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

April 8, 2019 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1418

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, X5003DCE
        • Instituto DAMIC
      • Rosario, Argentina, S2000DSV
        • Sanatorio Parque de Rosario
      • Rosario, Argentina, 2000
        • Sanatorio Britanico: Hematologia
  • Australia
    • Queensland
      • Cairns, Queensland, Australia, 4870
        • Cairns Base Hospital; Cancer Care Centre
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Frankston Hospital; Oncology/Haematology
      • Melbourne, Victoria, Australia, 3168
        • Monash Medical Centre; Haematology
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital
  • Austria
      • Innsbruck, Austria, 6020
        • Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
      • Salzburg, Austria, 5020
        • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
      • Wien, Austria, 1090
        • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie
  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90610-000
        • Hospital Sao Lucas - PUCRS
      • Porto Alegre, RS, Brazil, 90470-340
        • Hospital Mae de Deus
    • SC
      • Florianopolis, SC, Brazil, 88034-000
        • Centro de Pesquisas Oncologicas - CEPON
    • SP
      • Sao Paulo, SP, Brazil, 01236-030
        • Instituto de Ensino e Pesquisa Sao Lucas - IEP
      • Sao Paulo, SP, Brazil, 08270-070
        • Hospital Santa Marcelina;Oncologia
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre; Dept of Medicine
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BCCA-Vancouver Cancer Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Queen Elizabeth II Health Sciences Centre; Oncology
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa General Hospital
      • Toronto, Ontario, Canada, M2J 1V1
        • North York General Hospital
      • Toronto, Ontario, Canada, M3M 0B2
        • Humber River Hospital
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network; Princess Margaret Hospital; Medical Oncology Dept
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Hopital Maisonneuve- Rosemont; Oncology
      • Montreal, Quebec, Canada, H3A 1A1
        • Mcgill University - Royal Victoria Hospital; Oncology
      • Montreal, Quebec, Canada, H3T 1E2
        • McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
      • Montreal, Quebec, Canada, H2L 4M1
        • Chum Hopital Notre Dame; Centre D'Oncologie
      • Quebec City, Quebec, Canada, G1J 1Z4
        • Hopital de L'Enfant-Jesus; Hematology
      • Rimouski, Quebec, Canada, G5L 5T1
        • Centre De Sante Et De Services Sociaux Rimouski Neigette
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre; Uni of Saskatoon Campus
  • China
      • Beijing, China, 100021
        • Cancer Hospital Chinese Academy of Medical Sciences.
      • Beijing, China, 100142
        • Beijing Cancer Hospital
      • Beijing, China, 100071
        • The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
      • Beijing, China, 100034
        • Peking University First Hospital
      • Beijing, China, 100853
        • General Hospital of Chinese PLA; Department of Hematology
      • Beijing, China, 100730
        • Beijing Hospital of Ministry of Health; Hematology
      • Changchun, China, 130021
        • The First Hospital of Jilin University
      • Changsha, China, 410006
        • Hu Nan Provincial Cancer Hospital
      • Fujian, China, 350001
        • Fujian Medical University Union Hospital
      • Fuzhou, China, 350014
        • Fujian Cancer Hospital
      • Guangzhou, China, 510060
        • Sun Yet-sen University Cancer Center
      • Guangzhou, China, 510080
        • Guangdong General Hospital
      • Hangzhou, China, 310003
        • The First Affiliated Hospital of College of Medicine, Zhejiang University
      • Harbin, China, 150081
        • Harbin Medical University Cancer Hospital
      • Nanchang, China, 330006
        • The Second Affiliated Hospital to Nanchang University
      • Nanjing, China, 210036
        • Jiangsu Province Hospital
      • Nanjing, China, 210009
        • Jiangsu Cancer Hospital
      • Nanning, China, 530021
        • The First Affiliate Hospital of Guangxi Medical University
      • Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center
      • Shanghai, China, 200025
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
      • Shanghai, China, 200433
        • Changhai Hospital of Shanghai
      • Shenyang, China, 110001
        • First Hospital of China Medical University
      • Suzhou, China, 215006
