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.
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
COMPLETE RESPONSE RATE
Complete response (CR/CRu) rate at 120 weeks Response evaluation was as defined by International Working Group (IWG) Response Criteria (Cheson 1999). Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms if present before therapy.
Timeframe: CR/CRu rate at 120 weeks
Franck Morschhauser, MD, PhD
The Lymphoma Study Association (LYSA)
United States: Food and Drug Administration