Difference between revisions of "Transformed lymphoma"
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''Transformed lymphoma, often referred to as Richter's transformation, most commonly arises from a preceding indolent lymphoma - usually [[Follicular lymphoma|follicular lymphoma]] or [[Chronic lymphocytic leukemia|chronic lymphocytic leukemia]]. It is typically treated as per the histologic subtype, which is usually [[Diffuse large B-cell lymphoma|DLBCL]]. However, some regimens specific to transformed lymphoma have been developed and are included here.'' | ''Transformed lymphoma, often referred to as Richter's transformation, most commonly arises from a preceding indolent lymphoma - usually [[Follicular lymphoma|follicular lymphoma]] or [[Chronic lymphocytic leukemia|chronic lymphocytic leukemia]]. It is typically treated as per the histologic subtype, which is usually [[Diffuse large B-cell lymphoma|DLBCL]]. However, some regimens specific to transformed lymphoma have been developed and are included here.'' | ||
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=All lines of therapy= | =All lines of therapy= | ||
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==Axicabtagene ciloleucel monotherapy {{#subobject:78231d|Regimen=1}}== | ==Axicabtagene ciloleucel monotherapy {{#subobject:78231d|Regimen=1}}== | ||
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===Regimen {{#subobject:e3e516|Variant=1}}=== | ===Regimen {{#subobject:e3e516|Variant=1}}=== | ||
{| class="wikitable" style="color:white; background-color:#404040" | {| class="wikitable" style="color:white; background-color:#404040" | ||
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====Preceding treatment==== | ====Preceding treatment==== | ||
*Lymphodepletion with [[Autologous_HSCT#FC|FC]] | *Lymphodepletion with [[Autologous_HSCT#FC|FC]] | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Immunotherapy==== | ====Immunotherapy==== | ||
*[[Axicabtagene ciloleucel (Yescarta)]] target dose of 2 × 10<sup>6</sup> CAR T cells/kg IV once on day 0 | *[[Axicabtagene ciloleucel (Yescarta)]] target dose of 2 × 10<sup>6</sup> CAR T cells/kg IV once on day 0 | ||
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====Supportive therapy==== | ====Supportive therapy==== | ||
*[[Acetaminophen (Tylenol)]] 650 mg PO once on day 0, approximately 60 minutes prior to [[Axicabtagene ciloleucel (Yescarta)]] | *[[Acetaminophen (Tylenol)]] 650 mg PO once on day 0, approximately 60 minutes prior to [[Axicabtagene ciloleucel (Yescarta)]] | ||
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'''One course; patients with initial response and disease progression at least 3 months later could be retreated''' | '''One course; patients with initial response and disease progression at least 3 months later could be retreated''' | ||
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===References=== | ===References=== | ||
#'''ZUMA-1:''' Locke FL, Neelapu SS, Bartlett NL, Siddiqi T, Chavez JC, Hosing CM, Ghobadi A, Budde LE, Bot A, Rossi JM, Jiang Y, Xue AX, Elias M, Aycock J, Wiezorek J, Go WY. Phase 1 results of ZUMA-1: A multicenter study of KTE-C19 anti-CD19 CAR T cell therapy in refractory aggressive lymphoma. Mol Ther. 2017 Jan 4;25(1):285-295. Epub 2017 Jan 4. [https://doi.org/10.1016/j.ymthe.2016.10.020 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5363293/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28129122 PubMed] NCT02348216 | #'''ZUMA-1:''' Locke FL, Neelapu SS, Bartlett NL, Siddiqi T, Chavez JC, Hosing CM, Ghobadi A, Budde LE, Bot A, Rossi JM, Jiang Y, Xue AX, Elias M, Aycock J, Wiezorek J, Go WY. Phase 1 results of ZUMA-1: A multicenter study of KTE-C19 anti-CD19 CAR T cell therapy in refractory aggressive lymphoma. Mol Ther. 2017 Jan 4;25(1):285-295. Epub 2017 Jan 4. [https://doi.org/10.1016/j.ymthe.2016.10.020 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5363293/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28129122 PubMed] NCT02348216 | ||
##'''Update:''' Neelapu SS, Locke FL, Bartlett NL, Lekakis LJ, Miklos DB, Jacobson CA, Braunschweig I, Oluwole OO, Siddiqi T, Lin Y, Timmerman JM, Stiff PJ, Friedberg JW, Flinn IW, Goy A, Hill BT, Smith MR, Deol A, Farooq U, McSweeney P, Munoz J, Avivi I, Castro JE, Westin JR, Chavez JC, Ghobadi A, Komanduri KV, Levy R, Jacobsen ED, Witzig TE, Reagan P, Bot A, Rossi J, Navale L, Jiang Y, Aycock J, Elias M, Chang D, Wiezorek J, Go WY. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med. 2017 Dec 28;377(26):2531-2544. Epub 2017 Dec 10. [https://doi.org/10.1056/NEJMoa1707447 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5882485/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/29226797 PubMed] | ##'''Update:''' Neelapu SS, Locke FL, Bartlett NL, Lekakis LJ, Miklos DB, Jacobson CA, Braunschweig I, Oluwole OO, Siddiqi T, Lin Y, Timmerman JM, Stiff PJ, Friedberg JW, Flinn IW, Goy A, Hill BT, Smith MR, Deol A, Farooq U, McSweeney P, Munoz J, Avivi I, Castro JE, Westin JR, Chavez JC, Ghobadi A, Komanduri KV, Levy R, Jacobsen ED, Witzig TE, Reagan P, Bot A, Rossi J, Navale L, Jiang Y, Aycock J, Elias M, Chang D, Wiezorek J, Go WY. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med. 2017 Dec 28;377(26):2531-2544. Epub 2017 Dec 10. [https://doi.org/10.1056/NEJMoa1707447 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5882485/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/29226797 PubMed] | ||
##'''Update:''' Locke FL, Ghobadi A, Jacobson CA, Miklos DB, Lekakis LJ, Oluwole OO, Lin Y, Braunschweig I, Hill BT, Timmerman JM, Deol A, Reagan PM, Stiff P, Flinn IW, Farooq U, Goy A, McSweeney PA, Munoz J, Siddiqi T, Chavez JC, Herrera AF, Bartlett NL, Wiezorek JS, Navale L, Xue A, Jiang Y, Bot A, Rossi JM, Kim JJ, Go WY, Neelapu SS. Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1-2 trial. Lancet Oncol. 2019 Jan;20(1):31-42. Epub 2018 Dec 2. [https://doi.org/10.1016/S1470-2045(18)30864-7 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6733402/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/30518502 PubMed] | ##'''Update:''' Locke FL, Ghobadi A, Jacobson CA, Miklos DB, Lekakis LJ, Oluwole OO, Lin Y, Braunschweig I, Hill BT, Timmerman JM, Deol A, Reagan PM, Stiff P, Flinn IW, Farooq U, Goy A, McSweeney PA, Munoz J, Siddiqi T, Chavez JC, Herrera AF, Bartlett NL, Wiezorek JS, Navale L, Xue A, Jiang Y, Bot A, Rossi JM, Kim JJ, Go WY, Neelapu SS. Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1-2 trial. Lancet Oncol. 2019 Jan;20(1):31-42. Epub 2018 Dec 2. [https://doi.org/10.1016/S1470-2045(18)30864-7 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6733402/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/30518502 PubMed] | ||
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==Bendamustine monotherapy {{#subobject:40b6d7|Regimen=1}}== | ==Bendamustine monotherapy {{#subobject:40b6d7|Regimen=1}}== | ||
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===Regimen {{#subobject:2806ae|Variant=1}}=== | ===Regimen {{#subobject:2806ae|Variant=1}}=== | ||
{| class="wikitable" style="width: 40%; text-align:center;" | {| class="wikitable" style="width: 40%; text-align:center;" | ||
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====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Bendamustine]] 120 mg/m<sup>2</sup> IV once per day on days 1 & 2 | *[[Bendamustine]] 120 mg/m<sup>2</sup> IV once per day on days 1 & 2 | ||
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'''21-day cycle for up to 12 cycles''' | '''21-day cycle for up to 12 cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
<!-- Presented in part at the 48th Annual Meeting of the American Society of Hematology, December 9-12, 2006, Orlando, Florida --> | <!-- Presented in part at the 48th Annual Meeting of the American Society of Hematology, December 9-12, 2006, Orlando, Florida --> | ||
