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Brief Title: A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)
Official Title: 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)
Study ID: NCT01287741
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
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, Saint 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
Chattanooga Oncology and Hematology Associates, PC, Chattanooga, Tennessee, United States
Tennessee Onc., PLLC - SCRI, Nashville, Tennessee, United States
Texas Oncology, Pa - Amarillo, Amarillo, Texas, United States
Texas Oncology-Fort Worth 12th Ave, Fort Worth, Texas, United States
MD Anderson Cancer Center Department of Lymphoma & Myeloma, Houston, Texas, United States
Cancer Care Centers of South Texas-HOAST - San Antonio, New Braunfels, Texas, United States
Virginia Cancer Institute, Richmond, Virginia, United States
Blue Ridge Cancer Care, Roanoke, Virginia, United States
Virginia Cancer Specialists - Winchester, Winchester, Virginia, United States
Northwest Medical Specialties, Tacoma, Washington, United States
Wenatchee Valley Hospital & Clinics, Wenatchee, Washington, United States
Instituto Damic, Cordoba, , Argentina
Sanatorio Britanico: Hematologia, Rosario, , Argentina
Sanatorio Parque de Rosario, Rosario, , Argentina
Cairns Base Hospital; Cancer Care Centre, Cairns, Queensland, Australia
Frankston Hospital; Oncology/Haematology, Frankston, Victoria, Australia
Monash Medical Centre; Haematology, Melbourne, Victoria, Australia
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Fßr Hämatologie & Onkologie, Innsbruck, , Austria
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt., Salzburg, , Austria
Medizinische Universität Wien; Univ.Klinik fßr Innere Medizin I - Hämatologie & Hämostaseologie, Wien, , Austria
Hospital Mae de Deus, Porto Alegre, RS, Brazil
Hospital Sao Lucas - PUCRS, Porto Alegre, RS, Brazil
Centro de Pesquisas Oncologicas - CEPON, Florianopolis, SC, Brazil
Instituto de Ensino e Pesquisa Sao Lucas - IEP, Sao Paulo, SP, Brazil
Hospital Santa Marcelina;Oncologia, Sao Paulo, SP, Brazil
Tom Baker Cancer Centre; Dept of Medicine, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
BCCA-Vancouver Cancer Centre, Vancouver, British Columbia, Canada
Queen Elizabeth II Health Sciences Centre; Oncology, Halifax, Nova Scotia, Canada
Ottawa General Hospital, Ottawa, Ontario, Canada
North York General Hospital, Toronto, Ontario, Canada
Humber River Hospital, Toronto, Ontario, Canada
University Health Network; Princess Margaret Hospital; Medical Oncology Dept, Toronto, Ontario, Canada
Hopital Maisonneuve- Rosemont; Oncology, Montreal, Quebec, Canada
Chum Hopital Notre Dame; Centre D'Oncologie, Montreal, Quebec, Canada
Mcgill University - Royal Victoria Hospital; Oncology, Montreal, Quebec, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology, Montreal, Quebec, Canada
Hopital de L'Enfant-Jesus; Hematology, Quebec City, Quebec, Canada
Centre de sante et de services sociaux Rimouski Neigette, Rimouski, Quebec, Canada
Saskatoon Cancer Centre; Uni of Saskatoon Campus, Saskatoon, Saskatchewan, Canada
Cancer Hospital Chinese Academy of Medical Sciences., Beijing, , China
Peking University First Hospital, Beijing, , China
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA), Beijing, , China
Beijing Cancer Hospital, Beijing, , China
Beijing Hospital of Ministry of Health; Hematology, Beijing, , China
General Hospital of Chinese PLA; Department of Hematology, Beijing, , China
the First Hospital of Jilin University, Changchun, , China
Hu Nan Provincial Cancer Hospital, Changsha, , China
Fujian Medical University Union Hospital, Fujian, , China
Fujian Cancer Hospital, Fuzhou, , China
