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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

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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