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 (RELEVANCE)
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|ClinicalTrials.gov Identifier: NCT01650701|
Recruitment Status : Active, not recruiting
First Posted : July 26, 2012
Last Update Posted : April 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Follicular Lymphoma||Drug: Rituximab Drug: Lenalidomide Drug: Rituximab - CHOP Drug: Rituximab - CVP Drug: Rituximab - Bendamustine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1031 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||February 2012|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||September 2024|
Experimental: Lenalidomide + Rituximab
• 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.
Other Names:Drug: Lenalidomide
• Lenalidomide dose 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
Other Name: Revlimid
Active Comparator: Control
• 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.
Drug: Rituximab - CHOP
six cycles of R-CHOP in 21 day cycles followed by two 21 day cycles of 375 mg/m2 rituximab; and 7 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cyclesDrug: Rituximab - CVP
eight cycles of R-CVP in 21 day cycles; and 7 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles,Drug: Rituximab - Bendamustine
six cycles of R-B in 28 day cycles and 8 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
- COMPLETE RESPONSE RATE [ Time Frame: Timeframe: CR/CRu rate at 120 weeks ]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.
- Progression Free Survival (PFS) [ Time Frame: up to 13 years ]PFS is defined as the time from the start of study drug therapy to the 1st observation of disease progression or death due to any cause.
- Number of participants with adverse events [ Time Frame: up to13 years ]
- Time to Treatment Failure (TTF) [ Time Frame: up to13 years ]
- Event Free Survival (EFS) [ Time Frame: up to13 years ]
- Time to Next Anti-Lymphoma Treatment (TTNLT), [ Time Frame: up to13 years ]
- Time to Next Chemotherapy Treatment (TTNCT) [ Time Frame: up to13 years ]
- Overall Survival (OS) [ Time Frame: up to13 years ]
- Overall response rate at 120 weeks by International Working Group (IWG) 1999 criteria [ Time Frame: up to13 years ]
- Health related quality of life as measured by the EORTC QLQ-C30 [ Time Frame: up to13 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650701
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|Study Chair:||Franck Morschhauser, MD, PhD||The Lymphoma Study Association (LYSA)|