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

Sponsor
Fondazione Italiana Linfomi - ETS
Study ID
NCT01737177
Phase
PHASE2
Status
Completed

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bendamustine, Lenalidomide, Rituximab — DRUG
    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

Study Details

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.

Key Dates

Start date
Jul 31, 2012
Status verified
Mar 2018
Primary completion
Jul 31, 2014
Completion
Feb 2, 2017

Study Design

Enrollment
42 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bendamustina, Lenalidomide, Rituximab
    1 arm for all patients

Primary Outcome Measure

Complete Response (CR) rate [ Time Frame: At the end of the consolidation phase (6 months) ]

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