Sun Yet-sen University Cancer Center, Guangzhou, , China
Guangdong General Hospital, Guangzhou, , China
The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, , China
Harbin Medical University Cancer Hospital, Harbin, , China
The Second Affiliated Hospital to Nanchang University, Nanchang, , China
Jiangsu Cancer Hospital, Nanjing, , China
Jiangsu Province Hospital, Nanjing, , China
The First Affiliate Hospital of Guangxi Medical University, Nanning, , China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, , China
Fudan University Shanghai Cancer Center, Shanghai, , China
Changhai Hospital of Shanghai, Shanghai, , China
First Hospital of China Medical University, Shenyang, , China
The Second Affiliated Hospital of Soochow University, Suzhou, , China
First Affiliated Hospital of Soochow University, Suzhou, , China
Tianjin Cancer Hospital, Tianjin, , China
Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology, Wuhan, , China
Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center, Wuhan, , China
The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital), Xi'an, , China
Fundacion Cardioinfantil, Bogota, , Colombia
Organizacion Sanitas Internacional, Bogota, , Colombia
FOSCAL, Floridablanca, , Colombia
Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika, Brno, , Czechia
Fn Hr. Kralove; IV. Interni Hematologicka Klinika, Hradec Kralove, , Czechia
Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK, Praha 2, , Czechia
Rigshospitalet; HĂŚmatologisk Klinik, København Ă, , Denmark
Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium, Roskilde, , Denmark
Aarhus Universitetshospital, HĂŚmatologisk Afdeling R, Ă rhus, , Denmark
Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stammz, Aachen, , Germany
Onkologische Schwerpunktpraxis KurfĂźrstendamm, Berlin, , Germany
Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I, Dresden, , Germany
Friedrich-Alexander-Universität Erlangen-Nßrnberg; Medizinische Klinik V, Erlangen, , Germany
Klinik der Justus-Liebig-Universität; Innere Medizin, GieĂen, , Germany
Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V, Heidelberg, , Germany
Universitätsklinikum Wßrzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie, Wßrzburg, , Germany
Pamela Youde Nethersole Eastern Hospital; Department of Medicine, Hong Kong, , Hong Kong
Queen Mary Hospital; Dept of Medicine, Hong Kong, , Hong Kong
Semmelweis University, First Dept of Medicine, Budapest, , Hungary
National Institute of Oncology, A Dept of Internal Medicine, Budapest, , Hungary
University of Debrecen Medical and Health Science Center, Institute of Internal medicine Building B, Debrecen, , Hungary
Petz Aladar Megyei Korhaz; Hematologia, Gyor, , Hungary
Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology, Kaposvar, , Hungary
University of Pecs, I st Dept of Internal Medicine, Pecs, , Hungary
University of Szeged, II Dept of Internal Medicine, Szeged, , Hungary
Ospedale Riuniti; Divisione Di Ematologia, Reggio Calabria, Calabria, Italy
Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica, Napoli, Campania, Italy
Nuovo Policlinico, Ii Facolta; Divisione Di Ematologia, Napoli, Campania, Italy
Ospedale "A.Tortora" - Ematologia; Dipartimento Di Ematologia, Pagani (Sa), Campania, Italy
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna, Bologna, Emilia-Romagna, Italy
AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia, Reggio Emilia, Emilia-Romagna, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica, Udine, Friuli-Venezia Giulia, Italy
Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol, Roma, Lazio, Italy
A.O. Universitaria S. Martino Di Genova; Ematologia 1, Genova, Liguria, Italy
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia, Brescia, Lombardia, Italy
