Non Hodgkin Lymphoma Clinical Trial
A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)
Summary
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 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
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There are 221 Locations for this study
Birmingham Alabama, 35294, United States
Chandler Arizona, 85224, United States
Tucson Arizona, 85704, United States
Encinitas California, 92008, United States
Encinitas California, 92024, United States
Los Angeles California, 90095, United States
Aurora Colorado, 80012, United States
Fort Myers Florida, 33901, United States
Saint Petersburg Florida, 33719, United States
Macon Georgia, 31201, United States
Galesburg Illinois, 61401, United States
Joliet Illinois, 60435, United States
Niles Illinois, 60714, United States
Urbana Illinois, 61801, United States
Portland Maine, 04102, United States
Saint Louis Park Minnesota, 55426, United States
Woodbury Minnesota, 55125, United States
Albany New York, 12206, United States
Charlotte North Carolina, 28204, United States
Winston-Salem North Carolina, 27103, United States
Middletown Ohio, 45042, United States
Sandusky Ohio, 44870, United States
Springfield Oregon, 97477, United States
Charleston South Carolina, 29425, United States
Columbia South Carolina, 29210, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Amarillo Texas, 79106, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77030, United States
New Braunfels Texas, 78130, United States
Richmond Virginia, 23226, United States
Roanoke Virginia, 24014, United States
Winchester Virginia, 22601, United States
Tacoma Washington, 98405, United States
Wenatchee Washington, 98801, United States
Cordoba , X5003, Argentina
Rosario , 2000, Argentina
Rosario , S2000, Argentina
Cairns Queensland, 4870, Australia
Frankston Victoria, 3199, Australia
Melbourne Victoria, 3168, Australia
Murdoch Western Australia, 6150, Australia
Innsbruck , 6020, Austria
Salzburg , 5020, Austria
Wien , 1090, Austria
Porto Alegre RS, 90470, Brazil
Porto Alegre RS, 90610, Brazil
Florianopolis SC, 88034, Brazil
Sao Paulo SP, 01236, Brazil
Sao Paulo SP, 08270, Brazil
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Vancouver British Columbia, V5Z 4, Canada
Halifax Nova Scotia, B3H 2, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M2J 1, Canada
Toronto Ontario, M3M 0, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H1T 2, Canada
Montreal Quebec, H2L 4, Canada
Montreal Quebec, H3A 1, Canada
Montreal Quebec, H3T 1, Canada
Quebec City Quebec, G1J 1, Canada
Rimouski Quebec, G5L 5, Canada
Saskatoon Saskatchewan, S7N 4, Canada
Beijing , 10002, China
Beijing , 10003, China
Beijing , 10007, China
Beijing , 10014, China
Beijing , 10073, China
Beijing , 10085, China
Changchun , 13002, China
Changsha , 41000, China
Fujian , 35000, China
Fuzhou , 35001, China
Guangzhou , 51006, China
Guangzhou , 51008, China
Hangzhou , 31000, China
Harbin , 15008, China
Nanchang , 33000, China
Nanjing , 21000, China
Nanjing , 21003, China
Nanning , 53002, China
Shanghai , 20002, China
Shanghai , 20003, China
Shanghai , 20043, China
Shenyang , 11000, China
Suzhou , 21500, China
Suzhou , 21500, China
Tianjin , 30006, China
Wuhan , 43002, China
Wuhan , 43002, China
Xi'an , 71003, China
Bogota , , Colombia
Bogota , , Colombia
Floridablanca , , Colombia
Brno , 625 0, Czechia
Hradec Kralove , 500 0, Czechia
Praha 2 , 128 0, Czechia
København Ø , 2100, Denmark
Roskilde , 4000, Denmark
Ã…rhus , 8000, Denmark
Aachen , 52074, Germany
Berlin , 10707, Germany
Dresden , 01307, Germany
