Clinical Trial

Rituximab and Lenalidomide vs Rituximab Alone as Maintenance After R-chemoterapy for Relapsed/Refractory FL Patients

Study acronym: FIL_RENOIR12
Active, Not Recruiting Phase 3
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Summary
A randomized phase III multicenter trial assessing efficacy and toxicity of a combination of Rituximab and Lenalidomide (R2) vs Rituximab alone as maintenance after chemoimmunotherapy with Rituximab-chemotherapy (R-CHT) for relapsed/refractory FL patients not eligible for autologous transplantation (ASCT)
Protocol Amendment History 16 amendments
This ClinicalTrials.gov record has been amended 16 times since 2015-03-11; most recent amendment 2025-12-01.
Status change: Recruiting → Active, Not Recruiting 2023-09-12
Trial Details
NCT Number NCT02390869
Lead Sponsor Fondazione Italiana Linfomi - ETS
Conditions Lymphoma, Follicular
Enrollment 128 participants
Start Date 2014-05
Primary Completion 2023-01-25 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2025-12-02