A Phase Ib/II Study of OBINUTUZUMAB Combined to LENALIDOMIDE for the Treatment of Relapsed/Refractory Follicular and Aggressive (DLBCL and MCL) B-cell Lymphoma
This study is an open label, multicenter study with two phases:
The Phase IB part of the study is a dose escalation study of lenalidomide (Revlimid)
administered orally during on 3 weeks of every 28-day cycle, in combination with fixed doses
of obinutuzumab (GA101) in relapsed/refractory follicular lymphoma patients.
The Phase II part of the study is an efficacy study of the association of the recommended
dose of lenalidomide associated with GA101 in 2 separate populations of patients:
relapsed/refractory follicular lymphoma in one cohort and relapsed/refractory aggressive
lymphoma (diffuse large B-cell lymphoma and mantle cell lymphoma) in the second cohort.
First, all patients will receive a combination of obinutuzumab and lenalidomide for a total
of 6 cycles. Patients who achieve at least a partial response after 6 cycles will receive a
maintenance treatment with obinutuzumab for 2 years and Lenalidomide for 1 year as
tolerated, or until disease progression.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determination of the recommended dose of lenalidomide in combination with fixed doses of GA101
The determination of the recommended dose of lenalidomide in combination with fixed doses of GA101 will be performed by a dose escalation approach. Dose Limiting Toxicities (DLTs) observed during the administration of the first 2 cycles of the study will be listed for each escalation step.
Franck MORSCHHAUSER, Professor
Lymphoma Study Association
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)