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

Genentech

Status and phase: Completed; Phase 2

Conditions: Lymphocytic Leukemia, Chronic

Treatments: Drug: Corticosteroids; Drug: Obinutuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01414205

GO25677 (Other Identifier)

GAO4768g

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Obinutuzumab 1000 mg

Experimental group

Description:

Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.

Treatment:

Drug: Obinutuzumab

Drug: Corticosteroids

Obinutuzumab 2000 mg

Experimental group

Description:

Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.

Treatment:

Drug: Obinutuzumab

Drug: Corticosteroids