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Autologous Transplantation After a Rituximab/Ibrutinib/Ara-c Containing iNduction in Generalized Mantle Cell Lymphoma - a Randomized European Mcl Network Trial
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.
Details
| Lead sponsor | Prof. Dr. M. Dreyling (co-chairman) |
|---|---|
| Phase | Phase 3 |
| Status | RECRUITING |
| Enrolment | 870 |
| Start date | 2016-07 |
| Completion | 2026-05 |
Conditions
- Mantle Cell Lymphoma
Interventions
- R-CHOP/R-DHAP
- Ibrutinib (Induction)
- ASCT conditioning
- Ibrutinib (Maintenance)
Primary outcomes
- Failure Free Survival — From start of treatment until stable disease at end of immuno-chemotherapy, progressive disease, or death from any cause, whichever comes first, assessed up to 120 months.
Countries
Denmark, Germany, Italy, Norway, Sweden