        • First Affiliated Hospital of Soochow University
      • Suzhou, China, 215004
        • The Second Affiliated Hospital of Soochow University
      • Tianjin, China, 300060
        • Tianjin Cancer Hospital
      • Wuhan, China, 430023
        • Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center
      • Wuhan, China, 430022
        • Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
      • Xi'an, China, 710038
        • The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
  • Colombia
      • Bogota, Colombia
        • Fundacion Cardioinfantil
      • Bogota, Colombia
        • Organizacion Sanitas Internacional
      • Floridablanca, Colombia
        • FOSCAL
  • Czechia
      • Brno, Czechia, 625 00
        • Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika
      • Hradec Kralove, Czechia, 500 05
        • Fn Hr. Kralove; IV. Interni Hematologicka Klinika
      • Praha 2, Czechia, 128 08
        • Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK
  • Denmark
      • København Ø, Denmark, 2100
        • Rigshospitalet; Hæmatologisk Klinik
      • Roskilde, Denmark, 4000
        • Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium
      • Århus, Denmark, 8000
        • Aarhus Universitetshospital, Hæmatologisk Afdeling R
  • Germany
      • Aachen, Germany, 52074
        • Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stammz
      • Berlin, Germany, 10707
        • Onkologische Schwerpunktpraxis Kurfürstendamm
      • Dresden, Germany, 01307
        • Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I
      • Erlangen, Germany, 91054
        • Friedrich-Alexander-Universität Erlangen-Nürnberg; Medizinische Klinik V
      • Gießen, Germany, 35392
        • Klinik der Justus-Liebig-Universität; Innere Medizin
      • Heidelberg, Germany, 69120
        • Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V
      • Würzburg, Germany, 97080
        • Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital; Dept of Medicine
      • Hong Kong, Hong Kong
        • Pamela Youde Nethersole Eastern Hospital; Department of Medicine
  • Hungary
      • Budapest, Hungary, 1122
        • National Institute of Oncology, A Dept of Internal Medicine
      • Budapest, Hungary, 1083
        • Semmelweis University, First Dept of Medicine
      • Debrecen, Hungary, 4032
        • University of Debrecen Medical and Health Science Center, Institute of Internal medicine Building B
      • Gyor, Hungary, 9024
        • Petz Aladar Megyei Korhaz; Hematologia
      • Kaposvar, Hungary, 7400
        • Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology
      • Pecs, Hungary, 7624
        • University of Pecs, I st Dept of Internal Medicine
      • Szeged, Hungary, 6720
        • University of Szeged, II Dept of Internal Medicine
  • Italy
    • Calabria
      • Reggio Calabria, Calabria, Italy, 89100
        • Ospedale Riuniti; Divisione Di Ematologia
    • Campania
      • Napoli, Campania, Italy, 80131
        • Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica
      • Napoli, Campania, Italy, 80131
        • Nuovo Policlinico, Ii Facolta; Divisione Di Ematologia
      • Pagani (Sa), Campania, Italy, 84016
        • Ospedale "A.Tortora" - Ematologia; Dipartimento Di Ematologia
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
      • Reggio Emilia, Emilia-Romagna, Italy, 42100
        • AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia
    • Friuli-Venezia Giulia
      • Udine, Friuli-Venezia Giulia, Italy, 33100
        • A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica
    • Lazio
      • Roma, Lazio, Italy, 00161
        • Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol
    • Liguria
      • Genova, Liguria, Italy, 16132
        • A.O. Universitaria S. Martino Di Genova; Ematologia 1
    • Lombardia
      • Brescia, Lombardia, Italy, 25123
        • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
      • Milano, Lombardia, Italy, 20133
        • Ist. Nazionale Per Lo Studio E Cura Dei Tumori; Div. Ematologia Trapianto Midollo Osseo Allogenico
      • Milano, Lombardia, Italy, 20141
        • Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia
      • Milano, Lombardia, Italy, 20132
        • Hospital San Raffaele
      • Pavia, Lombardia, Italy, 27100
        • Irccs Policlinico San Matteo; Divisione Di Ematologia
    • Piemonte
      • Alessandria, Piemonte, Italy, 15121
        • Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia
      • Ivrea, Piemonte, Italy, 10015
        • Ospedali Riuniti del Canavese
      • Novara, Piemonte, Italy, 28100
        • Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad
      • Orbassano, Piemonte, Italy, 10043
        • Az. Osp. S. Luigi Gonzaga; S.C.D.U. Medicina Interna Ii
      • Torino, Piemonte, Italy, 10126
        • A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
      • Torino, Piemonte, Italy, 10126
        • A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia
    • Puglia
      • Bari, Puglia, Italy, 70124
        • Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
      • San Giovanni Rotondo, Puglia, Italy, 71013
        • IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo
      • Tricase - LE, Puglia, Italy, 73039
        • Az. Osp. C. Panico; Rep. Ematologia E Trapianto
    • Sicilia
      • Catania, Sicilia, Italy, 95124
        • Azienda Ospedaliero Univ
      • Messina, Sicilia, Italy, 98165
        • Az. Osp. Papardo; Struttura Complessa Di Ematologia
    • Toscana
      • Firenze, Toscana, Italy, 50141
        • Azienda Ospedaliera Univ
      • Pisa, Toscana, Italy, 56100
        • Ospedale Santa Chiara; Unita Operativa Di Ematologia
    • Umbria
      • Terni, Umbria, Italy, 05100
        • Az. Osp. S. Maria; Dept. Di Oncologia Medica
    • Veneto
      • Treviso, Veneto, Italy, 31100
        • Ospedale Ca Foncello; Ematologia
      • Verona, Veneto, Italy, 37130
        • Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia
      • Vicenza, Veneto, Italy, 36100
        • Ospedale Di Vicenza; Nefrologia, Ematologia
  • Japan
      • Aichi, Japan, 466-8650
        • Nagoya Daini Red Cross Hospital; Hematology & Oncology
      • Chiba, Japan, 260-8670
        • Chiba University Hospital; Hematology
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital; Hematology, Oncology & Cardiovascular medicine
      • Fukuoka, Japan, 830-0011
        • Kurume University Hospital; Hematology and Oncology
      • Gifu, Japan, 501-1194
        • Gifu University Hospital; First Department of Internal Medicine
      • Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital; Hematology
      • Hyogo, Japan, 650-0047
        • Kobe City Medical Center General Hospital; Hematology
      • Iwate, Japan, 020-8505
        • Iwate Medical University Hospital;Hematology and Oncology
      • Kanagawa, Japan, 236-0004
        • Yokohama City University Hospital; Hematology, Rheumatology, Infectious Disease
      • Kyoto, Japan, 606-8507
        • Kyoto University Hospital; Department of Hematology/Oncology
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital; Internal Medicine
      • Okayama, Japan, 710-8602
        • Kurashiki Central Hospital; Hematology
      • Osaka, Japan, 565-0871
        • Osaka University Hospital; Hematology and Oncology
      • Osaka, Japan, 545-8586
        • Osaka City University Hospital; Hematology
      • Osaka, Japan, 589-8511
        • Kindai University Hospital; Hematology and Rheumatology
      • Shimane, Japan, 693-8501
        • Shimane University Hospital;Hematology
      • Tochigi, Japan, 329-0498
        • Jichi Medical University Hospital; Hematology
      • Tokyo, Japan, 104-0045
        • National Cancer Center Hospital; Hematology
      • Tokyo, Japan, 105-8470
        • Toranomon Hospital; Hematology
      • Tokyo, Japan, 113-8603
        • Nippon Medical School Hospital; Hematology
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of JFCR; Hematology Oncology
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of, 10408
        • National Cancer Center
      • Jeollanam-do, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 120-752
        • Yonsei University Severance Hospital; Medical Oncology
      • Seoul, Korea, Republic of, 6351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center - Oncology
      • Seoul, Korea, Republic of, 137-701
        • St. Mary'S Hospital, the Catholic University School of Medicine; Internal Medicine
  • Mexico
      • Chihuahua, Mexico, 31000
        • Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre
      • Monterrey, Mexico, 64460
        • Hospital Universitario Dr. Jose E. Gonzalez; Haematology
      • Oaxaca, Mexico, 68000
        • Oaxaca Site Management Organization
      • Queretaro, Mexico, 76000
        • Centro de Estudios Clinicos de Queretaro, SC
  • Panama
      • Panama, Panama, 0832
        • Centro Hemato Oncologico Panama
  • Peru
      • Lima, Peru, 18
        • Instituto;Oncologico Miraflores
      • Lima, Peru, Lima 41
        • Clinica de Especialidades Medicas
      • Lima, Peru, 15038
        • Instituto Nacional de Enfermedades Neoplasicas
  • Poland
      • Brzozów, Poland, 36-200
        • Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny
      • Gdansk, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii
      • Lodz, Poland, 93-510
        • Medical University of Lodz; Hematology
      • Lublin, Poland, 20-081
        • Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie
      • Warszawa, Poland, 02-781
        • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego
      • Wroclaw, Poland, 50-367
        • Medical Uni of Wroclaw; Hematology
  • Russian Federation
      • Kazan, Russian Federation, 420029
        • Clinical Oncology Dispensary of Ministry of Health of Tatarstan
      • Moscow, Russian Federation, 115478
        • Blokhin Cancer Research Center; Clinical Oncology
      • Nizhny Novgorod, Russian Federation, 603126
        • Regional Clinical Hospital N.A. Semashko; Hematology
      • Penza, Russian Federation, 440071
        • Penza Regional Oncology Dispensary
      • Petrozavodsk, Russian Federation, 185019
        • Republican Clinical Hospital n.a. Baranov; Haematology
      • St Petersburg, Russian Federation, 191024
        • Research Inst. of Hematology & Blood Transfusion ; Hematology
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute of Hematology
      • Novi Sad, Serbia, 21000
        • Clinical Center Vojvodine; Clinic for Hematology
  • Slovakia
      • Bratislava, Slovakia, 833 10
        • National Oncology Inst. ; Dept. of Haematology
  • South Africa
      • Cape Town, South Africa, 7800
        • Constantiaberg Medical Clinic; Dept. of Haematology & Bone Marrow Translant
      • Groenkloof, South Africa, 0181
        • Mary Potter Oncology Centre
      • Johannesburg, South Africa, 2196
        • Medical Oncology Centre of Rosebank; Oncology
      • Parktown, Johannesburg, South Africa, 2193
        • Wits Donald Gordon Clinical Trial Centre; Medical Oncology
      • Pretoria, South Africa, 0044
        • Drs Thomson, Brittain an Partners Inc
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron; Servicio de Hematologia
      • Barcelona, Spain, 08036
        • Hospital Clínic i Provincial; Servicio de Hematología y Oncología
      • Barcelona, Spain, 08003
        • Hospital del Mar; Servicio de Hematologia
      • Barcelona, Spain, 08907
        • Hospital Duran i Reynals; Servicio de Hematologia
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal; Servicio de Hematologia
      • Pontevedra, Spain, 36002
        • Complejo Hospitalario de Pontevedra; Servicio de Oncologia
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena; Servicio de Oncologia
      • Toledo, Spain, 45004
        • Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Hospital de Navarra, Servicio de Hematología
    • Tarragona
      • Reus, Tarragona, Spain, 43204
        • Hospital Universitari Sant Joan de Reus; Servicio de Oncologia
  • Switzerland
      • Aarau, Switzerland, 5001
        • Kantonsspital Aarau; Zentrum Für Onkologie, Hämatologie & Transfusionsmedizin
      • Bellinzona, Switzerland, 6500
        • Ospedale San Giovanni; Oncologia
      • Chur, Switzerland, 7000
        • Kantonsspital Graubünden;Onkologie und Hämatologie
      • Zürich, Switzerland, 8091
        • UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan Universtiy Hospital; Division of Hematology
      • Taipei, Taiwan, 00112
        • Veterans General Hospital; Division of Oncology
      • Taipei, Taiwan, 112
        • Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
  • Thailand
      • Bangkok, Thailand, 10400
        • National Cancer Inst.
      • Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine
      • Bangkok, Thailand, 10400
        • Rajavithi Hospital; Medicine
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital; Division of Hematology, Department of Medicine
      • Bangkok, Thailand, 10700
        • Siriraj Hospital; Division of Hematology, Department of Medicine
      • Khon Kaen, Thailand, 40002
        • Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary; Haematology - Ward 16
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital; Department of Haematology
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrookes Hospital; Haematology
      • Leicester, United Kingdom, LE1 5WW
        • The HOPE Clinical Trials Unit
      • Wolverhampton, United Kingdom, WV10 0QP
        • New Cross Hospital; Dept. Of Haematology
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • University of Alabama at Birmingham
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Ironwood Cancer TX & Rsch Ctrs
      • Tucson, Arizona, United States, 85704
        • Arizona Oncology
