Spots Global Cancer Trial Database for 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
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Trial Identification
Brief 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
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.
Study ID: NCT01650701
Conditions
Study Description
Brief 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.
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Concord Repatriation General Hospital, Concord, New South Wales, Australia
Nepean Hospital, Penrith, New South Wales, Australia
Wollongong Hospital, Wollongong, New South Wales, Australia
CHU Mont-Godinne, Yvoir, , Belgium
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
Fraser Valley Cancer Centre, Surrey, British Columbia, Canada
BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada
Moncton Hospital, Moncton, New Brunswick, Canada
Atlantic Health Sciences Corp - Saint John Regional Hospital, Halifax, Nova Scotia, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
UHN-Princess Margaret Hospital, Toronto, Ontario, Canada
CHUM Hopital Notre-Dame, Montreal, Quebec, Canada
McGill University Department of Oncology, Montreal, Quebec, Canada
Hôpital de l'Enfant-Jesus, CHU de Quebec, Quebec city, Quebec, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
CHU Claude Huriez, Lille, , France
Medizinische Klinik der Universität Tübingen, Tübingen, Baden Wurtemberg, Germany
Uniklinik Köln, Köln, Nordrhein, Germany
LMU Munchën - Klinikum Grosshadern, Munchen, , Germany
Sant'Andrea Hospital, Roma, Lazio, Italy
Policlinico Sant'Orsola-Malpighi, Bologna, , Italy
Instituto Português Oncologia, Lisboa, , Portugal
Hospital Virgen del Rocio, Sevilla, Andaloucia, Spain
Hospital Universitario Mutua de Terrassa, Terrassa, Barcelona, Spain
Hospital Universitario de Canarias, Santa Cruz de Tenerife, Canarias, Spain
Hospital Son Llatzer, Palma, Mallorca, Spain
Hospital Clínico de Barcelona, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitario Vall d´Hebron, Barcelona, , Spain
Institut Català d'Oncologia de Girona (ICO Girona), Girona, , Spain
Hospital Ramon y Cajal, Madrid, , Spain
Hospital Costa del Sol, Marbella, , Spain
Hospital Universitario Salamanca, Salamanca, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain
Contact Details
Name: Franck Morschhauser, MD, PhD
Affiliation: The Lymphoma Study Association (LYSA)
Role: STUDY_CHAIR
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