, Marolleau JP, Tournilhac O, Branger B, Devillers A, Vuillez JP, Fest T, Colombat P, Costes V, Szablewski V, Béné MC, Delwail V; LYSA; GOELAMS. R-CHOP 14 with or without radiotherapy in nonbulky limited-stage diffuse large B-cell lymphoma. Blood. 2018 Jan 11;131(2):174-181. Epub 2017 Oct 23. [http://www.bloodjournal.org/content/131/2/174.long link to original article] | + | #'''LYSA/GOELAMS 02-03:''' Lamy T, Damaj G, Soubeyran P, Gyan E, Cartron G, Bouabdallah K, Gressin R, Cornillon J, Banos A, Le Du K, Benchalal M, Moles MP, Le Gouill S, Fleury J, Godmer P, Maisonneuve H, Deconinck E, Houot R, Laribi K, Marolleau JP, Tournilhac O, Branger B, Devillers A, Vuillez JP, Fest T, Colombat P, Costes V, Szablewski V, Béné MC, Delwail V; LYSA; GOELAMS. R-CHOP 14 with or without radiotherapy in nonbulky limited-stage diffuse large B-cell lymphoma. Blood. 2018 Jan 11;131(2):174-181. Epub 2017 Oct 23. [http://www.bloodjournal.org/content/131/2/174.long link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5757680/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/29061568/ PubMed] [https://clinicaltrials.gov/study/NCT00841945 NCT00841945] |
==Placebo== | ==Placebo== | ||
| − | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
| − | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
| Line 95: | Line 96: | ||
|NR | |NR | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
| − | |[[# | + | |[[#Enzastaurin_monotherapy_999|Enzastaurin]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of DFS | | style="background-color:#ffffbf" |Did not meet primary endpoint of DFS | ||
|- | |- | ||
| Line 101: | Line 102: | ||
|2009-2013 | |2009-2013 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
| − | |[[# | + | |[[#Everolimus_monotherapy_999|Everolimus]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of DFS<br>DFS24: 77% vs 77.8%<br>(HR 1.09, 95% CI 0.82-1.45) | | style="background-color:#ffffbf" |Did not meet primary endpoint of DFS<br>DFS24: 77% vs 77.8%<br>(HR 1.09, 95% CI 0.82-1.45) | ||
|- | |- | ||
| Line 112: | Line 113: | ||
|} | |} | ||
''No further antineoplastic treatment.'' | ''No further antineoplastic treatment.'' | ||
| + | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
| − | *PRELUDE: [[Diffuse_large_B-cell_lymphoma#R-CHOP|R-CHOP | + | *PRELUDE: [[Diffuse_large_B-cell_lymphoma#R-CHOP|R-CHOP]] induction |
*REMARC: [[Diffuse_large_B-cell_lymphoma#R-CHOP|R-CHOP21]] or [[Diffuse_large_B-cell_lymphoma#R-CHOP-14|R-CHOP-14]] induction | *REMARC: [[Diffuse_large_B-cell_lymphoma#R-CHOP|R-CHOP21]] or [[Diffuse_large_B-cell_lymphoma#R-CHOP-14|R-CHOP-14]] induction | ||
| − | + | </div></div> | |
===References=== | ===References=== | ||
<!-- Presented in part at the Annual Meeting of the American Society of Hematology, New Orleans, LA, December 8, 2013, and at the Annual Meeting of the American Association for Cancer Research, Philadelphia, PA, April 22, 2015. --> | <!-- Presented in part at the Annual Meeting of the American Society of Hematology, New Orleans, LA, December 8, 2013, and at the Annual Meeting of the American Association for Cancer Research, Philadelphia, PA, April 22, 2015. --> | ||
