A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)



Status:Completed
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/3/2018
Start Date:July 31, 2011
End Date:January 31, 2018

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A Phase III, Multicenter, Open-Label Randomized Trial Comparing the Efficacy of GA101 (RO5072759) in Combination With CHOP (G-CHOP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With CD20-Positive Diffuse Large B-Cell Lymphoma (DLBCL)

This open-label, randomized, parallel group study will evaluate the efficacy and safety of
obinutuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone
or prednisone (CHOP) chemotherapy versus rituximab (MabThera/Rituxan) with CHOP in previously
untreated participants with cluster of differentiation 20 (CD20)-positive diffuse large
B-cell lymphoma (DLBCL). Participants will be randomized to receive either obinutuzumab 1000
milligrams (mg) intravenously (IV) every 21 days or rituximab 375 milligrams per square meter
(mg/m^2) IV every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy IV
every 21 days. Participants randomized to the obinutuzumab arm will receive an additional two
doses on Days 8 and 15 of Cycle 1. Anticipated time on study treatment is 24 weeks.


Inclusion Criteria:

- Previously untreated CD20-positive DLBCL

- At least 1 bi-dimensionally measurable lesion (greater than [>]1.5 centimeters [cm] in
its largest dimension on the computed tomography [CT] scan)

- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2

- Adequate hematological function

- Low-intermediate, high-intermediate or high-risk International Prognostic Index (IPI)
score (low-risk IPI score: IPI 1 irrespective of bulky disease or IPI 0 with bulky
disease, defined as one lesion greater than equal to (>/=) 7.5 cm)

- Left ventricular ejection fraction (LVEF) >/=50 percent (%) on cardiac multiple-gated
acquisition (MUGA) scan or cardiac echocardiogram

Exclusion Criteria:

- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies or known sensitivity or allergy to murine products or to any component of
CHOP or obinutuzumab

- Contraindication to any of the individual components of CHOP, including prior receipt
of anthracyclines

- Participants with transformed lymphoma and participants with follicular lymphoma IIIB

- Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation

- Prior treatment with cytotoxic drugs or rituximab for another condition (for example,
rheumatoid arthritis) or prior use of an anti-CD20 antibody

- Prior use of any monoclonal antibody within 3 months of the start of Cycle 1

- Corticosteroid use of >30 milligrams per day (mg/day) of prednisone or equivalent, for
purposes other than lymphoma symptom control

- Primary central nervous system (CNS) lymphoma and secondary CNS involvement by
lymphoma, mantle-cell lymphoma (MCL), or histologic evidence of transformation to a
Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, plasmablastic
lymphoma, and primary cutaneous DLBCL
We found this trial at
37
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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Albany, New York 12206
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Amarillo, Texas 79106
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Aurora, Colorado 80012
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695 South Dobson Road
Chandler, Arizona 85224
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Charleston, South Carolina 29425
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1900 Brunswick Avenue
Charlotte, North Carolina 28204
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Chattanooga, Tennessee 37404
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Columbia, South Carolina 29210
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Cordoba, X5003
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477 North El Camino Real
Encinitas, California 92024
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4371 Veronica S Shoemaker Boulevard
Fort Myers, Florida 33916
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Fort Worth, Texas 76104
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336 Home Boulevard
Galesburg, Illinois 61401
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1515 Holcombe Boulevard
Houston, Texas 77030
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Macon, Georgia 31201
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Nashville, Tennessee 37203
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1448 Common Street
New Braunfels, Texas 78130
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195 Fore River Parkway
Portland, Maine 04102
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Richmond, Virginia 23235
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Roanoke, Virginia 24014
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3931 Louisiana Avenue South
Saint Louis Park, Minnesota 55426
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1201 5th Avenue North
Saint Petersburg, Florida 33719
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417 Quarry Lakes Drive
Sandusky, Ohio 44870
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Tacoma, Washington 98405
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Tucson, Arizona 85710
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602 W University Ave
Urbana, Illinois 61801
(217) 383-3010
Carle Cancer Center Carle Cancer Center delivers comprehensive care through leading-edge technology and advanced research,...
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Wenatchee, Washington 98801
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Winchester, Virginia 22601
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3333 Silas Creek Parkway
Winston-Salem, North Carolina 27103
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