Clinical Trial: Lenalidomide Plus Rituxan for Untreated Mantle Cell Lymphoma
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Phase II Study of Lenalidomide Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
Brief Summary: This is a phase II, multicenter study to determine the efficacy and safety of first-line lenalidomide plus rituximab therapy in patients with mantle cell lymphoma who have received no prior systemic therapy.
Detailed Summary:
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.
Sponsor: Weill Medical College of Cornell University
Current Primary Outcome: Overall Response Rate [ Time Frame: 30 months ]
Original Primary Outcome: To evaluate the efficacy of lenalidomide and rituximab based on Change in tumor burden from baseline (Cheson criteria) [ Time Frame: baseline, every 3 months for 3 years, then every 6 months for 2 years ]
Current Secondary Outcome: 2-year Progression-free Survival [ Time Frame: 30 months ]
Original Secondary Outcome: To evaluate the safety of lenalidomide plus rituxibmab based on adverse event assessments [ Time Frame: Day 1 of each cycle of study treatment (every 28 days) for up to 5 years ]
Information By: Weill Medical College of Cornell University
Dates:
Date Received: March 24, 2011
Date Started: June 2011
Date Completion: October 2020
Last Updated: February 23, 2017
Last Verified: February 2017