Difference between revisions of "Peripheral T-cell lymphoma"
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− | + | <span id="BackToTop"></span> | |
− | + | <div class="noprint" style="background-color:LightGray; position:fixed; bottom:2%; right:0.25%; padding-left:5px; padding-right:5px; margin: 15px; opacity:0.8; border-style: solid; border-color:DarkGray; border-width: 1px"> | |
− | + | [[#top|Back to Top]] | |
− | + | </div> | |
+ | {{#lst:Editorial board transclusions|tcl}} | ||
{| class="wikitable" style="float:right; margin-right: 5px;" | {| class="wikitable" style="float:right; margin-right: 5px;" | ||
|- | |- | ||
− | |<div style="background-color: # | + | |<div style="background-color: #fee0d1; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Regimen |limit=10000|format=sum}} [[Tutorial#Regimens|regimens]] on this page</b></font></div> |
− | <div style="background-color: # | + | <div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] on this page</b></font></div> |
|} | |} | ||
+ | ''Are you looking for a regimen but can't find it here? It is possible that we've moved it to the [[Peripheral_T-cell_lymphoma_-_historical|historical regimens page]]. If you still can't find it, please let us know so we can add it!''.<br> | ||
+ | Note: some subtypes of PTCL have been moved to dedicated pages: | ||
+ | *[[Anaplastic large cell lymphoma]] | ||
+ | *[[Extranodal NK- and T-cell lymphoma, nasal type]] | ||
+ | *[[NK- and T-cell lymphoma]] | ||
+ | |||
{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
+ | =Guidelines= | ||
+ | '''Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.''' | ||
+ | ==[https://www.esmo.org/ ESMO]== | ||
+ | *'''2015:''' d'Amore et al. [https://www.esmo.org/Guidelines/Haematological-Malignancies/Peripheral-T-Cell-Lymphomas Peripheral T-cell lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up] [https://pubmed.ncbi.nlm.nih.gov/26314772 PubMed] | ||
− | + | *'''2013:''' Dreyling et al. [https://doi.org/10.1093/annonc/mds643 ESMO Consensus conferences: guidelines on malignant lymphoma. part 2: marginal zone lymphoma, mantle cell lymphoma, peripheral T-cell lymphoma.] [https://pubmed.ncbi.nlm.nih.gov/23425945/ PubMed] | |
− | |||
− | |||
− | |||
− | == | + | ==NCCN== |
− | *[https://www.nccn.org/ | + | *''NCCN does not currently have guidelines at this granular level; please see [https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1483 NCCN Guidelines - T-cell Lymphomas].'' |
=Untreated, randomized data= | =Untreated, randomized data= | ||
− | + | ==BV-CHP {{#subobject:6964de|Regimen=1}}== | |
+ | BV-CHP: '''<u>B</u>'''rentuximab '''<u>V</u>'''edotin, '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>P</u>'''rednisone | ||
+ | <br>A+CHP: '''<u>A</u>'''dcetris (Brentuximab vedotin), '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>P</u>'''rednisone | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen {{#subobject:985a91|Variant=1}}=== | ||
+ | {| class="wikitable" style="color:white; background-color:#404040" | ||
+ | |<small>'''FDA-recommended dose'''</small> | ||
+ | |- | ||
+ | |} | ||
+ | {| 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://www.ncbi.nlm.nih.gov/pmc/articles/PMC6436818/ Horwitz et al. 2018 (ECHELON-2)] | ||
+ | |2013-2016 | ||
+ | | style="background-color:#1a9851" |Phase 3 (E-RT-switch-ooc) | ||
+ | |[[#CHOP|CHOP]] | ||
+ | | style="background-color:#91cf60" |Superior PFS (primary endpoint)<br>Median PFS: 48.2 vs 20.8 mo<br>(HR 0.71, 95% CI 0.54-0.93)<br><br>Seems to have superior OS<sup>1</sup> (secondary endpoint)<br>OS60: 70.1% vs 61%<br>(HR 0.72, 95% CI 0.53-0.99) | ||
+ | |- | ||
+ | |} | ||
+ | ''<sup>1</sup>Reported efficacy is based on the 2021 update.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Antibody-drug conjugate therapy==== | ||
+ | *[[Brentuximab vedotin (Adcetris)]] 1.8 mg/kg IV once on day 1, '''given fourth''' | ||
+ | ====Chemotherapy==== | ||
+ | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | ||
+ | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | ||
+ | ====Glucocorticoid therapy==== | ||
+ | *[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5 | ||
+ | '''21-day cycle for 6 to 8 cycles''' | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | #'''ECHELON-2:''' Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trümper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019 Jan 19;393(10168):229-240. Epub 2018 Dec 4. Erratum in: Lancet. 2019 Jan 19;393(10168):228. [https://doi.org/10.1016/S0140-6736(18)32984-2 link to original article] '''dosing details in abstract have been reviewed by our editors''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6436818/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30522922/ PubMed] [https://clinicaltrials.gov/study/NCT01777152 NCT01777152] | ||
+ | ##'''Update:''' Horwitz S, O'Connor OA, Pro B, Trümper L, Iyer S, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Menne T, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Zinzani PL, Miao H, Bunn V, Fenton K, Fanale M, Puhlmann M, Illidge T. The ECHELON-2 Trial: 5-year results of a randomized, phase III study of brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma. Ann Oncol. 2022 Mar;33(3):288-298. Epub 2021 Dec 16. [https://doi.org/10.1016/j.annonc.2021.12.002 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9447792/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34921960/ PubMed] | ||
==CHOP {{#subobject:38ee4a|Regimen=1}}== | ==CHOP {{#subobject:38ee4a|Regimen=1}}== | ||
− | {| class="wikitable" style=" | + | CHOP: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''rednisone |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen variant #1, 6 cycles, 40 mg/m<sup>2</sup> {{#subobject:d9nzc8|Variant=1}}=== | ||
+ | {| 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://doi.org/10.1200/jco.21.01815 Bachy et al. 2021 (LYSA Ro-CHOP)] | ||
+ | |2013-2017 | ||
+ | | style="background-color:#1a9851" |Phase 3 (C) | ||
+ | |[[#Ro-CHOP_333|Ro-CHOP]] | ||
+ | | style="background-color:#fee08b" |Might have inferior PFS<sup>1</sup> (primary endpoint)<br>Median PFS: 10.2 vs 12 mo<br>(HR 1.27, 95% CI 0.995-1.61) | ||
|- | |- | ||
− | |||
|} | |} | ||
− | + | ''<sup>1</sup>Reported efficacy is based on the 2024 update.'' | |
− | + | <div class="toccolours" style="background-color:#b3e2cd"> | |
− | + | ====Chemotherapy==== | |
− | + | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | |
− | + | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | |
− | + | *[[Vincristine (Oncovin)]] by the following age-based criteria: | |
− | ===Regimen {{#subobject:f500e0|Variant=1}}=== | + | **70 years old or younger: 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 |
− | {| class="wikitable" style="width: 100%; text-align:center;" | + | **Older than 70 years old: 1.4 mg/m<sup>2</sup> (maximum dose of 1.5 mg) IV once on day 1 |
− | !Study | + | ====Glucocorticoid therapy==== |
− | |[[Levels_of_Evidence#Evidence| | + | *[[Prednisone (Sterapred)]] 40 mg/m<sup>2</sup> PO once per day on days 1 to 5 |
− | !Comparator | + | '''21-day cycle for 6 cycles''' |
− | ![[Levels_of_Evidence# | + | </div></div><br> |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen variant #2, 6 cycles, prednisone 60 mg/m<sup>2</sup> {{#subobject:d9adc8|Variant=1}}=== | ||
+ | {| 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://doi.org/10.1038/sj.thj.6200359 Reimer et al. 2004] | ||
+ | |2000-2006 | ||
+ | | style="background-color:#91cf61" |Non-randomized | ||
+ | | style="background-color:#d3d3d3" | | ||
+ | | style="background-color:#d3d3d3" | | ||
+ | |- | ||
+ | |[https://doi.org/10.1111/bjh.14763 Li et al. 2017 (hnslblzlzx2011-3)] | ||
+ | |2010-2016 | ||
+ | | style="background-color:#1a9851" |Phase 3 (C) | ||
+ | |[[#GDPT|GDPT]] | ||
+ | | style="background-color:#d73027" |Inferior OS | ||
+ | |- | ||
+ | |} | ||
+ | ''Note: the abstract of Reimer et al. 2004 does not have dosing details.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | ||
+ | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | ||
+ | *[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | ||
+ | ====Glucocorticoid therapy==== | ||
+ | *[[Prednisone (Sterapred)]] 60 mg/m<sup>2</sup> PO once per day on days 1 to 5 | ||
+ | '''21-day cycle for 6 cycles''' | ||
+ | </div></div><br> | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen variant #2, 8 cycles {{#subobject:f500e0|Variant=1}}=== | ||
+ | {| 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://doi.org/10.1111/j.1365-2141.2010.08329.x Simon et al. 2010 (GOELAMS LTP95)] |
− | |style="background-color:#1a9851"|Phase | + | |1996-2002 |
− | |VIP-rABVD | + | | style="background-color:#1a9851" |Phase 3 (C) |
− | |style="background-color:#ffffbf"| | + | |[[#VIP-rABVD_999|VIP-rABVD]] |
+ | | style="background-color:#ffffbf" |Did not meet primary endpoint of EFS24 | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | ||
− | *[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose | + | *[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 |
+ | ====Glucocorticoid therapy==== | ||
*[[Prednisone (Sterapred)]] 100 mg/m<sup>2</sup> PO once per day on days 1 to 5 | *[[Prednisone (Sterapred)]] 100 mg/m<sup>2</sup> PO once per day on days 1 to 5 | ||
− | |||
'''21-day cycle for 8 cycles''' | '''21-day cycle for 8 cycles''' | ||
− | + | </div> | |
− | ==== | + | <div class="toccolours" style="background-color:#cbd5e7"> |
− | + | ====Subsequent treatment==== | |
− | + | *GOELAMS LTP95, patients with initial bulky disease (diameter at least 5 cm): [[#Radiation_therapy|IFRT]] consolidation x 4000 cGy | |
− | + | </div></div> | |
===References=== | ===References=== | ||
− | # Simon A, Peoch M, Casassus P, Deconinck E, Colombat P, Desablens B, Tournilhac O, Eghbali H, Foussard C, Jaubert J, Vilque JP, Rossi JF, Lucas V, Delwail V, Thyss A, Maloisel F, Milpied N, le Gouill S, Lamy T, Gressin R. Upfront VIP-reinforced-ABVD (VIP-rABVD) is not superior to CHOP/21 in newly diagnosed peripheral T cell lymphoma | + | #Reimer P, Schertlin T, Rüdiger T, Geissinger E, Roth S, Kunzmann V, Weissinger F, Nerl C, Schmitz N, Müller-Hermelink HK, Wilhelm M. Myeloablative radiochemotherapy followed by autologous peripheral blood stem cell transplantation as first-line therapy in peripheral T-cell lymphomas: first results of a prospective multicenter study. Hematol J. 2004;5(4):304-11. [https://doi.org/10.1038/sj.thj.6200359 link to original article] '''does not contain dosing details''' [https://pubmed.ncbi.nlm.nih.gov/15297846/ PubMed] |
− | + | ##'''Update:''' Reimer P, Rüdiger T, Geissinger E, Weissinger F, Nerl C, Schmitz N, Engert A, Einsele H, Müller-Hermelink HK, Wilhelm M. Autologous stem-cell transplantation as first-line therapy in peripheral T-cell lymphomas: results of a prospective multicenter study. J Clin Oncol. 2009 Jan 1;27(1):106-13. Epub 2008 Nov 24. [https://doi.org/10.1200/jco.2008.17.4870 link to original article] [https://pubmed.ncbi.nlm.nih.gov/19029417/ PubMed] | |
− | + | #'''GOELAMS-LTP95:''' Simon A, Peoch M, Casassus P, Deconinck E, Colombat P, Desablens B, Tournilhac O, Eghbali H, Foussard C, Jaubert J, Vilque JP, Rossi JF, Lucas V, Delwail V, Thyss A, Maloisel F, Milpied N, le Gouill S, Lamy T, Gressin R. Upfront VIP-reinforced-ABVD (VIP-rABVD) is not superior to CHOP/21 in newly diagnosed peripheral T cell lymphoma: results of the randomized phase III trial GOELAMS-LTP95. Br J Haematol. 2010 Oct;151(2):159-66. Epub 2010 Aug 25. [https://doi.org/10.1111/j.1365-2141.2010.08329.x link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/20738307/ PubMed] | |
− | + | #'''Meta-analysis:''' Abouyabis AN, Shenoy PJ, Sinha R, Flowers CR, Lechowicz MJ. A systematic review and meta-analysis of front-line anthracycline-based chemotherapy regimens for peripheral T-cell lymphoma. ISRN Hematol. 2011;2011:623924. Epub 2011 Jun 16. [https://doi.org/10.5402/2011/623924 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3197255/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/22084700/ PubMed] | |
− | + | #'''hnslblzlzx2011-3:''' Li L, Duan W, Zhang L, Li X, Fu X, Wang X, Wu J, Sun Z, Zhang X, Chang Y, Nan F, Yan J, Li Z, Young KH, Zhang M. The efficacy and safety of gemcitabine, cisplatin, prednisone, thalidomide versus CHOP in patients with newly diagnosed peripheral T-cell lymphoma with analysis of biomarkers. Br J Haematol. 2017 Sep;178(5):772-780. Epub 2017 Jun 9. [https://doi.org/10.1111/bjh.14763 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/28597542/ PubMed] [https://clinicaltrials.gov/study/NCT01664975 NCT01664975] | |
− | + | #'''ECHELON-2:''' Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trümper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019 Jan 19;393(10168):229-240. Epub 2018 Dec 4. Erratum in: Lancet. 2019 Jan 19;393(10168):228. [https://doi.org/10.1016/S0140-6736(18)32984-2 link to original article] '''dosing details in abstract have been reviewed by our editors''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6436818/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30522922/ PubMed] [https://clinicaltrials.gov/study/NCT01777152 NCT01777152] | |
− | + | ##'''Update:''' Horwitz S, O'Connor OA, Pro B, Trümper L, Iyer S, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Menne T, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Zinzani PL, Miao H, Bunn V, Fenton K, Fanale M, Puhlmann M, Illidge T. The ECHELON-2 Trial: 5-year results of a randomized, phase III study of brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma. Ann Oncol. 2022 Mar;33(3):288-298. Epub 2021 Dec 16. [https://doi.org/10.1016/j.annonc.2021.12.002 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9447792/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34921960/ PubMed] | |
− | + | #'''LYSA Ro-CHOP:''' Bachy E, Camus V, Thieblemont C, Sibon D, Casasnovas RO, Ysebaert L, Damaj G, Guidez S, Pica GM, Kim WS, Lim ST, André M, García-Sancho AM, Penarrubia MJ, Staber PB, Trotman J, Hüttmann A, Stefoni V, Re A, Gaulard P, Delfau-Larue MH, de Leval L, Meignan M, Li J, Morschhauser F, Delarue R. Romidepsin Plus CHOP Versus CHOP in Patients With Previously Untreated Peripheral T-Cell Lymphoma: Results of the Ro-CHOP Phase III Study (Conducted by LYSA). J Clin Oncol. 2022 Jan 20;40(3):242-251. Epub 2021 Nov 29. [https://doi.org/10.1200/jco.21.01815 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/34843406/ PubMed] [https://clinicaltrials.gov/study/NCT01796002 NCT01796002] | |
− | + | ##'''Update:''' Camus V, Thieblemont C, Gaulard P, Cheminant M, Casasnovas RO, Ysebaert L, Damaj GL, Guidez S, Pica GM, Kim WS, Lim ST, Andre M, Gutiérrez N, Penarrubia MJ, Staber PB, Trotman J, Hüttmann A, Stefoni V, Tucci A, Fogarty P, Farhat H, Abraham J, Abarah W, Belmecheri F, Ribrag V, Delfau-Larue MH, Cottereau AS, Itti E, Li J, Delarue R, de Leval L, Morschhauser F, Bachy E. Romidepsin Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone Versus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Previously Untreated Peripheral T-Cell Lymphoma: Final Analysis of the Ro-CHOP Trial. J Clin Oncol. 2024 May 10;42(14):1612-1618. Epub 2024 Feb 16. [https://doi.org/10.1200/jco.23.01687 link to original article] [https://pubmed.ncbi.nlm.nih.gov/38364196/ PubMed] | |
− | |||
− | ===Regimen {{#subobject: | + | ==CHOP-14 (Prednisolone) {{#subobject:e35g92|Regimen=1}}== |
− | {| class="wikitable" style="width: 100%; text-align:center;" | + | CHOP-14: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''rednisolone every '''<u>14</u>''' days |
− | !Study | + | <div class="toccolours" style="background-color:#eeeeee"> |
− | |[[Levels_of_Evidence#Evidence| | + | ===Regimen {{#subobject:b6yh3a|Variant=1}}=== |
+ | {| 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://doi.org/10.1038/s41375-020-0838-5 Wulf et al. 2020 (ACT-2)] |
− | |style="background-color:# | + | |2007-2013 |
+ | | style="background-color:#1a9851" |Phase 3 (C) | ||
+ | |[[#A-CHOP-14_999|A-CHOP-14]] | ||
+ | | style="background-color:#ffffbf" |Did not meet primary endpoint of EFS | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
+ | ====Preceding treatment==== | ||
+ | *ACT-2: [[#Vincristine_.26_Prednisolone_888|Vincristine & Prednisolone]] pre-phase | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | *[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | ||
− | *[[ | + | ====Glucocorticoid therapy==== |
− | + | *[[Prednisolone (Millipred)]] 100 mg PO once per day on days 1 to 5 | |
− | + | ====Supportive therapy==== | |
− | *[[ | + | *[[:Category:Granulocyte colony-stimulating factors|G-CSF]] support |
− | + | '''14-day cycle for 6 cycles''' | |
+ | </div></div> | ||
+ | ===References=== | ||
+ | #'''ACT-2:''' Wulf GG, Altmann B, Ziepert M, D'Amore F, Held G, Greil R, Tournilhac O, Relander T, Viardot A, Wilhelm M, Wilhelm C, Pezzutto A, Zijlstra JM, van den Neste E, Lugtenburg PJ, Doorduijn JK, Gelder MV, van Imhoff GW, Zettl F, Braulke F, Nickelsen M, Glass B, Rosenwald A, Gaulard P, Loeffler M, Pfreundschuh M, Schmitz N, Trümper L; DSHNHL. Alemtuzumab plus CHOP versus CHOP in elderly patients with peripheral T-cell lymphoma: the DSHNHL2006-1B/ACT-2 trial. Leukemia. 2021 Jan;35(1):143-155. Epub 2020 May 7. [https://doi.org/10.1038/s41375-020-0838-5 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/32382083/ PubMed] | ||
+ | ==CMED {{#subobject:1239e2|Regimen=1}}== | ||
+ | CMED: '''<u>C</u>'''yclophosphamide, '''<u>M</u>'''ethotrexate, '''<u>E</u>'''toposide, '''<u>D</u>'''examethasone | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen {{#subobject:c4a84c|Variant=1}}=== | ||
+ | {| 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://doi.org/10.1007/s12032-008-9046-2 Avilés et al. 2008] | ||
+ | |1994-2001 | ||
+ | | style="background-color:#1a9851" |Phase 3 (E-switch-ic) | ||
+ | |[[#CHOP|CHOP]] | ||
+ | | style="background-color:#1a9850" |Superior OS (co-primary endpoint) | ||
+ | |- | ||
+ | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Cyclophosphamide (Cytoxan)]] 2000 mg/m<sup>2</sup> IV once on day 1 | ||
+ | *[[Methotrexate (MTX)]] 300 mg/m<sup>2</sup> IV once on day 1 | ||
+ | *[[Etoposide (Vepesid)]] 400 mg/m<sup>2</sup> IV once per day on days 1 & 2 | ||
+ | ====Glucocorticoid therapy==== | ||
+ | *[[Dexamethasone (Decadron)]] 20 mg/m<sup>2</sup> PO once per day on days 1 to 5 | ||
+ | ====Supportive therapy==== | ||
+ | *[[Leucovorin (Folinic acid)]] 15 mg IV every 6 hours for 12 doses, '''started 24 hours after MTX''' | ||
'''14-day cycle for 6 cycles''' | '''14-day cycle for 6 cycles''' | ||
− | + | </div></div> | |
− | |||
− | |||
===References=== | ===References=== | ||
