drugset / Trial / NCT01737177

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

NCT01737177 ↗

Phase 2 Completed 42 enrolled Fondazione Italiana Linfomi - ETS
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2012-07-31
Primary completion
2014-07
Completion
2017-02-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Bendamustine Small molecule 70 mg/m2 —
Subject Lenalidomide Other / unclassified 15 mg —
Subject Rituximab Monoclonal antibody 375 mg/m2 —

Indications