A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)
Stopped early · Phase 3
Conditions studied: Diffuse Large B-Cell Lymphoma
In brief
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.
Key facts
- Study ID
- NCT01287741
- Run by
- Hoffmann-La Roche
- People needed
- 1418
- Starts
- 2011-07-26
- Expected to finish
- 2018-01-31
- Last updated by the study team
- 2019-04-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Ironwood Cancer TX & Rsch Ctrs — Chandler, Arizona, United States
- Arizona Oncology — Tucson, Arizona, United States
- California Cancer Associates for Research & Excellence, Inc. — Encinitas, California, United States
- cCare — Encinitas, California, United States
- UCLA - School of Medicine; Division of Hematology/Oncology — Los Angeles, California, United States
- Rocky Mountain Cancer Center - Aurora — Aurora, Colorado, United States
- Florida Cancer Specialists; Department of Oncology — Fort Myers, Florida, United States
- Florida Cancer Specialists; Saint Petersburg — St. Petersburg, Florida, United States
- Central Georgia Cancer Care PC — Macon, Georgia, United States
- Illinois Cancer Care, P.C. - Galesburg — Galesburg, Illinois, United States
- Joliet Oncology-Hematology; Associates, Ltd. — Joliet, Illinois, United States
- Cancer Care & Hematology; Specialists of Chicagoland — Niles, Illinois, United States
- Carle Cancer Center — Urbana, Illinois, United States
- Mercy Oncology / Hematology Center; Oncology — Portland, Maine, United States
- Park Nicollet Clin-Cancer Ctr — Saint Louis Park, Minnesota, United States
- Minnesota Oncology Hematology Woodbury — Woodbury, Minnesota, United States
- New York Oncology Hematology, P.C. — Albany, New York, United States
- Mecklenburg Medical Group Charlotte — Charlotte, North Carolina, United States
- Forsyth Regional Cancer Center; Piedmont Hematology/Oncology Associates — Winston-Salem, North Carolina, United States
- Signal Point Clinical; Research Center, LLC — Middletown, Ohio, United States
- Cleveland CL N Coast Cancer Cr — Sandusky, Ohio, United States
- Willamette Valley Cancer Insitute and Research Center — Springfield, Oregon, United States
- Medical University of SC (MUSC) — Charleston, South Carolina, United States
- South Carolina Oncology Associates - SCRI — Columbia, South Carolina, United States
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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