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

NCT01287741

TerminatedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Diffuse Large B-Cell Lymphoma

Interventions: Rituximab, Obinutuzumab, Cyclophosphamide, Doxorubicin, Vincristine

Countries: United States, Argentina, Australia, Austria, Brazil, Canada, China, Colombia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (235)
  • Birmingham, Alabama, United States
  • Chandler, Arizona, United States
  • Tucson, Arizona, United States
  • Encinitas, California, United States
  • Encinitas, California, United States
  • Los Angeles, California, United States
  • Aurora, Colorado, United States
  • Fort Myers, Florida, United States
  • St. Petersburg, Florida, United States
  • Macon, Georgia, United States
  • Galesburg, Illinois, United States
  • Joliet, Illinois, United States
  • Niles, Illinois, United States
  • Urbana, Illinois, United States
  • Portland, Maine, United States
  • Saint Louis Park, Minnesota, United States
  • Woodbury, Minnesota, United States
  • Albany, New York, United States
  • Charlotte, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Middletown, Ohio, United States
  • Sandusky, Ohio, United States
  • Springfield, Oregon, United States
  • Charleston, South Carolina, United States
  • Columbia, South Carolina, United States
  • Chattanooga, Tennessee, United States
  • Nashville, Tennessee, United States
  • Amarillo, Texas, United States
  • Fort Worth, Texas, United States
  • Houston, Texas, United States
  • + 205 more on CT.gov