This study is a randomized, three-arm, parallel-group, open-label, international, multicenter Phase III study comparing six alternating treatments with R-CHOP/R-DHAP (one cycle every 21 days) followed by ASCT to the combination with ibrutinib in induction and maintenance (2 years) or the experimental arm without ASCT.
Aim of the study
The aim of this study is to establish one of the three study arms - R-CHOP/R-DHAP followed by ASCT (control arm A), R-CHOP + ibrutinib/ R-DHAP followed by ASCT and ibrutinib maintenance (experimental arm A+I, and R-CHOP + ibrutinib/R-CHAP followed by ibrutinib maintenance (experimental arm I) - as a future standard based on the comparison of the Failure-Free Survival (FFS) determined by the investigator.
Who can take part?
Untreated patients (≥ 18 and ≤ 65 years) with mantle cell lymphoma (MCL)
Procedure
The maximum duration of study participation per patient is up to 10 years (18 weeks of induction therapy, 6 weeks of ASCT, 2 years of ibrutinib maintenance, observation until progression, and follow-up until the end of the study).
Compensation
Original study name
Autologous transplantation after rituximab/ibrutinib/arac-containing induction in generalized mantle cell lymphoma - a randomized study of the European Mcl network
BASEC number
2017-01342
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