Erlangen , 91054, Germany
Gießen , 35392, Germany
Heidelberg , 69120, Germany
Würzburg , 97080, Germany
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Budapest , 1083, Hungary
Budapest , 1122, Hungary
Debrecen , 4032, Hungary
Gyor , 9024, Hungary
Kaposvar , 7400, Hungary
Pecs , 7624, Hungary
Szeged , 6720, Hungary
Reggio Calabria Calabria, 89100, Italy
Napoli Campania, 80131, Italy
Napoli Campania, 80131, Italy
Pagani (Sa) Campania, 84016, Italy
Bologna Emilia-Romagna, 40138, Italy
Reggio Emilia Emilia-Romagna, 42100, Italy
Udine Friuli-Venezia Giulia, 33100, Italy
Roma Lazio, 00161, Italy
Genova Liguria, 16132, Italy
Brescia Lombardia, 25123, Italy
Milano Lombardia, 20132, Italy
Milano Lombardia, 20133, Italy
Milano Lombardia, 20141, Italy
Pavia Lombardia, 27100, Italy
Alessandria Piemonte, 15121, Italy
Ivrea Piemonte, 10015, Italy
Novara Piemonte, 28100, Italy
Orbassano Piemonte, 10043, Italy
Torino Piemonte, 10126, Italy
Torino Piemonte, 10126, Italy
Bari Puglia, 70124, Italy
San Giovanni Rotondo Puglia, 71013, Italy
Tricase - LE Puglia, 73039, Italy
Catania Sicilia, 95124, Italy
Messina Sicilia, 98165, Italy
Firenze Toscana, 50141, Italy
Pisa Toscana, 56100, Italy
Terni Umbria, 05100, Italy
Treviso Veneto, 31100, Italy
Verona Veneto, 37130, Italy
Vicenza Veneto, 36100, Italy
Aichi , 466-8, Japan
Chiba , 260-8, Japan
Fukuoka , 812-8, Japan
Fukuoka , 830-0, Japan
Gifu , 501-1, Japan
Hokkaido , 060-8, Japan
Hyogo , 650-0, Japan
Iwate , 020-8, Japan
Kanagawa , 236-0, Japan
Kyoto , 606-8, Japan
Niigata , 951-8, Japan
Okayama , 710-8, Japan
Osaka , 545-8, Japan
Osaka , 565-0, Japan
Osaka , 589-8, Japan
Shimane , 693-8, Japan
Tochigi , 329-0, Japan
Tokyo , 104-0, Japan
Tokyo , 105-8, Japan
Tokyo , 113-8, Japan
Tokyo , 135-8, Japan
Gyeonggi-do , 10408, Korea, Republic of
Jeollanam-do , 58128, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 120-7, Korea, Republic of
Seoul , 137-7, Korea, Republic of
Seoul , 6351, Korea, Republic of
Chihuahua , 31000, Mexico
Monterrey , 64460, Mexico
Oaxaca , 68000, Mexico
Queretaro , 76000, Mexico
Panama , 0832, Panama
Lima , 15038, Peru
Lima , 18, Peru
Lima , Lima , Peru
Brzozów , 36-20, Poland
Gdansk , 80-95, Poland
Lodz , 93-51, Poland
Lublin , 20-08, Poland
Warszawa , 02-78, Poland
Wroclaw , 50-36, Poland
Kazan , 42002, Russian Federation
Moscow , 11547, Russian Federation
Nizhny Novgorod , 60312, Russian Federation
Penza , 44007, Russian Federation
Petrozavodsk , 18501, Russian Federation
St Petersburg , 19102, Russian Federation
Belgrade , 11000, Serbia
Novi Sad , 21000, Serbia
Bratislava , 833 1, Slovakia
Cape Town , 7800, South Africa
Groenkloof , 0181, South Africa
Johannesburg , 2196, South Africa
Parktown, Johannesburg , 2193, South Africa
Pretoria , 0044, South Africa
Pamplona Navarra, 31008, Spain
Reus Tarragona, 43204, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 08907, Spain
Madrid , 28034, Spain
Pontevedra , 36002, Spain
Sevilla , 41009, Spain
Toledo , 45004, Spain
Aarau , 5001, Switzerland
Bellinzona , 6500, Switzerland
Chur , 7000, Switzerland
Zürich , 8091, Switzerland
Taipei , 00112, Taiwan
Taipei , 100, Taiwan
Taipei , 112, Taiwan
Taoyuan , 333, Taiwan
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Bangkok , 10400, Thailand
Bangkok , 10400, Thailand
Bangkok , 10700, Thailand
Khon Kaen , 40002, Thailand
Aberdeen , AB25 , United Kingdom
Birmingham , B9 5S, United Kingdom
Cambridge , CB2 0, United Kingdom
Leicester , LE1 5, United Kingdom
Wolverhampton , WV10 , United Kingdom
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