# Friedberg JW, Cohen P, Chen L, Robinson KS, Forero-Torres A, La Casce AS, Fayad LE, Bessudo A, Camacho ES, Williams ME, van der Jagt RH, Oliver JW, Cheson BD. Bendamustine in patients with rituximab-refractory indolent and transformed non-Hodgkin's lymphoma: results from a phase II multicenter, single-agent study. J Clin Oncol. 2008 Jan 10;26(2):204-10. Erratum in: J Clin Oncol. 2008 Apr 10;26(11) 1911. [https://doi.org/10.1200/jco.2007.12.5070 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/18182663 PubMed] | # Friedberg JW, Cohen P, Chen L, Robinson KS, Forero-Torres A, La Casce AS, Fayad LE, Bessudo A, Camacho ES, Williams ME, van der Jagt RH, Oliver JW, Cheson BD. Bendamustine in patients with rituximab-refractory indolent and transformed non-Hodgkin's lymphoma: results from a phase II multicenter, single-agent study. J Clin Oncol. 2008 Jan 10;26(2):204-10. Erratum in: J Clin Oncol. 2008 Apr 10;26(11) 1911. [https://doi.org/10.1200/jco.2007.12.5070 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/18182663 PubMed] | ||
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==<sup>131</sup>Iodine-Tositumomab monotherapy {{#subobject:4f79a4|Regimen=1}}== | ==<sup>131</sup>Iodine-Tositumomab monotherapy {{#subobject:4f79a4|Regimen=1}}== | ||
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===Regimen {{#subobject:1c0cb9|Variant=1}}=== | ===Regimen {{#subobject:1c0cb9|Variant=1}}=== | ||
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− | '' | + | ''Note: This was also evaluated in low-grade NHL but subtype was not specified. Now obsolete as this drug has been discontinued.'' |
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====Radioconjugate therapy, dosimetric step==== | ====Radioconjugate therapy, dosimetric step==== | ||
*On Day 0, infusions of: | *On Day 0, infusions of: | ||
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*Day 2, 3, or 4: Second scan of whole body dosimetry & redistribution | *Day 2, 3, or 4: Second scan of whole body dosimetry & redistribution | ||
*Day 6 or 7: Third scan of whole body dosimetry & redistribution | *Day 6 or 7: Third scan of whole body dosimetry & redistribution | ||
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====Radioconjugate therapy, therapeutic step==== | ====Radioconjugate therapy, therapeutic step==== | ||
*Any day from day 7-14, infusions of: | *Any day from day 7-14, infusions of: | ||
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***65 cGy total body dose used for patients with platelet counts of 100-150,000/mm3 | ***65 cGy total body dose used for patients with platelet counts of 100-150,000/mm3 | ||
''Calculated dose of I-131 is based on information from serial total-body gamma-camera counts'' | ''Calculated dose of I-131 is based on information from serial total-body gamma-camera counts'' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
# Vose JM, Wahl RL, Saleh M, Rohatiner AZ, Knox SJ, Radford JA, Zelenetz AD, Tidmarsh GF, Stagg RJ, Kaminski MS. Multicenter phase II study of iodine-131 tositumomab for chemotherapy-relapsed/refractory low-grade and transformed low-grade B-cell non-Hodgkin's lymphomas. J Clin Oncol. 2000 Mar;18(6):1316-23. [https://doi.org/10.1200/jco.2000.18.6.1316 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/10715303 PubMed] | # Vose JM, Wahl RL, Saleh M, Rohatiner AZ, Knox SJ, Radford JA, Zelenetz AD, Tidmarsh GF, Stagg RJ, Kaminski MS. Multicenter phase II study of iodine-131 tositumomab for chemotherapy-relapsed/refractory low-grade and transformed low-grade B-cell non-Hodgkin's lymphomas. J Clin Oncol. 2000 Mar;18(6):1316-23. [https://doi.org/10.1200/jco.2000.18.6.1316 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/10715303 PubMed] | ||
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==Lenalidomide monotherapy {{#subobject:590ccf|Regimen=1}}== | ==Lenalidomide monotherapy {{#subobject:590ccf|Regimen=1}}== | ||
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===Regimen {{#subobject:87163f|Variant=1}}=== | ===Regimen {{#subobject:87163f|Variant=1}}=== | ||
{| class="wikitable" style="width: 40%; text-align:center;" | {| class="wikitable" style="width: 40%; text-align:center;" | ||
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====Targeted therapy==== | ====Targeted therapy==== | ||
*[[Lenalidomide (Revlimid)]] 25 mg PO once per day on days 1 to 21 | *[[Lenalidomide (Revlimid)]] 25 mg PO once per day on days 1 to 21 | ||
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'''28-day cycles''' | '''28-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
# '''NHL-003:''' 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. [https://doi.org/10.1093/annonc/mdq626 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/21228334 PubMed] NCT00413036 | # '''NHL-003:''' 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. [https://doi.org/10.1093/annonc/mdq626 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/21228334 PubMed] NCT00413036 | ||
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==Lenalidomide & Rituximab (R<sup>2</sup>) {{#subobject:cce1e0|Regimen=1}}== | ==Lenalidomide & Rituximab (R<sup>2</sup>) {{#subobject:cce1e0|Regimen=1}}== | ||
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===Regimen {{#subobject:8347d9|Variant=1}}=== | ===Regimen {{#subobject:8347d9|Variant=1}}=== | ||
{| class="wikitable" style="width: 40%; text-align:center;" | {| class="wikitable" style="width: 40%; text-align:center;" | ||
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====Targeted therapy==== | ====Targeted therapy==== | ||
*[[Lenalidomide (Revlimid)]] 20 mg PO once per day on days 1 to 21 | *[[Lenalidomide (Revlimid)]] 20 mg PO once per day on days 1 to 21 | ||
*[[Rituximab (Rituxan)]] as follows: | *[[Rituximab (Rituxan)]] as follows: | ||
**Cycle 1: 375 mg/m<sup>2</sup> IV once per day on days 1, 8, 15, 22 | **Cycle 1: 375 mg/m<sup>2</sup> IV once per day on days 1, 8, 15, 22 | ||
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'''28-day cycles''' | '''28-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
# '''MDACC 2005-0461:''' Wang M, Fowler N, Wagner-Bartak N, Feng L, Romaguera J, Neelapu SS, Hagemeister F, Fanale M, Oki Y, Pro B, Shah J, Thomas S, Younes A, Hosing C, Zhang L, Newberry KJ, Desai M, Cheng N, Badillo M, Bejarano M, Chen Y, Young KH, Champlin R, Kwak L, Fayad L. Oral lenalidomide with rituximab in relapsed or refractory diffuse large cell, follicular and transformed lymphoma: a phase II clinical trial. Leukemia. 2013 Sep;27(9):1902-9. Epub 2013 Apr 2. [https://doi.org/10.1038/leu.2013.95 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/23545991 PubMed] NCT00294632 | # '''MDACC 2005-0461:''' Wang M, Fowler N, Wagner-Bartak N, Feng L, Romaguera J, Neelapu SS, Hagemeister F, Fanale M, Oki Y, Pro B, Shah J, Thomas S, Younes A, Hosing C, Zhang L, Newberry KJ, Desai M, Cheng N, Badillo M, Bejarano M, Chen Y, Young KH, Champlin R, Kwak L, Fayad L. Oral lenalidomide with rituximab in relapsed or refractory diffuse large cell, follicular and transformed lymphoma: a phase II clinical trial. Leukemia. 2013 Sep;27(9):1902-9. Epub 2013 Apr 2. [https://doi.org/10.1038/leu.2013.95 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/23545991 PubMed] NCT00294632 | ||
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==Lenalidomide & Tafasitamab {{#subobject:d4abx3|Regimen=1}}== | ==Lenalidomide & Tafasitamab {{#subobject:d4abx3|Regimen=1}}== | ||
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===Regimen {{#subobject:737708|Variant=1}}=== | ===Regimen {{#subobject:737708|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 60%; text-align:center;" | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
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|} | |} | ||
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====Targeted therapy==== | ====Targeted therapy==== | ||
*[[Lenalidomide (Revlimid)]] as follows: | *[[Lenalidomide (Revlimid)]] as follows: | ||
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**Cycles 2 & 3: 12 mg/kg IV over 2 hours once per day on days 1, 8, 15, 22 | **Cycles 2 & 3: 12 mg/kg IV over 2 hours once per day on days 1, 8, 15, 22 | ||
**Cycle 4 onwards: 12 mg/kg IV over 2 hours once per day on days 1 & 15 | **Cycle 4 onwards: 12 mg/kg IV over 2 hours once per day on days 1 & 15 | ||
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'''28-day cycles''' | '''28-day cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