| − | #'''PRELUDE:''' Crump M, Leppä S, Fayad L, Lee JJ, Di Rocco A, Ogura M, Hagberg H, Schnell F, Rifkin R, Mackensen A, Offner F, Pinter-Brown L, Smith S, Tobinai K, Yeh SP, Hsi ED, Nguyen T, Shi P, Hahka-Kemppinen M, Thornton D, Lin B, Kahl B, Schmitz N, Savage KJ, Habermann T. Randomized, double-blind, phase III trial of enzastaurin versus placebo in patients achieving remission after first-line therapy for high-risk diffuse large B-cell lymphoma. J Clin Oncol. 2016 Jul 20;34(21):2484-92. Epub 2016 May 23. [https://doi.org/10.1200/jco.2015.65.7171 link to original article] [https://pubmed.ncbi.nlm.nih.gov/27217449 PubMed] NCT00332202 | + | #'''PRELUDE:''' Crump M, Leppä S, Fayad L, Lee JJ, Di Rocco A, Ogura M, Hagberg H, Schnell F, Rifkin R, Mackensen A, Offner F, Pinter-Brown L, Smith S, Tobinai K, Yeh SP, Hsi ED, Nguyen T, Shi P, Hahka-Kemppinen M, Thornton D, Lin B, Kahl B, Schmitz N, Savage KJ, Habermann T. Randomized, double-blind, phase III trial of enzastaurin versus placebo in patients achieving remission after first-line therapy for high-risk diffuse large B-cell lymphoma. J Clin Oncol. 2016 Jul 20;34(21):2484-92. Epub 2016 May 23. [https://doi.org/10.1200/jco.2015.65.7171 link to original article] [https://pubmed.ncbi.nlm.nih.gov/27217449/ PubMed] [https://clinicaltrials.gov/study/NCT00332202 NCT00332202] |
<!-- # '''Abstract:''' Catherine Thieblemont, Hervé Tilly, Maria Gomez da Silva, Rene-Olivier Casasnovas, Christophe Fruchart, Franck Morschhauser, Corinne Haioun, Julien Lazarovici, Sebastian Grosicki, Aurore Perrot, Judith Trotman, Catherine Sebban, Dolores Caballero, Richard Greil, Koen Van Eygen, Josette Briere, Jose Cabecadas, Gilles Andre Salles, Philippe Gaulard, Andre Bosly and Bertrand Coiffier. First Analysis of an International Double-Blind Randomized Phase III Study of Lenalidomide Maintenance in Elderly Patients with DLBCL Treated with R-CHOP in First Line, the Remarc Study from Lysa. Blood 2016 128:471 [http://www.bloodjournal.org/content/128/22/471 link to abstract] --> | <!-- # '''Abstract:''' Catherine Thieblemont, Hervé Tilly, Maria Gomez da Silva, Rene-Olivier Casasnovas, Christophe Fruchart, Franck Morschhauser, Corinne Haioun, Julien Lazarovici, Sebastian Grosicki, Aurore Perrot, Judith Trotman, Catherine Sebban, Dolores Caballero, Richard Greil, Koen Van Eygen, Josette Briere, Jose Cabecadas, Gilles Andre Salles, Philippe Gaulard, Andre Bosly and Bertrand Coiffier. First Analysis of an International Double-Blind Randomized Phase III Study of Lenalidomide Maintenance in Elderly Patients with DLBCL Treated with R-CHOP in First Line, the Remarc Study from Lysa. Blood 2016 128:471 [http://www.bloodjournal.org/content/128/22/471 link to abstract] --> | ||
| − | #'''REMARC:''' Thieblemont C, Tilly H, Gomes da Silva M, Casasnovas RO, Fruchart C, Morschhauser F, Haioun C, Lazarovici J, Grosicka A, Perrot A, Trotman J, Sebban C, Caballero D, Greil R, van Eygen K, Cohen AM, Gonzalez H, Bouabdallah R, Oberic L, Corront B, Choufi B, Lopez-Guillermo A, Catalano J, Van Hoof A, Briere J, Cabeçadas J, Salles G, Gaulard P, Bosly A, Coiffier B. Lenalidomide maintenance compared with placebo in responding elderly patients with diffuse large B-cell lymphoma treated with first-line rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone. J Clin Oncol. 2017 Aug 1;35(22):2473-2481. Epub 2017 Apr 20. [https://doi.org/10.1200/JCO.2017.72.6984 link to original article] | + | #'''REMARC:''' Thieblemont C, Tilly H, Gomes da Silva M, Casasnovas RO, Fruchart C, Morschhauser F, Haioun C, Lazarovici J, Grosicka A, Perrot A, Trotman J, Sebban C, Caballero D, Greil R, van Eygen K, Cohen AM, Gonzalez H, Bouabdallah R, Oberic L, Corront B, Choufi B, Lopez-Guillermo A, Catalano J, Van Hoof A, Briere J, Cabeçadas J, Salles G, Gaulard P, Bosly A, Coiffier B. Lenalidomide maintenance compared with placebo in responding elderly patients with diffuse large B-cell lymphoma treated with first-line rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone. J Clin Oncol. 2017 Aug 1;35(22):2473-2481. Epub 2017 Apr 20. [https://doi.org/10.1200/JCO.2017.72.6984 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28426350/ PubMed] [https://clinicaltrials.gov/study/NCT01122472 NCT01122472] |
