A Study Comparing Obinutuzumab (RO5072759; GA101) 1000 Milligram (mg) Versus 2000 mg in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GAGE)
NCT ID: NCT01414205
Last Updated: 2017-04-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2011-10-31
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Obinutuzumab 1000 mg
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.
Obinutuzumab
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.
Corticosteroids
Participants were administered corticosteroids IV prior to the initial dose.
Obinutuzumab 2000 mg
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.
Obinutuzumab
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.
Corticosteroids
Participants were administered corticosteroids IV prior to the initial dose.
Interventions
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Obinutuzumab
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.
Corticosteroids
Participants were administered corticosteroids IV prior to the initial dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Texas Cancer Center - Sherman
Sherman, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
SW Virginia Hem Onc
Roanoke, Virginia, United States
Shenandoah Oncology Associates
Winchester, Virginia, United States
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States
Countries
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References
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Byrd JC, Flynn JM, Kipps TJ, Boxer M, Kolibaba KS, Carlile DJ, Fingerle-Rowson G, Tyson N, Hirata J, Sharman JP. Randomized phase 2 study of obinutuzumab monotherapy in symptomatic, previously untreated chronic lymphocytic leukemia. Blood. 2016 Jan 7;127(1):79-86. doi: 10.1182/blood-2015-03-634394. Epub 2015 Oct 15.
Other Identifiers
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GO25677
Identifier Type: OTHER
Identifier Source: secondary_id
GAO4768g
Identifier Type: -
Identifier Source: org_study_id
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