AN OPEN-LABEL, MULTICENTER, RANDOMIZED, PHASE III STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF BENDAMUSTINE COMPARED WITH BENDAMUSTINE + RO5072759 (GA101) IN PATIENTS WITH RITUXIMAB-REFRACTORY, INDOLENT NON-HODGKIN’S LYMPHOMA
The goal of this clinical research study is to learn if GA101 (obinutuzumab) in combination with bendamustine can help to control rituximab-refractory NHL compared to bendamustine alone. The safety of this drug combination will also studied.
Treatment Location: N/A
The primary objective for this study is as follows: • To evaluate clinical benefit in terms of Progression Free Survival (PFS), as assessed by an Independent Radiology Facility (IRF), for obinutuzumab when used in combination with bendamustine compared with bendamustine alone in patients with indolent NHL refractory to prior rituximab-containing therapy The secondary objectives for this study are as follows: • To compare PFS as assessed by the investigator • To compare overal survival (OS) between study arms • To evaluate in each study arm and compare between study arms the following: overall response rate (ORR = rate of complete response [CR] + partial response [PR]) and CRR at the Study Treatment Completion/Early Study Treatment Termination Visit best ORR achieved during treatment or within 12 months of the start of treatment disease-free survival in CR patients and duration of response in patients with CR and PR • To compare event-free survival (EFS) between the two study arms • To evaluate and compare the safety profiles of patients treated with the combination of obinutuzumab + bendamustine and bendamustine alone • To characterize the pharmacokinetics of obinutuzumab in combination with bendamustine and evaluate for drug-drug interactions by comparing the pharmacokinetics of the combination with the pharmacokinetics of bendamustine alone • To analyze pharmacoeconomics (medical resource utilization) in both arms of the study • To assess patient-reported outcomes (PROs) in both treatment arms
IRB Review and Approval Date: 12/13/2010
Recruitment Status: Closed
Projected Accrual: N/A