<!-- # '''Abstract:''' Thomas E. Witzig, Kensei Tobinai, Luigi Rigacci, Tongyu Lin, Takashi Ikeda, Anna Vanazzi, Masayuki Hino, Yuankai Shi, Jiri Mayer, Luciano J Costa, Carlos Daniel Bermudez, Jun Zhu, David Belada, Kamal Bouabdallah, Joseph Gergi Kattan, Cassandra Wu, Jenna Fan, Anne-Laure Louveau, Maurizio Voi, and Franco Cavalli. PILLAR-2: A randomized, double-blind, placebo-controlled, phase III study of adjuvant everolimus (EVE) in patients (pts) with poor-risk diffuse large B-cell lymphoma (DLBCL). Journal of Clinical Oncology 2016 34:15_suppl, 7506-7506 [https://doi.org/10.1200/JCO.2016.34.15_suppl.7506 link to abstract] --> | <!-- # '''Abstract:''' Thomas E. Witzig, Kensei Tobinai, Luigi Rigacci, Tongyu Lin, Takashi Ikeda, Anna Vanazzi, Masayuki Hino, Yuankai Shi, Jiri Mayer, Luciano J Costa, Carlos Daniel Bermudez, Jun Zhu, David Belada, Kamal Bouabdallah, Joseph Gergi Kattan, Cassandra Wu, Jenna Fan, Anne-Laure Louveau, Maurizio Voi, and Franco Cavalli. PILLAR-2: A randomized, double-blind, placebo-controlled, phase III study of adjuvant everolimus (EVE) in patients (pts) with poor-risk diffuse large B-cell lymphoma (DLBCL). Journal of Clinical Oncology 2016 34:15_suppl, 7506-7506 [https://doi.org/10.1200/JCO.2016.34.15_suppl.7506 link to abstract] --> | ||
| − | #'''PILLAR-2:''' Witzig TE, Tobinai K, Rigacci L, Ikeda T, Vanazzi A, Hino M, Shi Y, Mayer J, Costa LJ, Bermudez Silva CD, Zhu J, Belada D, Bouabdallah K, Kattan JG, Kuruvilla J, Kim WS, Larouche JF, Ogura M, Ozcan M, Fayad L, Wu C, Fan J, Louveau AL, Voi M, Cavalli F. Adjuvant everolimus in high-risk diffuse large B-cell lymphoma: final results from the PILLAR-2 randomized phase III trial. Ann Oncol. 2018 Mar 1;29(3):707-714. [https://doi.org/10.1093/annonc/mdx764 link to original article] [https://pubmed.ncbi.nlm.nih.gov/29253068 PubMed] NCT00790036 | + | #'''PILLAR-2:''' Witzig TE, Tobinai K, Rigacci L, Ikeda T, Vanazzi A, Hino M, Shi Y, Mayer J, Costa LJ, Bermudez Silva CD, Zhu J, Belada D, Bouabdallah K, Kattan JG, Kuruvilla J, Kim WS, Larouche JF, Ogura M, Ozcan M, Fayad L, Wu C, Fan J, Louveau AL, Voi M, Cavalli F. Adjuvant everolimus in high-risk diffuse large B-cell lymphoma: final results from the PILLAR-2 randomized phase III trial. Ann Oncol. 2018 Mar 1;29(3):707-714. [https://doi.org/10.1093/annonc/mdx764 link to original article] [https://pubmed.ncbi.nlm.nih.gov/29253068/ PubMed] [https://clinicaltrials.gov/study/NCT00790036 NCT00790036] |
=Maintenance after salvage therapy= | =Maintenance after salvage therapy= | ||
==Observation== | ==Observation== | ||
| − | + | <div class="toccolours" style="background-color:#eeeeee"> | |
| − | |||
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
| − | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
| Line 141: | Line 142: | ||
|1993-1997 | |1993-1997 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
| − | |[[#Anti-B4- | + | |[[#Anti-B4-bR_monotherapy_999|Anti-B4-bR]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of EFS | | style="background-color:#ffffbf" |Did not meet primary endpoint of EFS | ||
|- | |- | ||
| Line 147: | Line 148: | ||
|1995-2004 | |1995-2004 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