<!-- # '''Abstract:''' Kami J. Maddocks, Eva González Barca, Wojciech Jurczak, Anna Marina Liberati, Johannes Duell, Zsolt Nagy, Tomáš Papajík, Marc Andre, Nagesh Kalakonda, Martin H. Dreyling, Pier Luigi Zinzani, Sumeet Vijay Ambarkhane, Johannes Weirather, and Gilles A. Salles. L-mind: MOR208 combined with lenalidomide (LEN) in patients with relapsed or refractory diffuse large b-cell lymphoma (R-R DLBCL)—A single-arm phase II study. Journal of Clinical Oncology 2017 35:15_suppl, 7514-7514 [https://doi.org/10.1200/JCO.2017.35.15_suppl.7514 link to abstract] --> | <!-- # '''Abstract:''' Kami J. Maddocks, Eva González Barca, Wojciech Jurczak, Anna Marina Liberati, Johannes Duell, Zsolt Nagy, Tomáš Papajík, Marc Andre, Nagesh Kalakonda, Martin H. Dreyling, Pier Luigi Zinzani, Sumeet Vijay Ambarkhane, Johannes Weirather, and Gilles A. Salles. L-mind: MOR208 combined with lenalidomide (LEN) in patients with relapsed or refractory diffuse large b-cell lymphoma (R-R DLBCL)—A single-arm phase II study. Journal of Clinical Oncology 2017 35:15_suppl, 7514-7514 [https://doi.org/10.1200/JCO.2017.35.15_suppl.7514 link to abstract] --> | ||
# '''L-MIND:''' Salles G, Duell J, González Barca E, Tournilhac O, Jurczak W, Liberati AM, Nagy Z, Obr A, Gaidano G, André M, Kalakonda N, Dreyling M, Weirather J, Dirnberger-Hertweck M, Ambarkhane S, Fingerle-Rowson G, Maddocks K. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. Lancet Oncol. 2020 Jul;21(7):978-988. Epub 2020 Jun 5. [https://doi.org/10.1016/s1470-2045(20)30225-4 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/32511983 PubMed] NCT02399085 | # '''L-MIND:''' Salles G, Duell J, González Barca E, Tournilhac O, Jurczak W, Liberati AM, Nagy Z, Obr A, Gaidano G, André M, Kalakonda N, Dreyling M, Weirather J, Dirnberger-Hertweck M, Ambarkhane S, Fingerle-Rowson G, Maddocks K. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. Lancet Oncol. 2020 Jul;21(7):978-988. Epub 2020 Jun 5. [https://doi.org/10.1016/s1470-2045(20)30225-4 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/32511983 PubMed] NCT02399085 | ||
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==Lisocabtagene maraleucel monotherapy {{#subobject:6e6u14|Regimen=1}}== | ==Lisocabtagene maraleucel monotherapy {{#subobject:6e6u14|Regimen=1}}== | ||
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===Regimen {{#subobject:6nvha6|Variant=1}}=== | ===Regimen {{#subobject:6nvha6|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 60%; text-align:center;" | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
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====Immunotherapy==== | ====Immunotherapy==== | ||
*[[Lisocabtagene maraleucel (Breyanzi)]] | *[[Lisocabtagene maraleucel (Breyanzi)]] | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
#'''TRANSCEND NHL-001:''' Abramson JS, Palomba ML, Gordon LI, Lunning MA, Wang M, Arnason J, Mehta A, Purev E, Maloney DG, Andreadis C, Sehgal A, Solomon SR, Ghosh N, Albertson TM, Garcia J, Kostic A, Mallaney M, Ogasawara K, Newhall K, Kim Y, Li D, Siddiqi T. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study. Lancet. 2020 Sep 19;396(10254):839-852. Epub 2020 Sep 1. [https://doi.org/10.1016/s0140-6736(20)31366-0 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32888407 PubMed] NCT02631044 | #'''TRANSCEND NHL-001:''' Abramson JS, Palomba ML, Gordon LI, Lunning MA, Wang M, Arnason J, Mehta A, Purev E, Maloney DG, Andreadis C, Sehgal A, Solomon SR, Ghosh N, Albertson TM, Garcia J, Kostic A, Mallaney M, Ogasawara K, Newhall K, Kim Y, Li D, Siddiqi T. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study. Lancet. 2020 Sep 19;396(10254):839-852. Epub 2020 Sep 1. [https://doi.org/10.1016/s0140-6736(20)31366-0 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32888407 PubMed] NCT02631044 | ||
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==Loncastuximab tesirine monotherapy {{#subobject:jgua99|Regimen=1}}== | ==Loncastuximab tesirine monotherapy {{#subobject:jgua99|Regimen=1}}== | ||
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− | |||
===Regimen {{#subobject:jagix0|Variant=1}}=== | ===Regimen {{#subobject:jagix0|Variant=1}}=== | ||
{| class="wikitable sortable" style="color:white; background-color:#404040" | {| class="wikitable sortable" style="color:white; background-color:#404040" | ||
Line 209: | Line 196: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Antibody-drug conjugate therapy==== | ====Antibody-drug conjugate therapy==== | ||
*[[Loncastuximab tesirine (Zynlonta)]] as follows: | *[[Loncastuximab tesirine (Zynlonta)]] as follows: | ||
**Cycles 1 & 2: 0.15 mg/kg IV over 30 minutes once on day 1 | **Cycles 1 & 2: 0.15 mg/kg IV over 30 minutes once on day 1 | ||
**Cycle 3 onwards: 0.075 mg/kg IV over 30 minutes once on day 1 | **Cycle 3 onwards: 0.075 mg/kg IV over 30 minutes once on day 1 | ||
− | |||
====Supportive therapy==== | ====Supportive therapy==== | ||
*[[Dexamethasone (Decadron)]] 4 mg IV or PO twice per day on days -1 to 2 (3 days total) | *[[Dexamethasone (Decadron)]] 4 mg IV or PO twice per day on days -1 to 2 (3 days total) | ||
− | |||
'''21-day cycles for up to 18 cycles (1 year)''' | '''21-day cycles for up to 18 cycles (1 year)''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
#'''LOTIS-2:''' Caimi PF, Ai W, Alderuccio JP, Ardeshna KM, Hamadani M, Hess B, Kahl BS, Radford J, Solh M, Stathis A, Zinzani PL, Havenith K, Feingold J, He S, Qin Y, Ungar D, Zhang X, Carlo-Stella C. Loncastuximab tesirine in relapsed or refractory diffuse large B-cell lymphoma (LOTIS-2): a multicentre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):790-800. Epub 2021 May 11. [https://doi.org/10.1016/s1470-2045(21)00139-x link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/33989558/ PubMed] NCT03589469 | #'''LOTIS-2:''' Caimi PF, Ai W, Alderuccio JP, Ardeshna KM, Hamadani M, Hess B, Kahl BS, Radford J, Solh M, Stathis A, Zinzani PL, Havenith K, Feingold J, He S, Qin Y, Ungar D, Zhang X, Carlo-Stella C. Loncastuximab tesirine in relapsed or refractory diffuse large B-cell lymphoma (LOTIS-2): a multicentre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):790-800. Epub 2021 May 11. [https://doi.org/10.1016/s1470-2045(21)00139-x link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/33989558/ PubMed] NCT03589469 | ||
− | |||
==OFAR {{#subobject:bd6061|Regimen=1}}== | ==OFAR {{#subobject:bd6061|Regimen=1}}== | ||
− | |||
OFAR: '''<u>O</u>'''xaliplatin, '''<u>F</u>'''ludarabine, '''<u>A</u>'''ra-C (Cytarabine), '''<u>R</u>'''ituximab | OFAR: '''<u>O</u>'''xaliplatin, '''<u>F</u>'''ludarabine, '''<u>A</u>'''ra-C (Cytarabine), '''<u>R</u>'''ituximab | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:bd771f|Variant=1}}=== | ===Regimen {{#subobject:bd771f|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 80%; text-align:center;" | {| class="wikitable sortable" style="width: 80%; text-align:center;" | ||
Line 240: | Line 224: | ||
|} | |} | ||
''Note: the manuscript does not specify what sequence the rituximab is given in.'' | ''Note: the manuscript does not specify what sequence the rituximab is given in.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Oxaliplatin (Eloxatin)]] 25 mg/m<sup>2</sup> IV over 2 hours once per day on days 1 to 4, '''given first (see note)''' | *[[Oxaliplatin (Eloxatin)]] 25 mg/m<sup>2</sup> IV over 2 hours once per day on days 1 to 4, '''given first (see note)''' | ||
Line 248: | Line 233: | ||
**Cycle 1: 375 mg/m<sup>2</sup> IV over 4 to 6 hours once on day 3 | **Cycle 1: 375 mg/m<sup>2</sup> IV over 4 to 6 hours once on day 3 | ||
**Cycles 2 to 6: 375 mg/m<sup>2</sup> IV over 4 to 6 hours once on day 1 | **Cycles 2 to 6: 375 mg/m<sup>2</sup> IV over 4 to 6 hours once on day 1 | ||
− | |||
====Supportive therapy==== | ====Supportive therapy==== | ||
*[[Pegfilgrastim (Neulasta)]] 6 mg SC once on day 6 | *[[Pegfilgrastim (Neulasta)]] 6 mg SC once on day 6 | ||
*Herpes zoster and PCP (Pneumocystis jiroveci pneumonia) prophylaxis used | *Herpes zoster and PCP (Pneumocystis jiroveci pneumonia) prophylaxis used | ||
− | |||
'''28-day cycle for up to 6 cycles''' | '''28-day cycle for up to 6 cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