− | + | #Avilés A, Castañeda C, Neri N, Cleto S, Talavera A, González M, Huerta-Guzmán J, Nambo MJ. Results of a phase III clinical trial: CHOP versus CMED in peripheral T-cell lymphoma unspecified. Med Oncol. 2008;25(3):360-4. Epub 2008 Feb 5. [https://doi.org/10.1007/s12032-008-9046-2 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/18247163/ PubMed] | |
− | # | + | ==GDPT {{#subobject:e63a7d|Regimen=1}}== |
− | + | GDPT: '''<u>G</u>'''emcitabine, '''<u>D</u>'''DP (Cisplatin), '''<u>P</u>'''rednisone, '''<u>T</u>'''halidomide | |
− | == | + | <div class="toccolours" style="background-color:#eeeeee"> |
− | {| class="wikitable" style=" | + | ===Regimen {{#subobject:5cd5b6|Variant=1}}=== |
+ | {| 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://doi.org/10.1111/bjh.14763 Li et al. 2017 (hnslblzlzx2011-3)] | ||
+ | |2010-2016 | ||
+ | | style="background-color:#1a9851" |Phase 3 (E-switch-ooc) | ||
+ | |[[#CHOP|CHOP]] | ||
+ | | style="background-color:#1a9850" |Superior OS24 (secondary endpoint)<br>OS24: 71% vs 50% | ||
|- | |- | ||
− | |||
|} | |} | ||
− | CHOP: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>''' | + | <div class="toccolours" style="background-color:#b3e2cd"> |
− | + | ====Chemotherapy==== | |
− | + | *[[Gemcitabine (Gemzar)]] 800 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 & 8 | |
− | + | *[[Cisplatin (Platinol)]] 25 mg/m<sup>2</sup> IV once per day on days 1 to 3 | |
− | + | ====Glucocorticoid therapy==== | |
− | + | *[[Prednisone (Sterapred)]] 60 mg/m<sup>2</sup> PO once per day on days 1 to 5 | |
− | ===Regimen {{#subobject: | + | ====Targeted therapy==== |
− | {| class="wikitable" style="width: | + | *[[Thalidomide (Thalomid)]] 50 mg PO once per day, increased by 50 mg per day until target dose of 200 mg PO once per day |
− | !Study | + | ====Supportive therapy==== |
− | |[[Levels_of_Evidence#Evidence| | + | *[[Aspirin]] 100 mg PO once per day |
+ | '''21-day cycle for 6 cycles''' | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | #'''hnslblzlzx2011-3:''' Li L, Duan W, Zhang L, Li X, Fu X, Wang X, Wu J, Sun Z, Zhang X, Chang Y, Nan F, Yan J, Li Z, Young KH, Zhang M. The efficacy and safety of gemcitabine, cisplatin, prednisone, thalidomide versus CHOP in patients with newly diagnosed peripheral T-cell lymphoma with analysis of biomarkers. Br J Haematol. 2017 Sep;178(5):772-780. Epub 2017 Jun 9. [https://doi.org/10.1111/bjh.14763 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/28597542/ PubMed] [https://clinicaltrials.gov/study/NCT01664975 NCT01664975] | ||
+ | =Untreated, non-randomized or retrospective data= | ||
+ | ==A-CHOP {{#subobject:75a3d2|Regimen=1}}== | ||
+ | A-CHOP: '''<u>A</u>'''lemtuzumab, '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''redniso(lo)ne | ||
+ | <br>CHOP-AL: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''redniso(lo)ne, '''<u>AL</u>'''emtuzumab | ||
+ | <br>CHOP-C: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''redniso(lo)ne, '''<u>C</u>'''ampath (Alemtuzumab) | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen variant #1, 2 cycles {{#subobject:ab9c64|Variant=1}}=== | ||
+ | {| class="wikitable" style="width: 60%; text-align:center;" | ||
+ | !style="width: 33%"|Study | ||
+ | !style="width: 33%"|Dates of enrollment | ||
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
|- | |- | ||
− | | | + | |[https://doi.org/10.1038/leu.2014.79 Corradini et al. 2014 (PTCL-06)] |
− | |style="background-color:# | + | |2006-2010 |
+ | | style="background-color:#91cf61" |Phase 2 | ||
|- | |- | ||
|} | |} | ||
− | '' | + | ''Note: These are the details for "Clin A" which was the regimen used for patients younger than 60. Note: this is a component of a sequential treatment protocol; to our knowledge there are no references to support using it as a stand-alone treatment.'' |
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | *[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | ||
+ | ====Glucocorticoid therapy==== | ||
*[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5 | *[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5 | ||
− | + | ====Targeted therapy==== | |
− | + | *[[Alemtuzumab (Campath)]] as follows: | |
− | + | **Cycle 1: 3 mg IV once on day -2, then 10 mg IV once on day -1, then 20 mg IV once on day 0 | |
− | + | **Cycle 2: 30 mg IV once on day 0 (= day 21 of cycle 1) | |
− | + | '''21-day cycle for 2 cycles''' | |
− | === | + | </div> |
− | + | <div class="toccolours" style="background-color:#cbd5e7"> | |
− | + | ====Subsequent treatment==== | |
− | + | *[[#HyperCHidam|HyperCHidam]] consolidation x 2 | |
− | + | </div></div><br> | |
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | + | ===Regimen variant #2, 8 cycles {{#subobject:c8d06d|Variant=1}}=== | |
− | + | {| class="wikitable" style="width: 60%; text-align:center;" | |
− | + | !style="width: 33%"|Study | |
− | + | !style="width: 33%"|Dates of enrollment | |
− | + | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | |
− | ===Regimen {{#subobject: | ||
− | {| class="wikitable" style="width: | ||
− | !Study | ||
− | |[[Levels_of_Evidence#Evidence| | ||
|- | |- | ||
− | |[ | + | |[https://doi.org/10.1182/blood-2007-02-074641 Gallamini et al. 2007] |
− | |style="background-color:# | + | |2003-01 to 2005-12 |
+ | | style="background-color:#91cf61" |Phase 2 | ||
|- | |- | ||
|} | |} | ||
− | '' | + | ''Note: the paper reports using the CHOP dosing as specified by [https://doi.org/10.1056/NEJM199304083281404 Fisher et al. 1993]; however, note that the cycle length here is 28 days.'' |
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | *[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | ||
+ | ====Glucocorticoid therapy==== | ||
*[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5 | *[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5 | ||
− | *[[ | + | ====Targeted therapy==== |
− | + | *[[Alemtuzumab (Campath)]] as follows: | |
− | ''' | + | **Cycle 1: 3 mg IV once on day -2, then 10 mg IV once on day -1, then 20 mg IV once on day 0, then 30 mg IV once on day 1 |
− | + | **Cycles 2 to 8: 30 mg IV once on day 1 | |
+ | ====Supportive therapy==== | ||
+ | *[[Chlorpheniramine (Chlor-Trimeton)]] 10 mg IV once per infusion; 60 minutes prior to alemtuzumab | ||
+ | *[[Acetaminophen (Tylenol)]] 500 mg PO once per infusion; 30 minutes prior to alemtuzumab | ||
+ | *[[Alizapride (Litican)]] 100 mg IV once per infusion; 30 minutes prior to alemtuzumab | ||
+ | '''28-day cycle for 8 cycles''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | # | + | #Gallamini A, Zaja F, Patti C, Billio A, Specchia MR, Tucci A, Levis A, Manna A, Secondo V, Rigacci L, Pinto A, Iannitto E, Zoli V, Torchio P, Pileri S, Tarella C. Alemtuzumab (Campath-1H) and CHOP chemotherapy as first-line treatment of peripheral T-cell lymphoma: results of a GITIL (Gruppo Italiano Terapie Innovative nei Linfomi) prospective multicenter trial. Blood. 2007 Oct 1;110(7):2316-23. Epub 2007 Jun 20. [https://doi.org/10.1182/blood-2007-02-074641 link to original article] '''contains partial protocol''' [https://pubmed.ncbi.nlm.nih.gov/17581918/ PubMed] |
+ | #'''PTCL-06:''' Corradini P, Vitolo U, Rambaldi A, Miceli R, Patriarca F, Gallamini A, Olivieri A, Benedetti F, Todeschini G, Rossi G, Salvi F, Bruno B, Baldini L, Ferreri A, Patti C, Tarella C, Pileri S, Dodero A. Intensified chemo-immunotherapy with or without stem cell transplantation in newly diagnosed patients with peripheral T-cell lymphoma. Leukemia. 2014 Sep;28(9):1885-91. Epub 2014 Feb 20. [https://doi.org/10.1038/leu.2014.79 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/24662801/ PubMed] EudraCT 2006-004234-33 | ||
− | == | + | ==CHOEP-14 {{#subobject:e84b92|Regimen=1}}== |
− | {| class="wikitable" style=" | + | CHOEP-14: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>E</u>'''toposide, '''<u>P</u>'''rednisone every '''<u>14</u>''' days |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen {{#subobject:b15c3a|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
+ | !style="width: 33%"|Study | ||
+ | !style="width: 33%"|Dates of enrollment | ||
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | |- | ||
+ | |[https://doi.org/10.1200/jco.2011.40.2719 d'Amore et al. 2012 (NLG-T-01)] | ||
+ | |2001-10 to 2007-10 | ||
+ | | style="background-color:#91cf61" |Phase 2 | ||
|- | |- | ||
− | |||
|} | |} | ||
− | + | <div class="toccolours" style="background-color:#b3e2cd"> | |
− | + | ====Chemotherapy==== | |
+ | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | ||
+ | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | ||
+ | *[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | ||
+ | *[[Etoposide (Vepesid)]] by the following age-based criteria: | ||
+ | **60 years old or younger: 100 mg/m<sup>2</sup> IV once per day on days 1 to 3 | ||
+ | ====Glucocorticoid therapy==== | ||
+ | *[[Prednisone (Sterapred)]] 50 mg PO twice per day on days 1 to 5 | ||
+ | '''14-day cycle for 6 cycles''' | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#cbd5e7"> | ||
+ | ====Subsequent treatment==== | ||
+ | *If patients in PR or CR after three cycles, stem cells are mobilized off of cycles 5 and 6, followed by BEAC or [[#BEAM.2C_then_auto_HSCT|BEAM auto HSCT]] consolidation | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | <!-- Presented orally in part at the 48th Annual Meeting of the American Society of Hematology, Orlando, FL, December 9-12, 2006; 14th Annual Meeting of the European Hematology Association, Berlin, Germany, June 4-7, 2009; 11th International Conference on Malignant Lymphoma, Lugano, Switzerland, June 15-18, 2011; and American Society of Hematology Annual Meeting, San Diego, CA, December 10-13, 2011. --> | ||
+ | #'''NLG-T-01:''' d'Amore F, Relander T, Lauritzsen GF, Jantunen E, Hagberg H, Anderson H, Holte H, Österborg A, Merup M, Brown P, Kuittinen O, Erlanson M, Østenstad B, Fagerli UM, Gadeberg OV, Sundström C, Delabie J, Ralfkiaer E, Vornanen M, Toldbod HE. Up-front autologous stem-cell transplantation in peripheral T-cell lymphoma: NLG-T-01. J Clin Oncol. 2012 Sep 1;30(25):3093-9. Epub 2012 Jul 30. [https://doi.org/10.1200/jco.2011.40.2719 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/22851556/ PubMed] [https://clinicaltrials.gov/study/NCT00791947 NCT00791947] | ||
− | ===Regimen {{#subobject: | + | ==CHOP & Everolimus {{#subobject:a3439a|Regimen=1}}== |
− | {| class="wikitable" style="width: | + | CHOP & Everolimus: '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''redniso(lo)ne, Everolimus |
− | !Study | + | <div class="toccolours" style="background-color:#eeeeee"> |
− | |[[Levels_of_Evidence#Evidence| | + | ===Regimen {{#subobject:ccbdcf|Variant=1}}=== |
+ | {| class="wikitable sortable" style="width: 80%; text-align:center;" | ||
+ | !style="width: 25%"|Study | ||
+ | !style="width: 25%"|Dates of enrollment | ||
+ | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | !style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | ||
|- | |- | ||
− | |[ | + | |[https://doi.org/10.1093/annonc/mdv624 Kim et al. 2016 (RADCHOP)] |
− | |style="background-color:# | + | |2011-03 to 2013-06 |
+ | | style="background-color:#91cf61" |Phase 2 | ||
+ | | style="background-color:#e5e5e5" |ORR: 90% | ||
|- | |- | ||
|} | |} | ||
− | + | <div class="toccolours" style="background-color:#b3e2cd"> | |
− | + | ====Chemotherapy==== | |
− | |||
− | ====Chemotherapy | ||
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 1 | ||
*[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | *[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 1 | ||
+ | ====Glucocorticoid therapy==== | ||
*[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5 | *[[Prednisone (Sterapred)]] 100 mg PO once per day on days 1 to 5 | ||
− | *[[ | + | ====Targeted therapy==== |
− | + | *[[Everolimus (Afinitor)]] 5 mg PO once per day on days 1 to 14 | |
− | + | '''21-day cycle for up to 6 cycles''' | |
− | + | </div></div> | |
− | |||
− | |||
− | '''21-day cycle for | ||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
===References=== | ===References=== | ||
− | # | + | #'''RADCHOP:''' Kim SJ, Shin DY, Kim JS, Yoon DH, Lee WS, Lee H, Do YR, Kang HJ, Eom HS, Ko YH, Lee SH, Yoo HY, Hong M, Suh C, Kim WS. A phase II study of everolimus (RAD001), an mTOR inhibitor plus CHOP for newly diagnosed peripheral T-cell lymphomas. Ann Oncol. 2016 Apr;27(4):712-8. Epub 2016 Feb 8. [https://doi.org/10.1093/annonc/mdv624 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/26861608/ PubMed] [https://clinicaltrials.gov/study/NCT01198665 NCT01198665] |
==DA-EPOCH {{#subobject:9b4e41|Regimen=1}}== | ==DA-EPOCH {{#subobject:9b4e41|Regimen=1}}== | ||
− | |||
− | |||
− | |||
− | |||
DA-EPOCH: '''<u>D</u>'''ose '''<u>A</u>'''djusted '''<u>E</u>'''toposide, '''<u>P</u>'''rednisone, '''<u>O</u>'''ncovin (Vincristine), '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin) | DA-EPOCH: '''<u>D</u>'''ose '''<u>A</u>'''djusted '''<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:263b57|Variant=1}}=== | ===Regimen {{#subobject:263b57|Variant=1}}=== | ||
− | {| class="wikitable" style="width: | + | {| class="wikitable sortable" style="width: 80%; text-align:center;" |
− | !Study | + | !style="width: 25%"|Study |
− | |[[Levels_of_Evidence#Evidence| | + | !style="width: 25%"|Dates of enrollment |
− | ![[Levels_of_Evidence#Efficacy|Efficacy]] | + | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] |
+ | !style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | ||
|- | |- | ||
− | |[ | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5709109/ Maeda et al. 2017 (West-JHOG PTCL0707)] |
− | |style="background-color:# | + | |2007-09 to 2011-10 |
− | |style="background-color:#c7c7c7"|ORR: 78% (95% CI 62-89) | + | | style="background-color:#91cf61" |Phase 2 |
+ | | style="background-color:#c7c7c7" |ORR: 78% (95% CI 62-89) | ||
|- | |- | ||
|} | |} | ||
''Note: the authors state that they followed the Wilson et al. 2002 protocol, but there are some differences, in particular 1) it isn't clear whether prednisone is given once or twice per day; and 2) dose adjustments below level 1 are different based on age.'' | ''Note: the authors state that they followed the Wilson et al. 2002 protocol, but there are some differences, in particular 1) it isn't clear whether prednisone is given once or twice per day; and 2) dose adjustments below level 1 are different based on age.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | *[[Etoposide (Vepesid)]] 50 mg/m<sup>2</sup>/day IV continuous infusion on | + | *[[Etoposide (Vepesid)]] 50 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 200 mg/m<sup>2</sup>) |
− | + | *[[Vincristine (Oncovin)]] 0.4 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 1.6 mg/m<sup>2</sup>) | |
− | *[[Vincristine (Oncovin)]] 0.4 mg/m<sup>2</sup>/day IV continuous infusion on | ||
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV over 2 hours once on day 5 | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV over 2 hours once on day 5 | ||
− | *[[Doxorubicin (Adriamycin)]] 10 mg/m<sup>2</sup>/day IV continuous infusion on | + | *[[Doxorubicin (Adriamycin)]] 10 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 40 mg/m<sup>2</sup>) |
− | + | ====Glucocorticoid therapy==== | |
− | ====Supportive | + | *[[Prednisone (Sterapred)]] 60 mg/m<sup>2</sup>/day PO on days 1 to 5 |
− | *[[:Category:Granulocyte colony-stimulating factors|G-CSF]] starting on day 6 and continuing until ANC greater than 5000/ | + | ====Supportive therapy==== |
− | *[[Trimethoprim | + | *[[:Category:Granulocyte colony-stimulating factors|G-CSF]] starting on day 6 and continuing until ANC greater than 5000/μL past nadir |
+ | *[[Trimethoprim-Sulfamethoxazole (Bactrim DS)]] (dose not specified) | ||
*[[Fluconazole (Diflucan)]] (dose not specified) | *[[Fluconazole (Diflucan)]] (dose not specified) | ||
− | |||
'''21-day cycle for 6 to 8 cycles''' | '''21-day cycle for 6 to 8 cycles''' | ||
− | + | </div> | |
− | ====Dose | + | <div class="toccolours" style="background-color:#fff2ae"> |
+ | ====Dose and schedule modifications==== | ||
*Start cycle 1 as described above. | *Start cycle 1 as described above. | ||
*Obtain CBCs twice per week for nadir measurements. | *Obtain CBCs twice per week for nadir measurements. | ||
− | *If nadir ANC greater than 500/ | + | *If nadir ANC greater than 500/μL, increase etoposide, doxorubicin, and cyclophosphamide by 20% compared to previous cycle. |
− | *If nadir ANC less than 500/ | + | *If nadir ANC less than 500/μL on 1 or 2 measurements, use same doses as last cycle. |
− | *If nadir ANC less than 500/ | + | *If nadir ANC less than 500/μL on at least 3 measurements, decrease etoposide, doxorubicin, and cyclophosphamide by 20% compared to previous cycle. |
*And/or if nadir platelet count less than 25 x 10<sup>9</sup>/L on at least 1 measurement, decrease etoposide, doxorubicin, and cyclophosphamide by 20% compared to previous cycle. | *And/or if nadir platelet count less than 25 x 10<sup>9</sup>/L on at least 1 measurement, decrease etoposide, doxorubicin, and cyclophosphamide by 20% compared to previous cycle. | ||
− | *''' | + | *'''Younger than 70 years old:''' Dose adjustments below the cycle 1 starting dose only apply to cyclophosphamide. That is, the lowest etoposide and doxorubicin would be dosed is at the original cycle 1 dose. |
*'''Patients 70 and older:''' Dose adjustments below the cycle 1 starting dose apply to all drugs | *'''Patients 70 and older:''' Dose adjustments below the cycle 1 starting dose apply to all drugs | ||
− | *(Presumed, based on Wilson et al. 2002): Can start new cycle every 21 days if ANC greater than 1000/ | + | *(Presumed, based on Wilson et al. 2002): Can start new cycle every 21 days if ANC greater than 1000/μL and platelets greater than 100 x 10<sup>9</sup>/L. If counts are below those levels, check daily CBC and continue growth factor support until counts are adequate and next cycle can start. |
− | + | </div></div> | |
===References=== | ===References=== | ||
− | # Maeda Y, Nishimori H, Yoshida I, Hiramatsu Y, Uno M, Masaki Y, Sunami K, Masunari T, Nawa Y, Yamane H, Gomyo H, Takahashi T, Yano T, Matsuo K, Ohshima K, Nakamura S, Yoshino T, Tanimoto M. Dose-adjusted EPOCH chemotherapy for untreated peripheral T-cell lymphomas: a multicenter phase II trial of West-JHOG PTCL0707. Haematologica. 2017 Dec;102(12):2097-2103. Epub 2017 Sep 29. [ | + | #Maeda Y, Nishimori H, Yoshida I, Hiramatsu Y, Uno M, Masaki Y, Sunami K, Masunari T, Nawa Y, Yamane H, Gomyo H, Takahashi T, Yano T, Matsuo K, Ohshima K, Nakamura S, Yoshino T, Tanimoto M. Dose-adjusted EPOCH chemotherapy for untreated peripheral T-cell lymphomas: a multicenter phase II trial of West-JHOG PTCL0707. Haematologica. 2017 Dec;102(12):2097-2103. Epub 2017 Sep 29. [https://doi.org/10.3324/haematol.2017.167742 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5709109/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28971899/ PubMed] UMIN000000829 |
