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Original Articles

Phase II study of the novel antifolate agent pralatrexate in combination with the histone deacetylase inhibitor romidepsin for the treatment of patients with mature T-cell lymphoma

, , , , , , , , & show all
Pages 736-745 | Received 15 Mar 2023, Accepted 08 Mar 2024, Published online: 22 Mar 2024

References

  • Zain JM, Hanona P. Aggressive T-cell lymphomas: 2021 updates on diagnosis, risk stratification and management. Am J Hematol. 2021;96(8):1027–1046. doi:10.1002/ajh.26270
  • Swerdlow SH. In world health organization classification: tumours of hematopoietic and lymphoid tissues. IARC. Blood. 2016 May 19; 127(20): 2375–2390
  • Fiore D, Cappelli LV, Broccoli A, et al. Peripheral T cell lymphomas: from the bench to the clinic. Nat Rev Cancer. 2020;20(6):323–342. doi:10.1038/s41568-020-0247-0
  • Saleh K, Michot JM, Ribrag V. Updates in the treatment of peripheral T-cell lymphomas. J Exp Pharmacol. 2021;13:577–591. doi:10.2147/JEP.S262344
  • Shah UA, Shah N, Qiao B, et al. Epidemiology and survival trend of adult T-cell leukemia/lymphoma in the United States. Cancer. 2020;126(3):567–574. doi:10.1002/cncr.32556
  • Amengual JE, Raphael BG. Sustained, durable responses with alemtuzumab in refractory angioimmunoblastic T-cell lymphoma. Leuk Lymphoma. 2010;51(7):1347–1350. doi:10.3109/10428194.2010.486091
  • Dunleavy K, Wilson WH. Targeting CD52 as a novel therapeutic strategy in angioimmunoblastic T-cell lymphoma. Leuk Lymphoma. 2010;51(9):1583–1584. doi:10.3109/10428194.2010.508190
  • Horwitz SM, Advani RH, Bartlett NL, et al. Objective responses in relapsed T-cell lymphomas with single-agent brentuximab vedotin. Blood. 2014;123(20):3095–3100. doi:10.1182/blood-2013-12-542142
  • Horwitz S, O'Connor OA, Pro B, et al. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019;393(10168):229–240. doi:10.1016/S0140-6736(18)32984-2
  • Horwitz S, O'Connor OA, Pro B, et al. 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;33(3):288–298. doi:10.1016/j.annonc.2021.12.002
  • O'Connor OA, Pro B, Pinter-Brown L, et al. Pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma: results from the pivotal PROPEL study. J Clin Oncol. 2011;29(9):1182–1189. doi:10.1200/JCO.2010.29.9024
  • O'Connor OA. Innovative approach to determine overall survival (OS) benefit for orphan diseases using case match control analyses (CMCA): the PROPEL experience of pralatrexate in patients with relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL). J Clin Oncol. 2017;35(15_suppl):7521–7521. doi:10.1200/JCO.2017.35.15_suppl.7521
  • Atallah-Yunes SA, Robertson MJ, Davé UP. Epigenetic aberrations and targets in peripheral T-cell lymphoma. Clin Lymphoma Myeloma Leuk. 2022;22(9):659–665. doi:10.1016/j.clml.2022.04.015
  • O'Connor OA, Horwitz S, Masszi T, et al. 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;33(23):2492–2499. doi:10.1200/JCO.2014.59.2782
  • West AC, Johnstone RW. New and emerging HDAC inhibitors for cancer treatment. J Clin Invest. 2014;124(1):30–39. doi:10.1172/JCI69738
  • Chen IC, Sethy B, Liou JP. Recent update of HDAC inhibitors in lymphoma. Front Cell Dev Biol. 2020;8:576391. doi:10.3389/fcell.2020.576391
  • Zhang P, Zhang M. Epigenetic alterations and advancement of treatment in peripheral T-cell lymphoma. Clin Epigenetics. 2020;12(1):169. doi:10.1186/s13148-020-00962-x
  • Piekarz RL, Frye R, Prince HM, et al. Phase 2 trial of romidepsin in patients with peripheral T-cell lymphoma. Blood. 2011;117(22):5827–5834. doi:10.1182/blood-2010-10-312603
  • Iyer SP, Foss FF. Romidepsin for the treatment of peripheral T-cell lymphoma. Oncologist. 2015;20(9):1084–1091. doi:10.1634/theoncologist.2015-0043
  • Coiffier B, Pro B, Prince HM, et al. Results from a pivotal, open-label, phase II study of romidepsin in relapsed or refractory peripheral T-cell lymphoma after prior systemic therapy. J Clin Oncol. 2012;30(6):631–636. doi:10.1200/JCO.2011.37.4223
  • Coiffier B, Pro B, Prince HM, et al. Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses. J Hematol Oncol. 2014;7(1):11. doi:10.1186/1756-8722-7-11
