Non Hodgkin Lymphoma Clinical Trial
Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma
Summary
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.
Full 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 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
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There are 47 Locations for this study
Chandler Arizona, 85224, United States
Burbank California, 91505, United States
Corona California, 92829, United States
Fountain Valley California, 92708, United States
Fullerton California, 92835, United States
Los Angeles California, 90095, United States
Colorado Springs Colorado, 80909, United States
Southington Connecticut, 06489, United States
Boynton Beach Florida, 33426, United States
Englewood Florida, 34223, United States
Fort Lauderdale Florida, 33308, United States
Orlando Florida, 32806, United States
Saint Petersburg Florida, 33705, United States
Chicago Illinois, 60657, United States
Hazard Kentucky, 41701, United States
Lexington Kentucky, 40536, United States
New Orleans Louisiana, 70121, United States
Westminster Maryland, 21157, United States
Boston Massachusetts, 02114, United States
Southfield Michigan, 48075, United States
Saint Louis Missouri, 63110, United States
Omaha Nebraska, 68198, United States
Cherry Hill New Jersey, 08003, United States
Hackensack New Jersey, 07601, United States
Morristown New Jersey, 07960, United States
Somerset New Jersey, 08873, United States
Sparta New Jersey, 07871, United States
New York New York, 10019, United States
New York New York, 10021, United States
Fargo North Dakota, 58122, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75246, United States
Houston Texas, 77030, United States
Lubbock Texas, 79410, United States
Richmond Virginia, 23230, United States
Seattle Washington, 98109, United States
Chuo-ku , 104-0, Japan
Higashi-ku, Fukuoka , 812-8, Japan
Hiroshima , 72000, Japan
Hyogo , 650-0, Japan
Isehara City, Kanagawa , 259-1, Japan
Koto-ku , 135-8, Japan
Kyoto-city , 602-8, Japan
Minato-ku , 105-8, Japan
Okayama , 710-8, Japan
Sendai-city , 983-8, Japan
Shizuoka , 410-2, Japan
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