==DD-CHOP {{#subobject:b07d3a|Regimen=1}}== | ==DD-CHOP {{#subobject:b07d3a|Regimen=1}}== | ||
− | + | DD-CHOP: '''<u>D</u>'''enileukin, '''<u>D</u>'''iftitox, '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>'''redniso(lo)ne | |
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
− | |||
− | DD-CHOP: '''<u>D</u>'''enileukin, '''<u>D</u>'''iftitox, '''<u>C</u>'''yclophosphamide, '''<u>H</u>'''ydroxydaunorubicin (Doxorubicin), '''<u>O</u>'''ncovin (Vincristine), '''<u>P</u>''' | ||
− | |||
===Regimen {{#subobject:897f8d|Variant=1}}=== | ===Regimen {{#subobject:897f8d|Variant=1}}=== | ||
− | {| class="wikitable" style="width: | + | {| class="wikitable sortable" style="width: 80%; text-align:center;" |
− | !Study | + | !style="width: 25%"|Study |
− | |[[Levels_of_Evidence#Evidence| | + | !style="width: 25%"|Dates of enrollment |
− | ![[Levels_of_Evidence#Efficacy|Efficacy]] | + | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] |
+ | !style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | ||
|- | |- | ||
− | |[ | + | |[https://doi.org/10.3109/10428194.2012.742521 Foss et al. 2013 (CONCEPT)] |
− | |style="background-color:# | + | |2004-09 to 2009-12 |
− | |style="background-color:#a6a6a6"|ORR: 65% | + | | style="background-color:#91cf61" |Phase 2 |
+ | | style="background-color:#a6a6a6" |ORR: 65% | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Targeted therapy==== | ||
+ | *[[Denileukin diftitox (Ontak)]] 18 mcg/kg IV over 60 minutes once per day on days 1 & 2 | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | |||
*[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 3 | *[[Cyclophosphamide (Cytoxan)]] 750 mg/m<sup>2</sup> IV once on day 3 | ||
*[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 3 | *[[Doxorubicin (Adriamycin)]] 50 mg/m<sup>2</sup> IV once on day 3 | ||
*[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 3 | *[[Vincristine (Oncovin)]] 1.4 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once on day 3 | ||
+ | ====Glucocorticoid therapy==== | ||
*[[Prednisone (Sterapred)]] 100 mg PO once per day on days 3 to 7 | *[[Prednisone (Sterapred)]] 100 mg PO once per day on days 3 to 7 | ||
− | + | ====Supportive therapy==== | |
− | ====Supportive | + | *[[Dexamethasone (Decadron)]] 4 to 8 mg IV or PO once per day on days 1 & 2, prior to denileukin diftitox |
− | *[[Dexamethasone (Decadron)]] 4 to 8 mg IV | + | *[[Acetaminophen (Tylenol)]] 650 mg PO once per day on days 1 & 2, prior to denileukin diftitox |
− | *[[Acetaminophen (Tylenol)]] 650 mg PO prior to | + | *[[Diphenhydramine (Benadryl)]] 25 mg IV once per day on days 1 & 2, prior to denileukin diftitox |
− | *[[Diphenhydramine (Benadryl)]] 25 mg IV prior to | + | *[[Normal saline]] 250 to 500 cc IV, given before and after each denileukin diftitox infusion |
− | *Normal saline 250 to 500 cc before and after each | ||
*Antiemetics "per institutional standard" | *Antiemetics "per institutional standard" | ||
*[[:Category:Granulocyte colony-stimulating factors|G-CSF]] support beginning on day 4 | *[[:Category:Granulocyte colony-stimulating factors|G-CSF]] support beginning on day 4 | ||
− | |||
'''21-day cycle for 6 to 8 cycles''' | '''21-day cycle for 6 to 8 cycles''' | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | #'''CONCEPT:''' Foss FM, Sjak-Shie N, Goy A, Jacobsen E, Advani R, Smith MR, Komrokji R, Pendergrass K, Bolejack V. A multicenter phase II trial to determine the safety and efficacy of combination therapy with denileukin diftitox and cyclophosphamide, doxorubicin, vincristine and prednisone in untreated peripheral T-cell lymphoma: the CONCEPT study. Leuk Lymphoma. 2013 Jul;54(7):1373-9. Epub 2013 Jan 29. [https://doi.org/10.3109/10428194.2012.742521 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/23278639/ PubMed] [https://clinicaltrials.gov/study/NCT00211185 NCT00211185] | ||
+ | ==HyperCHidam {{#subobject:2cecf3|Regimen=1}}== | ||
+ | HyperCHidam: '''<u>Hyper</u>'''fractionated '''<u>C</u>'''yclophosphamide, '''<u>Hi</u>'''igh-'''<u>d</u>'''ose '''<u>a</u>'''ra-c (Cytarabine) & '''<u>m</u>'''ethotrexate | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen {{#subobject:46bec8|Variant=1}}=== | ||
+ | {| class="wikitable" style="width: 60%; text-align:center;" | ||
+ | !style="width: 33%"|Study | ||
+ | !style="width: 33%"|Dates of enrollment | ||
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | |- | ||
+ | |[https://doi.org/10.1038/leu.2014.79 Corradini et al. 2014 (PTCL-06)] | ||
+ | |2006-2010 | ||
+ | | style="background-color:#91cf61" |Phase 2 | ||
+ | |- | ||
+ | |} | ||
+ | ''Note: These are the details for "Clin A" which was the regimen used for patients younger than 60. Note: this is a component of a sequential treatment protocol; to our knowledge there are no references to support using it as a stand-alone treatment.'' | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
+ | ====Preceding treatment==== | ||
+ | *PTCL-06: [[#CHOP-AL|CHOP-AL]] induction x 2 | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Methotrexate (MTX)]] 1600 mg/m<sup>2</sup> IV continuous infusion (duration not specified), started on day 1 | ||
+ | *[[Cyclophosphamide (Cytoxan)]] 300 mg/m<sup>2</sup> IV every 12 hours for 3 days (start day not specified) | ||
+ | *[[Cytarabine (Ara-C)]] 2000 mg/m<sup>2</sup> IV every 12 hours for 3 days (start day not specified) | ||
+ | ====Supportive therapy==== | ||
+ | *[[:Category:Granulocyte_colony-stimulating_factors|Granulocyte-colony stimulating factor]] (type not specified) 5 mcg/kg once per day was given from day +5 (stop date not specified) | ||
+ | '''2 cycles (duration not specified)''' | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#cbd5e7"> | ||
+ | ====Subsequent treatment==== | ||
+ | *PTCL-06, responders (PR/CR): [[#Allogeneic_hematopoietic_stem_cell_transplant|allogeneic HSCT]] consolidation | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | # | + | #'''PTCL-06:''' Corradini P, Vitolo U, Rambaldi A, Miceli R, Patriarca F, Gallamini A, Olivieri A, Benedetti F, Todeschini G, Rossi G, Salvi F, Bruno B, Baldini L, Ferreri A, Patti C, Tarella C, Pileri S, Dodero A. Intensified chemo-immunotherapy with or without stem cell transplantation in newly diagnosed patients with peripheral T-cell lymphoma. Leukemia. 2014 Sep;28(9):1885-91. Epub 2014 Feb 20. [https://doi.org/10.1038/leu.2014.79 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/24662801/ PubMed] EudraCT 2006-004234-33 |
+ | =Consolidation after upfront therapy= | ||
+ | ==BEAM, then auto HSCT {{#subobject:1e26e2|Regimen=1}}== | ||
+ | BEAM: '''<u>B</u>'''iCNU (Carmustine), '''<u>E</u>'''toposide, '''<u>A</u>'''ra-C (Cytarabine), '''<u>M</u>'''elphalan | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen variant #1 {{#subobject:16f67g|Variant=1}}=== | ||
+ | {| 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://www.ncbi.nlm.nih.gov/pmc/articles/PMC9635528/ Schmitz et al. 2021 (MYS-07-HMO-CTIL)] | ||
+ | |2011-2014 | ||
+ | | style="background-color:#1a9851" |Phase 3 (C) | ||
+ | |[[#Fludarabine.2C_Busulfan.2C_Cyclophosphamide.2C_then_allo_HSCT_999|Fludarabine, Busulfan, Cyclophosphamide, then allo HSCT]] | ||
+ | | style="background-color:#ffffbf" |Did not meet primary endpoint of EFS36 | ||
+ | |- | ||
+ | |} | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
+ | ====Preceding treatment==== | ||
+ | *MYS-07-HMO-CTIL: [[#CHOEP-14|CHOEP-14]] induction x 4, then [[#DHAP_888|DHAP]] consolidation x 1 | ||
+ | </div> | ||
+ | {{#lst:Autologous HSCT|fa5ca6}} | ||
+ | </div></div><br> | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
− | = | + | ===Regimen variant #2 {{#subobject:16f7a3|Variant=1}}=== |
+ | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
+ | !style="width: 33%"|Study | ||
+ | !style="width: 33%"|Dates of enrollment | ||
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | |- | ||
+ | |[https://doi.org/10.1200/jco.2011.40.2719 d'Amore et al. 2012 (NLG-T-01)] | ||
+ | |2001-10 to 2007-10 | ||
+ | | style="background-color:#91cf61" |Phase 2 | ||
+ | |- | ||
+ | |} | ||
+ | {{#lst:Autologous HSCT|16f7a3}} | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | <!-- Presented orally in part at the 48th Annual Meeting of the American Society of Hematology, Orlando, FL, December 9-12, 2006; 14th Annual Meeting of the European Hematology Association, Berlin, Germany, June 4-7, 2009; 11th International Conference on Malignant Lymphoma, Lugano, Switzerland, June 15-18, 2011; and American Society of Hematology Annual Meeting, San Diego, CA, December 10-13, 2011. --> | ||
+ | #'''NLG-T-01:''' d'Amore F, Relander T, Lauritzsen GF, Jantunen E, Hagberg H, Anderson H, Holte H, Österborg A, Merup M, Brown P, Kuittinen O, Erlanson M, Østenstad B, Fagerli UM, Gadeberg OV, Sundström C, Delabie J, Ralfkiaer E, Vornanen M, Toldbod HE. Up-front autologous stem-cell transplantation in peripheral T-cell lymphoma: NLG-T-01. J Clin Oncol. 2012 Sep 1;30(25):3093-9. Epub 2012 Jul 30. [https://doi.org/10.1200/jco.2011.40.2719 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/22851556/ PubMed] [https://clinicaltrials.gov/study/NCT00791947 NCT00791947] | ||
+ | # '''MYS-07-HMO-CTIL:''' Schmitz N, Truemper L, Bouabdallah K, Ziepert M, Leclerc M, Cartron G, Jaccard A, Reimer P, Wagner E, Wilhelm M, Sanhes L, Lamy T, de Leval L, Rosenwald A, Roussel M, Kroschinsky F, Lindemann W, Dreger P, Viardot A, Milpied N, Gisselbrecht C, Wulf G, Gyan E, Gaulard P, Bay JO, Glass B, Poeschel V, Damaj G, Sibon D, Delmer A, Bilger K, Banos A, Haenel M, Dreyling M, Metzner B, Keller U, Braulke F, Friedrichs B, Nickelsen M, Altmann B, Tournilhac O. A randomized phase 3 trial of autologous vs allogeneic transplantation as part of first-line therapy in poor-risk peripheral T-NHL. Blood. 2021 May 13;137(19):2646-2656. [https://doi.org/10.1182/blood.2020008825 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9635528/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33512419/ PubMed] [https://clinicaltrials.gov/study/NCT00984412 NCT00984412] | ||
+ | ==Cyclophosphamide & TBI, then auto HSCT {{#subobject:0a4915|Regimen=1}}== | ||
+ | Cy/TBI: '''<u>Cy</u>'''clophosphamide & '''<u>T</u>'''otal '''<u>B</u>'''ody '''<u>I</u>'''rradiation | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen {{#subobject:a2b2d3|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
+ | !style="width: 33%"|Study | ||
+ | !style="width: 33%"|Dates of enrollment | ||
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | |- | ||
+ | |[https://doi.org/10.1038/sj.thj.6200359 Reimer et al. 2004] | ||
+ | |2000-2006 | ||
+ | | style="background-color:#91cf61" |Non-randomized | ||
+ | |- | ||
+ | |} | ||
+ | {{#lst:Autologous HSCT|a2b2d3}} | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | #Reimer P, Schertlin T, Rüdiger T, Geissinger E, Roth S, Kunzmann V, Weissinger F, Nerl C, Schmitz N, Müller-Hermelink HK, Wilhelm M. Myeloablative radiochemotherapy followed by autologous peripheral blood stem cell transplantation as first-line therapy in peripheral T-cell lymphomas: first results of a prospective multicenter study. Hematol J. 2004;5(4):304-11. [https://doi.org/10.1038/sj.thj.6200359 link to original article] [https://pubmed.ncbi.nlm.nih.gov/15297846/ PubMed] | ||
+ | ##'''Update:''' Reimer P, Rüdiger T, Geissinger E, Weissinger F, Nerl C, Schmitz N, Engert A, Einsele H, Müller-Hermelink HK, Wilhelm M. Autologous stem-cell transplantation as first-line therapy in peripheral T-cell lymphomas: results of a prospective multicenter study. J Clin Oncol. 2009 Jan 1;27(1):106-13. Epub 2008 Nov 24. [https://doi.org/10.1200/jco.2008.17.4870 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/19029417/ PubMed] | ||
− | == | + | ==Radiation therapy {{#subobject:784759|Regimen=1}}== |
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
+ | ===Regimen {{#subobject:ac7acb|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
+ | !style="width: 33%"|Study | ||
+ | !style="width: 33%"|Dates of enrollment | ||
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | |- | ||
+ | |[https://doi.org/10.1111/j.1365-2141.2010.08329.x Simon et al. 2010 (GOELAMS LTP95)] | ||
+ | |1996-2002 | ||
+ | | style="background-color:#91cf61" |Non-randomized part of phase 3 RCT | ||
+ | |- | ||
+ | |} | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
+ | ====Preceding treatment==== | ||
+ | *GOELAMS LTP95: [[#CHOP|CHOP]] x 8 versus [[#vVIP-rABVD_999|vVIP-rABVD]] induction | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Radiotherapy==== | ||
+ | *[[External beam radiotherapy]] 4000 cGy at 180 cGy/day to the involved field | ||
+ | '''4.5-week course''' | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | #'''GOELAMS-LTP95:''' Simon A, Peoch M, Casassus P, Deconinck E, Colombat P, Desablens B, Tournilhac O, Eghbali H, Foussard C, Jaubert J, Vilque JP, Rossi JF, Lucas V, Delwail V, Thyss A, Maloisel F, Milpied N, le Gouill S, Lamy T, Gressin R. Upfront VIP-reinforced-ABVD (VIP-rABVD) is not superior to CHOP/21 in newly diagnosed peripheral T cell lymphoma: results of the randomized phase III trial GOELAMS-LTP95. Br J Haematol. 2010 Oct;151(2):159-66. Epub 2010 Aug 25. [https://doi.org/10.1111/j.1365-2141.2010.08329.x link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/20738307/ PubMed] | ||
+ | ==TFC, then allo HSCT {{#subobject:ee93e3|Regimen=1}}== | ||
+ | TFC: '''<u>T</u>'''hiotepa, '''<u>F</u>'''ludarabine, '''<u>C</u>'''yclophosphamide | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen {{#subobject:81245f|Variant=1}}=== | ===Regimen {{#subobject:81245f|Variant=1}}=== | ||
− | {| class="wikitable" style="width: | + | {| class="wikitable sortable" style="width: 60%; text-align:center;" |
− | !Study | + | !style="width: 33%"|Study |
− | |[[Levels_of_Evidence#Evidence| | + | !style="width: 33%"|Dates of enrollment |
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | |- | ||
+ | |[https://doi.org/10.1182/blood.v99.1.75 Corradini et al. 2002] | ||
+ | |1998-09 to 2001-01 | ||
+ | | style="background-color:#91cf61" |Non-randomized | ||
|- | |- | ||
− | |[ | + | |[https://doi.org/10.1038/leu.2014.79 Corradini et al. 2014 (PTCL-06)] |
− | |style="background-color:# | + | |2006-11 to 2010-11 |
+ | | style="background-color:#91cf61" |Phase 2 | ||
|- | |- | ||
|} | |} | ||
+ | Details to be completed. | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
− | *[[ | + | *PTCL-06: [[#CHOP-AL|CHOP-AL]] induction x 2, then [[#HyperCHidam|HyperCHidam]] consolidation x 2 |
− | + | </div> | |
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | *[[Thiotepa (Thioplex)]] | ||
+ | *[[Fludarabine (Fludara)]] | ||
*[[Cyclophosphamide (Cytoxan)]] | *[[Cyclophosphamide (Cytoxan)]] | ||
− | *[[ | + | ====Immunotherapy==== |
− | + | *[[Allogeneic stem cells]] | |
− | + | '''Stem cells transfused on day 0''' | |
+ | </div></div> | ||
===References=== | ===References=== | ||
− | # Corradini P, Tarella C, Olivieri A, Gianni AM, Voena C, Zallio F, Ladetto M, Falda M, Lucesole M, Dodero A, Ciceri F, Benedetti F, Rambaldi A, Sajeva MR, Tresoldi M, Pileri A, Bordignon C, Bregni M. Reduced-intensity conditioning followed by allografting of hematopoietic cells can produce clinical and molecular remissions in patients with poor-risk hematologic malignancies. Blood. 2002 Jan 1;99(1):75-82. [ | + | #Corradini P, Tarella C, Olivieri A, Gianni AM, Voena C, Zallio F, Ladetto M, Falda M, Lucesole M, Dodero A, Ciceri F, Benedetti F, Rambaldi A, Sajeva MR, Tresoldi M, Pileri A, Bordignon C, Bregni M. Reduced-intensity conditioning followed by allografting of hematopoietic cells can produce clinical and molecular remissions in patients with poor-risk hematologic malignancies. Blood. 2002 Jan 1;99(1):75-82. [https://doi.org/10.1182/blood.v99.1.75 link to original article] [https://pubmed.ncbi.nlm.nih.gov/11756155/ PubMed] |
− | # Corradini P, Vitolo U, Rambaldi A, Miceli R, Patriarca F, Gallamini A, Olivieri A, Benedetti F, Todeschini G, Rossi G, Salvi F, Bruno B, Baldini L, Ferreri A, Patti C, Tarella C, Pileri S, Dodero A. Intensified chemo-immunotherapy with or without stem cell transplantation in newly diagnosed patients with peripheral T-cell lymphoma. Leukemia. 2014 Sep;28(9):1885-91. Epub 2014 Feb 20. [ | + | #'''PTCL-06:''' Corradini P, Vitolo U, Rambaldi A, Miceli R, Patriarca F, Gallamini A, Olivieri A, Benedetti F, Todeschini G, Rossi G, Salvi F, Bruno B, Baldini L, Ferreri A, Patti C, Tarella C, Pileri S, Dodero A. Intensified chemo-immunotherapy with or without stem cell transplantation in newly diagnosed patients with peripheral T-cell lymphoma. Leukemia. 2014 Sep;28(9):1885-91. Epub 2014 Feb 20. [https://doi.org/10.1038/leu.2014.79 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/24662801/ PubMed] EudraCT 2006-004234-33 |
− | == | + | =Relapsed or refractory, randomized data= |
− | '' | + | ==Bendamustine monotherapy {{#subobject:47c984|Regimen=1}}== |
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | ===Regimen {{#subobject: | + | ===Regimen variant #1, 90 mg/m<sup>2</sup> {{#subobject:1e490d|Variant=1}}=== |
− | {| class="wikitable" style="width: 100%; text-align:center;" | + | {| class="wikitable sortable" style="width: 100%; text-align:center;" |
− | !Study | + | !style="width: 20%"|Study |
− | |[[Levels_of_Evidence#Evidence| | + | !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://doi.org/10.1016/s2352-3026(24)00102-9 Dupuis et al. 2024 (ORACLE)] | ||
+ | |2018-11-09 to 2021-02-22 | ||
+ | | style="background-color:#1a9851" |Phase 3 (C) | ||
+ | |[[#Azacitidine_oral_monotherapy_999|Oral azacitidine]] | ||
+ | | style="background-color:#ffffbf" |Did not meet primary endpoint of PFS | ||
+ | |- | ||
+ | |} | ||
+ | ''Note: The majority of patients in ORACLE had angioimmunoblastic T-cell lymphoma (AITL). This was the lower bound of dosing in ORACLE.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Bendamustine]] 90 mg/m<sup>2</sup> IV once per day on days 1 & 2 | ||
+ | '''21-day cycle for 6 cycles''' | ||
+ | </div></div><br> | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen variant #2, 120 mg/m<sup>2</sup> {{#subobject:1e407d|Variant=1}}=== | ||
+ | {| 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://doi.org/10.1200/jco.2012.43.7285 Demaj et al. 2013 (BENTLY)] | ||
+ | |2009-2011 | ||
+ | | style="background-color:#91cf61" |Phase 2 | ||