# Tsimberidou AM, Wierda WG, Plunkett W, Kurzrock R, O'Brien S, Wen S, Ferrajoli A, Ravandi-Kashani F, Garcia-Manero G, Estrov Z, Kipps TJ, Brown JR, Fiorentino A, Lerner S, Kantarjian HM, Keating MJ. Phase I-II study of oxaliplatin, fludarabine, cytarabine, and rituximab combination therapy in patients with Richter's syndrome or fludarabine-refractory chronic lymphocytic leukemia. J Clin Oncol. 2008 Jan 10;26(2):196-203. [https://doi.org/10.1200/jco.2007.11.8513 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/18182662 PubMed] | # Tsimberidou AM, Wierda WG, Plunkett W, Kurzrock R, O'Brien S, Wen S, Ferrajoli A, Ravandi-Kashani F, Garcia-Manero G, Estrov Z, Kipps TJ, Brown JR, Fiorentino A, Lerner S, Kantarjian HM, Keating MJ. Phase I-II study of oxaliplatin, fludarabine, cytarabine, and rituximab combination therapy in patients with Richter's syndrome or fludarabine-refractory chronic lymphocytic leukemia. J Clin Oncol. 2008 Jan 10;26(2):196-203. [https://doi.org/10.1200/jco.2007.11.8513 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/18182662 PubMed] | ||
− | |||
==Pembrolizumab monotherapy {{#subobject:1089ff|Regimen=1}}== | ==Pembrolizumab monotherapy {{#subobject:1089ff|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
===Regimen {{#subobject:f10e64|Variant=1}}=== | ===Regimen {{#subobject:f10e64|Variant=1}}=== | ||
{| class="wikitable" style="width: 60%; text-align:center;" | {| class="wikitable" style="width: 60%; text-align:center;" | ||
Line 272: | Line 253: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Immunotherapy==== | ====Immunotherapy==== | ||
*[[Pembrolizumab (Keytruda)]] 200 mg IV once on day 1 | *[[Pembrolizumab (Keytruda)]] 200 mg IV once on day 1 | ||
− | |||
'''21-day cycle for up to 35 cycles (2 years)''' | '''21-day cycle for up to 35 cycles (2 years)''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
# '''MC1485:''' Ding W, LaPlant BR, Call TG, Parikh SA, Leis JF, He R, Shanafelt TD, Sinha S, Le-Rademacher J, Feldman AL, Habermann TM, Witzig TE, Wiseman GA, Lin Y, Asmus E, Nowakowski GS, Conte MJ, Bowen DA, Aitken CN, Van Dyke DL, Greipp PT, Liu X, Wu X, Zhang H, Secreto CR, Tian S, Braggio E, Wellik LE, Micallef I, Viswanatha DS, Yan H, Chanan-Khan AA, Kay NE, Dong H, Ansell SM. Pembrolizumab in patients with CLL and Richter transformation or with relapsed CLL. Blood. 2017 Jun 29;129(26):3419-3427. Epub 2017 Apr 19. [http://www.bloodjournal.org/content/129/26/3419.long link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5492091/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28424162 PubMed] | # '''MC1485:''' Ding W, LaPlant BR, Call TG, Parikh SA, Leis JF, He R, Shanafelt TD, Sinha S, Le-Rademacher J, Feldman AL, Habermann TM, Witzig TE, Wiseman GA, Lin Y, Asmus E, Nowakowski GS, Conte MJ, Bowen DA, Aitken CN, Van Dyke DL, Greipp PT, Liu X, Wu X, Zhang H, Secreto CR, Tian S, Braggio E, Wellik LE, Micallef I, Viswanatha DS, Yan H, Chanan-Khan AA, Kay NE, Dong H, Ansell SM. Pembrolizumab in patients with CLL and Richter transformation or with relapsed CLL. Blood. 2017 Jun 29;129(26):3419-3427. Epub 2017 Apr 19. [http://www.bloodjournal.org/content/129/26/3419.long link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5492091/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28424162 PubMed] | ||
− | |||
==R-DHAP {{#subobject:aacad1|Regimen=1}}== | ==R-DHAP {{#subobject:aacad1|Regimen=1}}== | ||
− | |||
R-DHAP: '''<u>R</u>'''ituximab, '''<u>D</u>'''examethasone, '''<u>H</u>'''igh-dose '''<u>A</u>'''ra-C (Cytarabine), '''<u>P</u>'''latinol (Cisplatin) | R-DHAP: '''<u>R</u>'''ituximab, '''<u>D</u>'''examethasone, '''<u>H</u>'''igh-dose '''<u>A</u>'''ra-C (Cytarabine), '''<u>P</u>'''latinol (Cisplatin) | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:482776|Variant=1}}=== | ===Regimen {{#subobject:482776|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 299: | Line 278: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
*[[Rituximab (Rituxan)]] 375 mg/m<sup>2</sup> IV once on day 1 | *[[Rituximab (Rituxan)]] 375 mg/m<sup>2</sup> IV once on day 1 | ||
Line 306: | Line 286: | ||
*[[Cytarabine (Ara-C)]] 2000 mg/m<sup>2</sup> IV over 3 hours every 12 hours on day 2 (total dose per cycle: 4000 mg/m<sup>2</sup>) | *[[Cytarabine (Ara-C)]] 2000 mg/m<sup>2</sup> IV over 3 hours every 12 hours on day 2 (total dose per cycle: 4000 mg/m<sup>2</sup>) | ||
*[[Cisplatin (Platinol)]] 100 mg/m<sup>2</sup> IV continuous infusion over 24 hours, started on day 1 | *[[Cisplatin (Platinol)]] 100 mg/m<sup>2</sup> IV continuous infusion over 24 hours, started on day 1 | ||
− | |||
'''21-day cycle for up to 3 cycles''' | '''21-day cycle for up to 3 cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
<!-- Presented in part at the Annual Meeting of the American Society of Hematology, Atlanta, GA, December 7-10, 2013, and the International Conference on Malignant Lymphoma, Lugano, Switzerland, June 19-22, 2013. --> | <!-- Presented in part at the Annual Meeting of the American Society of Hematology, Atlanta, GA, December 7-10, 2013, and the International Conference on Malignant Lymphoma, Lugano, Switzerland, June 19-22, 2013. --> | ||
# '''NCIC-CTG LY.12:''' Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. [https://doi.org/10.1200/jco.2013.53.9593 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/25267740 PubMed] NCT00078949 | # '''NCIC-CTG LY.12:''' Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. [https://doi.org/10.1200/jco.2013.53.9593 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/25267740 PubMed] NCT00078949 | ||
## '''Subgroup Analysis:''' Kuruvilla J, MacDonald DA, Kouroukis CT, Cheung M, Olney HJ, Turner AR, Anglin P, Seftel M, Ismail WS, Luminari S, Couban S, Baetz T, Meyer RM, Hay AE, Shepherd L, Djurfeldt MS, Alamoudi S, Chen BE, Crump M. Salvage chemotherapy and autologous stem cell transplantation for transformed indolent lymphoma: a subset analysis of NCIC-CTG LY12. Blood. 2015 Aug 6;126(6):733-8. Epub 2015 Jun 24. [http://www.bloodjournal.org/content/126/6/733.long link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/26109202 PubMed] | ## '''Subgroup Analysis:''' Kuruvilla J, MacDonald DA, Kouroukis CT, Cheung M, Olney HJ, Turner AR, Anglin P, Seftel M, Ismail WS, Luminari S, Couban S, Baetz T, Meyer RM, Hay AE, Shepherd L, Djurfeldt MS, Alamoudi S, Chen BE, Crump M. Salvage chemotherapy and autologous stem cell transplantation for transformed indolent lymphoma: a subset analysis of NCIC-CTG LY12. Blood. 2015 Aug 6;126(6):733-8. Epub 2015 Jun 24. [http://www.bloodjournal.org/content/126/6/733.long link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/26109202 PubMed] | ||
− | |||
==R-EPOCH {{#subobject:86a128|Regimen=1}}== | ==R-EPOCH {{#subobject:86a128|Regimen=1}}== | ||
− | |||
R-EPOCH: '''<u>R</u>'''ituximab, '''<u>E</u>'''toposide, '''<u>P</u>'''rednisone, '''<u>O</u>'''ncovin (Vincristine), '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin) | R-EPOCH: '''<u>R</u>'''ituximab, '''<u>E</u>'''toposide, '''<u>P</u>'''rednisone, '''<u>O</u>'''ncovin (Vincristine), '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin) | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:51d707|Variant=1}}=== | ===Regimen {{#subobject:51d707|Variant=1}}=== | ||
{| class="wikitable" style="width: 40%; text-align:center;" | {| class="wikitable" style="width: 40%; text-align:center;" | ||
Line 328: | Line 305: | ||
|} | |} | ||
''Note: this is not the dose-adjusted R-EPOCH regimen'' | ''Note: this is not the dose-adjusted R-EPOCH regimen'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
*[[Rituximab (Rituxan)]] 375 mg/m<sup>2</sup> IV once on day 1 | *[[Rituximab (Rituxan)]] 375 mg/m<sup>2</sup> IV once on day 1 | ||
Line 335: | Line 313: | ||
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 5 | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 5 | ||
*[[Doxorubicin (Adriamycin)]] 15 mg/m<sup>2</sup>/day IV continuous infusion over 72 hours, started on day 2 (total dose per cycle: 45 mg/m<sup>2</sup>) | *[[Doxorubicin (Adriamycin)]] 15 mg/m<sup>2</sup>/day IV continuous infusion over 72 hours, started on day 2 (total dose per cycle: 45 mg/m<sup>2</sup>) | ||
− | |||
====Glucocorticoid therapy==== | ====Glucocorticoid therapy==== | ||
*[[Prednisone (Sterapred)]] 60 mg/m<sup>2</sup>/day PO on days 1 to 14 | *[[Prednisone (Sterapred)]] 60 mg/m<sup>2</sup>/day PO on days 1 to 14 | ||
− | |||
'''21-day cycle for 4 to 6 cycles''' | '''21-day cycle for 4 to 6 cycles''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
