A PHASE 3, DOUBLE-BLIND RANDOMIZED STUDY TO COMPARE THE EFFICACY AND SAFETY OF RITUXIMAB PLUS LENALIDOMIDE (CC-5013) VERSUS RITUXIMAB PLUS PLACEBO IN SUBJECTS WITH RELAPSED/REFRACTORY INDOLENT LYMPHOMA
The goal of this research study is to learn if adding Revlimid® (lenalidomide) to rituximab can help to control FL and/or MZL. The safety of this drug combination will also be studied.
Treatment Location: N/A
Primary Objective The primary objective of the study is to compare the efficacy of rituximab plus lenalidomide to rituximab plus placebo in subjects with relapsed/refractory indolent lymphoma. Efficacy determination will be based upon progression free survival (PFS) as the primary endpoint, as assessed by the Independent Review Committee (IRC) using the 2007 International working group (IWG) criteria but without positron emission tomography (PET). Secondary Objectives The secondary objectives of the study are: - to compare the safety of rituximab plus lenalidomide versus rituximab plus placebo - to compare the efficacy of rituximab plus lenalidomide versus rituximab plus placebo using other parameters of efficacy: o Durable complete response rate (DCRR), overall response rate (ORR), duration of response (DoR) and duration of complete response (DoCR) by IWG 2007 without PET o Overall Survival (OS), Event Free Survival (EFS), time to next anti-lymphoma treatment (TTNLT) Exploratory Objectives The exploratory objectives of the study are: - to compare the effects of rituximab plus lenalidomide versus rituximab plus placebo on: o time to treatment failure (TTF), time to next chemotherapy treatment (TTNCT) and response rate to next anti-lymphoma treatment (RTNLT) o Complete Response/Complete Response unspecified (CR/CRu) rate in Folicular Lymphoma (FL) subjects based on the 1999 International Working Group (IWG) criteria o progression free survival on next anti-lymphoma treatment (PFS2) o time to histological transformation - health-related quality of life (QoL) as measured by the EORTC QLQ-C30 and EQ-5D - to investigate potential predictive biomarkers of clinical response including but not limited to gene expression, analysis of acquired chromosomal aberrations (for example, translocations, mutations, deletions, single nucleotide polymorphisms), microRNA and protein expression in archival diagnostic tumor samples in subjects who sign optional informed consent for these exploratory analyses.
IRB Review and Approval Date: 07/30/2015
Recruitment Status: Closed
Projected Accrual: N/A
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