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 Celgene Corporation
Collaborator The Lymphoma Academic Research Organisation
Start date December 2011
End date June 2024
Trial size 254 participants
Trial identifier NCT01476787, 2011-002792-42, RV-FOL-GELARC-0683C

Summary

The purpose of this study is to evaluate the effect of the combined treatment of lenalidomide and rituximab in controlling the Follicular Lymphoma disease and also increase the length of response compared to the available standard combination chemotherapy treatment for Follicular Lymphoma.

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 for 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 up to 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
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
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
7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
rituximab-cvp
7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
rituximab-bendamustine
7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.

Primary Outcomes

Measure
Complete Response Rate (CR/CRu) at 120 weeks
time frame: Up to approximately 2.5 years
Progression free survival (PFS)Follicular lymphoma
time frame: Up to 12 years
Safety in Follicular lymphoma
time frame: Up to 120 weeks

Secondary Outcomes

Measure
Number of participants with adverse events
time frame: Up to 13 years
Time to Treatment Failure (TTF)Follicular Lymphoma
time frame: Up to 13 years
Number of Participants who Survive without an Event(s)
time frame: Up to 13 years
Time to Next Anti-Lymphoma Treatment (TTNLT) for Follicular Lymphoma
time frame: Up to 12 years
Time to Next Chemotherapy Treatment (TTNCT) for Follicular Lymphoma
time frame: Up to 13 years
Number of participants alive or dead
time frame: Up to 13 years
Overall response by International Working Group (IWG) 1999 criteria
time frame: Up to 120 weeks
Health related quality of life as measured by the EORTC QLQ-C30 for Follicular Lymphoma patients
time frame: Up to 13 years
Event-Free Survival (EFS)
time frame: Up to 12 years
Overall Survival (OS)
time frame: up to 12 years
Complete Response Rate (CR/CRu) at 120 weeks
time frame: Up to approximately 2.5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically confirmed follicular lymphoma grade 1, 2 or 3a, Stage II-IV - Have no prior systemic treatment for lymphoma - Symptomatic follicular lymphoma requiring treatment. - Age ≥18 years - Eastern Cooperative oncology group performance status 0-2 - Willing to follow pregnancy precautions Exclusion Criteria: - Clinical evidence of transformed lymphoma or Grade 3b follicular lymphoma. - 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), human immunodeficiency virus (HIV) - Known sensitivity or allergy to murine products. - Presence or history of central nervous system involvement by lymphoma - At high risk for a venous thromboembolic event (VTE) and not willing to take VTE prophylaxis - Any of the following laboratory abnormalities: - serum aspartate transaminase or alanine transaminase > 3x upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma - total bilirubin > 2.0 mg/dl (34 µmol/L) except in cases of Gilberts Syndrome and documented liver or pancreatic involvement by lymphoma - creatinine clearance of < 30 mL/min

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 in Subjects With Previously Untreated Follicular Lymphoma
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. The 'Relevance' cooperative group trial 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 Follicular Lymphoma patients enrolled in both studies will be analyzed.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Celgene Corporation.
Location data was received from the National Cancer Institute and was last updated in April 2016.