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
  Purpose

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.


Condition Intervention Phase
Follicular Lymphoma
Drug: Rituximab
Drug: Lenalidomide
Drug: Rituximab - CHOP
Drug: Rituximab - CVP
Drug: Rituximab - Bendamustine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by The Lymphoma Academic Research Organisation:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1000
Study Start Date: February 2012
Estimated Study Completion Date: June 2024
Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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 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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650701

Contacts
Contact: Delphine Germain +33 4 72 66 93 33 delphine.germain@lysarc.org

Locations
France
CHU Claude Huriez Recruiting
Lille, France
Principal Investigator: Franck Morschhauser, MD, PhD         
Sponsors and Collaborators
The Lymphoma Academic Research Organisation
Celgene Corporation
Investigators
Study Chair: Franck Morschhauser, MD, PhD The Lymphoma Study Association (LYSA)
  More Information

No publications provided

Responsible Party: The Lymphoma Academic Research Organisation
ClinicalTrials.gov Identifier: NCT01650701     History of Changes
Other Study ID Numbers: RV-FOL-GELARC-0683, 2011-002792-42
Study First Received: July 24, 2012
Last Updated: July 24, 2012
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by The Lymphoma Academic Research Organisation:
follicular lymphoma
non-hodgkins follicular lymphoma
treatment for follicular lymphoma
rituximab treatment
rituximab and lenalidomide treatment

Additional relevant MeSH terms:
Lymphoma, Follicular
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Lenalidomide
Bendamustine
Thalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014