    • California
      • Encinitas, California, United States, 92008
        • California Cancer Associates for Research & Excellence, Inc.
      • Encinitas, California, United States, 92024
        • cCare
      • Los Angeles, California, United States, 90095-6984
        • UCLA - School of Medicine; Division of Hematology/Oncology
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Center - Aurora
    • Florida
      • Fort Myers, Florida, United States, 33901-8101
        • Florida Cancer Specialists; Department of Oncology
      • Saint Petersburg, Florida, United States, 33719
        • Florida Cancer Specialists; Saint Petersburg
    • Georgia
      • Macon, Georgia, United States, 31201
        • Central Georgia Cancer Care PC
    • Illinois
      • Galesburg, Illinois, United States, 61401
        • Illinois Cancer Care, P.C. - Galesburg
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology-Hematology; Associates, Ltd.
      • Niles, Illinois, United States, 60714
        • Cancer Care & Hematology; Specialists of Chicagoland
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
    • Maine
      • Portland, Maine, United States, 04102
        • Mercy Oncology / Hematology Center; Oncology
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
        • Park Nicollet Clin-Cancer Ctr
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology Woodbury
    • New York
      • Albany, New York, United States, 12206
        • New York Oncology Hematology, P.C.
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Mecklenburg Medical Group Charlotte
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Regional Cancer Center; Piedmont Hematology/Oncology Associates
    • Ohio
      • Middletown, Ohio, United States, 45042
        • Signal Point Clinical; Research Center, LLC
      • Sandusky, Ohio, United States, 44870
        • Cleveland CL N Coast Cancer Cr
    • Oregon
      • Springfield, Oregon, United States, 97477
        • Willamette Valley Cancer Insitute and Research Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of SC (MUSC)
      • Columbia, South Carolina, United States, 29210
        • South Carolina Oncology Associates - SCRI
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Oncology and Hematology Associates, PC
      • Nashville, Tennessee, United States, 37203
        • Tennessee Onc., PLLC - SCRI
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Oncology, Pa - Amarillo
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology-Fort Worth 12th Ave
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center Department of Lymphoma & Myeloma
      • New Braunfels, Texas, United States, 78130
        • Cancer Care Centers of South Texas-HOAST - San Antonio
    • Virginia
      • Richmond, Virginia, United States, 23226
        • Virginia Cancer Institute
      • Roanoke, Virginia, United States, 24014
        • Blue Ridge Cancer Care
      • Winchester, Virginia, United States, 22601
        • Virginia Cancer Specialists - Winchester
    • Washington
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties
      • Wenatchee, Washington, United States, 98801
        • Wenatchee Valley Hospital & Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Rituximab+Chemotherapy
Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Drug: Cyclophosphamide
Cyclophosphamide 750 milligrams per square metre (mg/m^2), administered intravenously (IV) on Day 1 of each 21-day cycle.
Drug: Doxorubicin
Doxorubicin 50 mg/m^2 IV, administered on Day 1 of each 21-day cycle.
Drug: Vincristine
Vincristine 1.4 mg/m^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle.
Drug: Rituximab
Rituximab at a dose of 375 mg/m^2, administered by intravenous (IV) infusion on Day 1 of each 21-day cycle for 8 cycles.
Other Names:
  • MabThera, Rituxan
Drug: Prednisone
Prednisone 100 mg (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle.
EXPERIMENTAL: Obinutuzumab+Chemotherapy
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Drug: Cyclophosphamide
Cyclophosphamide 750 milligrams per square metre (mg/m^2), administered intravenously (IV) on Day 1 of each 21-day cycle.
Drug: Doxorubicin
Doxorubicin 50 mg/m^2 IV, administered on Day 1 of each 21-day cycle.
Drug: Vincristine
Vincristine 1.4 mg/m^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle.
Drug: Prednisone
Prednisone 100 mg (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle.
Drug: Obinutuzumab
Obinutuzumab 1000 mg IV infusion, administered on Day 1 of each 21-day cycle for 8 cycles. During Cycle 1, obinutuzumab was also infused on Days 8 and 15.
Other Names:
  • GA101, RO5072759

