A Study of Obinutuzumab [RO5072759 (GA101)] in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER)



Status:Completed
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/27/2018
Start Date:August 31, 2011
End Date:December 23, 2016

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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

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.


Inclusion Criteria:

- Adult patients, ≥18 years of age

- 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:

- Transformed lymphoma (follicular IIIB) if previously treated with chemotherapy or
immunotherapy

- 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
We found this trial at
38
sites
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Ames, Iowa 50010
McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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12605 East 16th Avenue
Aurora, Colorado 80045
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Basking Ridge, New Jersey 07920
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Charleston, South Carolina 29425
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303 East Superior Street
Chicago, Illinois 60611
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Coeur d'Alene, Idaho 83814
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Commack, New York 11725
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1800 North Williams Street
Denver, Colorado 80218
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477 North El Camino Real
Encinitas, California 92024
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Farmington, New Mexico 87401
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4371 Veronica S Shoemaker Boulevard
Fort Myers, Florida 33916
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13501 Park Vista Boulevard
Fort Worth, Texas 76177
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Green Bay, Wisconsin 54311
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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302 West Westwood Avenue
High Point, North Carolina 27262
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1515 Holcombe Boulevard
Houston, Texas 77030
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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2401 Terra Crossing Boulevard
Louisville, Kentucky 40245
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340 Kennestone Hospital Boulevard
Marietta, Georgia 30060
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500 West Broadway Street
Missoula, Montana 59802
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Nashville, Tennessee 37203
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Norwalk, Connecticut 06856
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Peoria, Illinois 61615
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2013 Jefferson Street Southwest
Roanoke, Virginia 24014
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1000 North Village Avenue
Rockville Centre, New York 11570
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1201 5th Avenue North
Saint Petersburg, Florida 33719
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San Antonio, Texas 78229
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777 Broadway
Sleepy Hollow, New York 10591
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Spokane, Washington 99208
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910 East Houston Street
Tyler, Texas 75702
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Vancouver, Washington 98684
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55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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2811 Tieton Drive
Yakima, Washington 98902
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