| − | |[[#Interleukin- | + | |[[#Interleukin-2_monotherapy_999|IL-2]] |
| − | | style="background-color:#ffffbf" |Did not meet primary endpoints of PFS/OS | + | | style="background-color:#ffffbf" |Did not meet co-primary endpoints of PFS/OS |
|- | |- | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3664033/ Gisselbrecht et al. 2010 (CORAL)] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3664033/ Gisselbrecht et al. 2010 (CORAL)] | ||
| Line 154: | Line 155: | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
|[[Diffuse_large_B-cell_lymphoma#Rituximab_monotherapy_2|Rituximab]] | |[[Diffuse_large_B-cell_lymphoma#Rituximab_monotherapy_2|Rituximab]] | ||
| − | | style="background-color:#ffffbf" |Did not meet | + | | style="background-color:#ffffbf" |Did not meet secondary endpoint of EFS<sup>1</sup> |
|- | |- | ||
|} | |} | ||
''<sup>1</sup>Reported efficacy for CORAL is based on the 2012 update.''<br> | ''<sup>1</sup>Reported efficacy for CORAL is based on the 2012 update.''<br> | ||
''No further treatment.'' | ''No further treatment.'' | ||
| + | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
| − | *SWOG 9438: Cyclophosphamide, Etoposide, TBI with autologous hematopoietic stem cell transplant | + | *SWOG 9438: [[#Cyclophosphamide.2C_Etoposide.2C_TBI.2C_then_auto_HSCT|Cyclophosphamide, Etoposide, TBI with autologous hematopoietic stem cell transplant]] consolidation |
| − | *CORAL: [[Diffuse_large_B-cell_lymphoma#BEAM.2C_then_auto_HSCT|BEAM with autologous hematopoietic stem cell transplant]] | + | *CORAL: [[Diffuse_large_B-cell_lymphoma#BEAM.2C_then_auto_HSCT|BEAM with autologous hematopoietic stem cell transplant]] consolidation |
| + | </div></div> | ||
===References=== | ===References=== | ||
| − | + | #'''SWOG 9438:''' Thompson JA, Fisher RI, Leblanc M, Forman SJ, Press OW, Unger JM, Nademanee AP, Stiff PJ, Petersdorf SH, Fefer A. Total body irradiation, etoposide, cyclophosphamide, and autologous peripheral blood stem-cell transplantation followed by randomization to therapy with interleukin-2 versus observation for patients with non-Hodgkin lymphoma: results of a phase 3 randomized trial by the Southwest Oncology Group (SWOG 9438). Blood. 2008 Apr 15;111(8):4048-54. Epub 2008 Feb 6. [http://www.bloodjournal.org/content/111/8/4048.long link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2288718/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/18256325/ PubMed] [https://clinicaltrials.gov/study/NCT00002649 NCT00002649] | |
| − | #'''SWOG 9438:''' Thompson JA, Fisher RI, Leblanc M, Forman SJ, Press OW, Unger JM, Nademanee AP, Stiff PJ, Petersdorf SH, Fefer A. Total body irradiation, etoposide, cyclophosphamide, and autologous peripheral blood stem-cell transplantation followed by randomization to therapy with interleukin-2 versus observation for patients with non-Hodgkin lymphoma: results of a phase 3 randomized trial by the Southwest Oncology Group (SWOG 9438). Blood. 2008 Apr 15;111(8):4048-54. Epub 2008 Feb 6. [http://www.bloodjournal.org/content/111/8/4048.long link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2288718/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/18256325 PubMed] NCT00002649 | + | #'''CALGB 9254:''' Furman RR, Grossbard ML, Johnson JL, Pecora AL, Cassileth PA, Jung SH, Peterson BA, Nadler LM, Freedman A, Bayer RL, Bartlett NL, Hurd DD, Cheson BD; Cancer and Leukemia Group B; [[Study_Groups#ECOG|ECOG]]. A phase III study of anti-B4-blocked ricin as adjuvant therapy post-autologous bone marrow transplant: CALGB 9254. Leuk Lymphoma. 2011 Apr;52(4):587-96. Epub 2011 Jan 28. [https://doi.org/10.3109/10428194.2010.543714 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3682835/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21275630/ PubMed] |
