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LY16 Details
Status: Closed 
Activation Date: 2013JUN17
Closing Date: 2014NOV10
Phase: III 

Description: A Phase III Open-Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) versus Rituximab Plus Chemotherapy Followed by Rituximab in Subjects With Previously Untreated Follicular Lymphoma 

Eligibility: Investigator-assessed diagnosis of Stage II-IV CD20+ follicular lymphoma (grade 1-3a) 

Objective: Co-Primary: complete response (CR/CRu), progression free survival (PFS) Secondary: event free survival (EFS),time to next anti-lymphoma treatment (TTNLT, overall survival (OS), safety, Exploratory: CR rate at 120 weeks and PFS, time to treatment failure (TTF), time to next chemotherapy treatment (TTNCT) and overall response rate (ORR) at 120 weeks, biomarker analysis, health related QoL and health economics.  

Participation: Open to member centres 

Lay Description: The purpose of this study is to compare the effects on follicular lymphoma of a new drug lenalidomide in combination with rituximab compared to other drug regimens used to treat this disease. This research is being done because the combination of lenalidomide with rituximab in patients with follicular lymphoma has been studied in a few people and seems promising but it is not clear if it can offer better results than the treatments used in the control arm. The standard or usual treatment for this disease is treatment with chemotherapy and rituximab. 

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