+ | | style="background-color:#d3d3d3" | | ||
+ | | style="background-color:#9ebcda" |ORR: 50% | ||
|- | |- | ||
− | | | + | |[https://doi.org/10.1016/s2352-3026(24)00102-9 Dupuis et al. 2024 (ORACLE)] |
− | |style="background-color:# | + | |2018-11-09 to 2021-02-22 |
+ | | style="background-color:#1a9851" |Phase 3 (C) | ||
+ | |[[#Azacitidine_oral_monotherapy_999|Oral azacitidine]] | ||
+ | | style="background-color:#ffffbf" |Did not meet primary endpoint of PFS | ||
|- | |- | ||
|} | |} | ||
− | ==== | + | ''Note: The majority of patients in ORACLE had angioimmunoblastic T-cell lymphoma (AITL). This was the upper bound of dosing in ORACLE.'' |
− | *[[ | + | <div class="toccolours" style="background-color:#b3e2cd"> |
− | + | ====Chemotherapy==== | |
− | + | *[[Bendamustine]] 120 mg/m<sup>2</sup> IV once per day on days 1 & 2 | |
− | + | '''21-day cycle for 6 cycles''' | |
+ | </div></div> | ||
===References=== | ===References=== | ||
− | + | <!-- Presented in part at the 11th International Conference on Malignant Lymphoma, Lugano, Switzerland, June 15-18, 2011; at the T-Cell Lymphoma Forum, San Francisco, CA, January 26-28, 2012; and at the 48th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, June 1-6, 2012. --> | |
− | + | #'''BENTLY:''' Damaj G, Gressin R, Bouabdallah K, Cartron G, Choufi B, Gyan E, Banos A, Jaccard A, Park S, Tournilhac O, Schiano-de Collela JM, Voillat L, Joly B, Le Gouill S, Saad A, Cony-Makhoul P, Vilque JP, Sanhes L, Schmidt-Tanguy A, Bubenheim M, Houot R, Diouf M, Marolleau JP, Béné MC, Martin A, Lamy T. Results from a prospective, open-label, phase II trial of bendamustine in refractory or relapsed T-cell lymphomas: the BENTLY trial. J Clin Oncol. 2013 Jan 1;31(1):104-10. Epub 2012 Oct 29. [https://doi.org/10.1200/jco.2012.43.7285 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/23109692/ PubMed] [https://clinicaltrials.gov/study/NCT00959686 NCT00959686] | |
− | + | #'''ORACLE:''' Dupuis J, Bachy E, Morschhauser F, Cartron G, Fukuhara N, Daguindau N, Casasnovas RO, Snauwaert S, Gressin R, Fox CP, d'Amore FA, Staber PB, Tournilhac O, Bouabdallah K, Thieblemont C, André M, Rai S, Ennishi D, Gkasiamis A, Nishio M, Fornecker LM, Delfau-Larue MH, Sako N, Mule S, de Leval L, Gaulard P, Tsukasaki K, Lemonnier F. Oral azacitidine compared with standard therapy in patients with relapsed or refractory follicular helper T-cell lymphoma (ORACLE): an open-label randomised, phase 3 study. Lancet Haematol. 2024 Jun;11(6):e406-e414. [https://doi.org/10.1016/s2352-3026(24)00102-9 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/38796193/ PubMed] [https://clinicaltrials.gov/study/NCT03593018 NCT03593018] | |
− | |||
− | |||
− | |||
==DHAP {{#subobject:f4e87b|Regimen=1}}== | ==DHAP {{#subobject:f4e87b|Regimen=1}}== | ||
− | |||
− | |||
− | |||
− | |||
DHAP: '''<u>D</u>'''examethasone, '''<u>H</u>'''igh-dose '''<u>A</u>'''ra-C (Cytarabine), '''<u>P</u>'''latinol (Cisplatin) | DHAP: '''<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:f5009d|Variant=1}}=== | ===Regimen {{#subobject:f5009d|Variant=1}}=== | ||
− | {| class="wikitable" style="width: 100%; text-align:center;" | + | {| class="wikitable sortable" style="width: 100%; text-align:center;" |
− | !Study | + | !style="width: 20%"|Study |
− | |[[Levels_of_Evidence#Evidence| | + | !style="width: 20%"|Dates of enrollment |
− | !Comparator | + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] |
− | ![[Levels_of_Evidence# | + | !style="width: 20%"|Comparator |
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
− | |[ | + | |[https://doi.org/10.1200/jco.2013.53.9593 Crump et al. 2014 (NCIC-CTG LY.12)] |
− | |style="background-color:# | + | |2003-2011 |
− | |[[ | + | | style="background-color:#1a9851" |Phase 3 (C) |
− | |style="background-color:# | + | |[[#GDP|GDP]] |
+ | | style="background-color:#ffffbf" |Inconclusive whether non-inferior ORR<sup>1</sup> | ||
|- | |- | ||
|} | |} | ||
+ | ''<sup>1</sup>Reported efficacy is based on the 2017 subgroup analysis.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
+ | *[[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 | ||
+ | ====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> | |
===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. --> | ||
− | # 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. [ | + | #'''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] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/25267740/ PubMed] [https://clinicaltrials.gov/study/NCT00078949 NCT00078949] |
+ | ##'''Subgroup analysis:''' Skamene T, Crump M, Savage KJ, Reiman T, Kuruvilla J, Good D, LeBrun D, Meyer RM, Sehn LH, Soulières D, Stakiw J, Laferriere N, Luminari S, Shepherd LE, Djurfeldt M, Zhu L, Chen BE, Hay AE. Salvage chemotherapy and autologous stem cell transplantation for peripheral T-cell lymphoma: a subset analysis of the Canadian Cancer Trials Group LY.12 randomized phase 3 study(). Leuk Lymphoma. 2017 Oct;58(10):2319-2327. Epub 2017 May 15. [https://doi.org/10.1080/10428194.2017.1312379 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28504033/ PubMed] | ||
==GDP {{#subobject:7ceb1c|Regimen=1}}== | ==GDP {{#subobject:7ceb1c|Regimen=1}}== | ||
− | |||
− | |||
− | |||
− | |||
GDP: '''<u>G</u>'''emcitabine, '''<u>D</u>'''examethasone, '''<u>P</u>'''latinol (Cisplatin) | GDP: '''<u>G</u>'''emcitabine, '''<u>D</u>'''examethasone, '''<u>P</u>'''latinol (Cisplatin) | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:67023b|Variant=1}}=== | ===Regimen {{#subobject:67023b|Variant=1}}=== | ||
− | {| class="wikitable" style="width: 100%; text-align:center;" | + | {| class="wikitable sortable" style="width: 100%; text-align:center;" |
− | !Study | + | !style="width: 20%"|Study |
− | |[[Levels_of_Evidence#Evidence| | + | !style="width: 20%"|Dates of enrollment |
− | !Comparator | + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] |
− | ![[Levels_of_Evidence# | + | !style="width: 20%"|Comparator |
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
− | |[ | + | |[https://doi.org/10.1200/jco.2013.53.9593 Crump et al. 2014 (NCIC-CTG LY.12)] |
− | |style="background-color:# | + | |2003-2011 |
− | |[[ | + | | style="background-color:#1a9851" |Phase 3 (E-switch-ic) |
− | |style="background-color:# | + | |[[#DHAP|DHAP]] |
+ | | style="background-color:#ffffbf" |Inconclusive whether non-inferior ORR<sup>1</sup> (co-primary endpoint) | ||
|- | |- | ||
|} | |} | ||
+ | ''<sup>1</sup>Reported efficacy is based on the 2017 subgroup analysis.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1 & 8 | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1 & 8 | ||
+ | *[[Cisplatin (Platinol)]] 75 mg/m<sup>2</sup> IV once on day 1 | ||
+ | ====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> | |
===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. --> | ||
− | # 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. [ | + | #'''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] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/25267740/ PubMed] [https://clinicaltrials.gov/study/NCT00078949 NCT00078949] |
− | + | ##'''Subgroup analysis:''' Skamene T, Crump M, Savage KJ, Reiman T, Kuruvilla J, Good D, LeBrun D, Meyer RM, Sehn LH, Soulières D, Stakiw J, Laferriere N, Luminari S, Shepherd LE, Djurfeldt M, Zhu L, Chen BE, Hay AE. Salvage chemotherapy and autologous stem cell transplantation for peripheral T-cell lymphoma: a subset analysis of the Canadian Cancer Trials Group LY.12 randomized phase 3 study(). Leuk Lymphoma. 2017 Oct;58(10):2319-2327. Epub 2017 May 15. [https://doi.org/10.1080/10428194.2017.1312379 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28504033/ PubMed] | |
− | + | ==Gemcitabine monotherapy {{#subobject:7dbc1c|Regimen=1}}== | |
− | == | + | <div class="toccolours" style="background-color:#eeeeee"> |
− | {| class="wikitable" style=" | + | ===Regimen variant #1, 1000 mg/m<sup>2</sup>; 3 weeks out of 4 {{#subobject:51923b|Variant=1}}=== |
+ | {| 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://www.ncbi.nlm.nih.gov/pmc/articles/pmc6494247/ O'Connor et al. 2019 (LUMIERE)] | ||
+ | |2012-2014 | ||
+ | | style="background-color:#1a9851" |Phase 3 (C) | ||
+ | |[[#Alisertib_monotherapy_999|Alisertib]] | ||
+ | | style="background-color:#ffffbf" |Did not meet co-primary endpoints of ORR/PFS | ||
|- | |- | ||
− | |||
|} | |} | ||
− | + | ''Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.'' | |
− | ===Regimen {{#subobject: | + | <div class="toccolours" style="background-color:#b3e2cd"> |
− | {| class="wikitable" style="width: 100%; text-align:center;" | + | ====Chemotherapy==== |
− | !Study | + | *[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15 |
− | |[[Levels_of_Evidence#Evidence| | + | '''28-day cycles''' |
− | | | + | </div></div><br> |
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | + | ===Regimen variant #2, 1200 mg/m<sup>2</sup>; 3 weeks out of 4 {{#subobject:51663b|Variant=1}}=== | |
+ | {| 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:// | + | |[https://doi.org/10.1016/s2352-3026(24)00102-9 Dupuis et al. 2024 (ORACLE)] |
− | |style="background-color:# | + | |2018-11-09 to 2021-02-22 |
+ | | style="background-color:#1a9851" |Phase 3 (C) | ||
+ | |[[#Azacitidine_oral_monotherapy_999|Oral azacitidine]] | ||
+ | | style="background-color:#ffffbf" |Did not meet primary endpoint of PFS | ||
|- | |- | ||
|} | |} | ||
+ | ''Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm. The majority of patients in this study had angioimmunoblastic T-cell lymphoma (AITL).'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | *[[ | + | *[[Gemcitabine (Gemzar)]] 1200 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15 |
− | + | '''28-day cycle for 6 cycles''' | |
− | ''' | + | </div></div> |
− | |||
===References=== | ===References=== | ||
− | + | #'''LUMIERE:''' O'Connor OA, Özcan M, Jacobsen ED, Roncero JM, Trotman J, Demeter J, Masszi T, Pereira J, Ramchandren R, Beaven A, Caballero D, Horwitz SM, Lennard A, Turgut M, Hamerschlak N, d'Amore FA, Foss F, Kim WS, Leonard JP, Zinzani PL, Chiattone CS, Hsi ED, Trümper L, Liu H, Sheldon-Waniga E, Ullmann CD, Venkatakrishnan K, Leonard EJ, Shustov AR; Lumiere Study Investigators. Randomized phase III study of alisertib or investigator's choice (selected single agent) in patients with relapsed or refractory peripheral T-cell lymphoma. J Clin Oncol. 2019 Mar 10;37(8):613-623. Epub 2019 Feb 1. [https://doi.org/10.1200/JCO.18.00899 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6494247/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30707661/ PubMed] [https://clinicaltrials.gov/study/NCT01482962 NCT01482962] | |
− | + | #'''ORACLE:''' Dupuis J, Bachy E, Morschhauser F, Cartron G, Fukuhara N, Daguindau N, Casasnovas RO, Snauwaert S, Gressin R, Fox CP, d'Amore FA, Staber PB, Tournilhac O, Bouabdallah K, Thieblemont C, André M, Rai S, Ennishi D, Gkasiamis A, Nishio M, Fornecker LM, Delfau-Larue MH, Sako N, Mule S, de Leval L, Gaulard P, Tsukasaki K, Lemonnier F. Oral azacitidine compared with standard therapy in patients with relapsed or refractory follicular helper T-cell lymphoma (ORACLE): an open-label randomised, phase 3 study. Lancet Haematol. 2024 Jun;11(6):e406-e414. [https://doi.org/10.1016/s2352-3026(24)00102-9 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/38796193/ PubMed] [https://clinicaltrials.gov/study/NCT03593018 NCT03593018] | |
− | |||
− | |||
− | == | + | ==Pralatrexate monotherapy {{#subobject:c2c35b|Regimen=1}}== |
− | {| class="wikitable" style=" | + | ===Example orders=== |
+ | *[[Example orders for Pralatrexate (Folotyn) in peripheral T-cell lymphoma]] | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen {{#subobject:9606fa|Variant=1}}=== | ||
+ | {| 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://www.ncbi.nlm.nih.gov/pmc/articles/PMC3083873/ O'Connor et al. 2011 (PROPEL)] | ||
+ | |2006-2008 | ||
+ | | style="background-color:#91cf61" |Phase 2 (RT) | ||
+ | | style="background-color:#d3d3d3" | | ||
+ | | style="background-color:#4d4d4d; color:white" |ORR: 29% | ||
+ | |- | ||
+ | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6494247/ O'Connor et al. 2019 (LUMIERE)] | ||
+ | |2012-2014 | ||
+ | | style="background-color:#1a9851" |Phase 3 (C) | ||
+ | |[[#Alisertib_monotherapy_999|Alisertib]] | ||
+ | | style="background-color:#ffffbf" |Did not meet co-primary endpoints of ORR/PFS | ||
|- | |- | ||
− | |||
|} | |} | ||
+ | ''Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Pralatrexate (Folotyn)]] 30 mg/m<sup>2</sup> IV over 3 to 5 minutes once per day on days 1, 8, 15, 22, 29, 36 | ||
+ | ====Supportive therapy==== | ||
+ | *[[Cyanocobalamin (Vitamin B12)]] 1 mg IM once every 8 to 10 weeks | ||
+ | *[[Folic acid (Folate)]] 1 to 1.25 mg PO once per day | ||
+ | **"Elevated methylmalonic acid (greater than 200 nmol/L) and/or homocysteine (greater than 10 µmol/L) at screening required initiation of [[Folic acid (Folate)]] and [[Cyanocobalamin (Vitamin B12)]] at least 10 days before the first dose of pralatrexate." | ||
+ | '''7-week cycles''' | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | <!-- Presented in part at the 52nd Annual Meeting of the American Society of Hematology, Orlando, FL, December 4-7, 2010; at the 5th Biennial Workshop on the Clinical Translation of Epigenetics in Cancer Therapy, San Diego, CA, January 14-16, 2011; at the T-Cell Lymphoma Forum, San Francisco, CA, January 27-29, 2011; and at the 47th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, June 3-7, 2011. --> | ||
+ | #'''PROPEL:''' O'Connor OA, Pro B, Pinter-Brown L, Bartlett N, Popplewell L, Coiffier B, Lechowicz MJ, Savage KJ, Shustov AR, Gisselbrecht C, Jacobsen E, Zinzani PL, Furman R, Goy A, Haioun C, Crump M, Zain JM, Hsi E, Boyd A, Horwitz S. Pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma: results from the pivotal PROPEL study. J Clin Oncol. 2011 Mar 20;29(9):1182-9. Epub 2011 Jan 18. [https://doi.org/10.1200/jco.2010.29.9024 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3083873/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21245435/ PubMed] [https://clinicaltrials.gov/study/NCT00364923 NCT00364923] | ||
+ | #'''LUMIERE:''' Connor OA, Özcan M, Jacobsen ED, Roncero JM, Trotman J, Demeter J, Masszi T, Pereira J, Ramchandren R, Beaven A, Caballero D, Horwitz SM, Lennard A, Turgut M, Hamerschlak N, d'Amore FA, Foss F, Kim WS, Leonard JP, Zinzani PL, Chiattone CS, Hsi ED, Trümper L, Liu H, Sheldon-Waniga E, Ullmann CD, Venkatakrishnan K, Leonard EJ, Shustov AR; Lumiere Study Investigators. Randomized phase III study of alisertib or investigator's choice (selected single agent) in patients with relapsed or refractory peripheral T-cell lymphoma. J Clin Oncol. 2019 Mar 10;37(8):613-623. Epub 2019 Feb 1. [https://doi.org/10.1200/JCO.18.00899 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6494247/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30707661/ PubMed] [https://clinicaltrials.gov/study/NCT01482962 NCT01482962] | ||
− | ===Regimen {{#subobject: | + | ==Romidepsin monotherapy {{#subobject:romc1c|Regimen=1}}== |
− | {| class="wikitable" style="width: 100%; text-align:center;" | + | <div class="toccolours" style="background-color:#eeeeee"> |
− | !Study | + | ===Regimen {{#subobject:51romb|Variant=1}}=== |
− | |[[Levels_of_Evidence#Evidence| | + | {| 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://doi.org/10.1016/s2352-3026(24)00102-9 Dupuis et al. 2024 (ORACLE)] |
− | |style="background-color:# | + | |2018-11-09 to 2021-02-22 |
+ | | style="background-color:#1a9851" |Phase 3 (C) | ||
+ | |[[#Azacitidine_oral_monotherapy_999|Oral azacitidine]] | ||
+ | | style="background-color:#ffffbf" |Did not meet primary endpoint of PFS | ||
|- | |- | ||
|} | |} | ||
− | + | ''Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm. The majority of patients in this study had angioimmunoblastic T-cell lymphoma (AITL).'' | |
− | ''Note: | + | <div class="toccolours" style="background-color:#b3e2cd"> |
− | *[[ | + | ====Targeted therapy==== |
− | + | *[[Romidepsin (Istodax)]] 14 mg/m<sup>2</sup> IV once per day on days 1, 8, 15 | |
− | ''' | + | '''28-day cycles''' |
+ | </div></div> | ||
===References=== | ===References=== | ||
− | + | #'''ORACLE:''' Dupuis J, Bachy E, Morschhauser F, Cartron G, Fukuhara N, Daguindau N, Casasnovas RO, Snauwaert S, Gressin R, Fox CP, d'Amore FA, Staber PB, Tournilhac O, Bouabdallah K, Thieblemont C, André M, Rai S, Ennishi D, Gkasiamis A, Nishio M, Fornecker LM, Delfau-Larue MH, Sako N, Mule S, de Leval L, Gaulard P, Tsukasaki K, Lemonnier F. Oral azacitidine compared with standard therapy in patients with relapsed or refractory follicular helper T-cell lymphoma (ORACLE): an open-label randomised, phase 3 study. Lancet Haematol. 2024 Jun;11(6):e406-e414. [https://doi.org/10.1016/s2352-3026(24)00102-9 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/38796193/ PubMed] [https://clinicaltrials.gov/study/NCT03593018 NCT03593018] | |
− | |||
− | == | + | =Relapsed or refractory, non-randomized or retrospective data= |
− | {| class="wikitable" style=" | + | ==Belinostat monotherapy {{#subobject:2a8653|Regimen=1}}== |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen {{#subobject:682543|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 80%; text-align:center;" | ||
+ | !style="width: 25%"|Study | ||
+ | !style="width: 25%"|Dates of enrollment | ||
+ | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | !style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | ||
|- | |- | ||
− | |[ | + | |[https://doi.org/10.1111/bjh.13222 Foss et al. 2014 (PXD101-CLN-6)] |
− | | | + | |2006-2009 |
− | = | + | | style="background-color:#91cf61" |Phase 2 |
− | + | | style="background-color:#404040; color:white" |ORR: 25% | |
− | |||
− | | | ||
− | |||
|- | |- | ||
− | |[ | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5087312/ O'Connor et al. 2015 (BELIEF)] |
− | |style="background-color:# | + | |2009-2011 |
− | | | + | | style="background-color:#91cf61" |Phase 2 (RT) |
+ | | style="background-color:#404040; color:white" |ORR: 26% | ||
|- | |- | ||
|} | |} | ||
− | ==== | + | <div class="toccolours" style="background-color:#b3e2cd"> |
− | *[[ | + | ====Targeted therapy==== |
− | + | *[[Belinostat (Beleodaq)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 to 5 | |
− | + | '''21-day cycles''' | |
− | '''21-day | + | </div></div> |
− | |||
===References=== | ===References=== | ||
