A Phase 3 interventional study of Rituximab and Lenalidomide in Follicular Lymphoma, sponsored by The Lymphoma Academic Research Organisation. Completed at 35 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by The Lymphoma Academic Research Organisation · Phase 3, Interventional, and Treatment
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.
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.
931 studies on the registry are indexed under Lymphoma, Follicular; 237 are open to participants now.
This study's enrollment of 1,030 is above the median of 48 across 797 interventional studies indexed under Lymphoma, Follicular.
Browse Lymphoma, Follicular studies →The Lymphoma Academic Research Organisation is the lead sponsor of 60 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* 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 * 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.
Drug: Rituximab · Drug: Lenalidomide
• 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 · Drug: Rituximab - CVP · Drug: Rituximab - Bendamustine
• 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.
Also known as: mabthera, rituxan
• 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
Also known as: Revlimid
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 cycles
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,
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
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.
Time frame: Timeframe: CR/CRu rate at 120 weeks
Progression Free Survival (PFS)
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.
Time frame: up to 13 years
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
Plan to share: No
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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The Lymphoma Academic Research Organisation