Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma (RELEVANCE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Celgene Corporation
Sponsor:
Collaborator:
The Lymphoma Academic Research Organisation
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01476787
First received: November 18, 2011
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to evaluate the effect of the combined treatment of lenalidomide and rituximab in controlling the Follicular Lymphoma disease and also increase the length of response compared to the available standard combination chemotherapy treatment for Follicular Lymphoma.


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)

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Complete response (CR/CRu) rate for Follicular Lymphoma [ Time Frame: 120 weeks ] [ Designated as safety issue: No ]

    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.

    Complete response unconfirmed (CRu) is defined as those patients who fulfill the criteria for CR above but with with indeterminant bone marrow or with residual disease that has decreased in size by greater than 75%.


  • Progression free survival (PFS)Follicular lymphoma [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
    Progression-free survival is defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause.

  • Safety in Follicular lymphoma [ Time Frame: Up to 120 weeks ] [ Designated as safety issue: Yes ]
    Safety in Follicular lymphoma


Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: Up to 13 years ] [ Designated as safety issue: Yes ]
  • Time to Treatment Failure (TTF)Follicular Lymphoma [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
    Time to Treatment Failure (TTF)Follicular Lymphoma

  • Number of Participants who Survive without an Event(s) [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
    Event Free Survival (EFS)Follicular Lymphoma

  • Time to Next Anti-Lymphoma Treatment (TTNLT) for Follicular Lymphoma [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
    Time to Next Anti-Lymphoma Treatment (TTNLT) for Follicular Lymphoma

  • Time to Next Chemotherapy Treatment (TTNCT) for Follicular Lymphoma [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
    Time to Next Chemotherapy Treatment (TTNCT) for Follicular Lymphoma

  • Number of participants alive or dead [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
  • Overall response by International Working Group (IWG) 1999 criteria [ Time Frame: Up to 120 weeks ] [ Designated as safety issue: No ]
  • Health related quality of life as measured by the EORTC QLQ-C30 for Follicular Lymphoma patients [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
    Health related quality of life as measured by the EORTC QLQ-C30 for Follicular Lymphoma patients


Estimated Enrollment: 1000
Study Start Date: November 2011
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 for 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 up to 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
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: Lenalidomide
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
7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
Drug: Rituximab-CVP
7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
Drug: Rituximab-Bendamustine
7 to 8 weeks later responding patients will 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.

The 'Relevance' cooperative group trial 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 Follicular Lymphoma patients enrolled in both studies will be analyzed.

  Eligibility

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

Inclusion Criteria:

  • Histologically confirmed follicular lymphoma grade 1, 2 or 3a, Stage II-IV
  • Have no prior systemic treatment for lymphoma
  • Symptomatic follicular lymphoma requiring treatment.
  • Age ≥18 years
  • Eastern Cooperative oncology group performance status 0-2
  • Willing to follow pregnancy precautions

Exclusion Criteria:

  • Clinical evidence of transformed lymphoma or Grade 3b follicular lymphoma.
  • 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), human immunodeficiency virus (HIV)
  • Known sensitivity or allergy to murine products.
  • Presence or history of central nervous system involvement by lymphoma
  • At high risk for a venous thromboembolic event (VTE) and not willing to take VTE prophylaxis
  • Any of the following laboratory abnormalities:
  • serum aspartate transaminase or alanine transaminase > 3x upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma
  • total bilirubin > 2.0 mg/dl (34 µmol/L) except in cases of Gilberts Syndrome and documented liver or pancreatic involvement by lymphoma
  • creatinine clearance of < 30 mL/min
  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: NCT01476787

Contacts
Contact: Caroline Piganeau +49 211 92965957 cpiganeau@celgene.com
Contact: Christian Aeschlimann, MSc +41 32 729 87 92 caeschlimann@celgene.com

  Show 45 Study Locations
Sponsors and Collaborators
Celgene Corporation
The Lymphoma Academic Research Organisation
Investigators
Study Chair: Nathan H Fowler, M.D. Assistant Professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX
  More Information

No publications provided by Celgene Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01476787     History of Changes
Other Study ID Numbers: RV-FOL-GELARC-0683C, 2011-002792-42
Study First Received: November 18, 2011
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Celgene Corporation:
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 22, 2014