− | # | + | <!-- # '''Abstract:''' Pohlman, Brad, Advani, Ranjana, Duvic, Madeleine, Hymes, Kenneth B., Intragumtornchai, Tanin, Lekhakula, Arnuparp, Shpilberg, Ofer, Lerner, Adam, Ben-Yehuda, Dina, beylot-Barry, Marie, Hillen, Uwe, Fagerberg, Jan, Foss, Francine M. Final Results of a Phase II Trial of Belinostat (PXD101) in Patients with Recurrent or Refractory Peripheral or Cutaneous T-Cell Lymphoma. ASH Annual Meeting Abstracts 2009 114: 920. --> |
− | + | #'''PXD101-CLN-6:''' Foss F, Advani R, Duvic M, Hymes KB, Intragumtornchai T, Lekhakula A, Shpilberg O, Lerner A, Belt RJ, Jacobsen ED, Laurent G, Ben-Yehuda D, Beylot-Barry M, Hillen U, Knoblauch P, Bhat G, Chawla S, Allen LF, Pohlman B. A phase II trial of belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma. Br J Haematol. 2015 Mar;168(6):811-9. Epub 2014 Nov 17. [https://doi.org/10.1111/bjh.13222 link to original article] '''dosing details in abstract have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/25404094/ PubMed] [https://clinicaltrials.gov/study/NCT00274651 NCT00274651] | |
+ | <!-- # '''Abstract:''' Owen A. O'Connor, Tamás Masszi, Kerry J. Savage, Lauren C. Pinter-Brown, Francine M. Foss, Leslie Popplewell, Amanda F. Cashen, Jeanette Doorduijn, Shanta Chawla, Poul Knoblauch, Pier Luigi Zinzani, Peter Brown, Georg Hess, Achiel Van Hoof, Steven M. Horwitz, Andrei R. Shustov. Belinostat, a novel pan-histone deacetylase inhibitor (HDACi), in relapsed or refractory peripheral T-cell lymphoma (R/R PTCL): Results from the BELIEF trial. J Clin Oncol 31, 2013 (suppl; abstr 8507) --> | ||
+ | #'''BELIEF:''' O'Connor OA, Horwitz S, Masszi T, Van Hoof A, Brown P, Doorduijn J, Hess G, Jurczak W, Knoblauch P, Chawla S, Bhat G, Choi MR, Walewski J, Savage K, Foss F, Allen LF, Shustov A. Belinostat in patients with relapsed or refractory peripheral T-cell lymphoma: results of the pivotal phase II BELIEF (CLN-19) study. J Clin Oncol. 2015 Aug 10;33(23):2492-9. Epub 2015 Jun 22. [https://doi.org/10.1200/jco.2014.59.2782 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5087312/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26101246/ PubMed] [https://clinicaltrials.gov/study/NCT00865969 NCT00865969] | ||
==Brentuximab vedotin monotherapy {{#subobject:b71ea8|Regimen=1}}== | ==Brentuximab vedotin monotherapy {{#subobject:b71ea8|Regimen=1}}== | ||
− | {| class="wikitable" style=" | + | <div class="toccolours" style="background-color:#eeeeee"> |
+ | ===Regimen {{#subobject:e3235|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 80%; text-align:center;" | ||
+ | !style="width: 25%"|Study | ||
+ | !style="width: 25%"|Dates of enrollment | ||
+ | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | !style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | ||
+ | |- | ||
+ | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4425442/ Horwitz et al. 2014 (SGN35-012<sub>CD30+T-NHL</sub>)] | ||
+ | |2011-09 to 2012-11 | ||
+ | | style="background-color:#91cf61" |Phase 2 | ||
+ | | style="background-color:#8c96c6" |ORR: 41% | ||
|- | |- | ||
− | |||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Antibody-drug conjugate therapy==== | ||
+ | *[[Brentuximab vedotin (Adcetris)]] 1.8 mg/kg IV over 30 minutes once on day 1 | ||
+ | '''21-day cycles''' | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | <!-- Presented in part at the 13th International Conference on Malignant Lymphoma, Lugano, Switzerland, June 2013. --> | ||
+ | #'''SGN35-012<sub>CD30+T-NHL</sub>:''' Horwitz SM, Advani RH, Bartlett NL, Jacobsen ED, Sharman JP, O'Connor OA, Siddiqi T, Kennedy DA, Oki Y. Objective responses in relapsed T-cell lymphomas with single-agent brentuximab vedotin. Blood. 2014 May 15;123(20):3095-100. Epub 2014 Mar 20. [https://doi.org/10.1182/blood-2013-12-542142 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4425442/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/24652992/ PubMed] [https://clinicaltrials.gov/study/NCT01421667 NCT01421667] | ||
− | ===Regimen {{#subobject: | + | ==Chidamide monotherapy {{#subobject:5a869f|Regimen=1}}== |
− | {| class="wikitable" style="width: | + | <div class="toccolours" style="background-color:#eeeeee"> |
− | !Study | + | ===Regimen {{#subobject:3a6a27|Variant=1}}=== |
− | |[[Levels_of_Evidence#Evidence| | + | {| class="wikitable sortable" style="width: 80%; text-align:center;" |
− | | | + | !style="width: 25%"|Study |
+ | !style="width: 25%"|Dates of enrollment | ||
+ | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | !style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1093/annonc/mdv237 Shi et al. 2015] |
− | |style="background-color:# | + | |2010-04 to 2012-05 |
− | | | + | | style="background-color:#91cf61" |Phase 2 |
+ | |ORR: 28% | ||
|- | |- | ||
|} | |} | ||
− | ==== | + | <div class="toccolours" style="background-color:#b3e2cd"> |
− | *[[ | + | ====Targeted therapy==== |
− | + | *[[Chidamide (Epidaza)]] 30 mg PO twice per week | |
− | ''' | + | '''Continued indefinitely''' |
− | + | </div></div> | |
===References=== | ===References=== | ||
− | + | #Shi Y, Dong M, Hong X, Zhang W, Feng J, Zhu J, Yu L, Ke X, Huang H, Shen Z, Fan Y, Li W, Zhao X, Qi J, Huang H, Zhou D, Ning Z, Lu X. Results from a multicenter, open-label, pivotal phase II study of chidamide in relapsed or refractory peripheral T-cell lymphoma. Ann Oncol. 2015 Aug;26(8):1766-71. Epub 2015 Jun 23. [https://doi.org/10.1093/annonc/mdv237 link to original article] '''dosing details in abstract have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/26105599/ PubMed] ChiCTR-TNC-10000811 | |
− | |||
− | == | + | ==Darinaparsin monotherapy {{#subobject:2cgcb4|Regimen=1}}== |
− | {| class="wikitable" style=" | + | <div class="toccolours" style="background-color:#eeeeee"> |
+ | ===Regimen {{#subobject:13c9e9|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
+ | !style="width: 33%"|Study | ||
+ | !style="width: 33%"|Dates of enrollment | ||
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | |- | ||
+ | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc10463191/ Kim et al. 2023 (SP-02)] | ||
+ | |Not reported | ||
+ | | style="background-color:#91cf61" |Phase 2 | ||
|- | |- | ||
− | |||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Antineoplastic therapy==== | ||
+ | *[[Darinaparsin (Darvias)]] 300 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1 to 5 | ||
+ | '''21-day cycles''' | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | #'''SP-02:''' Kim WS, Fukuhara N, Yoon DH, Yamamoto K, Uchida T, Negoro E, Izutsu K, Terui Y, Nakajima H, Ando K, Suehiro Y, Kang HJ, Ko PS, Nagahama F, Sonehara Y, Nagai H, Tien HF, Kwong YL, Tobinai K. Darinaparsin in patients with relapsed or refractory peripheral T-cell lymphoma: results of an Asian phase 2 study. Blood Adv. 2023 Sep 12;7(17):4903-4912. [https://doi.org/10.1182/bloodadvances.2022008615 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc10463191/ link to PMC article] '''dosing details in abstract have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/36661315/ PubMed] [https://clinicaltrials.gov/study/NCT02653976 NCT02653976] | ||
− | ===Regimen {{#subobject: | + | ==Duvelisib monotherapy {{#subobject:2ccg33|Regimen=1}}== |
− | {| class="wikitable" style="width: | + | <div class="toccolours" style="background-color:#eeeeee"> |
− | !Study | + | ===Regimen {{#subobject:cg22e9|Variant=1}}=== |
− | |[[Levels_of_Evidence#Evidence| | + | {| class="wikitable sortable" style="width: 60%; text-align:center;" |
− | + | !style="width: 33%"|Study | |
− | + | !style="width: 33%"|Dates of enrollment | |
− | + | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | |
|- | |- | ||
− | |[https:// | + | |[https://clinicaltrials.gov/study/NCT03372057 Awaiting publication (PRIMO)] |
− | |style="background-color:# | + | |2018-ongoing |
+ | | style="background-color:#91cf61" |Phase 2 | ||
|- | |- | ||
|} | |} | ||
− | ==== | + | ''Note: This is the dose used in the expansion phase; this trial remains unpublished.'' |
− | *[[ | + | <div class="toccolours" style="background-color:#b3e2cd"> |
− | + | ====Targeted therapy==== | |
+ | *[[Duvelisib (Copiktra)]] as follows: | ||
+ | **Cycles 1 & 2: 75 mg PO twice per day on days 1 to 28 | ||
+ | **Cycle 3 onwards: 25 mg PO twice per day on days 1 to 28 | ||
'''28-day cycles''' | '''28-day cycles''' | ||
+ | </div></div> | ||
− | ''' | + | ===References=== |
+ | #'''PRIMO:''' [https://clinicaltrials.gov/study/NCT03372057 NCT03372057] | ||
+ | ==Forodesine monotherapy {{#subobject:2310b4|Regimen=1}}== | ||
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
+ | ===Regimen {{#subobject:d759e9|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 80%; text-align:center;" | ||
+ | !style="width: 25%"|Study | ||
+ | !style="width: 25%"|Dates of enrollment | ||
+ | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | !style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | ||
+ | |- | ||
+ | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6334730/ Maruyama et al. 2018 (FDS-J02)] | ||
+ | |2013-01 to 2017-02 | ||
+ | | style="background-color:#91cf61" |Phase 1/2 | ||
+ | |ORR: 22% | ||
+ | |- | ||
+ | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Forodesine (Fodosine)]] 300 mg PO twice per day | ||
+ | '''Continued indefinitely''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | # | + | #'''FDS-J02:''' Maruyama D, Tsukasaki K, Uchida T, Maeda Y, Shibayama H, Nagai H, Kurosawa M, Suehiro Y, Hatake K, Ando K, Yoshida I, Hidaka M, Murayama T, Okitsu Y, Tsukamoto N, Taniwaki M, Suzumiya J, Tamura K, Yamauchi T, Ueda R, Tobinai K. Multicenter phase 1/2 study of forodesine in patients with relapsed peripheral T cell lymphoma. Ann Hematol. 2019 Jan;98(1):131-142. Epub 2018 Jul 5. Erratum in: Ann Hematol. 2018 Jul 27. [https://doi.org/10.1007/s00277-018-3418-2 link to original article] '''dosing details in abstract have been reviewed by our editors''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6334730/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/29974231/ PubMed] [https://clinicaltrials.gov/study/NCT01776411 NCT01776411] |
− | |||
− | |||
− | == | + | ==Lenalidomide monotherapy {{#subobject:372121|Regimen=1}}== |
− | {| class="wikitable" style=" | + | <div class="toccolours" style="background-color:#eeeeee"> |
+ | ===Regimen variant #1, limited duration {{#subobject:b6993e|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 80%; text-align:center;" | ||
+ | !style="width: 25%"|Study | ||
+ | !style="width: 25%"|Dates of enrollment | ||
+ | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | !style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | ||
+ | |- | ||
+ | |[https://doi.org/10.1016/j.ejca.2013.04.029 Morschhauser et al. 2013 (EXPECT)] | ||
+ | |Not reported | ||
+ | | style="background-color:#91cf61" |Phase 2 | ||
+ | | style="background-color:#666666; color:white" |ORR: 41% | ||
|- | |- | ||
− | |||
|} | |} | ||
− | === | + | <div class="toccolours" style="background-color:#b3e2cd"> |
− | *[[ | + | ====Targeted therapy==== |
− | + | *[[Lenalidomide (Revlimid)]] 25 mg PO once per day on days 1 to 21 | |
− | ===Regimen {{#subobject: | + | '''28-day cycle for up to 26 cycles (2 years)''' |
− | {| class="wikitable" style="width: | + | </div></div><br> |
− | !Study | + | <div class="toccolours" style="background-color:#eeeeee"> |
− | |[[Levels_of_Evidence#Evidence| | + | ===Regimen variant #2, indefinite {{#subobject:868aa6|Variant=1}}=== |
+ | {| class="wikitable sortable" style="width: 80%; text-align:center;" | ||
+ | !style="width: 25%"|Study | ||
+ | !style="width: 25%"|Dates of enrollment | ||
+ | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | !style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1002/cncr.25377 Dueck et al. 2010] |
− | |style="background-color:# | + | |2006-09 to 2008-11 |
+ | | style="background-color:#91cf61" |Phase 2 | ||
+ | | style="background-color:#4d4d4d; color:white" |ORR: 30% | ||
|- | |- | ||
|} | |} | ||
− | == | + | <div class="toccolours" style="background-color:#b3e2cd"> |
− | + | ====Targeted therapy==== | |
− | + | *[[Lenalidomide (Revlimid)]] 25 mg PO once per day on days 1 to 21 | |
− | ==== | + | '''28-day cycles''' |
− | *[[ | + | </div></div> |
− | |||
− | |||
− | |||
− | ''' | ||
− | |||
===References=== | ===References=== | ||
− | + | #Dueck G, Chua N, Prasad A, Finch D, Stewart D, White D, van der Jagt R, Johnston J, Belch A, Reiman T. Interim report of a phase 2 clinical trial of lenalidomide for T-cell non-Hodgkin lymphoma. Cancer. 2010 Oct 1;116(19):4541-8. [https://doi.org/10.1002/cncr.25377 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/20572046/ PubMed] [https://clinicaltrials.gov/study/NCT00322985 NCT00322985] | |
− | # | + | ##'''Update:''' Toumishey E, Prasad A, Dueck G, Chua N, Finch D, Johnston J, van der Jagt R, Stewart D, White D, Belch A, Reiman T. Final report of a phase 2 clinical trial of lenalidomide monotherapy for patients with T-cell lymphoma. Cancer. 2015 Mar 1;121(5):716-23. Epub 2014 Oct 29. [https://doi.org/10.1002/cncr.29103 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25355245/ PubMed] |
+ | #'''EXPECT:''' Morschhauser F, Fitoussi O, Haioun C, Thieblemont C, Quach H, Delarue R, Glaisner S, Gabarre J, Bosly A, Lister J, Li J, Coiffier B. A phase 2, multicentre, single-arm, open-label study to evaluate the safety and efficacy of single-agent lenalidomide (Revlimid®) in subjects with relapsed or refractory peripheral T-cell non-Hodgkin lymphoma: The EXPECT trial. Eur J Cancer. 2013 Sep;49(13):2869-76. Epub 2013 May 31. [https://doi.org/10.1016/j.ejca.2013.04.029 link to original article] '''dosing details in abstract have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/23731832/ PubMed] [https://clinicaltrials.gov/study/NCT00655668 NCT00655668] | ||
− | == | + | ==Mogamulizumab monotherapy {{#subobject:8d8ae3|Regimen=1}}== |
− | {| class="wikitable" style=" | + | <div class="toccolours" style="background-color:#eeeeee"> |
+ | ===Regimen {{#subobject:2848bf|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
+ | !style="width: 33%"|Study | ||
+ | !style="width: 33%"|Dates of enrollment | ||
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | |- | ||
+ | |[https://doi.org/10.1200/jco.2013.52.0924 Ogura et al. 2014 (KW-0761-004)] | ||
+ | |Not reported | ||
+ | | style="background-color:#91cf61" |Phase 2 | ||
|- | |- | ||
− | |||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Targeted therapy==== | ||
+ | *[[Mogamulizumab (Poteligeo)]] 1 mg/kg IV once per day on days 1, 8, 15, 22 | ||
+ | '''28-day cycle for 2 cycles''' | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | #'''KW-0761-004:''' Ogura M, Ishida T, Hatake K, Taniwaki M, Ando K, Tobinai K, Fujimoto K, Yamamoto K, Miyamoto T, Uike N, Tanimoto M, Tsukasaki K, Ishizawa K, Suzumiya J, Inagaki H, Tamura K, Akinaga S, Tomonaga M, Ueda R. Multicenter phase II study of mogamulizumab (KW-0761), a defucosylated anti-cc chemokine receptor 4 antibody, in patients with relapsed peripheral T-cell lymphoma and cutaneous T-cell lymphoma. J Clin Oncol. 2014 Apr 10;32(11):1157-63. Epub 2014 Mar 10. [https://doi.org/10.1200/jco.2013.52.0924 link to original article] '''dosing details in abstract have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/24616310/ PubMed] [https://clinicaltrials.gov/study/NCT01192984 NCT01192984] | ||
− | ===Regimen {{#subobject: | + | =Consolidation after salvage therapy= |
− | {| class="wikitable" style="width: | + | ==Fludarabine, Busulfan, Cyclophosphamide, then allo HSCT {{#subobject:84acb0|Regimen=1}}== |
− | !Study | + | FluBuCy: '''<u>Flu</u>'''darabine, '''<u>Bu</u>'''sulfan, '''<u>Cy</u>'''clophosphamide |
− | |[[Levels_of_Evidence#Evidence| | + | <div class="toccolours" style="background-color:#eeeeee"> |
− | + | ===Regimen variant #1, oral {{#subobject:bfe434|Variant=1}}=== | |
− | + | {| class="wikitable sortable" style="width: 60%; text-align:center;" | |
+ | !style="width: 33%"|Study | ||
+ | !style="width: 33%"|Dates of enrollment | ||
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1016/S1470-2045(14)70161-5 Glass et al. 2014 (DSHNHL R3)] |
− | |style="background-color:# | + | |2004-06-16 to 2009-03-24 |
− | + | | style="background-color:#91cf61" |Phase 2 | |
− | |||
|- | |- | ||
− | |[ | + | |} |
− | |style="background-color:# | + | {{#lst:Allogeneic HSCT|bfe434}} |
− | + | </div></div><br> | |
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
+ | ===Regimen variant #2, intravenous {{#subobject:bfe434|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
+ | !style="width: 33%"|Study | ||
+ | !style="width: 33%"|Dates of enrollment | ||
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | |- | ||
+ | |[https://doi.org/10.1016/S1470-2045(14)70161-5 Glass et al. 2014 (DSHNHL R3)] | ||
+ | |2004-06-16 to 2009-03-24 | ||
+ | | style="background-color:#91cf61" |Phase 2 | ||
|- | |- | ||
|} | |} | ||
− | + | {{#lst:Allogeneic HSCT|bfe435}} | |
− | + | </div></div> | |
− | |||
− | |||
− | |||
===References=== | ===References=== | ||
− | # | + | <!-- # Glass B, rabbits Kamp J, Wulf G, Dreger P, Pfreundschuh M, Gramatzki M Silling G, Wilhelm C, Zeis M, Görlitz A, Pfeiffer S, Hilgers R, Truemper L, Schmitz N. High-dose chemotherapy Followed by allogeneic stem cell transplantation in relapsed and refractory high-risk aggressive non-Hodgkin's lymphoma: Results of a prospective study of the German high-grade non-Hodgkin's lymphoma study group. J Clin Oncol 30, 2012 (suppl; abstr 8004) --> |
− | + | #'''DSHNHL R3:''' Glass B, Hasenkamp J, Wulf G, Dreger P, Pfreundschuh M, Gramatzki M, Silling G, Wilhelm C, Zeis M, Görlitz A, Pfeiffer S, Hilgers R, Truemper L, Schmitz N; German High-Grade Lymphoma Study Group. Rituximab after lymphoma-directed conditioning and allogeneic stem-cell transplantation for relapsed and refractory aggressive non-Hodgkin lymphoma (DSHNHL R3): an open-label, randomised, phase 2 trial. Lancet Oncol. 2014 Jun;15(7):757-66. Epub 2014 May 11. [https://doi.org/10.1016/S1470-2045(14)70161-5 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/24827808/ PubMed] [https://clinicaltrials.gov/study/NCT00785330 NCT00785330] | |
− | |||
− | |||
− | |||
− | |||
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[[Category:Peripheral T-cell lymphoma regimens]] | [[Category:Peripheral T-cell lymphoma regimens]] | ||
[[Category:Disease-specific pages]] | [[Category:Disease-specific pages]] | ||
[[Category:T-cell lymphomas]] | [[Category:T-cell lymphomas]] |
Latest revision as of 23:36, 15 July 2024
Section editor | |
---|---|
Bhagirathbhai Dholaria, MBBS Vanderbilt University Nashville, TN, USA |
30 regimens on this page
37 variants on this page
|
Are you looking for a regimen but can't find it here? It is possible that we've moved it to the historical regimens page. If you still can't find it, please let us know so we can add it!.
