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

NCT02390869 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2025-12-02

No results posted yet for this study

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)

Conditions

  • Lymphoma, Follicular

Interventions

DRUG

R2-MANT

A) Rituximab 375 mg/sqm on day 1 every 90 days for 8 cycles B) Lenalidomide (10 mg daily on days 1-21 every 28 days) for 24 cycles

DRUG

R-MANT

A) Rituximab 375 mg/sqm on day 1 every 90 days for 8 cycles

Sponsors & Collaborators

  • Fondazione Italiana Linfomi - ETS

    lead OTHER

Principal Investigators

  • Umberto Vitolo, MD · Candiolo Cancer Institute, FPO-IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2023-01-25
Completion
2027-08-31

Countries

  • Italy

Study Locations

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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 NCT02390869 on ClinicalTrials.gov