  • Shimony S, Horowitz N, Ribakovsky E, et al. Romidepsin treatment for relapsed or refractory peripheral and cutaneous T-cell lymphoma: real-life data from a national multicenter observational study. Hematol Oncol. 2019;37(5):569–577. doi:10.1002/hon.2691
  • Bachy E, Camus V, Thieblemont C, et al. 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;40(3):242–251. doi:10.1200/JCO.21.01815
  • Ma H, Davarifar A, Amengual JE. The future of combination therapies for peripheral T cell lymphoma (PTCL). Curr Hematol Malig Rep. 2018;13(1):13–24. doi:10.1007/s11899-018-0432-3
  • Ruan J, Zain J, Palmer B, et al. Multicenter phase 2 study of romidepsin plus lenalidomide for previously untreated peripheral T-cell lymphoma. Blood Adv. 2023;7(19):5771–5779. doi:10.1182/bloodadvances.2023009767
  • Jain S, Jirau-Serrano X, Zullo KM, et al. Preclinical pharmacologic evaluation of pralatrexate and romidepsin confirms potent synergy of the combination in a murine model of human T-cell lymphoma. Clin Cancer Res. 2015;21(9):2096–2106. doi:10.1158/1078-0432.CCR-14-2249
  • Amengual JE, Lichtenstein R, Lue J, et al. A phase 1 study of romidepsin and pralatrexate reveals marked activity in relapsed and refractory T-cell lymphoma. Blood. 2018;131(4):397–407. doi:10.1182/blood-2017-09-806737
  • Olsen EA, Whittaker S, Kim YH, et al. Clinical end points and response criteria in mycosis fungoides and sezary syndrome: a consensus statement of the international society for cutaneous lymphomas, the United States cutaneous lymphoma consortium, and the cutaneous lymphoma task force of the European Organisation for research and treatment of cancer. J Clin Oncol. 2011;29(18):2598–2607. doi:10.1200/JCO.2010.32.0630
  • Brammer J, Zinzani P, Zain J, et al. Duvelisib in patients with relapsed/refractory peripheral T-cell lymphoma from the phase 2 primo trial: results of an interim analysis. Blood. 2021;138(Supplement 1):2456–2456. doi:10.1182/blood-2021-148939
  • Horwitz SM, Moskowitz AJ, Mehta-Shah N, et al. The combination of duvelisib and romidepsin (DR) is highly active against relapsed/refractory peripheral T-cell lymphoma with low rates of transaminitis: final results. Ann Oncol. 2022 Mar;33(3):288–298. doi:10.1002/hon.56_2879
  • O'Connor OA, Falchi L, Lue JK, et al. Oral 5-azacytidine and romidepsin exhibit marked activity in patients with PTCL: a multicenter phase 1 study. Blood. 2019;134(17):1395–1405. doi:10.1182/blood.2019001285
  • Falchi L, Ma H, Klein S, et al. Combined oral 5-azacytidine and romidepsin are highly effective in patients with PTCL: a multicenter phase 2 study. Blood. 2021;137(16):2161–2170. doi:10.1182/blood.2020009004
  • Pombo De Oliveira MS, Loureiro P, Bittencourt A, et al. Geographic diversity of adult t-cell leukemia/lymphoma in Brazil. The Brazilian ATLL study group. Int J Cancer. 1999;83(3):291–298. doi:10.1002/(SICI)1097-0215(19991029)83:3<291::AID-IJC1>3.0.CO;2-P
  • Katsuya H, Ishitsuka K, Utsunomiya A, et al. Treatment and survival among 1594 patients with ATL. Blood. 2015;126(24):2570–2577. doi:10.1182/blood-2015-03-632489
  • Mehta-Shah N, Ratner L, Horwitz SM. Adult T-cell leukemia/lymphoma. J Oncol Pract. 2017;13(8):487–492. doi:10.1200/JOP.2017.021907
  • Cook L, Rowan A, Bangham C. Adult T-cell leukemia/lymphoma—pathobiology and implications for modern clinical management. Ann Lymphoma. 2021;5:29–29. doi:10.21037/aol-21-6
  • Shimoyama M. Diagnostic criteria and classification of clinical subtypes of adult T-cell leukaemia-lymphoma. A report from the lymphoma study group (1984-87). Br J Haematol. 1991;79(3):428–437. doi:10.1111/j.1365-2141.1991.tb08051.x
  • Malpica L, Pimentel A, Reis IM, et al. Epidemiology, clinical features, and outcome of HTLV-1-related ATLL in an area of prevalence in the United States. Blood Adv. 2018;2(6):607–620. doi:10.1182/bloodadvances.2017011106
  • Izutsu K, Makita S, Nosaka K, et al. An open-label, single-arm phase 2 trial of valemetostat for relapsed or refractory adult T-cell leukemia/lymphoma. Blood. 2023;141(10):1159–1168. doi:10.1182/blood.2022016862

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