# Jermann M, Jost LM, Taverna Ch, Jacky E, Honegger HP, Betticher DC, Egli F, Kroner T, Stahel RA. Rituximab-EPOCH, an effective salvage therapy for relapsed, refractory or transformed B-cell lymphomas: results of a phase II study. Ann Oncol. 2004 Mar;15(3):511-6. [https://doi.org/10.1093/annonc/mdh093 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/14998858 PubMed] | # Jermann M, Jost LM, Taverna Ch, Jacky E, Honegger HP, Betticher DC, Egli F, Kroner T, Stahel RA. Rituximab-EPOCH, an effective salvage therapy for relapsed, refractory or transformed B-cell lymphomas: results of a phase II study. Ann Oncol. 2004 Mar;15(3):511-6. [https://doi.org/10.1093/annonc/mdh093 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/14998858 PubMed] | ||
− | |||
==R-GDP {{#subobject:8624f9|Regimen=1}}== | ==R-GDP {{#subobject:8624f9|Regimen=1}}== | ||
− | |||
R-GDP: '''<u>R</u>'''ituximab, '''<u>G</u>'''emcitabine, '''<u>D</u>'''examethasone, '''<u>P</u>'''latinol (Cisplatin) | R-GDP: '''<u>R</u>'''ituximab, '''<u>G</u>'''emcitabine, '''<u>D</u>'''examethasone, '''<u>P</u>'''latinol (Cisplatin) | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:7e2222|Variant=1}}=== | ===Regimen {{#subobject:7e2222|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 363: | Line 337: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
*[[Rituximab (Rituxan)]] 375 mg/m<sup>2</sup> IV once on day 1 | *[[Rituximab (Rituxan)]] 375 mg/m<sup>2</sup> IV once on day 1 | ||
Line 370: | Line 345: | ||
====Glucocorticoid therapy==== | ====Glucocorticoid therapy==== | ||
*[[Dexamethasone (Decadron)]] 40 mg PO once per day on days 1 to 4 | *[[Dexamethasone (Decadron)]] 40 mg PO once per day on days 1 to 4 | ||
− | |||
'''21-day cycle for up to 3 cycles''' | '''21-day cycle for up to 3 cycles''' | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#cbd5e7"> | ||
====Subsequent treatment==== | ====Subsequent treatment==== | ||
*Responders: autologous HSCT | *Responders: autologous HSCT | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
<!-- Presented in part at the Annual Meeting of the American Society of Hematology, Atlanta, GA, December 7-10, 2013, and the International Conference on Malignant Lymphoma, Lugano, Switzerland, June 19-22, 2013. --> | <!-- Presented in part at the Annual Meeting of the American Society of Hematology, Atlanta, GA, December 7-10, 2013, and the International Conference on Malignant Lymphoma, Lugano, Switzerland, June 19-22, 2013. --> | ||
# '''NCIC-CTG LY.12:''' Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. [https://doi.org/10.1200/jco.2013.53.9593 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/25267740 PubMed] NCT00078949 | # '''NCIC-CTG LY.12:''' Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. [https://doi.org/10.1200/jco.2013.53.9593 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/25267740 PubMed] NCT00078949 | ||
## '''Subgroup Analysis:''' Kuruvilla J, MacDonald DA, Kouroukis CT, Cheung M, Olney HJ, Turner AR, Anglin P, Seftel M, Ismail WS, Luminari S, Couban S, Baetz T, Meyer RM, Hay AE, Shepherd L, Djurfeldt MS, Alamoudi S, Chen BE, Crump M. Salvage chemotherapy and autologous stem cell transplantation for transformed indolent lymphoma: a subset analysis of NCIC-CTG LY12. Blood. 2015 Aug 6;126(6):733-8. Epub 2015 Jun 24. [http://www.bloodjournal.org/content/126/6/733.long link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/26109202 PubMed] | ## '''Subgroup Analysis:''' Kuruvilla J, MacDonald DA, Kouroukis CT, Cheung M, Olney HJ, Turner AR, Anglin P, Seftel M, Ismail WS, Luminari S, Couban S, Baetz T, Meyer RM, Hay AE, Shepherd L, Djurfeldt MS, Alamoudi S, Chen BE, Crump M. Salvage chemotherapy and autologous stem cell transplantation for transformed indolent lymphoma: a subset analysis of NCIC-CTG LY12. Blood. 2015 Aug 6;126(6):733-8. Epub 2015 Jun 24. [http://www.bloodjournal.org/content/126/6/733.long link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/26109202 PubMed] | ||
− | |||
==Selinexor monotherapy {{#subobject:d68g71|Regimen=1}}== | ==Selinexor monotherapy {{#subobject:d68g71|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:y42c19|Variant=1}}=== | ===Regimen {{#subobject:y42c19|Variant=1}}=== | ||
{| class="wikitable" style="color:white; background-color:#404040" | {| class="wikitable" style="color:white; background-color:#404040" | ||
Line 397: | Line 372: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
*[[Selinexor (Xpovio)]] 60 mg PO once per day on days 1 & 3 | *[[Selinexor (Xpovio)]] 60 mg PO once per day on days 1 & 3 | ||
− | |||
'''7-day cycles''' | '''7-day cycles''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
#'''SADAL:''' Kalakonda N, Maerevoet M, Cavallo F, Follows G, Goy A, Vermaat JSP, Casasnovas O, Hamad N, Zijlstra JM, Bakhshi S, Bouabdallah R, Choquet S, Gurion R, Hill B, Jaeger U, Sancho JM, Schuster M, Thieblemont C, De la Cruz F, Egyed M, Mishra S, Offner F, Vassilakopoulos TP, Warzocha K, McCarthy D, Ma X, Corona K, Saint-Martin JR, Chang H, Landesman Y, Joshi A, Wang H, Shah J, Shacham S, Kauffman M, Van Den Neste E, Canales MA. Selinexor in patients with relapsed or refractory diffuse large B-cell lymphoma (SADAL): a single-arm, multinational, multicentre, open-label, phase 2 trial. Lancet Haematol. 2020 Jul;7(7):e511-e522. [https://doi.org/10.1016/s2352-3026(20)30120-4 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/32589977/ PubMed] NCT02227251 | #'''SADAL:''' Kalakonda N, Maerevoet M, Cavallo F, Follows G, Goy A, Vermaat JSP, Casasnovas O, Hamad N, Zijlstra JM, Bakhshi S, Bouabdallah R, Choquet S, Gurion R, Hill B, Jaeger U, Sancho JM, Schuster M, Thieblemont C, De la Cruz F, Egyed M, Mishra S, Offner F, Vassilakopoulos TP, Warzocha K, McCarthy D, Ma X, Corona K, Saint-Martin JR, Chang H, Landesman Y, Joshi A, Wang H, Shah J, Shacham S, Kauffman M, Van Den Neste E, Canales MA. Selinexor in patients with relapsed or refractory diffuse large B-cell lymphoma (SADAL): a single-arm, multinational, multicentre, open-label, phase 2 trial. Lancet Haematol. 2020 Jul;7(7):e511-e522. [https://doi.org/10.1016/s2352-3026(20)30120-4 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/32589977/ PubMed] NCT02227251 | ||
− | |||
==Tisagenlecleucel monotherapy {{#subobject:d68f14|Regimen=1}}== | ==Tisagenlecleucel monotherapy {{#subobject:d68f14|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:60fc19|Variant=1}}=== | ===Regimen {{#subobject:60fc19|Variant=1}}=== | ||
{| class="wikitable" style="color:white; background-color:#404040" | {| class="wikitable" style="color:white; background-color:#404040" | ||
Line 422: | Line 397: | ||
|} | |} | ||
''The range given is the FDA-recommended dose.'' | ''The range given is the FDA-recommended dose.'' | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
*Lymphodepleting therapy with [[Autologous_HSCT#FC|FC]] or [[Autologous_HSCT#Bendamustine_monotherapy|Bendamustine]] | *Lymphodepleting therapy with [[Autologous_HSCT#FC|FC]] or [[Autologous_HSCT#Bendamustine_monotherapy|Bendamustine]] | ||
− | + | </div> | |
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Immunotherapy==== | ====Immunotherapy==== | ||
*[[Tisagenlecleucel (Kymriah)]] 0.6 to 6 x 10<sup>8</sup> CTL019 transduced viable T-cells IV once on day 0 | *[[Tisagenlecleucel (Kymriah)]] 0.6 to 6 x 10<sup>8</sup> CTL019 transduced viable T-cells IV once on day 0 | ||
− | |||
'''One course''' | '''One course''' | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
<!-- # '''Abstract:''' Schuster SJ, Bishop MR, Tam C, et al. Global Pivotal Phase 2 Trial of the CD19-Targeted Therapy CTL019 in Adult Patients with Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)—an Interim Analysis. Hematological Oncology. 2017;35(S2):27. [https://doi.org/full/10.1002/hon.2437_6 link to abstract] --> | <!-- # '''Abstract:''' Schuster SJ, Bishop MR, Tam C, et al. Global Pivotal Phase 2 Trial of the CD19-Targeted Therapy CTL019 in Adult Patients with Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)—an Interim Analysis. Hematological Oncology. 2017;35(S2):27. [https://doi.org/full/10.1002/hon.2437_6 link to abstract] --> | ||