Hospital San Raffaele, Milano, Lombardia, Italy
Ist. Nazionale Per Lo Studio E Cura Dei Tumori; Div. Ematologia Trapianto Midollo Osseo Allogenico, Milano, Lombardia, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia, Milano, Lombardia, Italy
Irccs Policlinico San Matteo; Divisione Di Ematologia, Pavia, Lombardia, Italy
Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia, Alessandria, Piemonte, Italy
Ospedali Riuniti del Canavese, Ivrea, Piemonte, Italy
Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad, Novara, Piemonte, Italy
Az. Osp. S. Luigi Gonzaga; S.C.D.U. Medicina Interna Ii, Orbassano, Piemonte, Italy
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1, Torino, Piemonte, Italy
A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia, Torino, Piemonte, Italy
Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica, Bari, Puglia, Italy
IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo, San Giovanni Rotondo, Puglia, Italy
Az. Osp. C. Panico; Rep. Ematologia E Trapianto, Tricase - LE, Puglia, Italy
Azienda Ospedaliero Univ, Catania, Sicilia, Italy
Az. Osp. Papardo; Struttura Complessa Di Ematologia, Messina, Sicilia, Italy
Azienda Ospedaliera Univ, Firenze, Toscana, Italy
Ospedale Santa Chiara; Unita Operativa Di Ematologia, Pisa, Toscana, Italy
Az. Osp. S. Maria; Dept. Di Oncologia Medica, Terni, Umbria, Italy
Ospedale Ca Foncello; Ematologia, Treviso, Veneto, Italy
Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia, Verona, Veneto, Italy
Ospedale Di Vicenza; Nefrologia, Ematologia, Vicenza, Veneto, Italy
Nagoya Daini Red Cross Hospital; Hematology & Oncology, Aichi, , Japan
Chiba University Hospital; Hematology, Chiba, , Japan
Kyushu University Hospital; Hematology, Oncology & Cardiovascular medicine, Fukuoka, , Japan
Kurume University Hospital; Hematology and Oncology, Fukuoka, , Japan
Gifu University Hospital; First Department of Internal Medicine, Gifu, , Japan
Hokkaido University Hospital; Hematology, Hokkaido, , Japan
Kobe City Medical Center General Hospital; Hematology, Hyogo, , Japan
Iwate Medical University Hospital;Hematology and Oncology, Iwate, , Japan
Yokohama City University Hospital; Hematology, Rheumatology, Infectious Disease, Kanagawa, , Japan
Kyoto University Hospital; Department of Hematology/Oncology, Kyoto, , Japan
Niigata Cancer Center Hospital; Internal Medicine, Niigata, , Japan
Kurashiki Central Hospital; Hematology, Okayama, , Japan
Osaka City University Hospital; Hematology, Osaka, , Japan
Osaka University Hospital; Hematology and Oncology, Osaka, , Japan
Kindai University Hospital; Hematology and Rheumatology, Osaka, , Japan
Shimane University Hospital;Hematology, Shimane, , Japan
Jichi Medical University Hospital; Hematology, Tochigi, , Japan
National Cancer Center Hospital; Hematology, Tokyo, , Japan
Toranomon Hospital; Hematology, Tokyo, , Japan
Nippon Medical School Hospital; Hematology, Tokyo, , Japan
The Cancer Institute Hospital of JFCR; Hematology Oncology, Tokyo, , Japan
National Cancer Center, Gyeonggi-do, , Korea, Republic of
Chonnam National University Hwasun Hospital, Jeollanam-do, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center - Oncology, Seoul, , Korea, Republic of
Yonsei University Severance Hospital; Medical Oncology, Seoul, , Korea, Republic of
St. Mary'S Hospital, the Catholic University School of Medicine; Internal Medicine, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre, Chihuahua, , Mexico
Hospital Universitario Dr. Jose E. Gonzalez; Haematology, Monterrey, , Mexico
Oaxaca Site Management Organization, Oaxaca, , Mexico
Centro de Estudios Clinicos de Queretaro, SC, Queretaro, , Mexico
Centro Hemato Oncologico Panama, Panama, , Panama
Instituto Nacional de Enfermedades Neoplasicas, Lima, , Peru
