Spots Global Cancer Trial Database for 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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Trial Identification
Brief Title: A Study Comparing Obinutuzumab (RO5072759; GA101) 1000 Milligram (mg) Versus 2000 mg in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GAGE)
Official Title: An Open-label, Multicenter, Randomized Phase II Trial Comparing the Efficacy, Safety, and Pharmacokinetics of GA101 1000 mg Versus 2000 mg in Patients With Previously Untreated Chronic Lymphocytic Leukemia
Study ID: NCT01414205
Conditions
Study Description
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 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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