Note: some subtypes of PTCL have been moved to dedicated pages:
- Anaplastic large cell lymphoma
- Extranodal NK- and T-cell lymphoma, nasal type
- NK- and T-cell lymphoma
Guidelines
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.
ESMO
- 2015: d'Amore et al. Peripheral T-cell lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up PubMed
- 2013: Dreyling et al. ESMO Consensus conferences: guidelines on malignant lymphoma. part 2: marginal zone lymphoma, mantle cell lymphoma, peripheral T-cell lymphoma. PubMed
NCCN
- NCCN does not currently have guidelines at this granular level; please see NCCN Guidelines - T-cell Lymphomas.
Untreated, randomized data
BV-CHP
BV-CHP: Brentuximab Vedotin, Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Prednisone
A+CHP: Adcetris (Brentuximab vedotin), Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Prednisone
Regimen
FDA-recommended dose |
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Horwitz et al. 2018 (ECHELON-2) | 2013-2016 | Phase 3 (E-RT-switch-ooc) | CHOP | Superior PFS (primary endpoint) Median PFS: 48.2 vs 20.8 mo (HR 0.71, 95% CI 0.54-0.93) Seems to have superior OS1 (secondary endpoint) OS60: 70.1% vs 61% (HR 0.72, 95% CI 0.53-0.99) |
1Reported efficacy is based on the 2021 update.
Antibody-drug conjugate therapy
- Brentuximab vedotin (Adcetris) 1.8 mg/kg IV once on day 1, given fourth
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
Glucocorticoid therapy
- Prednisone (Sterapred) 100 mg PO once per day on days 1 to 5
21-day cycle for 6 to 8 cycles
References
- ECHELON-2: Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trümper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019 Jan 19;393(10168):229-240. Epub 2018 Dec 4. Erratum in: Lancet. 2019 Jan 19;393(10168):228. link to original article dosing details in abstract have been reviewed by our editors link to PMC article PubMed NCT01777152
- Update: Horwitz S, O'Connor OA, Pro B, Trümper L, Iyer S, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Menne T, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Zinzani PL, Miao H, Bunn V, Fenton K, Fanale M, Puhlmann M, Illidge T. The ECHELON-2 Trial: 5-year results of a randomized, phase III study of brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma. Ann Oncol. 2022 Mar;33(3):288-298. Epub 2021 Dec 16. link to original article link to PMC article PubMed
CHOP
CHOP: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisone
Regimen variant #1, 6 cycles, 40 mg/m2
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Bachy et al. 2021 (LYSA Ro-CHOP) | 2013-2017 | Phase 3 (C) | Ro-CHOP | Might have inferior PFS1 (primary endpoint) Median PFS: 10.2 vs 12 mo (HR 1.27, 95% CI 0.995-1.61) |
1Reported efficacy is based on the 2024 update.
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) by the following age-based criteria:
- 70 years old or younger: 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
- Older than 70 years old: 1.4 mg/m2 (maximum dose of 1.5 mg) IV once on day 1
Glucocorticoid therapy
- Prednisone (Sterapred) 40 mg/m2 PO once per day on days 1 to 5
21-day cycle for 6 cycles
Regimen variant #2, 6 cycles, prednisone 60 mg/m2
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Reimer et al. 2004 | 2000-2006 | Non-randomized | ||
Li et al. 2017 (hnslblzlzx2011-3) | 2010-2016 | Phase 3 (C) | GDPT | Inferior OS |
Note: the abstract of Reimer et al. 2004 does not have dosing details.
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
Glucocorticoid therapy
- Prednisone (Sterapred) 60 mg/m2 PO once per day on days 1 to 5
21-day cycle for 6 cycles
Regimen variant #2, 8 cycles
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Simon et al. 2010 (GOELAMS LTP95) | 1996-2002 | Phase 3 (C) | VIP-rABVD | Did not meet primary endpoint of EFS24 |
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
Glucocorticoid therapy
- Prednisone (Sterapred) 100 mg/m2 PO once per day on days 1 to 5
21-day cycle for 8 cycles
Subsequent treatment
- GOELAMS LTP95, patients with initial bulky disease (diameter at least 5 cm): IFRT consolidation x 4000 cGy
References
- Reimer P, Schertlin T, Rüdiger T, Geissinger E, Roth S, Kunzmann V, Weissinger F, Nerl C, Schmitz N, Müller-Hermelink HK, Wilhelm M. Myeloablative radiochemotherapy followed by autologous peripheral blood stem cell transplantation as first-line therapy in peripheral T-cell lymphomas: first results of a prospective multicenter study. Hematol J. 2004;5(4):304-11. link to original article does not contain dosing details PubMed
- Update: Reimer P, Rüdiger T, Geissinger E, Weissinger F, Nerl C, Schmitz N, Engert A, Einsele H, Müller-Hermelink HK, Wilhelm M. Autologous stem-cell transplantation as first-line therapy in peripheral T-cell lymphomas: results of a prospective multicenter study. J Clin Oncol. 2009 Jan 1;27(1):106-13. Epub 2008 Nov 24. link to original article PubMed
- GOELAMS-LTP95: Simon A, Peoch M, Casassus P, Deconinck E, Colombat P, Desablens B, Tournilhac O, Eghbali H, Foussard C, Jaubert J, Vilque JP, Rossi JF, Lucas V, Delwail V, Thyss A, Maloisel F, Milpied N, le Gouill S, Lamy T, Gressin R. Upfront VIP-reinforced-ABVD (VIP-rABVD) is not superior to CHOP/21 in newly diagnosed peripheral T cell lymphoma: results of the randomized phase III trial GOELAMS-LTP95. Br J Haematol. 2010 Oct;151(2):159-66. Epub 2010 Aug 25. link to original article dosing details in manuscript have been reviewed by our editors PubMed
- Meta-analysis: Abouyabis AN, Shenoy PJ, Sinha R, Flowers CR, Lechowicz MJ. A systematic review and meta-analysis of front-line anthracycline-based chemotherapy regimens for peripheral T-cell lymphoma. ISRN Hematol. 2011;2011:623924. Epub 2011 Jun 16. link to original article link to PMC article PubMed
- hnslblzlzx2011-3: Li L, Duan W, Zhang L, Li X, Fu X, Wang X, Wu J, Sun Z, Zhang X, Chang Y, Nan F, Yan J, Li Z, Young KH, Zhang M. The efficacy and safety of gemcitabine, cisplatin, prednisone, thalidomide versus CHOP in patients with newly diagnosed peripheral T-cell lymphoma with analysis of biomarkers. Br J Haematol. 2017 Sep;178(5):772-780. Epub 2017 Jun 9. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT01664975
- ECHELON-2: Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trümper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019 Jan 19;393(10168):229-240. Epub 2018 Dec 4. Erratum in: Lancet. 2019 Jan 19;393(10168):228. link to original article dosing details in abstract have been reviewed by our editors link to PMC article PubMed NCT01777152
- Update: Horwitz S, O'Connor OA, Pro B, Trümper L, Iyer S, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Menne T, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Zinzani PL, Miao H, Bunn V, Fenton K, Fanale M, Puhlmann M, Illidge T. The ECHELON-2 Trial: 5-year results of a randomized, phase III study of brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma. Ann Oncol. 2022 Mar;33(3):288-298. Epub 2021 Dec 16. link to original article link to PMC article PubMed
- LYSA Ro-CHOP: Bachy E, Camus V, Thieblemont C, Sibon D, Casasnovas RO, Ysebaert L, Damaj G, Guidez S, Pica GM, Kim WS, Lim ST, André M, García-Sancho AM, Penarrubia MJ, Staber PB, Trotman J, Hüttmann A, Stefoni V, Re A, Gaulard P, Delfau-Larue MH, de Leval L, Meignan M, Li J, Morschhauser F, Delarue R. Romidepsin Plus CHOP Versus CHOP in Patients With Previously Untreated Peripheral T-Cell Lymphoma: Results of the Ro-CHOP Phase III Study (Conducted by LYSA). J Clin Oncol. 2022 Jan 20;40(3):242-251. Epub 2021 Nov 29. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT01796002
- Update: Camus V, Thieblemont C, Gaulard P, Cheminant M, Casasnovas RO, Ysebaert L, Damaj GL, Guidez S, Pica GM, Kim WS, Lim ST, Andre M, Gutiérrez N, Penarrubia MJ, Staber PB, Trotman J, Hüttmann A, Stefoni V, Tucci A, Fogarty P, Farhat H, Abraham J, Abarah W, Belmecheri F, Ribrag V, Delfau-Larue MH, Cottereau AS, Itti E, Li J, Delarue R, de Leval L, Morschhauser F, Bachy E. Romidepsin Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone Versus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Previously Untreated Peripheral T-Cell Lymphoma: Final Analysis of the Ro-CHOP Trial. J Clin Oncol. 2024 May 10;42(14):1612-1618. Epub 2024 Feb 16. link to original article PubMed
CHOP-14 (Prednisolone)
CHOP-14: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Prednisolone every 14 days
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Wulf et al. 2020 (ACT-2) | 2007-2013 | Phase 3 (C) | A-CHOP-14 | Did not meet primary endpoint of EFS |
Preceding treatment
- ACT-2: Vincristine & Prednisolone pre-phase
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
Glucocorticoid therapy
- Prednisolone (Millipred) 100 mg PO once per day on days 1 to 5
Supportive therapy
- G-CSF support
14-day cycle for 6 cycles
References
- ACT-2: Wulf GG, Altmann B, Ziepert M, D'Amore F, Held G, Greil R, Tournilhac O, Relander T, Viardot A, Wilhelm M, Wilhelm C, Pezzutto A, Zijlstra JM, van den Neste E, Lugtenburg PJ, Doorduijn JK, Gelder MV, van Imhoff GW, Zettl F, Braulke F, Nickelsen M, Glass B, Rosenwald A, Gaulard P, Loeffler M, Pfreundschuh M, Schmitz N, Trümper L; DSHNHL. Alemtuzumab plus CHOP versus CHOP in elderly patients with peripheral T-cell lymphoma: the DSHNHL2006-1B/ACT-2 trial. Leukemia. 2021 Jan;35(1):143-155. Epub 2020 May 7. link to original article dosing details in manuscript have been reviewed by our editors PubMed
CMED
CMED: Cyclophosphamide, Methotrexate, Etoposide, Dexamethasone
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Avilés et al. 2008 | 1994-2001 | Phase 3 (E-switch-ic) | CHOP | Superior OS (co-primary endpoint) |
Chemotherapy
- Cyclophosphamide (Cytoxan) 2000 mg/m2 IV once on day 1
- Methotrexate (MTX) 300 mg/m2 IV once on day 1
- Etoposide (Vepesid) 400 mg/m2 IV once per day on days 1 & 2
Glucocorticoid therapy
- Dexamethasone (Decadron) 20 mg/m2 PO once per day on days 1 to 5
Supportive therapy
- Leucovorin (Folinic acid) 15 mg IV every 6 hours for 12 doses, started 24 hours after MTX
14-day cycle for 6 cycles
References
- Avilés A, Castañeda C, Neri N, Cleto S, Talavera A, González M, Huerta-Guzmán J, Nambo MJ. Results of a phase III clinical trial: CHOP versus CMED in peripheral T-cell lymphoma unspecified. Med Oncol. 2008;25(3):360-4. Epub 2008 Feb 5. link to original article dosing details in manuscript have been reviewed by our editors PubMed
GDPT
GDPT: Gemcitabine, DDP (Cisplatin), Prednisone, Thalidomide
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Li et al. 2017 (hnslblzlzx2011-3) | 2010-2016 | Phase 3 (E-switch-ooc) | CHOP | Superior OS24 (secondary endpoint) OS24: 71% vs 50% |
Chemotherapy
- Gemcitabine (Gemzar) 800 mg/m2 IV over 30 minutes once per day on days 1 & 8
- Cisplatin (Platinol) 25 mg/m2 IV once per day on days 1 to 3
Glucocorticoid therapy
- Prednisone (Sterapred) 60 mg/m2 PO once per day on days 1 to 5
Targeted therapy
- Thalidomide (Thalomid) 50 mg PO once per day, increased by 50 mg per day until target dose of 200 mg PO once per day
Supportive therapy
- Aspirin 100 mg PO once per day
21-day cycle for 6 cycles
References
- hnslblzlzx2011-3: Li L, Duan W, Zhang L, Li X, Fu X, Wang X, Wu J, Sun Z, Zhang X, Chang Y, Nan F, Yan J, Li Z, Young KH, Zhang M. The efficacy and safety of gemcitabine, cisplatin, prednisone, thalidomide versus CHOP in patients with newly diagnosed peripheral T-cell lymphoma with analysis of biomarkers. Br J Haematol. 2017 Sep;178(5):772-780. Epub 2017 Jun 9. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT01664975
Untreated, non-randomized or retrospective data
A-CHOP
A-CHOP: Alemtuzumab, Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Predniso(lo)ne
CHOP-AL: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Predniso(lo)ne, ALemtuzumab
CHOP-C: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Predniso(lo)ne, Campath (Alemtuzumab)
Regimen variant #1, 2 cycles
Study | Dates of enrollment | Evidence |
---|---|---|
Corradini et al. 2014 (PTCL-06) | 2006-2010 | Phase 2 |
Note: These are the details for "Clin A" which was the regimen used for patients younger than 60. Note: this is a component of a sequential treatment protocol; to our knowledge there are no references to support using it as a stand-alone treatment.
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
Glucocorticoid therapy
- Prednisone (Sterapred) 100 mg PO once per day on days 1 to 5
Targeted therapy
- Alemtuzumab (Campath) as follows:
- Cycle 1: 3 mg IV once on day -2, then 10 mg IV once on day -1, then 20 mg IV once on day 0
- Cycle 2: 30 mg IV once on day 0 (= day 21 of cycle 1)
21-day cycle for 2 cycles
Subsequent treatment
- HyperCHidam consolidation x 2
Regimen variant #2, 8 cycles
Study | Dates of enrollment | Evidence |
---|---|---|
Gallamini et al. 2007 | 2003-01 to 2005-12 | Phase 2 |
Note: the paper reports using the CHOP dosing as specified by Fisher et al. 1993; however, note that the cycle length here is 28 days.