# '''JULIET:''' Schuster SJ, Bishop MR, Tam CS, Waller EK, Borchmann P, McGuirk JP, Jäger U, Jaglowski S, Andreadis C, Westin JR, Fleury I, Bachanova V, Foley SR, Ho PJ, Mielke S, Magenau JM, Holte H, Pantano S, Pacaud LB, Awasthi R, Chu J, Anak Ö, Salles G, Maziarz RT; JULIET Investigators. Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma. N Engl J Med. 2019 Jan 3;380(1):45-56. Epub 2018 Dec 1. [https://doi.org/10.1056/NEJMoa1804980 link to original article] [https://pubmed.ncbi.nlm.nih.gov/30501490 PubMed] NCT02445248 | # '''JULIET:''' Schuster SJ, Bishop MR, Tam CS, Waller EK, Borchmann P, McGuirk JP, Jäger U, Jaglowski S, Andreadis C, Westin JR, Fleury I, Bachanova V, Foley SR, Ho PJ, Mielke S, Magenau JM, Holte H, Pantano S, Pacaud LB, Awasthi R, Chu J, Anak Ö, Salles G, Maziarz RT; JULIET Investigators. Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma. N Engl J Med. 2019 Jan 3;380(1):45-56. Epub 2018 Dec 1. [https://doi.org/10.1056/NEJMoa1804980 link to original article] [https://pubmed.ncbi.nlm.nih.gov/30501490 PubMed] NCT02445248 | ||
##'''Update:''' Schuster SJ, Tam CS, Borchmann P, Worel N, McGuirk JP, Holte H, Waller EK, Jaglowski S, Bishop MR, Damon LE, Foley SR, Westin JR, Fleury I, Ho PJ, Mielke S, Teshima T, Janakiram M, Hsu JM, Izutsu K, Kersten MJ, Ghosh M, Wagner-Johnston N, Kato K, Corradini P, Martinez-Prieto M, Han X, Tiwari R, Salles G, Maziarz RT. Long-term clinical outcomes of tisagenlecleucel in patients with relapsed or refractory aggressive B-cell lymphomas (JULIET): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2021 Oct;22(10):1403-1415. Epub 2021 Sep 10. [https://doi.org/10.1016/s1470-2045(21)00375-2 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34516954/ PubMed] | ##'''Update:''' Schuster SJ, Tam CS, Borchmann P, Worel N, McGuirk JP, Holte H, Waller EK, Jaglowski S, Bishop MR, Damon LE, Foley SR, Westin JR, Fleury I, Ho PJ, Mielke S, Teshima T, Janakiram M, Hsu JM, Izutsu K, Kersten MJ, Ghosh M, Wagner-Johnston N, Kato K, Corradini P, Martinez-Prieto M, Han X, Tiwari R, Salles G, Maziarz RT. Long-term clinical outcomes of tisagenlecleucel in patients with relapsed or refractory aggressive B-cell lymphomas (JULIET): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2021 Oct;22(10):1403-1415. Epub 2021 Sep 10. [https://doi.org/10.1016/s1470-2045(21)00375-2 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34516954/ PubMed] | ||
− | |||
=Consolidation after salvage therapy= | =Consolidation after salvage therapy= | ||
==BFR, then allo HSCT {{#subobject:c2659b|Regimen=1}}== | ==BFR, then allo HSCT {{#subobject:c2659b|Regimen=1}}== | ||
− | |||
BFR: '''<u>B</u>'''endamustine, '''<u>F</u>'''ludarabine, '''<u>R</u>'''ituximab | BFR: '''<u>B</u>'''endamustine, '''<u>F</u>'''ludarabine, '''<u>R</u>'''ituximab | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:41fd04|Variant=1}}=== | ===Regimen {{#subobject:41fd04|Variant=1}}=== | ||
{| class="wikitable" style="width: 40%; text-align:center;" | {| class="wikitable" style="width: 40%; text-align:center;" | ||
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|} | |} | ||
{{#lst:Allogeneic HSCT|41fd04}} | {{#lst:Allogeneic HSCT|41fd04}} | ||
− | + | </div></div> | |
− | |||
− | |||
===References=== | ===References=== | ||
# '''MDACC 2008-0246:''' Khouri IF, Wei W, Korbling M, Turturro F, Ahmed S, Alousi A, Anderlini P, Ciurea S, Jabbour E, Oran B, Popat UR, Rondon G, Bassett RL Jr, Gulbis A. BFR (bendamustine, fludarabine, and rituximab) allogeneic conditioning for chronic lymphocytic leukemia/lymphoma: reduced myelosuppression and GVHD. Blood. 2014 Oct 2;124(14):2306-12. Epub 2014 Aug 21. [http://www.bloodjournal.org/content/124/14/2306.long link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4260365/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/25145344 PubMed] NCT00880815 | # '''MDACC 2008-0246:''' Khouri IF, Wei W, Korbling M, Turturro F, Ahmed S, Alousi A, Anderlini P, Ciurea S, Jabbour E, Oran B, Popat UR, Rondon G, Bassett RL Jr, Gulbis A. BFR (bendamustine, fludarabine, and rituximab) allogeneic conditioning for chronic lymphocytic leukemia/lymphoma: reduced myelosuppression and GVHD. Blood. 2014 Oct 2;124(14):2306-12. Epub 2014 Aug 21. [http://www.bloodjournal.org/content/124/14/2306.long link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4260365/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/25145344 PubMed] NCT00880815 | ||
− | |||
[[Category:Transformed lymphoma regimens]] | [[Category:Transformed lymphoma regimens]] | ||
[[Category:Disease-specific pages]] | [[Category:Disease-specific pages]] | ||
[[Category:Aggressive lymphomas]] | [[Category:Aggressive lymphomas]] | ||
[[Category:Non-Hodgkin lymphomas]] | [[Category:Non-Hodgkin lymphomas]] |
Revision as of 12:11, 29 October 2022
18 regimens on this page
18 variants on this page
|
Transformed lymphoma, often referred to as Richter's transformation, most commonly arises from a preceding indolent lymphoma - usually follicular lymphoma or chronic lymphocytic leukemia. It is typically treated as per the histologic subtype, which is usually DLBCL. However, some regimens specific to transformed lymphoma have been developed and are included here.
All lines of therapy
Axicabtagene ciloleucel monotherapy
Regimen
FDA-recommended dose |
Study | Years of enrollment | Evidence | Efficacy |
---|---|---|---|
Locke et al. 2017 (ZUMA-1) | 2015-2016 | Phase 1/2, <20 pts in subgroup (RT) | ORR: 82% |
Preceding treatment
- Lymphodepletion with FC
Immunotherapy
- Axicabtagene ciloleucel (Yescarta) target dose of 2 × 106 CAR T cells/kg IV once on day 0
Supportive therapy
- Acetaminophen (Tylenol) 650 mg PO once on day 0, approximately 60 minutes prior to Axicabtagene ciloleucel (Yescarta)
- Diphenhydramine (Benadryl) 12.5 mg IV or PO once on day 0, approximately 60 minutes prior to Axicabtagene ciloleucel (Yescarta)
One course; patients with initial response and disease progression at least 3 months later could be retreated
References
- ZUMA-1: Locke FL, Neelapu SS, Bartlett NL, Siddiqi T, Chavez JC, Hosing CM, Ghobadi A, Budde LE, Bot A, Rossi JM, Jiang Y, Xue AX, Elias M, Aycock J, Wiezorek J, Go WY. Phase 1 results of ZUMA-1: A multicenter study of KTE-C19 anti-CD19 CAR T cell therapy in refractory aggressive lymphoma. Mol Ther. 2017 Jan 4;25(1):285-295. Epub 2017 Jan 4. link to original article link to PMC article PubMed NCT02348216
- Update: Neelapu SS, Locke FL, Bartlett NL, Lekakis LJ, Miklos DB, Jacobson CA, Braunschweig I, Oluwole OO, Siddiqi T, Lin Y, Timmerman JM, Stiff PJ, Friedberg JW, Flinn IW, Goy A, Hill BT, Smith MR, Deol A, Farooq U, McSweeney P, Munoz J, Avivi I, Castro JE, Westin JR, Chavez JC, Ghobadi A, Komanduri KV, Levy R, Jacobsen ED, Witzig TE, Reagan P, Bot A, Rossi J, Navale L, Jiang Y, Aycock J, Elias M, Chang D, Wiezorek J, Go WY. Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med. 2017 Dec 28;377(26):2531-2544. Epub 2017 Dec 10. link to original article contains dosing details in manuscript link to PMC article PubMed
- Update: Locke FL, Ghobadi A, Jacobson CA, Miklos DB, Lekakis LJ, Oluwole OO, Lin Y, Braunschweig I, Hill BT, Timmerman JM, Deol A, Reagan PM, Stiff P, Flinn IW, Farooq U, Goy A, McSweeney PA, Munoz J, Siddiqi T, Chavez JC, Herrera AF, Bartlett NL, Wiezorek JS, Navale L, Xue A, Jiang Y, Bot A, Rossi JM, Kim JJ, Go WY, Neelapu SS. Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1-2 trial. Lancet Oncol. 2019 Jan;20(1):31-42. Epub 2018 Dec 2. link to original article link to PMC article contains dosing details in manuscript PubMed
Bendamustine monotherapy
Regimen
Study | Evidence |
---|---|
Friedberg et al. 2008 | Phase 2, <20 pts in this subgroup |
References
- Friedberg JW, Cohen P, Chen L, Robinson KS, Forero-Torres A, La Casce AS, Fayad LE, Bessudo A, Camacho ES, Williams ME, van der Jagt RH, Oliver JW, Cheson BD. Bendamustine in patients with rituximab-refractory indolent and transformed non-Hodgkin's lymphoma: results from a phase II multicenter, single-agent study. J Clin Oncol. 2008 Jan 10;26(2):204-10. Erratum in: J Clin Oncol. 2008 Apr 10;26(11) 1911. link to original article contains dosing details in manuscript PubMed
131Iodine-Tositumomab monotherapy
Regimen
Study | Evidence |
---|---|
Vose et al. 2000 | Phase 2 |
Note: This was also evaluated in low-grade NHL but subtype was not specified. Now obsolete as this drug has been discontinued.