Instituto;Oncologico Miraflores, Lima, , Peru
Clinica de Especialidades Medicas, Lima, , Peru
Szpital Specjalistyczny Podkarpacki OĹrodek Onkologiczny, BrzozĂłw, , Poland
Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii, Gdansk, , Poland
Medical University of Lodz; Hematology, Lodz, , Poland
Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie, Lublin, , Poland
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego, Warszawa, , Poland
Medical Uni of Wroclaw; Hematology, Wroclaw, , Poland
Clinical Oncology Dispensary of Ministry of Health of Tatarstan, Kazan, , Russian Federation
Blokhin Cancer Research Center; Clinical Oncology, Moscow, , Russian Federation
Regional Clinical Hospital N.A. Semashko; Hematology, Nizhny Novgorod, , Russian Federation
Penza Regional Oncology Dispensary, Penza, , Russian Federation
Republican Clinical Hospital n.a. Baranov; Haematology, Petrozavodsk, , Russian Federation
Research Inst. of Hematology & Blood Transfusion ; Hematology, St Petersburg, , Russian Federation
Institute of Hematology, Belgrade, , Serbia
Clinical Center Vojvodine; Clinic for Hematology, Novi Sad, , Serbia
National Oncology Inst. ; Dept. of Haematology, Bratislava, , Slovakia
Constantiaberg Medical Clinic; Dept. of Haematology & Bone Marrow Translant, Cape Town, , South Africa
Mary Potter Oncology Centre, Groenkloof, , South Africa
Medical Oncology Centre of Rosebank; Oncology, Johannesburg, , South Africa
Wits Donald Gordon Clinical Trial Centre; Medical Oncology, Parktown, Johannesburg, , South Africa
Drs Thomson, Brittain an Partners Inc, Pretoria, , South Africa
Hospital de Navarra, Servicio de HematologĂa, Pamplona, Navarra, Spain
Hospital Universitari Sant Joan de Reus; Servicio de Oncologia, Reus, Tarragona, Spain
Hospital del Mar; Servicio de Hematologia, Barcelona, , Spain
Hospital Universitari Vall d'Hebron; Servicio de Hematologia, Barcelona, , Spain
Hospital ClĂnic i Provincial; Servicio de HematologĂa y OncologĂa, Barcelona, , Spain
Hospital Duran i Reynals; Servicio de Hematologia, Barcelona, , Spain
Hospital Ramon y Cajal; Servicio de Hematologia, Madrid, , Spain
Complejo Hospitalario de Pontevedra; Servicio de Oncologia, Pontevedra, , Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia, Sevilla, , Spain
Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia, Toledo, , Spain
Kantonsspital Aarau; Zentrum Fßr Onkologie, Hämatologie & Transfusionsmedizin, Aarau, , Switzerland
Ospedale San Giovanni; Oncologia, Bellinzona, , Switzerland
Kantonsspital Graubßnden;Onkologie und Hämatologie, Chur, , Switzerland
UniversitätsSpital Zßrich; Zentrum fßr Hämatologie und Onkologie, Klinik fßr Onkologie, Zßrich, , Switzerland
Veterans General Hospital; Division of Oncology, Taipei, , Taiwan
National Taiwan Universtiy Hospital; Division of Hematology, Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology, Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology, Taoyuan, , Taiwan
King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine, Bangkok, , Thailand
National Cancer Inst., Bangkok, , Thailand
Rajavithi Hospital; Medicine, Bangkok, , Thailand
Ramathibodi Hospital; Division of Hematology, Department of Medicine, Bangkok, , Thailand
Siriraj Hospital; Division of Hematology, Department of Medicine, Bangkok, , Thailand
Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine, Khon Kaen, , Thailand
Aberdeen Royal Infirmary; Haematology - Ward 16, Aberdeen, , United Kingdom
Birmingham Heartlands Hospital; Department of Haematology, Birmingham, , United Kingdom
Addenbrookes Hospital; Haematology, Cambridge, , United Kingdom
The HOPE Clinical Trials Unit, Leicester, , United Kingdom
New Cross Hospital; Dept. Of Haematology, Wolverhampton, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR