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