Radioconjugate therapy, dosimetric step
- On Day 0, infusions of:
- Tositumomab 450 mg IV over 1 hour
- Tositumomab 35 mg labeled with 5 mCi of Iodine-131 IV over 20 minutes
- First scan of whole body dosimetry & redistribution
- Day 2, 3, or 4: Second scan of whole body dosimetry & redistribution
- Day 6 or 7: Third scan of whole body dosimetry & redistribution
Radioconjugate therapy, therapeutic step
- Any day from day 7-14, infusions of:
- Tositumomab 450 mg IV over 1 hour
- Tositumomab 35 mg labeled with an individually calculated dose of Iodine-131 that will provide 75 cGy of radiation to the total body IV over 20 minutes
- 65 cGy total body dose used for patients with platelet counts of 100-150,000/mm3
Calculated dose of I-131 is based on information from serial total-body gamma-camera counts
References
- Vose JM, Wahl RL, Saleh M, Rohatiner AZ, Knox SJ, Radford JA, Zelenetz AD, Tidmarsh GF, Stagg RJ, Kaminski MS. Multicenter phase II study of iodine-131 tositumomab for chemotherapy-relapsed/refractory low-grade and transformed low-grade B-cell non-Hodgkin's lymphomas. J Clin Oncol. 2000 Mar;18(6):1316-23. link to original article contains dosing details in manuscript PubMed
Lenalidomide monotherapy
Regimen
Study | Evidence |
---|---|
Witzig et al. 2011 (NHL-003) | Phase 2 |
References
- NHL-003: 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 dosing details in manuscript PubMed NCT00413036
Lenalidomide & Rituximab (R2)
Regimen
Study | Evidence |
---|---|
Wang et al. 2013 (MDACC 2005-0461) | Phase 2, <20 pts in this subgroup |
Targeted therapy
- Lenalidomide (Revlimid) 20 mg PO once per day on days 1 to 21
- Rituximab (Rituxan) as follows:
- Cycle 1: 375 mg/m2 IV once per day on days 1, 8, 15, 22
28-day cycles
References
- MDACC 2005-0461: Wang M, Fowler N, Wagner-Bartak N, Feng L, Romaguera J, Neelapu SS, Hagemeister F, Fanale M, Oki Y, Pro B, Shah J, Thomas S, Younes A, Hosing C, Zhang L, Newberry KJ, Desai M, Cheng N, Badillo M, Bejarano M, Chen Y, Young KH, Champlin R, Kwak L, Fayad L. Oral lenalidomide with rituximab in relapsed or refractory diffuse large cell, follicular and transformed lymphoma: a phase II clinical trial. Leukemia. 2013 Sep;27(9):1902-9. Epub 2013 Apr 2. link to original article contains dosing details in manuscript PubMed NCT00294632
Lenalidomide & Tafasitamab
Regimen
Study | Years of enrollment | Evidence |
---|---|---|
Salles et al. 2020 (L-MIND) | 2016-2017 | Phase 2 (RT) |
Targeted therapy
- Lenalidomide (Revlimid) as follows:
- Cycles 1 to 12: 25 mg PO once per day on days 1 to 21
- Tafasitamab (Monjuvi) as follows:
- Cycle 1: 12 mg/kg IV over 2 hours once per day on days 1, 4, 8, 15, 22
- Cycles 2 & 3: 12 mg/kg IV over 2 hours once per day on days 1, 8, 15, 22
- Cycle 4 onwards: 12 mg/kg IV over 2 hours once per day on days 1 & 15
28-day cycles
References
- L-MIND: Salles G, Duell J, González Barca E, Tournilhac O, Jurczak W, Liberati AM, Nagy Z, Obr A, Gaidano G, André M, Kalakonda N, Dreyling M, Weirather J, Dirnberger-Hertweck M, Ambarkhane S, Fingerle-Rowson G, Maddocks K. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. Lancet Oncol. 2020 Jul;21(7):978-988. Epub 2020 Jun 5. link to original article contains dosing details in manuscript PubMed NCT02399085
Lisocabtagene maraleucel monotherapy
Regimen
Study | Years of enrollment | Evidence |
---|---|---|
Abramson et al. 2020 (TRANSCEND NHL-001) | 2016-2019 | Phase 1 (RT) |
Immunotherapy
References
- TRANSCEND NHL-001: Abramson JS, Palomba ML, Gordon LI, Lunning MA, Wang M, Arnason J, Mehta A, Purev E, Maloney DG, Andreadis C, Sehgal A, Solomon SR, Ghosh N, Albertson TM, Garcia J, Kostic A, Mallaney M, Ogasawara K, Newhall K, Kim Y, Li D, Siddiqi T. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study. Lancet. 2020 Sep 19;396(10254):839-852. Epub 2020 Sep 1. link to original article PubMed NCT02631044
Loncastuximab tesirine monotherapy
Regimen
FDA-recommended dose |
Study | Years of enrollment | Evidence |
---|---|---|
Caimi et al. 2021 (LOTIS-2) | 2018-2019 | Phase 2 (RT) |
Antibody-drug conjugate therapy
- Loncastuximab tesirine (Zynlonta) as follows:
- Cycles 1 & 2: 0.15 mg/kg IV over 30 minutes once on day 1
- Cycle 3 onwards: 0.075 mg/kg IV over 30 minutes once on day 1
Supportive therapy
- Dexamethasone (Decadron) 4 mg IV or PO twice per day on days -1 to 2 (3 days total)
21-day cycles for up to 18 cycles (1 year)
References
- LOTIS-2: Caimi PF, Ai W, Alderuccio JP, Ardeshna KM, Hamadani M, Hess B, Kahl BS, Radford J, Solh M, Stathis A, Zinzani PL, Havenith K, Feingold J, He S, Qin Y, Ungar D, Zhang X, Carlo-Stella C. Loncastuximab tesirine in relapsed or refractory diffuse large B-cell lymphoma (LOTIS-2): a multicentre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):790-800. Epub 2021 May 11. link to original article contains dosing details in abstract PubMed NCT03589469
OFAR
OFAR: Oxaliplatin, Fludarabine, Ara-C (Cytarabine), Rituximab
Regimen
Study | Years of enrollment | Evidence | Efficacy |
---|---|---|---|
Tsimberidou et al. 2008 | 2004-2006 | Phase 2 | Likely has true ORR > 20% |
Note: the manuscript does not specify what sequence the rituximab is given in.
