Status:
COMPLETED
A Study Comparing Obinutuzumab (RO5072759; GA101) 1000 Milligram (mg) Versus 2000 mg in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GAGE)
Lead Sponsor:
Genentech, Inc.
Conditions:
Lymphocytic Leukemia, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 CL...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 31 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2016
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01414205
Start Date
October 31 2011
End Date
March 31 2016
Last Update
April 17 2017
Active Locations (31)
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1
Univ of Alabama at Birmingham; UAB Comprehensive Cancer Ctr
Birmingham, Alabama, United States, 35291-3300
2
Arizona Oncology
Tucson, Arizona, United States, 85704
3
Arizona Clinical Research Ctr
Tucson, Arizona, United States, 85715
4
University of California; Moores Cancer Center
La Jolla, California, United States, 92093