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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

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Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Mar 2024

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At a glance

  • Drugs Lenalidomide (Primary) ; Rituximab (Primary) ; Bendamustine; Cyclophosphamide; Doxorubicin; Prednisolone; Vincristine
  • Indications Follicular lymphoma
  • Focus Therapeutic Use
  • Acronyms RELEVANCE

    • Most Recent Events

    • 13 Mar 2024 Planned End Date changed from 1 Sep 2024 to 1 Apr 2024.
    • 13 Dec 2022 Results assessing the prognostic value of baseline TMTV for FL patients with previously untreated advanced FL included in in the phase 3 RELEVANCE trial comparing R2 vs R-chemo with both regimens followed by rituximab maintenance therapy (NCT01476787 and NCT01650701), presented at the 64th American Society of Hematology Annual Meeting and Exposition.
    • 10 Aug 2022 Second interim analysis results of the RELEVANCE trial after 6 years of follow-up published in the Journal of Clinical Oncology
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