A Study Comparing Obinutuzumab (RO5072759; GA101) 1000 Milligram (mg) Versus 2000 mg in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GAGE)

Phase 2 Completed 80 enrolled Genentech, Inc.

RandomizedParallel-groupOpen-labelTreatment

Summary

This open-label, multicenter, randomized study compared the efficacy, safety and pharmacokinetics of obinutuzumab (RO5072759; GA101) 1000 mg versus 2000 mg in participants with previously untreated CLL. Participants were randomized to receive a maximum of 8 cycles (28-day cycle) of obinutuzumab (1000 mg intravenous \[IV\] infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of each subsequent cycle up to 8 cycles or maximum of 8 cycles of obinutuzumab (2000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of each subsequent cycle up to 8 cycles.

Timeline

Start: 2011-10-31
Primary completion: 2013-03-31
Completion: 2016-03-31

Outcome

Missed primary endpoint

registry Obinutuzumab 1000 mg vs Obinutuzumab 2000 mg; p = 0.0779; Difference (Hauck-Anderson) 17.89 (95% CI -4.95 to 40.72) NCT01414205 ↗

paper ORR (67% vs 49%, P = .08) and complete response (CR) or CR with incomplete cytopenia response (20% vs 5%) favored 2000 mg obinutuzumab. PMID 26472752 ↗

Publications

Byrd JC, Flynn JM, Kipps TJ, Boxer M, Kolibaba KS, Carlile DJ, Fingerle-Rowson G, Tyson N, Hirata J, Sharman JP. Randomized phase 2 study of obinutuzumab monotherapy in symptomatic, previously untreated chronic lymphocytic leukemia. Blood. 2016 Jan 7;127(1):79-86. doi: 10.1182/blood-2015-03-634394. Epub 2015 Oct 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Obinutuzumab	Monoclonal antibody	1000 mg	Intravenous
Subject	Obinutuzumab	Monoclonal antibody	2000 mg	Intravenous