Spots Global Cancer Trial Database for Lenalidomide and Obinutuzumab for Previously Untreated CLL

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Trial Identification

Brief Title: Lenalidomide and Obinutuzumab for Previously Untreated CLL

Official Title: A Phase 2 Clinical Trial To Evaluate Lenalidomide And Obinutuzumab For The Treatment Of Patients With Not Previously Treated Chronic Lymphocytic Leukemia

Study ID: NCT02371590

Conditions

Chronic Lymphocytic Leukemia

Interventions

Lenalidomide

Obinutuzumab

Study Description

Brief Summary: This is phase 1/2 study for patients with CLL or (SLL) who have not been previously treated. This study will evaluate whether obinutuzumab and lenalidomide is safe and tolerable in this setting and induce complete clinical responses.

Detailed Description: This is phase 1/2 study for patients with CLL or (SLL) who have not been previously treated. The primary endpoint is to determine safety and tolerability of the regimen and determine complete response (CR) to therapy. The secondary endpoints will assess the impact of treatment on progression free and overall survival Eligible patients will receive obinutuzumab for 6 x 28 day cycles. Patients will also receive lenalidomide orally once daily on days 8-28 of each 28 day cycles. The starting dose for all patients is 5 mg PO daily. At the start of each cycle, there is intra-patient dose-escalation to a maximum of 25mg daily, as tolerated.