New Clinical Trial: Phase 3 Study to Compare Rituximab + Lenalidomide to Rituximab + Placebo in Patients with Relapsed/Refractory Indolent LymphomaPosted: January 30, 2015
The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with relapsed/refractory indolent lymphoma. The study sponsor is the Celgene Corporation, and the principal investigator at Weill Cornell is Dr. John Leonard. For more information about the study, please call Amelyn Rodgriguez, RN at (212) 746-1362 or e-mail Amelyn at email@example.com.
- Men and women age 18 and older
- Histologically confirmed MZL or Grade 1,2, or 3a FL
- Relapsed, refractory, or progressive disease after treatment with systemic therapy, and must be rituximab-sensitive if had received rituximab or R-chemo regimen therapy
- Detailed eligibility reviewed when you contact the study team
This phase 3 multicenter, double-blind, randomized study is designed to evaluate the efficacy and safety of rituximab plus lenalidomide versus rituximab plus placebo. Subjects must have an investigator-assessed diagnosis of relapsed/refractory indolent lymphoma, defined in this clinical trial as Grade 1, 2 or 3a follicular lymphoma or marginal zone lymphoma, must have been previously treated for their lymphoma with systemic therapy (chemotherapy, immunotherapy, or chemo immunotherapy), must be refractory to or have relapsed after their last treatment, may be rituximab-naïve or rituximab-sensitive, must have at least one measurable lesion by computed axial tomography (CT) or magnetic resonance imaging (MRI) scan, and must have adequate bone marrow function, liver function and renal function.
The study is divided into the Screening Period (up to 28 days), Treatment Period (up to 12 28-day cycles), and Follow-up Period. Approximately 350 subjects are planned to be randomized with 5 subjects at WCMC. Each patient will receive rituximab weekly during cycle 1 and then on day 1 of cycles 2-5. Depending on randomization, subjects will also receive either lenalidomide or placebo on days 1-21 of cycles 1-12.