NCT01472562

Lenalidomide Plus Rituxan for Untreated Mantle Cell Lymphoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	lenalidomide	Induction phase: 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. Maintenance phase: Lenalidomide will be given at 15 mg/day for days 1-21 of a 28-day cycle.
BIOLOGICAL	rituximab	Induction phase: 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: Rituximab at 375 mg/m2 per dose will be administered for one dose every 8 weeks, starting at week 52.

Timeline

• Start date: 2011-07-29
• Primary completion: 2014-04-01
• Completion: 2023-07-30
• First posted: 2011-11-16
• Last updated: 2024-07-16
• Results posted: 2017-04-07

Locations

4 sites across 1 country: United States