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.
Objectives and Endpoints
Primary Objective:
To establish one of 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-DHAP followed by ibrutinib maintenance experimental arm I) as future standard based on the comparison of the investigator-assessed failure-free survival (FFS).
Secondary Objectives:
Primary Endpoint:
FFS defined as time from start of treatment to stable disease at end of immuno-chemotherapy, progressive disease, or death from any cause.
Secondary Efficacy Endpoints:
Secondary Toxicity Endpoints:
Exploratory Objectives:
Exploratory Endpoints:
Exploratory objectives may be evaluated only in a subset of patients according to local standards and resources.
Condition | Mantle Cell Lymphoma |
---|---|
Treatment | R-CHOP/R-DHAP, Ibrutinib (Induction), ASCT conditioning, Ibrutinib (Maintenance) |
Clinical Study Identifier | NCT02858258 |
Sponsor | Prof. Dr. M. Dreyling (co-chairman) |
Last Modified on | 23 February 2022 |
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