A Study Comparing Obinutuzumab (RO5072759; GA101) 1000 Milligram (mg) Versus 2000 mg in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GAGE)
Condition: Lymphocytic Leukemia, Chronic
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Obinutuzumab; Corticosteroids
Intervention description: Participants were administered obinutuzumab either at 1000 mg or 2000 mg on Day 1, 8, 15 of Cycle 1 and then on Day 1 of each 21 day cycles for up to 8 cycles.; Participants were administered corticosteroids IV prior to the initial dose.
Intervention MeSH terms: Obinutuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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