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
Glucocorticoid therapy
- Prednisone (Sterapred) 100 mg PO once per day on days 1 to 5
Targeted therapy
- Alemtuzumab (Campath) as follows:
- Cycle 1: 3 mg IV once on day -2, then 10 mg IV once on day -1, then 20 mg IV once on day 0, then 30 mg IV once on day 1
- Cycles 2 to 8: 30 mg IV once on day 1
Supportive therapy
- Chlorpheniramine (Chlor-Trimeton) 10 mg IV once per infusion; 60 minutes prior to alemtuzumab
- Acetaminophen (Tylenol) 500 mg PO once per infusion; 30 minutes prior to alemtuzumab
- Alizapride (Litican) 100 mg IV once per infusion; 30 minutes prior to alemtuzumab
28-day cycle for 8 cycles
References
- Gallamini A, Zaja F, Patti C, Billio A, Specchia MR, Tucci A, Levis A, Manna A, Secondo V, Rigacci L, Pinto A, Iannitto E, Zoli V, Torchio P, Pileri S, Tarella C. Alemtuzumab (Campath-1H) and CHOP chemotherapy as first-line treatment of peripheral T-cell lymphoma: results of a GITIL (Gruppo Italiano Terapie Innovative nei Linfomi) prospective multicenter trial. Blood. 2007 Oct 1;110(7):2316-23. Epub 2007 Jun 20. link to original article contains partial protocol PubMed
- PTCL-06: Corradini P, Vitolo U, Rambaldi A, Miceli R, Patriarca F, Gallamini A, Olivieri A, Benedetti F, Todeschini G, Rossi G, Salvi F, Bruno B, Baldini L, Ferreri A, Patti C, Tarella C, Pileri S, Dodero A. Intensified chemo-immunotherapy with or without stem cell transplantation in newly diagnosed patients with peripheral T-cell lymphoma. Leukemia. 2014 Sep;28(9):1885-91. Epub 2014 Feb 20. link to original article dosing details in manuscript have been reviewed by our editors PubMed EudraCT 2006-004234-33
CHOEP-14
CHOEP-14: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Etoposide, Prednisone every 14 days
Regimen
Study | Dates of enrollment | Evidence |
---|---|---|
d'Amore et al. 2012 (NLG-T-01) | 2001-10 to 2007-10 | Phase 2 |
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
- Etoposide (Vepesid) by the following age-based criteria:
- 60 years old or younger: 100 mg/m2 IV once per day on days 1 to 3
Glucocorticoid therapy
- Prednisone (Sterapred) 50 mg PO twice per day on days 1 to 5
14-day cycle for 6 cycles
Subsequent treatment
- If patients in PR or CR after three cycles, stem cells are mobilized off of cycles 5 and 6, followed by BEAC or BEAM auto HSCT consolidation
References
- NLG-T-01: d'Amore F, Relander T, Lauritzsen GF, Jantunen E, Hagberg H, Anderson H, Holte H, Österborg A, Merup M, Brown P, Kuittinen O, Erlanson M, Østenstad B, Fagerli UM, Gadeberg OV, Sundström C, Delabie J, Ralfkiaer E, Vornanen M, Toldbod HE. Up-front autologous stem-cell transplantation in peripheral T-cell lymphoma: NLG-T-01. J Clin Oncol. 2012 Sep 1;30(25):3093-9. Epub 2012 Jul 30. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT00791947
CHOP & Everolimus
CHOP & Everolimus: Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Predniso(lo)ne, Everolimus
Regimen
Study | Dates of enrollment | Evidence | Efficacy |
---|---|---|---|
Kim et al. 2016 (RADCHOP) | 2011-03 to 2013-06 | Phase 2 | ORR: 90% |
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 1
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 1
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 1
Glucocorticoid therapy
- Prednisone (Sterapred) 100 mg PO once per day on days 1 to 5
Targeted therapy
- Everolimus (Afinitor) 5 mg PO once per day on days 1 to 14
21-day cycle for up to 6 cycles
References
- RADCHOP: Kim SJ, Shin DY, Kim JS, Yoon DH, Lee WS, Lee H, Do YR, Kang HJ, Eom HS, Ko YH, Lee SH, Yoo HY, Hong M, Suh C, Kim WS. A phase II study of everolimus (RAD001), an mTOR inhibitor plus CHOP for newly diagnosed peripheral T-cell lymphomas. Ann Oncol. 2016 Apr;27(4):712-8. Epub 2016 Feb 8. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT01198665
DA-EPOCH
DA-EPOCH: Dose Adjusted Etoposide, Prednisone, Oncovin (Vincristine), Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin)
Regimen
Study | Dates of enrollment | Evidence | Efficacy |
---|---|---|---|
Maeda et al. 2017 (West-JHOG PTCL0707) | 2007-09 to 2011-10 | Phase 2 | ORR: 78% (95% CI 62-89) |
Note: the authors state that they followed the Wilson et al. 2002 protocol, but there are some differences, in particular 1) it isn't clear whether prednisone is given once or twice per day; and 2) dose adjustments below level 1 are different based on age.
Chemotherapy
- Etoposide (Vepesid) 50 mg/m2/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 200 mg/m2)
- Vincristine (Oncovin) 0.4 mg/m2/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 1.6 mg/m2)
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV over 2 hours once on day 5
- Doxorubicin (Adriamycin) 10 mg/m2/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 40 mg/m2)
Glucocorticoid therapy
- Prednisone (Sterapred) 60 mg/m2/day PO on days 1 to 5
Supportive therapy
- G-CSF starting on day 6 and continuing until ANC greater than 5000/μL past nadir
- Trimethoprim-Sulfamethoxazole (Bactrim DS) (dose not specified)
- Fluconazole (Diflucan) (dose not specified)
21-day cycle for 6 to 8 cycles
Dose and schedule modifications
- Start cycle 1 as described above.
- Obtain CBCs twice per week for nadir measurements.
- If nadir ANC greater than 500/μL, increase etoposide, doxorubicin, and cyclophosphamide by 20% compared to previous cycle.
- If nadir ANC less than 500/μL on 1 or 2 measurements, use same doses as last cycle.
- If nadir ANC less than 500/μL on at least 3 measurements, decrease etoposide, doxorubicin, and cyclophosphamide by 20% compared to previous cycle.
- And/or if nadir platelet count less than 25 x 109/L on at least 1 measurement, decrease etoposide, doxorubicin, and cyclophosphamide by 20% compared to previous cycle.
- Younger than 70 years old: Dose adjustments below the cycle 1 starting dose only apply to cyclophosphamide. That is, the lowest etoposide and doxorubicin would be dosed is at the original cycle 1 dose.
- Patients 70 and older: Dose adjustments below the cycle 1 starting dose apply to all drugs
- (Presumed, based on Wilson et al. 2002): Can start new cycle every 21 days if ANC greater than 1000/μL and platelets greater than 100 x 109/L. If counts are below those levels, check daily CBC and continue growth factor support until counts are adequate and next cycle can start.
References
- Maeda Y, Nishimori H, Yoshida I, Hiramatsu Y, Uno M, Masaki Y, Sunami K, Masunari T, Nawa Y, Yamane H, Gomyo H, Takahashi T, Yano T, Matsuo K, Ohshima K, Nakamura S, Yoshino T, Tanimoto M. Dose-adjusted EPOCH chemotherapy for untreated peripheral T-cell lymphomas: a multicenter phase II trial of West-JHOG PTCL0707. Haematologica. 2017 Dec;102(12):2097-2103. Epub 2017 Sep 29. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed UMIN000000829
DD-CHOP
DD-CHOP: Denileukin, Diftitox, Cyclophosphamide, Hydroxydaunorubicin (Doxorubicin), Oncovin (Vincristine), Predniso(lo)ne
Regimen
Study | Dates of enrollment | Evidence | Efficacy |
---|---|---|---|
Foss et al. 2013 (CONCEPT) | 2004-09 to 2009-12 | Phase 2 | ORR: 65% |
Targeted therapy
- Denileukin diftitox (Ontak) 18 mcg/kg IV over 60 minutes once per day on days 1 & 2
Chemotherapy
- Cyclophosphamide (Cytoxan) 750 mg/m2 IV once on day 3
- Doxorubicin (Adriamycin) 50 mg/m2 IV once on day 3
- Vincristine (Oncovin) 1.4 mg/m2 (maximum dose of 2 mg) IV once on day 3
Glucocorticoid therapy
- Prednisone (Sterapred) 100 mg PO once per day on days 3 to 7
Supportive therapy
- Dexamethasone (Decadron) 4 to 8 mg IV or PO once per day on days 1 & 2, prior to denileukin diftitox
- Acetaminophen (Tylenol) 650 mg PO once per day on days 1 & 2, prior to denileukin diftitox
- Diphenhydramine (Benadryl) 25 mg IV once per day on days 1 & 2, prior to denileukin diftitox
- Normal saline 250 to 500 cc IV, given before and after each denileukin diftitox infusion
- Antiemetics "per institutional standard"
- G-CSF support beginning on day 4
21-day cycle for 6 to 8 cycles
References
- CONCEPT: Foss FM, Sjak-Shie N, Goy A, Jacobsen E, Advani R, Smith MR, Komrokji R, Pendergrass K, Bolejack V. A multicenter phase II trial to determine the safety and efficacy of combination therapy with denileukin diftitox and cyclophosphamide, doxorubicin, vincristine and prednisone in untreated peripheral T-cell lymphoma: the CONCEPT study. Leuk Lymphoma. 2013 Jul;54(7):1373-9. Epub 2013 Jan 29. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT00211185
HyperCHidam
HyperCHidam: Hyperfractionated Cyclophosphamide, Hiigh-dose ara-c (Cytarabine) & methotrexate
Regimen
Study | Dates of enrollment | Evidence |
---|---|---|
Corradini et al. 2014 (PTCL-06) | 2006-2010 | Phase 2 |
Note: These are the details for "Clin A" which was the regimen used for patients younger than 60. Note: this is a component of a sequential treatment protocol; to our knowledge there are no references to support using it as a stand-alone treatment.
Preceding treatment
- PTCL-06: CHOP-AL induction x 2
Chemotherapy
- Methotrexate (MTX) 1600 mg/m2 IV continuous infusion (duration not specified), started on day 1
- Cyclophosphamide (Cytoxan) 300 mg/m2 IV every 12 hours for 3 days (start day not specified)
- Cytarabine (Ara-C) 2000 mg/m2 IV every 12 hours for 3 days (start day not specified)
Supportive therapy
- Granulocyte-colony stimulating factor (type not specified) 5 mcg/kg once per day was given from day +5 (stop date not specified)
2 cycles (duration not specified)
Subsequent treatment
- PTCL-06, responders (PR/CR): allogeneic HSCT consolidation
References
- PTCL-06: Corradini P, Vitolo U, Rambaldi A, Miceli R, Patriarca F, Gallamini A, Olivieri A, Benedetti F, Todeschini G, Rossi G, Salvi F, Bruno B, Baldini L, Ferreri A, Patti C, Tarella C, Pileri S, Dodero A. Intensified chemo-immunotherapy with or without stem cell transplantation in newly diagnosed patients with peripheral T-cell lymphoma. Leukemia. 2014 Sep;28(9):1885-91. Epub 2014 Feb 20. link to original article dosing details in manuscript have been reviewed by our editors PubMed EudraCT 2006-004234-33
Consolidation after upfront therapy
BEAM, then auto HSCT
BEAM: BiCNU (Carmustine), Etoposide, Ara-C (Cytarabine), Melphalan
Regimen variant #1
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Schmitz et al. 2021 (MYS-07-HMO-CTIL) | 2011-2014 | Phase 3 (C) | Fludarabine, Busulfan, Cyclophosphamide, then allo HSCT | Did not meet primary endpoint of EFS36 |
Chemotherapy
- Carmustine (BCNU) 300 mg/m2 IV once on day -7
- Etoposide (Vepesid) 200 mg/m2 IV once per day on days -6 to -3
- Cytarabine (Ara-C) 200 mg/m2 IV every 12 hours on days -6 to -3 (total dose: 1600 mg/m2)
- Melphalan (Alkeran) 140 mg/m2 IV once on day -2
Supportive therapy
- Autologous stem cells re-infused on day 0
One course
Regimen variant #2
Study | Dates of enrollment | Evidence |
---|---|---|
d'Amore et al. 2012 (NLG-T-01) | 2001-10 to 2007-10 | Phase 2 |
Chemotherapy
- Carmustine (BCNU) 300 mg/m2 IV once on day -6
- Etoposide (Vepesid) 100 mg/m2 IV every 12 hours on days -5 to -2 (total dose: 800 mg/m2)
- Cytarabine (Ara-C) 200 mg/m2 IV every 12 hours on days -5 to -2 (total dose: 1600 mg/m2)
- Melphalan (Alkeran) 140 mg/m2 IV once on day -1
Supportive therapy
- Autologous stem cells re-infused on day 0
- (described in some publications)
- Filgrastim (Neupogen) by the following weight-based criteria:
- Less than 70 kg: 300 mcg SC once per day, starting on day +7 after stem cell transplant
- More than 70 kg (reference did not clarify which dosage to use for patients who are exactly 70 kg): 480 mcg SC once per day, starting on day +7 after stem cell transplant
- Trimethoprim-Sulfamethoxazole (Bactrim DS) 160/800 mg PO twice per day on Monday and Thursdays, until 6 months after BEAM
- Ciprofloxacin (Cipro) 500 mg PO twice per day while ANC less than 500/μL
- Antifungal prophylaxis with one of the following:
- Fluconazole (Diflucan) 100 mg PO once per day while ANC less than 500/μL
- Nystatin (Mycostatin) 500,000 units swish & swallow four times per day while ANC less than 500/μL
- Acyclovir (Zovirax) 400 mg PO three times per day while ANC less than 500/μL
One course
References
- NLG-T-01: d'Amore F, Relander T, Lauritzsen GF, Jantunen E, Hagberg H, Anderson H, Holte H, Österborg A, Merup M, Brown P, Kuittinen O, Erlanson M, Østenstad B, Fagerli UM, Gadeberg OV, Sundström C, Delabie J, Ralfkiaer E, Vornanen M, Toldbod HE. Up-front autologous stem-cell transplantation in peripheral T-cell lymphoma: NLG-T-01. J Clin Oncol. 2012 Sep 1;30(25):3093-9. Epub 2012 Jul 30. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT00791947
- MYS-07-HMO-CTIL: Schmitz N, Truemper L, Bouabdallah K, Ziepert M, Leclerc M, Cartron G, Jaccard A, Reimer P, Wagner E, Wilhelm M, Sanhes L, Lamy T, de Leval L, Rosenwald A, Roussel M, Kroschinsky F, Lindemann W, Dreger P, Viardot A, Milpied N, Gisselbrecht C, Wulf G, Gyan E, Gaulard P, Bay JO, Glass B, Poeschel V, Damaj G, Sibon D, Delmer A, Bilger K, Banos A, Haenel M, Dreyling M, Metzner B, Keller U, Braulke F, Friedrichs B, Nickelsen M, Altmann B, Tournilhac O. A randomized phase 3 trial of autologous vs allogeneic transplantation as part of first-line therapy in poor-risk peripheral T-NHL. Blood. 2021 May 13;137(19):2646-2656. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT00984412
Cyclophosphamide & TBI, then auto HSCT
Cy/TBI: Cyclophosphamide & Total Body Irradiation
Regimen
Study | Dates of enrollment | Evidence |
---|---|---|
Reimer et al. 2004 | 2000-2006 | Non-randomized |
Chemotherapy
- Cyclophosphamide (Cytoxan) 60 mg/kg IV once per day on days -3 & -2
Radiotherapy
- Total body irradiation (TBI) 1200 cGy in fractions on days –6 to –4 (pulmonary dosage was limited to 800 cGy)
Supportive therapy
- Autologous stem cells re-infused on day 0
One course
References
- Reimer P, Schertlin T, Rüdiger T, Geissinger E, Roth S, Kunzmann V, Weissinger F, Nerl C, Schmitz N, Müller-Hermelink HK, Wilhelm M. Myeloablative radiochemotherapy followed by autologous peripheral blood stem cell transplantation as first-line therapy in peripheral T-cell lymphomas: first results of a prospective multicenter study. Hematol J. 2004;5(4):304-11. link to original article PubMed
- Update: Reimer P, Rüdiger T, Geissinger E, Weissinger F, Nerl C, Schmitz N, Engert A, Einsele H, Müller-Hermelink HK, Wilhelm M. Autologous stem-cell transplantation as first-line therapy in peripheral T-cell lymphomas: results of a prospective multicenter study. J Clin Oncol. 2009 Jan 1;27(1):106-13. Epub 2008 Nov 24. link to original article dosing details in manuscript have been reviewed by our editors PubMed
Radiation therapy
Regimen
Study | Dates of enrollment | Evidence |
---|---|---|
Simon et al. 2010 (GOELAMS LTP95) | 1996-2002 | Non-randomized part of phase 3 RCT |
Preceding treatment
- GOELAMS LTP95: CHOP x 8 versus vVIP-rABVD induction
Radiotherapy
- External beam radiotherapy 4000 cGy at 180 cGy/day to the involved field
4.5-week course
References
- GOELAMS-LTP95: Simon A, Peoch M, Casassus P, Deconinck E, Colombat P, Desablens B, Tournilhac O, Eghbali H, Foussard C, Jaubert J, Vilque JP, Rossi JF, Lucas V, Delwail V, Thyss A, Maloisel F, Milpied N, le Gouill S, Lamy T, Gressin R. Upfront VIP-reinforced-ABVD (VIP-rABVD) is not superior to CHOP/21 in newly diagnosed peripheral T cell lymphoma: results of the randomized phase III trial GOELAMS-LTP95. Br J Haematol. 2010 Oct;151(2):159-66. Epub 2010 Aug 25. link to original article dosing details in manuscript have been reviewed by our editors PubMed
TFC, then allo HSCT
TFC: Thiotepa, Fludarabine, Cyclophosphamide
Regimen
Study | Dates of enrollment | Evidence |
---|---|---|
Corradini et al. 2002 | 1998-09 to 2001-01 | Non-randomized |
Corradini et al. 2014 (PTCL-06) | 2006-11 to 2010-11 | Phase 2 |
Details to be completed.
Preceding treatment
- PTCL-06: CHOP-AL induction x 2, then HyperCHidam consolidation x 2
Chemotherapy
Immunotherapy
Stem cells transfused on day 0
References
- Corradini P, Tarella C, Olivieri A, Gianni AM, Voena C, Zallio F, Ladetto M, Falda M, Lucesole M, Dodero A, Ciceri F, Benedetti F, Rambaldi A, Sajeva MR, Tresoldi M, Pileri A, Bordignon C, Bregni M. Reduced-intensity conditioning followed by allografting of hematopoietic cells can produce clinical and molecular remissions in patients with poor-risk hematologic malignancies. Blood. 2002 Jan 1;99(1):75-82. link to original article PubMed
- PTCL-06: Corradini P, Vitolo U, Rambaldi A, Miceli R, Patriarca F, Gallamini A, Olivieri A, Benedetti F, Todeschini G, Rossi G, Salvi F, Bruno B, Baldini L, Ferreri A, Patti C, Tarella C, Pileri S, Dodero A. Intensified chemo-immunotherapy with or without stem cell transplantation in newly diagnosed patients with peripheral T-cell lymphoma. Leukemia. 2014 Sep;28(9):1885-91. Epub 2014 Feb 20. link to original article dosing details in manuscript have been reviewed by our editors PubMed EudraCT 2006-004234-33
Relapsed or refractory, randomized data
Bendamustine monotherapy
Regimen variant #1, 90 mg/m2
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Dupuis et al. 2024 (ORACLE) | 2018-11-09 to 2021-02-22 | Phase 3 (C) | Oral azacitidine | Did not meet primary endpoint of PFS |
Note: The majority of patients in ORACLE had angioimmunoblastic T-cell lymphoma (AITL). This was the lower bound of dosing in ORACLE.
Regimen variant #2, 120 mg/m2
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Demaj et al. 2013 (BENTLY) | 2009-2011 | Phase 2 | ORR: 50% | |
Dupuis et al. 2024 (ORACLE) | 2018-11-09 to 2021-02-22 | Phase 3 (C) | Oral azacitidine | Did not meet primary endpoint of PFS |
Note: The majority of patients in ORACLE had angioimmunoblastic T-cell lymphoma (AITL). This was the upper bound of dosing in ORACLE.
References
- BENTLY: Damaj G, Gressin R, Bouabdallah K, Cartron G, Choufi B, Gyan E, Banos A, Jaccard A, Park S, Tournilhac O, Schiano-de Collela JM, Voillat L, Joly B, Le Gouill S, Saad A, Cony-Makhoul P, Vilque JP, Sanhes L, Schmidt-Tanguy A, Bubenheim M, Houot R, Diouf M, Marolleau JP, Béné MC, Martin A, Lamy T. Results from a prospective, open-label, phase II trial of bendamustine in refractory or relapsed T-cell lymphomas: the BENTLY trial. J Clin Oncol. 2013 Jan 1;31(1):104-10. Epub 2012 Oct 29. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT00959686
- ORACLE: Dupuis J, Bachy E, Morschhauser F, Cartron G, Fukuhara N, Daguindau N, Casasnovas RO, Snauwaert S, Gressin R, Fox CP, d'Amore FA, Staber PB, Tournilhac O, Bouabdallah K, Thieblemont C, André M, Rai S, Ennishi D, Gkasiamis A, Nishio M, Fornecker LM, Delfau-Larue MH, Sako N, Mule S, de Leval L, Gaulard P, Tsukasaki K, Lemonnier F. Oral azacitidine compared with standard therapy in patients with relapsed or refractory follicular helper T-cell lymphoma (ORACLE): an open-label randomised, phase 3 study. Lancet Haematol. 2024 Jun;11(6):e406-e414. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT03593018
DHAP
DHAP: Dexamethasone, High-dose Ara-C (Cytarabine), Platinol (Cisplatin)
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Crump et al. 2014 (NCIC-CTG LY.12) | 2003-2011 | Phase 3 (C) | GDP | Inconclusive whether non-inferior ORR1 |
1Reported efficacy is based on the 2017 subgroup analysis.
