A Study of Obinutuzumab [RO5072759 (GA101)] in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER)
NCT ID: NCT01414855
Last Updated: 2018-04-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2011-08-31
2016-12-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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obinutuzumab + CHOP
Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy (cyclophosphamide, doxorubicin, vincristine and prednisone) for 6 cycles.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Previously untreated cluster of differentiation antigen 20 (CD20)-positive diffuse large B-cell lymphoma
* Ann Arbour Stage III/IV and bulky II (mass \>10 cm)
* At least one bi-dimensionally measurable lesion defined as \>1.5 cm in its largest dimension by CT scan
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
* Left ventricular ejection fraction ≥50%
* Adequate hematologic function
Exclusion Criteria
* Prior therapy for diffuse large B-cell lymphoma except for nodal biopsy or local irradiation
* Central nervous system (CNS) lymphoma, primary mediastinal large cell lymphoma, primary cutaneous lymphoma, primary effusion lymphoma
* Patients who received cytotoxic drugs or rituximab as part of their treatment for another condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody
* Chemotherapy or other investigational therapy within 28 days prior to the start of Cycle 1
* Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
* History of other malignancy, except for curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix, or malignancy treated with or without curative intent and in remission without treatment for ≥2 years prior to enrolment
* Positive for hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or human T-cell leukemia virus (HTLV-1) infection
* Pregnant or lactating women
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
Genentech, Inc.
Locations
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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
Countries
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References
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Gibiansky E, Gibiansky L, Buchheit V, Frey N, Brewster M, Fingerle-Rowson G, Jamois C. Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study. Br J Clin Pharmacol. 2019 Sep;85(9):1935-1945. doi: 10.1111/bcp.13974. Epub 2019 Jul 12.
Sharman JP, Forero-Torres A, Costa LJ, Flinn IW, Inhorn L, Kelly K, Bessudo A, Fayad LE, Kaminski MS, Evens AM, Flowers CR, Sahin D, Mundt KE, Sandmann T, Fingerle-Rowson G, Vignal C, Mobasher M, Zelenetz AD. Obinutuzumab plus CHOP is effective and has a tolerable safety profile in previously untreated, advanced diffuse large B-cell lymphoma: the phase II GATHER study. Leuk Lymphoma. 2019 Apr;60(4):894-903. doi: 10.1080/10428194.2018.1515940. Epub 2018 Oct 2.
Other Identifiers
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GAO4915g
Identifier Type: -
Identifier Source: org_study_id
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