Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma
Launched by CELGENE · Nov 18, 2011
Trial Information
Current as of May 21, 2025
Completed
Keywords
ClinConnect Summary
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-0...
Gender
ALL
Eligibility 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
About Celgene
Celgene, now a part of Bristol Myers Squibb, is a global biopharmaceutical company dedicated to advancing innovative therapies for patients with cancer and other serious diseases. With a strong emphasis on research and development, Celgene focuses on discovering and delivering transformative medicines that address unmet medical needs. The company is committed to enhancing patient outcomes through rigorous clinical trials, cutting-edge science, and collaboration with healthcare professionals, ultimately striving to improve the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lexington, Kentucky, United States
New York, New York, United States
Saint Louis, Missouri, United States
Colorado Springs, Colorado, United States
Seattle, Washington, United States
Lubbock, Texas, United States
Fargo, North Dakota, United States
Fort Lauderdale, Florida, United States
Houston, Texas, United States
Nashville, Tennessee, United States
Richmond, Virginia, United States
Boston, Massachusetts, United States
Hazard, Kentucky, United States
Hackensack, New Jersey, United States
Chicago, Illinois, United States
New York, New York, United States
Southington, Connecticut, United States
Dallas, Texas, United States
Southfield, Michigan, United States
Englewood, Florida, United States
Shizuoka, , Japan
Boynton Beach, Florida, United States
Hyogo, , Japan
Orlando, Florida, United States
Okayama, , Japan
New Orleans, Louisiana, United States
Isehara City, Kanagawa, , Japan
Chandler, Arizona, United States
Fullerton, California, United States
Saint Petersburg, Florida, United States
Burbank, California, United States
Corona, California, United States
Fountain Valley, California, United States
Los Angeles, California, United States
Westminster, Maryland, United States
Omaha, Nebraska, United States
Cherry Hill, New Jersey, United States
Morristown, New Jersey, United States
Somerset, New Jersey, United States
Sparta, New Jersey, United States
Chuo Ku, , Japan
Higashi Ku, Fukuoka, , Japan
Hiroshima, , Japan
Koto Ku, , Japan
Kyoto City, , Japan
Minato Ku, , Japan
Sendai City, , Japan
Chuo Ku, Tokyo, Japan
Dallas, Texas, United States
Houston, Texas, United States
Koto Ku, Tokyo, Japan
Lubbock, Texas, United States
Southfield, Michigan, United States
Sendai City, , Japan
Minato Ku, Tokyo, Japan
Fukuoka, , Japan
Hiroshima, , Japan
Isehara City, Kanagawa, , Japan
Kobe City, , Japan
Kyoto City, , Japan
Shizuoka, , Japan
Chandler, Arizona, United States
Fullerton, California, United States
Los Angeles, California, United States
Colorado Springs, Colorado, United States
Englewood, Florida, United States
Orlando, Florida, United States
Saint Petersburg, Florida, United States
Chicago, Illinois, United States
Lexington, Kentucky, United States
Westminster, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Saint Louis, Missouri, United States
Cherry Hill, New Jersey, United States
Hackensack, New Jersey, United States
Morristown, New Jersey, United States
Sparta, New Jersey, United States
New York, New York, United States
New York, New York, United States
Nashville, Tennessee, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Patients applied
Trial Officials
Franck Morschhauser, MD, PhD
Study Chair
The Lymphoma Study Association (LYSA)
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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