Lenalidomide Plus Rituxan for Untreated Mantle Cell Lymphoma

Mantle Cell Lymphoma Clinical Trial

Official title: Phase II Study of Lenalidomide Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma

Status Completed

Clinical Trial 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.

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

• NCT number: NCT01472562
• Study type: Interventional
• Source: Weill Medical College of Cornell University
• Status: Completed
• Phase: Phase 2
• Start date: July 29, 2011
• Completion date: July 30, 2023