drugset / Trial / NCT02858258
ASCT After a Rituximab/Ibrutinib/Ara-c Containing iNduction in Generalized Mantle Cell Lymphoma
RandomizedParallel-groupOpen-labelTreatment
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
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 |