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 |
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.
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
1515 Holcombe Boulevard
Houston, Texas 77030
Houston, Texas 77030
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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4371 Veronica S Shoemaker Boulevard
Fort Myers, Florida 33916
Fort Myers, Florida 33916
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1448 Common Street
New Braunfels, Texas 78130
New Braunfels, Texas 78130
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Carle Cancer Center Carle Cancer Center delivers comprehensive care through leading-edge technology and advanced research,...
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3333 Silas Creek Parkway
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
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