NCT01737177

Bendamustine/Lenalidomide/Rituximab: Combination as a Second-Line Therapy for 1st Relapsed-Refractory MCL

Bendamustine, Lenalidomide and Rituximab (R2-B) Combination as a Second-Line Therapy for First Relapsed-Refractory Mantle Cell Lymphomas: A Phase II Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Fondazione Italiana Linfomi - ETS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter phase II trial designed to evaluate the safety and activity of the combination of Bendamustine, Lenalidomide and Rituximab (R2-B) in patients with first relapsed/refractory mantle cell lymphoma (MCL) and the efficacy and safety of a maintenance treatment with Lenalidomide for 18 months from the end of R2-B (from month 7 to 24) for those responding to the induction.

Detailed description

This is a phase II study, non randomized, multicenter. Patients with MCL refractory to front line therapy or in first relapse will be enrolled. The study includes an induction phase, a consolidation phase, a maintenance phase and a follow up phase.

Conditions

• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Bendamustine, Lenalidomide, Rituximab	INDUCTION PHASE (COURSE 1-4) * Bendamustine: 70 mg/m2 on day 2 and 3 every 28 * Lenalidomide: 10 mg/daily on day 1 to 14 of a 28 days course * Rituximab: 375 mg/m2 on day 1 every 28 days; only for the first cycle in the induction phase will start on day 8 CONSOLIDATION PHASE (courses 5-6) Patients in CR and PR at the end of the induction phase * Lenalidomide: 15 mg/daily on day 1 to 21 of a 28 days course. * Rituximab: 375 mg/m2 on day 1 every 28 days MAINTENANCE PHASE (courses 7-24) Patients in CR or PR at the end of the consolidation treatment with Lenalidomide until disease progression or unacceptable toxicity up to 18 months (from month 7 to month 24) \- Lenalidomide: 15 mg/daily on day 1 to 21 of a 28 days

Timeline

• Start date: 2012-07-31
• Primary completion: 2014-07-01
• Completion: 2017-02-02
• First posted: 2012-11-29
• Last updated: 2018-03-09

Locations

43 sites across 1 country: Italy