Canadian Cancer Trials Group Bulletins

Trial Management Group


Trial Activation

Canadian Cancer Trials Group LY.16 (LYSARC Relevance Trial) - 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 - was centrally activated June 17, 2013.

The primary objective of the study is to compare the efficacy of rituximab plus lenalidomide to rituximab plus chemotherapy followed by Rituximab in patients with previously untreated follicular lymphoma. Efficacy determination will be based upon the co-primary endpoints of complete response (CR/CRu) rate at 120 weeks and PFS assessed by the Independent Review Committee (IRC) using the IWG (Cheson, 1999) criteria.

The secondary objectives of the study are:
  • To compare the efficacy of rituximab plus lenalidomide versus rituximab plus chemotherapy followed by rituximab using other parameters of efficacy:
  • Event Free Survival (EFS), Time to Next Anti-Lymphoma Treatment (TTNLT), Overall Survival (OS).
  • To compare the safety of rituximab plus lenalidomide versus rituximab plus chemotherapy followed by rituximab.