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

NCT01737177 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2018-03-09

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Fondazione Italiana Linfomi - ETS

    lead OTHER

Principal Investigators

  • Francesco Zaja, M.D. · Clinica Ematologica - Udine - Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01737177 on ClinicalTrials.gov