Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma

Status: Recruiting
Phase: Phase 3
Diagnosis: Non-Hodgkin's Lymphoma
NCT ID: NCT01476787 (View complete trial on
DFCI Protocol ID: 11-447


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.


Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Harvard Medical School

Overall PI:
Jeffery Barnes, MD, Dana Farber Cancer Institute

Site-responsible Investigators:
David C. Fisher, MD, Dana-Farber Cancer Institute

Dana-Farber Cancer Institute: Kathleen McDermott,
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

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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