ASCT After a Rituximab/Ibrutinib/Ara-c Containing iNduction in Generalized Mantle Cell Lymphoma

Summary

The primary objective of the the trial is to establish one of three study arms, as future standard based on the comparison of the investigator-assessed failure-free survival.

Timeline

Start

2016-07

Primary completion

2021-05

Completion

2026-05

Outcome

Mixed primary results

paper Three pairwise one-sided log-rank tests for the primary outcome of failure-free survival were statistically monitored. PMID 38705160 ↗

paper group A+I was superior to group A with 3-year failure-free survival of 88% (95% CI 84-92) versus 72% PMID 38705160 ↗

paper Superiority of group A over group I was not shown with 3-year failure-free survival 72% (67-79) versus 86% (82-91 PMID 38705160 ↗

Publications

• Dreyling M, Doorduijn J, Gine E, Jerkeman M, Walewski J, Hutchings M, Mey U, Riise J, Trneny M, Vergote VKJ, Shpilberg O, da Silva MG, Leppa S, Jiang L, Stilgenbauer S, Kerkhoff A, Jachimowicz RD, Hess G, Meerten TV, Wirths S, Herhaus P, Novak U, Dierlamm J, Hanel M, Hanoun C, Sonnevi K, Visco C, Donnarumma D, Ferreri AJM, Patti C, Stefani PM, Pott C, Klapper W, Schmidt C, Unterhalt M, Tix T, Ladetto M, Hoster E; European Mantle Cell Lymphoma Network. Addition of autologous stem-cell transplantation to an ibrutinib-containing first-line treatment in patients aged 18-65 years with mantle cell lymphoma (TRIANGLE): 4.5-year follow-up of a three-arm, randomised, open-label, phase 3 superiority trial of the European MCL Network. Lancet. 2026 May 16;407(10542):1953-1967. doi: 10.1016/S0140-6736(26)00362-4.
• Dreyling M, Doorduijn J, Gine E, Jerkeman M, Walewski J, Hutchings M, Mey U, Riise J, Trneny M, Vergote V, Shpilberg O, Gomes da Silva M, Leppa S, Jiang L, Stilgenbauer S, Kerkhoff A, Jachimowicz RD, Celli M, Hess G, Arcaini L, Visco C, van Meerten T, Wirths S, Zinzani PL, Novak U, Herhaus P, Benedetti F, Sonnevi K, Hanoun C, Hanel M, Dierlamm J, Pott C, Klapper W, Gozel D, Schmidt C, Unterhalt M, Ladetto M, Hoster E. Ibrutinib combined with immunochemotherapy with or without autologous stem-cell transplantation versus immunochemotherapy and autologous stem-cell transplantation in previously untreated patients with mantle cell lymphoma (TRIANGLE): a three-arm, randomised, open-label, phase 3 superiority trial of the European Mantle Cell Lymphoma Network. Lancet. 2024 May 25;403(10441):2293-2306. doi: 10.1016/S0140-6736(24)00184-3. Epub 2024 May 2.
• Kumar A. What is the role of up-front autologous stem cell transplantation in mantle cell lymphoma? Hematology Am Soc Hematol Educ Program. 2022 Dec 9;2022(1):155-162. doi: 10.1182/hematology.2022000333.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cytarabine	Small molecule	2000 mg/m2	Intravenous
Subject	Etoposide	Small molecule	—	—
Subject	Ibrutinib	Small molecule	560 mg	Oral
Subject	Melphalan	Small molecule	—	—
Subject	carmustine	Small molecule	—	—
Background	Cisplatin	Other / unclassified	100 mg/m2	Intravenous
Background	Cyclophosphamide	Other / unclassified	750 mg/m2	Intravenous
Background	Dexamethasone	Small molecule	40 mg	Intravenous
Background	Doxorubicin	Other / unclassified	50 mg/m2	Intravenous
Background	Prednisone	Other / unclassified	100 mg	Oral
Background	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous
Background	Vincristine	Small molecule	1.4 mg/m2	Intravenous

Indications