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)
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:
Exclusion Criteria:
Encinitas, California 92008, United States
Los Angeles, California 90095-6984, United States
Winston-Salem, North Carolina 27103, United States
Innsbruck, 6020, Austria
Vienna, 1090, Austria
Toronto, Ontario M5G 2M9, Canada
Montreal, Quebec H3T 1E2, Canada
Beijing, 100071, China
Wuhan, 430022, China
Xi'an, 710038, China
Prague, 128 08, Czechia
Aachen, 52074, Germany
Dresden, 01307, Germany
Würzburg, 97080, Germany
Debrecen, 4032, Hungary
Bari, Apulia 70124, Italy
San Giovanni Rotondo, Apulia 71013, Italy
Tricase - LE, Apulia 73039, Italy
Naples, Campania 80131, Italy
Reggio Emilia, Emilia-Romagna 42100, Italy
Udine, Friuli Venezia Giulia 33100, Italy
Rome, Lazio 00161, Italy
Milan, Lombardy 20133, Italy
Novara, Piedmont 28100, Italy
Turin, Piedmont 10126, Italy
Turin, Piedmont 10126, Italy
Hokkaido, 060-8648, Japan
Kanagawa, 236-0004, Japan
Chihuahua City, 31000, Mexico
Lublin, 20-081, Poland
Warsaw, 02-781, Poland
Cape Town, 7800, South Africa
Parktown, Johannesburg, 2193, South Africa
Jeollanam-do, 58128, South Korea
Seoul, 137-701, South Korea
Aarau, 5001, Switzerland
Zurich, 8091, Switzerland
Bangkok, 10330, Thailand