A Study Comparing Obinutuzumab (RO5072759; GA101) 1000 Milligram (mg) Versus 2000 mg in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GAGE)
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Keep this study
Lead
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study Comparing Obinutuzumab (RO5072759; GA101) 1000 Milligram (mg) Versus 2000 mg in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GAGE)
