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)
18 Years
N/A
Both
Follicular Lymphoma
Trial Information
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)
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete response (CR/CRu) rate for Follicular Lymphoma
Outcome Description:
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%.
Outcome Time Frame:
120 weeks
Safety Issue:
No
Principal Investigator
Nathan H Fowler, M.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Assistant Professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX
Authority:
United States: Food and Drug Administration
Study ID:
RV-FOL-GELARC-0683C
NCT ID:
NCT01476787
Start Date:
November 2011
Completion Date:
June 2024
Related Keywords:
- Follicular Lymphoma
- Follicular lymphoma
- Non-Hodgkins Follicular Lymphoma
- treatment for Follicular Lymphoma
- rituximab treatment
- rituximab and lenalidomide treatment
- Lymphoma
- Lymphoma, Follicular
Name | Location |
|---|---|
| Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
| MD Anderson Cancer Center | Houston, Texas 77030-4096 |
| MD Anderson Cancer Center Orlando | Orlando, Florida 32806 |
| Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
| University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
| Florida Cancer Specialists | Fort Myers, Florida 33901 |
| Memorial Hospital | Colorado Springs, Colorado 80909 |
| Seattle Cancer Care Alliance | Seattle, Washington 98109 |
| Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
| Sarah Cannon Cancer Center | Nashville, Tennessee 37203 |
| University of Kentucky | Lexington, Kentucky 40536-0098 |
| Virginia Cancer Institute | Richmond, Virginia 23230 |
| Compassionate Cancer Care medical Group, Inc. | Fountain Valley, California 92708 |
| Somerset Hematology Oncology Associates | Somerset, New Jersey 08873 |
| Kentucky Cancer Clinic | Pikeville, Kentucky 41501 |
| Providence Saint Joseph Medical Center | Burbank, California 91505-4866 |
| St. Luke's-Roosevelt Hospital Center | New York, New York |
| Florida Cancer Specialist | Fort Myers, Florida 33901 |
| Santa Monica Hematology/Oncology | Santa Monica, California 90404 |
| The Cancer Center at Hackensack University Medical Center | Hackensack, New Jersey 07601 |
| Roger Maris Cancer Center | Fargo, North Dakota 58122 |
| St. Jude Heritage Medical Group | Fullerton, California 92835 |
| Cancer Center of Central Connecticut | Southington, Connecticut |
| Baylor Sammons Cancer Center | Dallas, Texas 75246 |
| Advocate Illinois Masonic Medical Center | Chicago, Illinois 60657 |
| Newland Medical Associates | Southfield, Michigan 48075 |
| University Cancer Institute | Boyton Beach, Florida 33426 |
| Lalita Pandit, MD Inc. | Fountain Valley, California 92708 |
| Saint Joseph's Medical Center | Westminister, Maryland 21157 |
| Harvard Medical School-Mass General Hospital | Boston, Massachusetts 02114 |
| Washington University School of Medicine Siteman Cancer Center Hematology Labs | St. Louis, Missouri 63141 |
| Hematology-Oncology Associates of North New Jersey | Morristown, New Jersey 07960 |
| Ochsner Clinic Baton Rouge | Baton Rouge, Louisiana 70809 |
