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Brief Title: Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma
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
Study ID: NCT01476787
Brief 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.
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Local Institution - 53003, Southfield, Michigan, United States
Local Institution - 51203, Dallas, Texas, United States
Local Institution - 51103, Houston, Texas, United States
Local Institution - 54003, Lubbock, Texas, United States
Local Institution - 40222, Koto-ku, Tokyo, Japan
Local Institution - 41022, Sendai-city, , Japan
Name: Franck Morschhauser, MD, PhD
Affiliation: The Lymphoma Study Association (LYSA)
Role: STUDY_CHAIR