Efficacy of Alternating Immunochemotherapy Consisting of R-CHOP + R-HAD vs R-CHOP Alone, Followed by Maintenance Therapy Consisting of Additional Lenalidomide + Rituximab vs Rituximab Alone for Older Patients With Mantle Cell Lymphoma
This study aims to evaluate whether the addition of lenalidomide to rituximab-maintenance
improves progression free survival (PFS) compared to standard rituximab maintenance after
induction treatment consisting of R-CHOP + R-HAD versus R-CHOP alone in older patients (≥ 60
year old) with mantle cell lymphoma. 643 patients will be randomized in induction phase and
433 in maintenance phase.
The treatments consist of two phases:
- induction treatment will be 3 cycles of R-CHOP21 + 3 cycles of R-HAD28(alternating)
versus 8 cycles of R-CHOP21 alone
- maintenance treatment will be 13 cycles of rituximab every 8 weeks + 26 cycles of
lenalidomide every 4 weeks vs 13 cycles of rituximab every 8 weeks.
Patients will be followed 2.5 years after the last patient randomized for maintenance for
final analysis. All subjects who complete or discontinue the maintenance treatment for any
reason will be followed for at least 3 years after his/her last study treatment
administration in maintenance period for Second Primary Malignancies (SPM). A long term
follow-up for progression/death will be done up to the end of period of SPM data collection.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival
2.5 years after last patient randomized in maintenance
2.5 years
No
Martin Dreyling, Prof. Dr.
Principal Investigator
MCL Network
France: Agence Nationale de Sécurité du Médicament et des produits de santé
MCL R2 Elderly
NCT01865110
September 2013
March 2024
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