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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by The Lymphoma Academic Research Organisation
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier:
NCT01650701
First received: July 24, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted

July 24, 2012
July 24, 2012
February 2012
June 2024   (final data collection date for primary outcome measure)
  • COMPLETE RESPONSE RATE [ Time Frame: Timeframe: CR/CRu rate at 120 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
No Changes Posted
  • Number of participants with adverse events [ Time Frame: up to13 years ] [ Designated as safety issue: Yes ]
  • Time to Treatment Failure (TTF) [ Time Frame: up to13 years ] [ Designated as safety issue: No ]
  • Event Free Survival (EFS) [ Time Frame: up to13 years ] [ Designated as safety issue: No ]
  • Time to Next Anti-Lymphoma Treatment (TTNLT), [ Time Frame: up to13 years ] [ Designated as safety issue: No ]
  • Time to Next Chemotherapy Treatment (TTNCT) [ Time Frame: up to13 years ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: up to13 years ] [ Designated as safety issue: No ]
  • Overall response rate at 120 weeks by International Working Group (IWG) 1999 criteria [ Time Frame: up to13 years ] [ Designated as safety issue: No ]
  • Health related quality of life as measured by the EORTC QLQ-C30 [ Time Frame: up to13 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Follicular Lymphoma
  • Drug: 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:
    • mabthera
    • rituxan
  • 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
  • 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 cycles
  • Drug: 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.
  • Experimental: Lenalidomide + Rituximab
    • 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.
    Interventions:
    • Drug: Rituximab
    • Drug: Lenalidomide
  • 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.
    Interventions:
    • Drug: Rituximab - CHOP
    • Drug: Rituximab - CVP
    • Drug: Rituximab - Bendamustine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
June 2024
June 2024   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed CD20+ follicular lymphoma grade 1, 2 or 3a
  • Have no prior systemic treatment for lymphoma.
  • Must be in need of treatment
  • Bi-dimensionally measurable disease with at least one mass lesion > 2 cm that was not previously irradiated.
  • Stage II, III or IV disease.
  • Must be ≥ 18 years and sign an informed consent.
  • Performance status ≤ 2 on the ECOG scale.
  • Adequate hematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow)
  • Willing to follow pregnancy precautions

Exclusion Criteria:

  • Clinical evidence of transformed lymphoma by investigator assessment or Grade 3b follicular lymphoma.
  • Patients taking corticosteroids during the last 4 weeks, unless administered at a dose equivalent to < 10 mg/day prednisone (over these 4 weeks).
  • Major surgery (excluding lymph node biopsy) within 28 days prior to signing informed consent.
  • Known Seropositive for or active viral infection with hepatitis B virus (HBV), hepatitis C virus (HCV)or human immunodeficiency virus (HIV).
  • Life expectancy < 6 months.
  • Known sensitivity or allergy to murine products.
  • Prior history of malignancies, other than follicular lymphoma, unless the patient has been free of the disease for ≥ 10 years.
  • Prior use of lenalidomide.
  • Neuropathy > Grade 1.
  • Presence or history of CNS involvement by lymphoma.
  • Patients who are at a high risk for a thromboembolic event and are not willing to take venous thromboembolic (VTE) prophylaxis.
  • serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) > 3x upper limit of normal (ULN), except in patients with documented liver or pancreatic involvement by lymphoma
  • total bilirubin > 2.0 mg/dl (34 µmol/L) except in cases of Gilberts Syndrome and documented liver involvement by lymphoma
  • creatinine clearance of < 30 mL/min
  • Pregnant or lactating females.
  • Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study, or which confounds the ability to interpret data from the study.
Both
18 Years and older
No
Contact: Delphine Germain +33 4 72 66 93 33 delphine.germain@lysarc.org
France
 
NCT01650701
RV-FOL-GELARC-0683, 2011-002792-42
Yes
The Lymphoma Academic Research Organisation
The Lymphoma Academic Research Organisation
Celgene Corporation
Study Chair: Franck Morschhauser, MD, PhD The Lymphoma Study Association (LYSA)
The Lymphoma Academic Research Organisation
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP