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

• Status: Completed
• Trial end date: 2016-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Obinutuzumab

Criteria

Inclusion Criteria:

• Confirmed diagnosis of CD20-positive B-cell CLL (per International Workshop on Chronic Lymphocytic Leukemia [IWCLL] guidelines)

• Rai Stage III/IV or Binet Stage C disease, or Rai Stage I/II or Binet Stage B disease that requires treatment according to IWCLL guidelines

• No previous treatment for CLL chemotherapy, radiotherapy or immunotherapy; no previous rituximab treatment for autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP); prior use of steroids for AIHA or ITP is allowed

• Eastern Cooperative Oncology Group performance status of 0, 1 or 2

Exclusion Criteria:

• Confirmed diagnosis of Transformation of CLL to aggressive B-cell malignancy

• History of severe allergic or anaphylactic reactions to monoclonal antibody therapy

• Evidence of severe, uncontrolled concomitant disease

• Known active infection or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks before the start of Cycle 1

• Seropositive for human immunodeficiency virus (HIV)

• Positive for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HBsAg] serology)

• Positive for hepatitis C (hepatitis C virus [HCV] antibody serology testing)

• Pregnant or lactating women

• Concurrent (or within 7 days prior to first dose of study treatment) systemic corticosteroid use, except for low-dose corticosteroid therapy used to treat chronic medical conditions