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

Completed · Phase 2

Conditions studied: Lymphocytic Leukemia, Chronic

In brief

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.

Key facts

Study ID

NCT01414205

Run by

Genentech, Inc.

People needed

80

Starts

2011-10-31

Expected to finish

2016-03-31

Last updated by the study team

2017-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Univ of Alabama at Birmingham; UAB Comprehensive Cancer Ctr — Birmingham, Alabama, United States
• Arizona Oncology — Tucson, Arizona, United States
• Arizona Clinical Research Ctr — Tucson, Arizona, United States
• University of California; Moores Cancer Center — La Jolla, California, United States
• USC Norris Cancer Center — Los Angeles, California, United States
• USC/Norris Can Ctr; IDS Pharm — Los Angeles, California, United States
• Ventura County Hematology-Oncology Specialists — Oxnard, California, United States
• Wilshire Oncology Medical Group — Pasadena, California, United States
• Univ of Colorado Canc Ctr — Aurora, Colorado, United States
• Rocky Mountain Cancer Center; Medical Oncology — Denver, Colorado, United States
• Kootenai Cancer Center — Post Falls, Idaho, United States
• Goshen Hlth Sys Ctr Can Care — Goshen, Indiana, United States
• Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• Horizon Oncology Research, Inc. — Lafayette, Indiana, United States
• Purchase Cancer Group — Paducah, Kentucky, United States
• Hem Onc Assoc of Northern NJ; Carol G. Simon Canc Ctr — Morristown, New Jersey, United States
• Columbia University Medical Center — New York, New York, United States
• Ohio State University — Columbus, Ohio, United States
• Mark H. Zangmeister Center — Columbus, Ohio, United States
• Kettering Medical Center — Kettering, Ohio, United States
• INTEGRIS Cancer Inst of OK — Oklahoma City, Oklahoma, United States
• Willamette Valley Cancer Ctr - 520 Country Club — Eugene, Oregon, United States
• Texas Oncology-Medical City Dallas — Dallas, Texas, United States
• Texas Oncology - Dallas Presbyterian Hospital — Dallas, Texas, United States
• US Oncology Research Pharm. — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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