Overview

This trial is active, not recruiting.

Condition follicular lymphoma
Treatments rituximab, lenalidomide, rituximab - chop, rituximab - cvp, rituximab - bendamustine
Phase phase 3
Target CD20
Sponsor The Lymphoma Academic Research Organisation
Collaborator Celgene Corporation
Start date February 2012
End date June 2024
Trial size 1031 participants
Trial identifier NCT01650701, 2011-002792-42, RV-FOL-GELARC-0683

Summary

The purpose of this study is to find out if lenalidomide when given along with rituximab can help to control the disease and also increase the length of your response (complete or partial response) compared to the standard of care rituximab chemotherapy treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Lenalidomide dose 20-mg on days 2-22 every 28 days x 6 cycles, if CR then 10-mg on days 2-22 every 28 days for 12 cycles. PR after 6 cycles, continue 20 mg for 3~6 cycles and then 10 mg on days 2-22 every 28-day cycles for upto 18 cycles Rituximab, 375 mg/m2 on days 1, 8, 15 and 22 of cycle 1, day 1 of cycles 2 to 6; 8 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
rituximab mabthera
• Rituximab, 375 mg/m2 on days 1, 8, 15 and 22 of cycle 1, day 1 of cycles 2 to 6; 8 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
lenalidomide Revlimid
• Lenalidomide dose 20-mg on days 2-22 every 28 days x 6 cycles, if CR then 10-mg on days 2-22 every 28 days for 12 cycles. PR after 6 cycles, continue 20 mg for 3~6 cycles and then 10 mg on days 2-22 every 28-day cycles for upto 18 cycles
(Active Comparator)
• ONE of the following: Rituximab - CHOP, Rituximab - CVP, Rituximab - Bendamustine. 7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
rituximab - chop
six cycles of R-CHOP in 21 day cycles followed by two 21 day cycles of 375 mg/m2 rituximab; and 7 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles
rituximab - cvp
eight cycles of R-CVP in 21 day cycles; and 7 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles,
rituximab - bendamustine
six cycles of R-B in 28 day cycles and 8 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.

Primary Outcomes

Measure
COMPLETE RESPONSE RATE
time frame: Timeframe: CR/CRu rate at 120 weeks
Progression Free Survival (PFS)
time frame: up to 13 years

Secondary Outcomes

Measure
Number of participants with adverse events
time frame: up to13 years
Time to Treatment Failure (TTF)
time frame: up to13 years
Event Free Survival (EFS)
time frame: up to13 years
Time to Next Anti-Lymphoma Treatment (TTNLT),
time frame: up to13 years
Time to Next Chemotherapy Treatment (TTNCT)
time frame: up to13 years
Overall Survival (OS)
time frame: up to13 years
Overall response rate at 120 weeks by International Working Group (IWG) 1999 criteria
time frame: up to13 years
Health related quality of life as measured by the EORTC QLQ-C30
time frame: up to13 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically confirmed CD20+ follicular lymphoma grade 1, 2 or 3a - Have no prior systemic treatment for lymphoma. - Must be in need of treatment - Bi-dimensionally measurable disease with at least one mass lesion > 2 cm that was not previously irradiated. - Stage II, III or IV disease. - Must be ≥ 18 years and sign an informed consent. - Performance status ≤ 2 on the ECOG scale. - Adequate hematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow) - Willing to follow pregnancy precautions Exclusion Criteria: - Clinical evidence of transformed lymphoma by investigator assessment or Grade 3b follicular lymphoma. - Patients taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to < 10 mg/day prednisone (over these 4 weeks). - Major surgery (excluding lymph node biopsy) within 28 days prior to signing informed consent. - Known Seropositive for or active viral infection with hepatitis B virus (HBV), hepatitis C virus (HCV)or human immunodeficiency virus (HIV). - Life expectancy < 6 months. - Known sensitivity or allergy to murine products. - Prior history of malignancies, other than follicular lymphoma, unless the patient has been free of the disease for ≥ 10 years. - Prior use of lenalidomide. - Neuropathy > Grade 1. - Presence or history of CNS involvement by lymphoma. - Patients who are at a high risk for a thromboembolic event and are not willing to take venous thromboembolic (VTE) prophylaxis. - serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) > 3x upper limit of normal (ULN), except in patients with documented liver or pancreatic involvement by lymphoma - total bilirubin > 2.0 mg/dl (34 µmol/L) except in cases of Gilberts Syndrome and documented liver involvement by lymphoma - creatinine clearance of < 30 mL/min - Pregnant or lactating females. - Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study, or which confounds the ability to interpret data from the study.

Additional Information

Official title A PHASE 3 OPEN-LABEL RANDOMIZED STUDY TO COMPARE THE EFFICACY AND SAFETY OF RITUXIMAB PLUS LENALIDOMIDE (CC-5013) VERSUS RITUXIMAB PLUS CHEMOTHERAPY FOLLOWED BY RITUXIMAB IN SUBJECTS WITH PREVIOUSLY UNTREATED FOLLICULAR LYMPHOMA The "RELEVANCE" Trial (Rituximab Lenalidomide Versus ANy ChEmotherapy)is Being Conducted as Two Companion Studies: RV-FOL-GELARC-0683 (N=750) and RV-FOL-GELARC-0683C (N=250); the Combined Total of 1000 Patients Enrolled in Both Studies Will be Analyzed.
Description Follicular Lymphoma (FL) is a cancer of a B lymphocyte, a type of white blood cell. FL is typically a slowly progressing but incurable disease. Follicular lymphoma cells produce a specific defect in the patient's immune system impairing their ability to control their cancer. Lenalidomide has been shown to reverse the specific immune defect caused by FL in the patient. By including lenalidomide, the RELEVANCE study aims to eliminate the cancer while restoring the patient's immune competence.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by The Lymphoma Academic Research Organisation.