| − | #'''CALGB 9254:''' Furman RR, Grossbard ML, Johnson JL, Pecora AL, Cassileth PA, Jung SH, Peterson BA, Nadler LM, Freedman A, Bayer RL, Bartlett NL, Hurd DD, Cheson BD; Cancer and Leukemia Group B; [[Study_Groups#ECOG|ECOG]]. A phase III study of anti-B4-blocked ricin as adjuvant therapy post-autologous bone marrow transplant: CALGB 9254. Leuk Lymphoma. 2011 Apr;52(4):587-96. Epub 2011 Jan 28. [https:// | ||
<!-- Presented at the 45th Annual Meeting of the American Society of Clinical Oncology, June 4-6, 2011, Chicago, IL. --> | <!-- Presented at the 45th Annual Meeting of the American Society of Clinical Oncology, June 4-6, 2011, Chicago, IL. --> | ||
| − | #'''CORAL:''' Gisselbrecht C, Glass B, Mounier N, Singh Gill D, Linch DC, Trneny M, Bosly A, Ketterer N, Shpilberg O, Hagberg H, Ma D, Brière J, Moskowitz CH, Schmitz N. Salvage regimens with autologous transplantation for relapsed large B-cell lymphoma in the rituximab era. J Clin Oncol. 2010 Sep 20;28(27):4184-90. Epub 2010 Jul 26. Erratum in: J Clin Oncol. 2012 May 20;30(15):1896. [https://doi.org/10.1200/jco.2010.28.1618 link to original article] | + | #'''CORAL:''' Gisselbrecht C, Glass B, Mounier N, Singh Gill D, Linch DC, Trneny M, Bosly A, Ketterer N, Shpilberg O, Hagberg H, Ma D, Brière J, Moskowitz CH, Schmitz N. Salvage regimens with autologous transplantation for relapsed large B-cell lymphoma in the rituximab era. J Clin Oncol. 2010 Sep 20;28(27):4184-90. Epub 2010 Jul 26. Erratum in: J Clin Oncol. 2012 May 20;30(15):1896. [https://doi.org/10.1200/jco.2010.28.1618 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3664033/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/20660832/ PubMed] [https://clinicaltrials.gov/study/NCT00137995 NCT00137995] |
| − | ##'''Update:''' Gisselbrecht C, Schmitz N, Mounier N, Singh Gill D, Linch DC, Trneny M, Bosly A, Milpied NJ, Radford J, Ketterer N, Shpilberg O, Dührsen U, Hagberg H, Ma DD, Viardot A, Lowenthal R, Brière J, Salles G, Moskowitz CH, Glass B. Rituximab maintenance therapy after autologous stem-cell transplantation in patients with relapsed CD20(+) diffuse large B-cell lymphoma: final analysis of the collaborative trial in relapsed aggressive lymphoma. J Clin Oncol. 2012 Dec 20;30(36):4462-9. Epub 2012 Oct 22. [https://doi.org/10.1200/jco.2012.41.9416 link to original article] | + | ##'''Update:''' Gisselbrecht C, Schmitz N, Mounier N, Singh Gill D, Linch DC, Trneny M, Bosly A, Milpied NJ, Radford J, Ketterer N, Shpilberg O, Dührsen U, Hagberg H, Ma DD, Viardot A, Lowenthal R, Brière J, Salles G, Moskowitz CH, Glass B. Rituximab maintenance therapy after autologous stem-cell transplantation in patients with relapsed CD20(+) diffuse large B-cell lymphoma: final analysis of the collaborative trial in relapsed aggressive lymphoma. J Clin Oncol. 2012 Dec 20;30(36):4462-9. Epub 2012 Oct 22. [https://doi.org/10.1200/jco.2012.41.9416 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3646314/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/23091101/ PubMed] |
==Placebo== | ==Placebo== | ||
| − | + | <div class="toccolours" style="background-color:#eeeeee"> | |
| − | |||
===Regimen=== | ===Regimen=== | ||
| + | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
| + | !style="width: 20%"|Study | ||
| + | !style="width: 20%"|Dates of enrollment | ||
| + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
| + | !style="width: 20%"|Comparator | ||
| + | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
| + | |- | ||
| + | |[https://clinicaltrials.gov/study/NCT02443077 Awaiting publication (Alliance A051301)] | ||
| + | |2016-2023 | ||
| + | | style="background-color:#1a9851" |Phase 3 (C) | ||
| + | |[[#Ibrutinib_monotherapy_666|Ibrutinib]] | ||
| + | | style="background-color:#d3d3d3" |TBD if different primary endpoint of PFS24 | ||
| + | |- | ||
| + | |} | ||
''No further active antineoplastic treatment.'' | ''No further active antineoplastic treatment.'' | ||
| + | </div> | ||
===References=== | ===References=== | ||
| − | *'''Alliance A051301:''' NCT02443077 | + | *'''Alliance A051301:''' [https://clinicaltrials.gov/study/NCT02443077 NCT02443077] |
[[Category:Diffuse large B-cell lymphoma regimens]] | [[Category:Diffuse large B-cell lymphoma regimens]] | ||
[[Category:Null regimens]] | [[Category:Null regimens]] | ||
[[Category:Disease-specific pages]] | [[Category:Disease-specific pages]] | ||
| − | [[Category:Aggressive lymphomas]] | + | [[Category:Aggressive non-Hodgkin lymphomas]] |
| + | [[Category:B-cell lymphomas]] | ||
Revision as of 15:00, 13 April 2024
The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main DLBCL page for regimens that include active anticancer treatment.
Consolidation after upfront therapy
Observation
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Horning et al. 2004 (ECOG E1484) | 1984-1992 | Phase 3 (C) | IFRT | Seems to have inferior DFS |
| Bonnet et al. 2007 | 1993-2002 | Phase 3 (E-de-esc) | IFRT | Did not meet primary endpoint of EFS |
| Habermann et al. 2006 (ECOG E4494) | 1998-2001 | Phase 3 (C) | Rituximab | Did not meet primary endpoint of FFS |
| Haioun et al. 2009 (LNH 98-3) | 1999-2004 | Phase 3 (C) | Rituximab | Might have inferior EFS |
| Witzens-Harig et al. 2015 (HD2002) | 2002-2011 | Phase 3 (C) | Rituximab | Inferior OS in males |
| Jaeger et al. 2015 (NHL13) | 2004-2010 | Phase 3 (C) | Rituximab | Did not meet primary endpoint of EFS |
| Lamy et al. 2017 (LYSA/GOELAMS 02-03) | 2005-2014 | Phase 3 (C) | IFRT | Non-inferior EFS |
No further treatment, also variously termed "observation" and "watchful waiting". Note: in ECOG E4494, a statistically signficant disadvantage to observation was seen in the group receiving CHOP induction, which is no longer standard of care.
References
- ECOG E1484: Horning SJ, Weller E, Kim K, Earle JD, O'Connell MJ, Habermann TM, Glick JH. Chemotherapy with or without radiotherapy in limited-stage diffuse aggressive non-Hodgkin's lymphoma: Eastern Cooperative Oncology Group study 1484. J Clin Oncol. 2004 Aug 1;22(15):3032-8. Epub 2004 Jun 21. link to original article PubMed
- ECOG E4494: Habermann TM, Weller EA, Morrison VA, Gascoyne RD, Cassileth PA, Cohn JB, Dakhil SR, Woda B, Fisher RI, Peterson BA, Horning SJ. Rituximab-CHOP versus CHOP alone or with maintenance rituximab in older patients with diffuse large B-cell lymphoma. J Clin Oncol. 2006 Jul 1;24(19):3121-7. Epub 2006 Jun 5. link to original article PubMed NCT00003150
- Bonnet C, Fillet G, Mounier N, Ganem G, Molina TJ, Thiéblemont C, Fermé C, Quesnel B, Martin C, Gisselbrecht C, Tilly H, Reyes F; Groupe d'Etude des Lymphomes de l'Adulte. CHOP alone compared with CHOP plus radiotherapy for localized aggressive lymphoma in elderly patients: a study by the Groupe d'Etude des Lymphomes de l'Adulte. J Clin Oncol. 2007 Mar 1;25(7):787-92. Epub 2007 Jan 16. link to original article PubMed
