drugset / Trial / NCT01865110
R-CHOP + R-HAD vs R-CHOP Followed by Maintenance Lenalidomide + Rituximab vs Rituximab for Older Patients With MCL
RandomizedParallel-groupOpen-labelTreatment
Summary
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 vs R-CHOP alone in older patients (≥ 60 year old) with mantle cell lymphoma. The treatments consist of two phases: induction treatment (3 R-CHOP21 + 3 cycles of R-HAD28 alternating) vs 8 cycles of R-CHOP21) followed by maintenance treatment (13 cycles of rituximab + 26 cycles of lenalidomide vs 13 cycles of rituximab).
Timeline
- Start
- 2013-11
- Primary completion
- 2020-11-30
- Completion
- 2025-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | — | — |
| Subject | Cytarabine | Small molecule | — | — |
| Subject | Dexamethasone | Small molecule | — | — |
| Comparator | Doxorubicin | Other / unclassified | — | — |
| Subject | Lenalidomide | Other / unclassified | 15 mg | — |
| Comparator | Prednisone | Other / unclassified | — | — |
| Comparator | Vincristine | Small molecule | — | — |
| Background | Rituximab | Monoclonal antibody | 1400 mg | Subcutaneous |