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
Glucocorticoid therapy
- Dexamethasone (Decadron) 40 mg PO once per day on days 1 to 4
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 dosing details in manuscript have been reviewed by our editors PubMed NCT00078949
- Subgroup analysis: Skamene T, Crump M, Savage KJ, Reiman T, Kuruvilla J, Good D, LeBrun D, Meyer RM, Sehn LH, Soulières D, Stakiw J, Laferriere N, Luminari S, Shepherd LE, Djurfeldt M, Zhu L, Chen BE, Hay AE. Salvage chemotherapy and autologous stem cell transplantation for peripheral T-cell lymphoma: a subset analysis of the Canadian Cancer Trials Group LY.12 randomized phase 3 study(). Leuk Lymphoma. 2017 Oct;58(10):2319-2327. Epub 2017 May 15. link to original article PubMed
GDP
GDP: Gemcitabine, Dexamethasone, Platinol (Cisplatin)
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Crump et al. 2014 (NCIC-CTG LY.12) | 2003-2011 | Phase 3 (E-switch-ic) | DHAP | Inconclusive whether non-inferior ORR1 (co-primary endpoint) |
1Reported efficacy is based on the 2017 subgroup analysis.
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
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 dosing details in manuscript have been reviewed by our editors PubMed NCT00078949
- Subgroup analysis: Skamene T, Crump M, Savage KJ, Reiman T, Kuruvilla J, Good D, LeBrun D, Meyer RM, Sehn LH, Soulières D, Stakiw J, Laferriere N, Luminari S, Shepherd LE, Djurfeldt M, Zhu L, Chen BE, Hay AE. Salvage chemotherapy and autologous stem cell transplantation for peripheral T-cell lymphoma: a subset analysis of the Canadian Cancer Trials Group LY.12 randomized phase 3 study(). Leuk Lymphoma. 2017 Oct;58(10):2319-2327. Epub 2017 May 15. link to original article PubMed
Gemcitabine monotherapy
Regimen variant #1, 1000 mg/m2; 3 weeks out of 4
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
O'Connor et al. 2019 (LUMIERE) | 2012-2014 | Phase 3 (C) | Alisertib | Did not meet co-primary endpoints of ORR/PFS |
Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.
Chemotherapy
- Gemcitabine (Gemzar) 1000 mg/m2 IV over 30 minutes once per day on days 1, 8, 15
28-day cycles
Regimen variant #2, 1200 mg/m2; 3 weeks out of 4
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Dupuis et al. 2024 (ORACLE) | 2018-11-09 to 2021-02-22 | Phase 3 (C) | Oral azacitidine | Did not meet primary endpoint of PFS |
Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm. The majority of patients in this study had angioimmunoblastic T-cell lymphoma (AITL).
Chemotherapy
- Gemcitabine (Gemzar) 1200 mg/m2 IV over 30 minutes once per day on days 1, 8, 15
28-day cycle for 6 cycles
References
- LUMIERE: O'Connor OA, Özcan M, Jacobsen ED, Roncero JM, Trotman J, Demeter J, Masszi T, Pereira J, Ramchandren R, Beaven A, Caballero D, Horwitz SM, Lennard A, Turgut M, Hamerschlak N, d'Amore FA, Foss F, Kim WS, Leonard JP, Zinzani PL, Chiattone CS, Hsi ED, Trümper L, Liu H, Sheldon-Waniga E, Ullmann CD, Venkatakrishnan K, Leonard EJ, Shustov AR; Lumiere Study Investigators. Randomized phase III study of alisertib or investigator's choice (selected single agent) in patients with relapsed or refractory peripheral T-cell lymphoma. J Clin Oncol. 2019 Mar 10;37(8):613-623. Epub 2019 Feb 1. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT01482962
- ORACLE: Dupuis J, Bachy E, Morschhauser F, Cartron G, Fukuhara N, Daguindau N, Casasnovas RO, Snauwaert S, Gressin R, Fox CP, d'Amore FA, Staber PB, Tournilhac O, Bouabdallah K, Thieblemont C, André M, Rai S, Ennishi D, Gkasiamis A, Nishio M, Fornecker LM, Delfau-Larue MH, Sako N, Mule S, de Leval L, Gaulard P, Tsukasaki K, Lemonnier F. Oral azacitidine compared with standard therapy in patients with relapsed or refractory follicular helper T-cell lymphoma (ORACLE): an open-label randomised, phase 3 study. Lancet Haematol. 2024 Jun;11(6):e406-e414. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT03593018
Pralatrexate monotherapy
Example orders
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
O'Connor et al. 2011 (PROPEL) | 2006-2008 | Phase 2 (RT) | ORR: 29% | |
O'Connor et al. 2019 (LUMIERE) | 2012-2014 | Phase 3 (C) | Alisertib | Did not meet co-primary endpoints of ORR/PFS |
Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.
Chemotherapy
- Pralatrexate (Folotyn) 30 mg/m2 IV over 3 to 5 minutes once per day on days 1, 8, 15, 22, 29, 36
Supportive therapy
- Cyanocobalamin (Vitamin B12) 1 mg IM once every 8 to 10 weeks
- Folic acid (Folate) 1 to 1.25 mg PO once per day
- "Elevated methylmalonic acid (greater than 200 nmol/L) and/or homocysteine (greater than 10 µmol/L) at screening required initiation of Folic acid (Folate) and Cyanocobalamin (Vitamin B12) at least 10 days before the first dose of pralatrexate."
7-week cycles
References
- PROPEL: O'Connor OA, Pro B, Pinter-Brown L, Bartlett N, Popplewell L, Coiffier B, Lechowicz MJ, Savage KJ, Shustov AR, Gisselbrecht C, Jacobsen E, Zinzani PL, Furman R, Goy A, Haioun C, Crump M, Zain JM, Hsi E, Boyd A, Horwitz S. Pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma: results from the pivotal PROPEL study. J Clin Oncol. 2011 Mar 20;29(9):1182-9. Epub 2011 Jan 18. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT00364923
- LUMIERE: Connor OA, Özcan M, Jacobsen ED, Roncero JM, Trotman J, Demeter J, Masszi T, Pereira J, Ramchandren R, Beaven A, Caballero D, Horwitz SM, Lennard A, Turgut M, Hamerschlak N, d'Amore FA, Foss F, Kim WS, Leonard JP, Zinzani PL, Chiattone CS, Hsi ED, Trümper L, Liu H, Sheldon-Waniga E, Ullmann CD, Venkatakrishnan K, Leonard EJ, Shustov AR; Lumiere Study Investigators. Randomized phase III study of alisertib or investigator's choice (selected single agent) in patients with relapsed or refractory peripheral T-cell lymphoma. J Clin Oncol. 2019 Mar 10;37(8):613-623. Epub 2019 Feb 1. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT01482962
Romidepsin monotherapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Dupuis et al. 2024 (ORACLE) | 2018-11-09 to 2021-02-22 | Phase 3 (C) | Oral azacitidine | Did not meet primary endpoint of PFS |
Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm. The majority of patients in this study had angioimmunoblastic T-cell lymphoma (AITL).
References
- ORACLE: Dupuis J, Bachy E, Morschhauser F, Cartron G, Fukuhara N, Daguindau N, Casasnovas RO, Snauwaert S, Gressin R, Fox CP, d'Amore FA, Staber PB, Tournilhac O, Bouabdallah K, Thieblemont C, André M, Rai S, Ennishi D, Gkasiamis A, Nishio M, Fornecker LM, Delfau-Larue MH, Sako N, Mule S, de Leval L, Gaulard P, Tsukasaki K, Lemonnier F. Oral azacitidine compared with standard therapy in patients with relapsed or refractory follicular helper T-cell lymphoma (ORACLE): an open-label randomised, phase 3 study. Lancet Haematol. 2024 Jun;11(6):e406-e414. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT03593018
Relapsed or refractory, non-randomized or retrospective data
Belinostat monotherapy
Regimen
Study | Dates of enrollment | Evidence | Efficacy |
---|---|---|---|
Foss et al. 2014 (PXD101-CLN-6) | 2006-2009 | Phase 2 | ORR: 25% |
O'Connor et al. 2015 (BELIEF) | 2009-2011 | Phase 2 (RT) | ORR: 26% |
Targeted therapy
- Belinostat (Beleodaq) 1000 mg/m2 IV over 30 minutes once per day on days 1 to 5
21-day cycles
References
- PXD101-CLN-6: Foss F, Advani R, Duvic M, Hymes KB, Intragumtornchai T, Lekhakula A, Shpilberg O, Lerner A, Belt RJ, Jacobsen ED, Laurent G, Ben-Yehuda D, Beylot-Barry M, Hillen U, Knoblauch P, Bhat G, Chawla S, Allen LF, Pohlman B. A phase II trial of belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T-cell lymphoma. Br J Haematol. 2015 Mar;168(6):811-9. Epub 2014 Nov 17. link to original article dosing details in abstract have been reviewed by our editors PubMed NCT00274651
- BELIEF: O'Connor OA, Horwitz S, Masszi T, Van Hoof A, Brown P, Doorduijn J, Hess G, Jurczak W, Knoblauch P, Chawla S, Bhat G, Choi MR, Walewski J, Savage K, Foss F, Allen LF, Shustov A. Belinostat in patients with relapsed or refractory peripheral T-cell lymphoma: results of the pivotal phase II BELIEF (CLN-19) study. J Clin Oncol. 2015 Aug 10;33(23):2492-9. Epub 2015 Jun 22. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT00865969
Brentuximab vedotin monotherapy
Regimen
Study | Dates of enrollment | Evidence | Efficacy |
---|---|---|---|
Horwitz et al. 2014 (SGN35-012CD30+T-NHL) | 2011-09 to 2012-11 | Phase 2 | ORR: 41% |
Antibody-drug conjugate therapy
- Brentuximab vedotin (Adcetris) 1.8 mg/kg IV over 30 minutes once on day 1
21-day cycles
References
- SGN35-012CD30+T-NHL: Horwitz SM, Advani RH, Bartlett NL, Jacobsen ED, Sharman JP, O'Connor OA, Siddiqi T, Kennedy DA, Oki Y. Objective responses in relapsed T-cell lymphomas with single-agent brentuximab vedotin. Blood. 2014 May 15;123(20):3095-100. Epub 2014 Mar 20. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT01421667
Chidamide monotherapy
Regimen
Study | Dates of enrollment | Evidence | Efficacy |
---|---|---|---|
Shi et al. 2015 | 2010-04 to 2012-05 | Phase 2 | ORR: 28% |
References
- Shi Y, Dong M, Hong X, Zhang W, Feng J, Zhu J, Yu L, Ke X, Huang H, Shen Z, Fan Y, Li W, Zhao X, Qi J, Huang H, Zhou D, Ning Z, Lu X. Results from a multicenter, open-label, pivotal phase II study of chidamide in relapsed or refractory peripheral T-cell lymphoma. Ann Oncol. 2015 Aug;26(8):1766-71. Epub 2015 Jun 23. link to original article dosing details in abstract have been reviewed by our editors PubMed ChiCTR-TNC-10000811
Darinaparsin monotherapy
Regimen
Study | Dates of enrollment | Evidence |
---|---|---|
Kim et al. 2023 (SP-02) | Not reported | Phase 2 |
Antineoplastic therapy
- Darinaparsin (Darvias) 300 mg/m2 IV over 60 minutes once per day on days 1 to 5
21-day cycles
References
- SP-02: Kim WS, Fukuhara N, Yoon DH, Yamamoto K, Uchida T, Negoro E, Izutsu K, Terui Y, Nakajima H, Ando K, Suehiro Y, Kang HJ, Ko PS, Nagahama F, Sonehara Y, Nagai H, Tien HF, Kwong YL, Tobinai K. Darinaparsin in patients with relapsed or refractory peripheral T-cell lymphoma: results of an Asian phase 2 study. Blood Adv. 2023 Sep 12;7(17):4903-4912. link to original article link to PMC article dosing details in abstract have been reviewed by our editors PubMed NCT02653976
Duvelisib monotherapy
Regimen
Study | Dates of enrollment | Evidence |
---|---|---|
Awaiting publication (PRIMO) | 2018-ongoing | Phase 2 |
Note: This is the dose used in the expansion phase; this trial remains unpublished.
Targeted therapy
- Duvelisib (Copiktra) as follows:
- Cycles 1 & 2: 75 mg PO twice per day on days 1 to 28
- Cycle 3 onwards: 25 mg PO twice per day on days 1 to 28
28-day cycles
References
- PRIMO: NCT03372057
Forodesine monotherapy
Regimen
Study | Dates of enrollment | Evidence | Efficacy |
---|---|---|---|
Maruyama et al. 2018 (FDS-J02) | 2013-01 to 2017-02 | Phase 1/2 | ORR: 22% |
References
- FDS-J02: Maruyama D, Tsukasaki K, Uchida T, Maeda Y, Shibayama H, Nagai H, Kurosawa M, Suehiro Y, Hatake K, Ando K, Yoshida I, Hidaka M, Murayama T, Okitsu Y, Tsukamoto N, Taniwaki M, Suzumiya J, Tamura K, Yamauchi T, Ueda R, Tobinai K. Multicenter phase 1/2 study of forodesine in patients with relapsed peripheral T cell lymphoma. Ann Hematol. 2019 Jan;98(1):131-142. Epub 2018 Jul 5. Erratum in: Ann Hematol. 2018 Jul 27. link to original article dosing details in abstract have been reviewed by our editors link to PMC article PubMed NCT01776411
Lenalidomide monotherapy
Regimen variant #1, limited duration
Study | Dates of enrollment | Evidence | Efficacy |
---|---|---|---|
Morschhauser et al. 2013 (EXPECT) | Not reported | Phase 2 | ORR: 41% |
Targeted therapy
- Lenalidomide (Revlimid) 25 mg PO once per day on days 1 to 21
28-day cycle for up to 26 cycles (2 years)
Regimen variant #2, indefinite
Study | Dates of enrollment | Evidence | Efficacy |
---|---|---|---|
Dueck et al. 2010 | 2006-09 to 2008-11 | Phase 2 | ORR: 30% |
References
- Dueck G, Chua N, Prasad A, Finch D, Stewart D, White D, van der Jagt R, Johnston J, Belch A, Reiman T. Interim report of a phase 2 clinical trial of lenalidomide for T-cell non-Hodgkin lymphoma. Cancer. 2010 Oct 1;116(19):4541-8. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT00322985
- Update: Toumishey E, Prasad A, Dueck G, Chua N, Finch D, Johnston J, van der Jagt R, Stewart D, White D, Belch A, Reiman T. Final report of a phase 2 clinical trial of lenalidomide monotherapy for patients with T-cell lymphoma. Cancer. 2015 Mar 1;121(5):716-23. Epub 2014 Oct 29. link to original article PubMed
- EXPECT: Morschhauser F, Fitoussi O, Haioun C, Thieblemont C, Quach H, Delarue R, Glaisner S, Gabarre J, Bosly A, Lister J, Li J, Coiffier B. A phase 2, multicentre, single-arm, open-label study to evaluate the safety and efficacy of single-agent lenalidomide (Revlimid®) in subjects with relapsed or refractory peripheral T-cell non-Hodgkin lymphoma: The EXPECT trial. Eur J Cancer. 2013 Sep;49(13):2869-76. Epub 2013 May 31. link to original article dosing details in abstract have been reviewed by our editors PubMed NCT00655668
Mogamulizumab monotherapy
Regimen
Study | Dates of enrollment | Evidence |
---|---|---|
Ogura et al. 2014 (KW-0761-004) | Not reported | Phase 2 |
Targeted therapy
- Mogamulizumab (Poteligeo) 1 mg/kg IV once per day on days 1, 8, 15, 22
28-day cycle for 2 cycles
References
- KW-0761-004: Ogura M, Ishida T, Hatake K, Taniwaki M, Ando K, Tobinai K, Fujimoto K, Yamamoto K, Miyamoto T, Uike N, Tanimoto M, Tsukasaki K, Ishizawa K, Suzumiya J, Inagaki H, Tamura K, Akinaga S, Tomonaga M, Ueda R. Multicenter phase II study of mogamulizumab (KW-0761), a defucosylated anti-cc chemokine receptor 4 antibody, in patients with relapsed peripheral T-cell lymphoma and cutaneous T-cell lymphoma. J Clin Oncol. 2014 Apr 10;32(11):1157-63. Epub 2014 Mar 10. link to original article dosing details in abstract have been reviewed by our editors PubMed NCT01192984
Consolidation after salvage therapy
Fludarabine, Busulfan, Cyclophosphamide, then allo HSCT
FluBuCy: Fludarabine, Busulfan, Cyclophosphamide
Regimen variant #1, oral
Study | Dates of enrollment | Evidence |
---|---|---|
Glass et al. 2014 (DSHNHL R3) | 2004-06-16 to 2009-03-24 | Phase 2 |
Chemotherapy
- Fludarabine (Fludara) 25 mg/m2/day IV on days -8 to -4
- Busulfan (Myleran) 4 mg/kg/day PO on days -6 to -4
- Cyclophosphamide (Cytoxan) 60 mg/kg/day IV on days -3 and -2
Immunotherapy
- Allogeneic stem cells transfused on day 0
GVHD prophylaxis
- Antithymocyte globulin, rabbit ATG (Thymoglobulin) 2 mg/kg IV from day -3 to -1 (unclear if this is a total dose or a daily dose)
- Option also to use ATG-Fresenius S at a higher dose of 10 mg/kg
- Tacrolimus (Prograf) 8 to 12 mcg/L (route/frequency not specified) starting on day -1, tapered from day +100 in absence of GVHD
- Mycophenolate mofetil (CellCept) 1000 mg (route not specified) twice per day from day +1 to +28
One course
Regimen variant #2, intravenous
Study | Dates of enrollment | Evidence |
---|---|---|
Glass et al. 2014 (DSHNHL R3) | 2004-06-16 to 2009-03-24 | Phase 2 |
Chemotherapy
- Fludarabine (Fludara) 25 mg/m2/day IV on days -8 to -4
- Busulfan (Myleran) 3.2 mg/kg/day IV on days -6 to -4
- Cyclophosphamide (Cytoxan) 60 mg/kg/day IV on days -3 and -2
Immunotherapy
- Allogeneic stem cells transfused on day 0
GVHD prophylaxis
- Antithymocyte globulin, rabbit ATG (Thymoglobulin) 2 mg/kg IV from day -3 to -1 (unclear if this is a total dose or a daily dose)
- Option also to use ATG-Fresenius S at a higher dose of 10 mg/kg
- Tacrolimus (Prograf) 8 to 12 mcg/L (route/frequency not specified) starting on day -1, tapered from day +100 in absence of GVHD
- Mycophenolate mofetil (CellCept) 1000 mg (route not specified) twice per day from day +1 to +28
One course
References
- DSHNHL R3: Glass B, Hasenkamp J, Wulf G, Dreger P, Pfreundschuh M, Gramatzki M, Silling G, Wilhelm C, Zeis M, Görlitz A, Pfeiffer S, Hilgers R, Truemper L, Schmitz N; German High-Grade Lymphoma Study Group. Rituximab after lymphoma-directed conditioning and allogeneic stem-cell transplantation for relapsed and refractory aggressive non-Hodgkin lymphoma (DSHNHL R3): an open-label, randomised, phase 2 trial. Lancet Oncol. 2014 Jun;15(7):757-66. Epub 2014 May 11. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT00785330