- LNH 98-3: Haioun C, Mounier N, Emile JF, Ranta D, Coiffier B, Tilly H, Récher C, Fermé C, Gabarre J, Herbrecht R, Morchhauser F, Gisselbrecht C. Rituximab versus observation after high-dose consolidative first-line chemotherapy with autologous stem-cell transplantation in patients with poor-risk diffuse large B-cell lymphoma. Ann Oncol. 2009 Dec;20(12):1985-92. Epub 2009 Jun 30. link to original article PubMed NCT00169169
- NHL13: Jaeger U, Trneny M, Melzer H, Praxmarer M, Nawarawong W, Ben Yehuda D, Goldstein D, Mihaljevic B, Ilhan O, Ballova V, Hedenus M, Hsiao LT, Au WY, Burgstaller S, Weidinger G, Keil F, Dittrich C, Skrabs C, Klingler A, Chott A, Fridrik MA, Greil R. Rituximab maintenance for patients with aggressive B-cell lymphoma in first remission: results of the randomized NHL13 trial. Haematologica. 2015 Jul;100(7):955-63. Epub 2015 Apr 24. link to original article link to PMC article PubMed NCT00400478
- HD2002: Witzens-Harig M, Benner A, McClanahan F, Klemmer J, Brandt J, Brants E, Rieger M, Meissner J, Hensel M, Neben K, Dreger P, Lengfelder E, Schmidt-Wolf I, Krämer A, Ho AD. Rituximab maintenance improves survival in male patients with diffuse large B-cell lymphoma: results of the HD2002 prospective multicentre randomized phase III trial. Br J Haematol. 2015 Dec;171(5):710-9. Epub 2015 Oct 9. link to original article PubMed NCT01933711
- LYSA/GOELAMS 02-03: Lamy T, Damaj G, Soubeyran P, Gyan E, Cartron G, Bouabdallah K, Gressin R, Cornillon J, Banos A, Le Du K, Benchalal M, Moles MP, Le Gouill S, Fleury J, Godmer P, Maisonneuve H, Deconinck E, Houot R, Laribi K, Marolleau JP, Tournilhac O, Branger B, Devillers A, Vuillez JP, Fest T, Colombat P, Costes V, Szablewski V, Béné MC, Delwail V; LYSA; GOELAMS. R-CHOP 14 with or without radiotherapy in nonbulky limited-stage diffuse large B-cell lymphoma. Blood. 2018 Jan 11;131(2):174-181. Epub 2017 Oct 23. link to original article link to PMC article PubMed NCT00841945
Placebo
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Crump et al. 2016 (PRELUDE) | NR | Phase 3 (C) | Enzastaurin | Did not meet primary endpoint of DFS |
| Witzig et al. 2018 (PILLAR-2) | 2009-2013 | Phase 3 (C) | Everolimus | Did not meet primary endpoint of DFS DFS24: 77% vs 77.8% (HR 1.09, 95% CI 0.82-1.45) |
| Thieblemont et al. 2017 (REMARC) | 2009-2014 | Phase 3 (C) | Lenalidomide | Inferior PFS |
No further antineoplastic treatment.
References
- PRELUDE: Crump M, Leppä S, Fayad L, Lee JJ, Di Rocco A, Ogura M, Hagberg H, Schnell F, Rifkin R, Mackensen A, Offner F, Pinter-Brown L, Smith S, Tobinai K, Yeh SP, Hsi ED, Nguyen T, Shi P, Hahka-Kemppinen M, Thornton D, Lin B, Kahl B, Schmitz N, Savage KJ, Habermann T. Randomized, double-blind, phase III trial of enzastaurin versus placebo in patients achieving remission after first-line therapy for high-risk diffuse large B-cell lymphoma. J Clin Oncol. 2016 Jul 20;34(21):2484-92. Epub 2016 May 23. link to original article PubMed NCT00332202
- REMARC: Thieblemont C, Tilly H, Gomes da Silva M, Casasnovas RO, Fruchart C, Morschhauser F, Haioun C, Lazarovici J, Grosicka A, Perrot A, Trotman J, Sebban C, Caballero D, Greil R, van Eygen K, Cohen AM, Gonzalez H, Bouabdallah R, Oberic L, Corront B, Choufi B, Lopez-Guillermo A, Catalano J, Van Hoof A, Briere J, Cabeçadas J, Salles G, Gaulard P, Bosly A, Coiffier B. Lenalidomide maintenance compared with placebo in responding elderly patients with diffuse large B-cell lymphoma treated with first-line rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone. J Clin Oncol. 2017 Aug 1;35(22):2473-2481. Epub 2017 Apr 20. link to original article PubMed NCT01122472