Chemotherapy
- Oxaliplatin (Eloxatin) 25 mg/m2 IV over 2 hours once per day on days 1 to 4, given first (see note)
- Fludarabine (Fludara) 30 mg/m2 IV once per day on days 2 & 3, given second, within 30 minutes of completion of oxaliplatin (see note)
- Cytarabine (Ara-C) 1000 mg/m2 IV over 2 hours once per day on days 2 & 3, given third, 4 hours after start of fludarabine (see note)
Targeted therapy
- Rituximab (Rituxan) as follows (see note):
- Cycle 1: 375 mg/m2 IV over 4 to 6 hours once on day 3
- Cycles 2 to 6: 375 mg/m2 IV over 4 to 6 hours once on day 1
Supportive therapy
- Pegfilgrastim (Neulasta) 6 mg SC once on day 6
- Herpes zoster and PCP (Pneumocystis jiroveci pneumonia) prophylaxis used
28-day cycle for up to 6 cycles
References
- Tsimberidou AM, Wierda WG, Plunkett W, Kurzrock R, O'Brien S, Wen S, Ferrajoli A, Ravandi-Kashani F, Garcia-Manero G, Estrov Z, Kipps TJ, Brown JR, Fiorentino A, Lerner S, Kantarjian HM, Keating MJ. Phase I-II study of oxaliplatin, fludarabine, cytarabine, and rituximab combination therapy in patients with Richter's syndrome or fludarabine-refractory chronic lymphocytic leukemia. J Clin Oncol. 2008 Jan 10;26(2):196-203. link to original article contains dosing details in abstract PubMed
Pembrolizumab monotherapy
Regimen
Study | Evidence | Efficacy |
---|---|---|
Ding et al. 2017 (MC1485) | Phase 2, <20 pts in this subgroup | Unlikely to have true ORR > 20% |
Immunotherapy
- Pembrolizumab (Keytruda) 200 mg IV once on day 1
21-day cycle for up to 35 cycles (2 years)
References
- MC1485: Ding W, LaPlant BR, Call TG, Parikh SA, Leis JF, He R, Shanafelt TD, Sinha S, Le-Rademacher J, Feldman AL, Habermann TM, Witzig TE, Wiseman GA, Lin Y, Asmus E, Nowakowski GS, Conte MJ, Bowen DA, Aitken CN, Van Dyke DL, Greipp PT, Liu X, Wu X, Zhang H, Secreto CR, Tian S, Braggio E, Wellik LE, Micallef I, Viswanatha DS, Yan H, Chanan-Khan AA, Kay NE, Dong H, Ansell SM. Pembrolizumab in patients with CLL and Richter transformation or with relapsed CLL. Blood. 2017 Jun 29;129(26):3419-3427. Epub 2017 Apr 19. link to original article contains dosing details in manuscript link to PMC article PubMed
R-DHAP
R-DHAP: Rituximab, Dexamethasone, High-dose Ara-C (Cytarabine), Platinol (Cisplatin)
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Crump et al. 2014 (NCIC-CTG LY.12) | 2003-2011 | Phase 3 (C) | R-GDP | Not reported |
Targeted therapy
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
Glucocorticoid therapy
- Dexamethasone (Decadron) 40 mg PO once per day on days 1 to 4
Chemotherapy
- Cytarabine (Ara-C) 2000 mg/m2 IV over 3 hours every 12 hours on day 2 (total dose per cycle: 4000 mg/m2)
- Cisplatin (Platinol) 100 mg/m2 IV continuous infusion over 24 hours, started on day 1
21-day cycle for up to 3 cycles
References
- NCIC-CTG LY.12: Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. link to original article contains dosing details in manuscript PubMed NCT00078949
- Subgroup Analysis: Kuruvilla J, MacDonald DA, Kouroukis CT, Cheung M, Olney HJ, Turner AR, Anglin P, Seftel M, Ismail WS, Luminari S, Couban S, Baetz T, Meyer RM, Hay AE, Shepherd L, Djurfeldt MS, Alamoudi S, Chen BE, Crump M. Salvage chemotherapy and autologous stem cell transplantation for transformed indolent lymphoma: a subset analysis of NCIC-CTG LY12. Blood. 2015 Aug 6;126(6):733-8. Epub 2015 Jun 24. link to original article contains dosing details in manuscript PubMed
R-EPOCH
R-EPOCH: Rituximab, Etoposide, Prednisone, Oncovin (Vincristine), Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin)
Regimen
Study | Evidence |
---|---|
Jermann et al. 2004 | Phase 2, <20 pts in this subgroup |
Note: this is not the dose-adjusted R-EPOCH regimen
Targeted therapy
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
Chemotherapy
- Etoposide (Vepesid) 65 mg/m2/day IV continuous infusion over 72 hours, started on day 2 (total dose per cycle: 195 mg/m2)
- Vincristine (Oncovin) 0.5 mg/m2/day IV continuous infusion over 72 hours, started on day 2 (total dose per cycle: 1.5 mg/m2)
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 5
- Doxorubicin (Adriamycin) 15 mg/m2/day IV continuous infusion over 72 hours, started on day 2 (total dose per cycle: 45 mg/m2)
Glucocorticoid therapy
- Prednisone (Sterapred) 60 mg/m2/day PO on days 1 to 14
21-day cycle for 4 to 6 cycles
References
- Jermann M, Jost LM, Taverna Ch, Jacky E, Honegger HP, Betticher DC, Egli F, Kroner T, Stahel RA. Rituximab-EPOCH, an effective salvage therapy for relapsed, refractory or transformed B-cell lymphomas: results of a phase II study. Ann Oncol. 2004 Mar;15(3):511-6. link to original article contains dosing details in manuscript PubMed
R-GDP
R-GDP: Rituximab, Gemcitabine, Dexamethasone, Platinol (Cisplatin)
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Crump et al. 2014 (NCIC-CTG LY.12) | 2003-2011 | Phase 3 (E-switch-ic) | R-DHAP | Not reported |
Targeted therapy
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
Chemotherapy
- Gemcitabine (Gemzar) 1000 mg/m2 IV once per day on days 1 & 8
- Cisplatin (Platinol) 75 mg/m2 IV once on day 1
Glucocorticoid therapy
- Dexamethasone (Decadron) 40 mg PO once per day on days 1 to 4
21-day cycle for up to 3 cycles
Subsequent treatment
- Responders: autologous HSCT
References
- NCIC-CTG LY.12: Crump M, Kuruvilla J, Couban S, MacDonald DA, Kukreti V, Kouroukis CT, Rubinger M, Buckstein R, Imrie KR, Federico M, Di Renzo N, Howson-Jan K, Baetz T, Kaizer L, Voralia M, Olney HJ, Turner AR, Sussman J, Hay AE, Djurfeldt MS, Meyer RM, Chen BE, Shepherd LE. Randomized comparison of gemcitabine, dexamethasone, and cisplatin versus dexamethasone, cytarabine, and cisplatin chemotherapy before autologous stem-cell transplantation for relapsed and refractory aggressive lymphomas: NCIC-CTG LY.12. J Clin Oncol. 2014 Nov 1;32(31):3490-6. Epub 2014 Sep 29. link to original article contains dosing details in manuscript PubMed NCT00078949
- Subgroup Analysis: Kuruvilla J, MacDonald DA, Kouroukis CT, Cheung M, Olney HJ, Turner AR, Anglin P, Seftel M, Ismail WS, Luminari S, Couban S, Baetz T, Meyer RM, Hay AE, Shepherd L, Djurfeldt MS, Alamoudi S, Chen BE, Crump M. Salvage chemotherapy and autologous stem cell transplantation for transformed indolent lymphoma: a subset analysis of NCIC-CTG LY12. Blood. 2015 Aug 6;126(6):733-8. Epub 2015 Jun 24. link to original article contains dosing details in manuscript PubMed
Selinexor monotherapy
Regimen
FDA-recommended dose |
Study | Years of enrollment | Evidence |
---|---|---|
Kalakonda et al. 2020 (SADAL) | 2015-2019 | Phase 2b (RT) |
References
- SADAL: Kalakonda N, Maerevoet M, Cavallo F, Follows G, Goy A, Vermaat JSP, Casasnovas O, Hamad N, Zijlstra JM, Bakhshi S, Bouabdallah R, Choquet S, Gurion R, Hill B, Jaeger U, Sancho JM, Schuster M, Thieblemont C, De la Cruz F, Egyed M, Mishra S, Offner F, Vassilakopoulos TP, Warzocha K, McCarthy D, Ma X, Corona K, Saint-Martin JR, Chang H, Landesman Y, Joshi A, Wang H, Shah J, Shacham S, Kauffman M, Van Den Neste E, Canales MA. Selinexor in patients with relapsed or refractory diffuse large B-cell lymphoma (SADAL): a single-arm, multinational, multicentre, open-label, phase 2 trial. Lancet Haematol. 2020 Jul;7(7):e511-e522. link to original article contains dosing details in abstract PubMed NCT02227251
Tisagenlecleucel monotherapy
Regimen
FDA-recommended dose |
Study | Evidence | Efficacy |
---|---|---|
Schuster et al. 2018 (JULIET) | Phase 2 | ORR: 59% (95% CI, 44-72) |
The range given is the FDA-recommended dose.
Preceding treatment
- Lymphodepleting therapy with FC or Bendamustine
Immunotherapy
- Tisagenlecleucel (Kymriah) 0.6 to 6 x 108 CTL019 transduced viable T-cells IV once on day 0
One course
References
- JULIET: Schuster SJ, Bishop MR, Tam CS, Waller EK, Borchmann P, McGuirk JP, Jäger U, Jaglowski S, Andreadis C, Westin JR, Fleury I, Bachanova V, Foley SR, Ho PJ, Mielke S, Magenau JM, Holte H, Pantano S, Pacaud LB, Awasthi R, Chu J, Anak Ö, Salles G, Maziarz RT; JULIET Investigators. Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma. N Engl J Med. 2019 Jan 3;380(1):45-56. Epub 2018 Dec 1. link to original article PubMed NCT02445248
- Update: Schuster SJ, Tam CS, Borchmann P, Worel N, McGuirk JP, Holte H, Waller EK, Jaglowski S, Bishop MR, Damon LE, Foley SR, Westin JR, Fleury I, Ho PJ, Mielke S, Teshima T, Janakiram M, Hsu JM, Izutsu K, Kersten MJ, Ghosh M, Wagner-Johnston N, Kato K, Corradini P, Martinez-Prieto M, Han X, Tiwari R, Salles G, Maziarz RT. Long-term clinical outcomes of tisagenlecleucel in patients with relapsed or refractory aggressive B-cell lymphomas (JULIET): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2021 Oct;22(10):1403-1415. Epub 2021 Sep 10. link to original article PubMed
Consolidation after salvage therapy
BFR, then allo HSCT
BFR: Bendamustine, Fludarabine, Rituximab
Regimen
Study | Evidence |
---|---|
Khouri et al. 2014 (MDACC 2008-0246) | Phase 2, <20 pts in this subgroup |
Chemotherapy
- Bendamustine 130 mg/m2 IV once per day on days -5 to -3
- Fludarabine (Fludara) 30 mg/m2 IV over 30 minutes once per day on days -5 to -3
Targeted therapy
- Rituximab (Rituxan) 375 mg/m2 IV once per day on days -13, -6, +1, +8
Immunotherapy
- Allogeneic stem cells transfused on day 0
GVHD prophylaxis
- See article for GVHD prophylaxis information
One course
References
- MDACC 2008-0246: Khouri IF, Wei W, Korbling M, Turturro F, Ahmed S, Alousi A, Anderlini P, Ciurea S, Jabbour E, Oran B, Popat UR, Rondon G, Bassett RL Jr, Gulbis A. BFR (bendamustine, fludarabine, and rituximab) allogeneic conditioning for chronic lymphocytic leukemia/lymphoma: reduced myelosuppression and GVHD. Blood. 2014 Oct 2;124(14):2306-12. Epub 2014 Aug 21. link to original article contains dosing details in manuscript link to PMC article PubMed NCT00880815