Lenalidomide Plus Rituxan for Untreated Mantle Cell Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 31
Summary
- Conditions
- Mantle Cell Lymphoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Induction Phase (week 1 - 48): Lenalidomide will be given at 20 mg/day for days 1-21 of a 28-day cycle for 12 cycles. If no excess toxicity is observed the dose will be increased to 25 mg/day. Rituximab will be administered at 375 mg/m2 per dose for a total of 9 doses. The first 4 doses will be admi...
Induction Phase (week 1 - 48): Lenalidomide will be given at 20 mg/day for days 1-21 of a 28-day cycle for 12 cycles. If no excess toxicity is observed the dose will be increased to 25 mg/day. Rituximab will be administered at 375 mg/m2 per dose for a total of 9 doses. The first 4 doses will be administered weekly starting on day 1 of lenalidomide (e.g. days 1, 8, 15 and 22). Subsequent rituximab doses will be administered for one dose each at weeks 12, 20, 28, 36 and 44. Maintenance Phase (week 49 - progression of disease): Lenalidomide will be given at 15 mg/day for days 1-21 of a 28-day cycle. Rituximab at 375 mg/m2 per dose will be administered for one dose every 8 weeks, starting at week 52. Response Assessment Year 1-2: Conventional restaging CT scan (or MRI) with IV contrast every 3 months from cycle 1 day 1 of the study. Year 3 onwards: Conventional restaging CT scan (or MRI) with IV contrast every 6 months until progression.
Tracking Information
- NCT #
- NCT01472562
- Collaborators
- Celgene
- Investigators
- Principal Investigator: Jia Ruan, MD, PhD Weill Medical College of Cornell University
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