- PILLAR-2: Witzig TE, Tobinai K, Rigacci L, Ikeda T, Vanazzi A, Hino M, Shi Y, Mayer J, Costa LJ, Bermudez Silva CD, Zhu J, Belada D, Bouabdallah K, Kattan JG, Kuruvilla J, Kim WS, Larouche JF, Ogura M, Ozcan M, Fayad L, Wu C, Fan J, Louveau AL, Voi M, Cavalli F. Adjuvant everolimus in high-risk diffuse large B-cell lymphoma: final results from the PILLAR-2 randomized phase III trial. Ann Oncol. 2018 Mar 1;29(3):707-714. link to original article PubMed NCT00790036
Maintenance after salvage therapy
Observation
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Furman et al. 2011 (CALGB 9254) | 1993-1997 | Phase 3 (C) | Anti-B4-bR | Did not meet primary endpoint of EFS |
| Thompson et al. 2008 (SWOG 9438) | 1995-2004 | Phase 3 (C) | IL-2 | Did not meet co-primary endpoints of PFS/OS |
| Gisselbrecht et al. 2010 (CORAL) | 2003-2007 | Phase 3 (C) | Rituximab | Did not meet secondary endpoint of EFS1 |
1Reported efficacy for CORAL is based on the 2012 update.
No further treatment.
Preceding treatment
- SWOG 9438: Cyclophosphamide, Etoposide, TBI with autologous hematopoietic stem cell transplant consolidation
- CORAL: BEAM with autologous hematopoietic stem cell transplant consolidation
References
- SWOG 9438: Thompson JA, Fisher RI, Leblanc M, Forman SJ, Press OW, Unger JM, Nademanee AP, Stiff PJ, Petersdorf SH, Fefer A. Total body irradiation, etoposide, cyclophosphamide, and autologous peripheral blood stem-cell transplantation followed by randomization to therapy with interleukin-2 versus observation for patients with non-Hodgkin lymphoma: results of a phase 3 randomized trial by the Southwest Oncology Group (SWOG 9438). Blood. 2008 Apr 15;111(8):4048-54. Epub 2008 Feb 6. link to original article link to PMC article PubMed NCT00002649
- CALGB 9254: Furman RR, Grossbard ML, Johnson JL, Pecora AL, Cassileth PA, Jung SH, Peterson BA, Nadler LM, Freedman A, Bayer RL, Bartlett NL, Hurd DD, Cheson BD; Cancer and Leukemia Group B; ECOG. A phase III study of anti-B4-blocked ricin as adjuvant therapy post-autologous bone marrow transplant: CALGB 9254. Leuk Lymphoma. 2011 Apr;52(4):587-96. Epub 2011 Jan 28. link to original article link to PMC article PubMed
- CORAL: Gisselbrecht C, Glass B, Mounier N, Singh Gill D, Linch DC, Trneny M, Bosly A, Ketterer N, Shpilberg O, Hagberg H, Ma D, Brière J, Moskowitz CH, Schmitz N. Salvage regimens with autologous transplantation for relapsed large B-cell lymphoma in the rituximab era. J Clin Oncol. 2010 Sep 20;28(27):4184-90. Epub 2010 Jul 26. Erratum in: J Clin Oncol. 2012 May 20;30(15):1896. link to original article link to PMC article PubMed NCT00137995
- Update: Gisselbrecht C, Schmitz N, Mounier N, Singh Gill D, Linch DC, Trneny M, Bosly A, Milpied NJ, Radford J, Ketterer N, Shpilberg O, Dührsen U, Hagberg H, Ma DD, Viardot A, Lowenthal R, Brière J, Salles G, Moskowitz CH, Glass B. Rituximab maintenance therapy after autologous stem-cell transplantation in patients with relapsed CD20(+) diffuse large B-cell lymphoma: final analysis of the collaborative trial in relapsed aggressive lymphoma. J Clin Oncol. 2012 Dec 20;30(36):4462-9. Epub 2012 Oct 22. link to original article link to PMC article PubMed
Placebo
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Awaiting publication (Alliance A051301) | 2016-2023 | Phase 3 (C) | Ibrutinib | TBD if different primary endpoint of PFS24 |
No further active antineoplastic treatment.
References
- Alliance A051301: NCT02443077