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A Study of Obinutuzumab [RO5072759 (GA101)] in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER)
Sponsor: Genentech, Inc.
Summary
This open-label, multicenter study will evaluate the efficacy and safety of obinutuzumab \[RO5072759 (GA101)\] in combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) chemotherapy in patients with advanced diffuse large B-cell lymphoma. Patients will receive 8 cycles of obinutuzumab (1000 mg intravenously on Day 1 of each 21-day cycle, during Cycle 1 obinutuzumab will also be infused on Days 8 and 15) in combination with CHOP chemotherapy on Day 1 of cycles 1 to 6. A substudy will investigate the drug-drug interaction of obinutuzumab with CHOP chemotherapy agents. For the substudy, an additional cohort of approximately 15 patients are planned to be enrolled at a subset of investigational sites.
Official title: A Phase II, Open-Label, Multicenter Study of Efficacy, Safety, and Biomarkers in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma Treated With GA101 (RO5072759) in Combination With CHOP Chemotherapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2011-08-31
Completion Date
2016-12-23
Last Updated
2026-09-29
Healthy Volunteers
No
Conditions
Interventions
obinutuzumab
1000 mg intravenously on Day 1 of each 21-day cycle, 8 cycles; during Cycle 1 administration also on Days 8 and 15.
cyclophosphamide
750 mg/m\^2 intravenous (IV), Day 1 of each 21-day cycle, 6 cycles.
doxorubicin
50 mg/m\^2 IV, Day 1 of each 21-cycle, 6 cycles.
prednisone
100 mg/day, Days 1 through 5 of each 21-day cycle, 6 cycles.
vincristine
1.4 mg/m\^2 IV, Day 1 of each 21-day cycle, 6 cycles.
Locations (38)
University of Alabama at Birmingham
Birmingham, Alabama, United States
cCare
Encinitas, California, United States
University of Colorado Cancer Center Department of Hematology
Aurora, Colorado, United States
Rocky Mountain Cancer Ctr - Denver (Williams)
Denver, Colorado, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Florida Cancer Specialists; Department of Oncology
Fort Myers, Florida, United States
Florida Cancer Specialists; Saint Petersburg
St. Petersburg, Florida, United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, United States
Kootenai Medical Center
Coeur d'Alene, Idaho, United States
Northwestern University; Robert H. Lurie Comp Can Ctr
Chicago, Illinois, United States
Onc Hem Assoc of Central IL
Peoria, Illinois, United States
McFarland Clinic
Ames, Iowa, United States
Jewish Cancer Care
Louisville, Kentucky, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
MT Cancer Inst Fndtn; MT Can Spec
Missoula, Montana, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
MSKCC at Basking Ridge
Basking Ridge, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
Memorial Sloan-Kettering; Cancer Center
Commack, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
MSKCC at Mercy Med Ctr
Rockville Centre, New York, United States
MSKCC at Sleepy Hollow
Sleepy Hollow, New York, United States
Emerywood Hematology and Onc
High Point, North Carolina, United States
Willamette Valley Cancer Insitute and Research Center
Springfield, Oregon, United States
Medical University of SC (MUSC)
Charleston, South Carolina, United States
SCRI-Tennessee Oncology
Nashville, Tennessee, United States
Onc & Hem Assoc; USO Cent Pharm
Fort Worth, Texas, United States
MD Anderson Cancer Center Department of Lymphoma & Myeloma
Houston, Texas, United States
Methodist Hospital Research Institute
Houston, Texas, United States
Cancer Therapy & Research Center
San Antonio, Texas, United States
USO - Tyler Cancer Ctr
Tyler, Texas, United States
Blue Ridge Cancer Care - Roanoke
Roanoke, Virginia, United States
Medical Oncology Associates
Spokane, Washington, United States
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States
Aurora Bay Care Medical Center
Green Bay, Wisconsin, United States