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Time to Progression-Free Survival (PFS), Investigator-Assessed
Time Frame: Baseline up to approximately 6.5 years (up to 31 January 2018)
Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease [PD]). Progression-free survival was defined as the time from randomization until the first documented day of disease progression or relapse, using a modified version of the Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on the basis of investigator assessments. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI).
Baseline up to approximately 6.5 years (up to 31 January 2018)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Time to Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed
Time Frame: Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
Kaplan Meier estimate of median PFS was defined as time at which half of participants have progressed (progressive disease [PD]). Progression-free survival was defined as time from randomization until first documented day of disease progression or relapse, using a modified version of Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on basis of IRC assessments. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 cm or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT or MRI. This outcome measure used data from primary analysis which included all 1418 participants.
Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
Median Time to Overall Survival (OS)
Time Frame: Baseline up to approximately 6.5 years (up to 31 January 2018)
Kaplan Meier estimate of median OS was defined as the time at which half of the participants had died, regardless of the cause of death. Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause.
Baseline up to approximately 6.5 years (up to 31 January 2018)
Overall Response Rate (ORR), Investigator-Assessed
Time Frame: Baseline up to approximately 6.5 years (up to 31 January 2018)
Overall response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites.
Baseline up to approximately 6.5 years (up to 31 January 2018)
Overall Response Rate (ORR), IRC-Assessed
Time Frame: Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
Overall response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites. This outcome measure used data from primary analysis which included all 1418 participants.
Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
Complete Response (CR) at the End of Treatment, Investigator-Assessed
Time Frame: Baseline up to approximately 6.5 years (up to 31 January 2018)
Percentage of participants with complete response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease.
Baseline up to approximately 6.5 years (up to 31 January 2018)
Complete Response (CR) at the End of Treatment, IRC-Assessed
Time Frame: Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
Percentage of participants with complete response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease. This outcome measure used data from primary analysis which included all 1418 participants.
Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
Median Time to Event-Free Survival (EFS), Investigator-Assessed
Time Frame: Baseline up to death or disease progression, or initiation of new anti-lymphoma treatment (NALT), whichever occurred first, approximately 6.5 years (up to 31 January 2018)
Kaplan Meier estimate of median EFS is the time at which half of the participants have progressed. Event-free survival was defined as the time from the date of randomization until the date of disease progression, relapse, initiation of a new non-protocol-specified anti-lymphoma treatment, or death from any cause on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI.
Baseline up to death or disease progression, or initiation of new anti-lymphoma treatment (NALT), whichever occurred first, approximately 6.5 years (up to 31 January 2018)
Median Time to Disease-Free Survival (DFS), Investigator-Assessed
Time Frame: Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)
Kaplan Meier estimate of median DFS was defined as time at which half of participants have disease progression/relapse or death from any cause. Disease-free survival was defined as time from date of the first occurrence of a documented CR to date of disease progression/relapse or death from any cause on basis of investigator assessments with use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm.
Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)
Duration of Response (DOR), Investigator-Assessed
Time Frame: Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)
DOR: time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with CT/MRI. CR: disappearance of all target lesions. PR: >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodule regression >/= 50%. Progression/relapse: at least 50% increase in nodal lesions or >/=50% increase in any node > 1 cm or >/= 50% increase in other target lesions (e.g., splenic or hepatic nodules) and/or any new bone marrow involvement and/or any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. A participant in the Rituximab+CHOP arm with the longest follow-up, 53 months, had an event. The criterion for median was the minimum time when survival went below 50%.
Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)
Time to Next Anti-Lymphoma Treatment (TTNALT)
Time Frame: Baseline up to start of next anti-lymphoma treatment or death due to any cause, whichever occurred first, approximately 6.5 years (31 January 2018)
Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause.
Baseline up to start of next anti-lymphoma treatment or death due to any cause, whichever occurred first, approximately 6.5 years (31 January 2018)
Percentage of Participants With Adverse Events (AEs)
Time Frame: Baseline up to approximately 6.5 years (up to 31 January 2018)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Baseline up to approximately 6.5 years (up to 31 January 2018)
Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Time Frame: Pre-dose (Hour 0) on Cycle (C) 4 Day (D) 1, at end of treatment/early termination (up to Month 6), every 6 months thereafter for 30 months (cycle length = 21 days)
The presence of HAHAs to obinutuzumab was assessed in the first 100 randomized participants.
Pre-dose (Hour 0) on Cycle (C) 4 Day (D) 1, at end of treatment/early termination (up to Month 6), every 6 months thereafter for 30 months (cycle length = 21 days)
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score
Time Frame: Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to approximately 6.5 years, (cycle length = 21 days)
The FACT-Lym subscale was developed to assess health-related quality of life in participants with non-Hodgkin lymphoma. The score range is 0-60, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement.
Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to approximately 6.5 years, (cycle length = 21 days)
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
Time Frame: Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to data cut-off, up to approximately 6.5 years, (cycle length = 21 days)
The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants.
Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to data cut-off, up to approximately 6.5 years, (cycle length = 21 days)
Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Time Frame: C1: D1 post-infusion and 20-28 and 66-80 hours after end of infusion, D8 and D15 pre-and post-infusion; C2: D1 pre- and post-infusion; C4: D1 pre- and post-infusion; C6: D1 pre- and post-infusion; C8: D1 pre- and post-infusion (cycle length = 21 days)
Serum samples for assessment of obinutuzumab serum concentrations were collected only from a subset of Japanese participants following administration of 1000 mg obinutuzumab.
C1: D1 post-infusion and 20-28 and 66-80 hours after end of infusion, D8 and D15 pre-and post-infusion; C2: D1 pre- and post-infusion; C4: D1 pre- and post-infusion; C6: D1 pre- and post-infusion; C8: D1 pre- and post-infusion (cycle length = 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Collaborators

Fondazione Italiana Linfomi ONLUS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 26, 2011

Primary Completion (ACTUAL)

April 29, 2016

Study Completion (ACTUAL)

January 31, 2018

Study Registration Dates

First Submitted

January 31, 2011

First Submitted That Met QC Criteria

January 31, 2011

First Posted (ESTIMATE)

February 1, 2011

Study Record Updates

Last Update Posted (ACTUAL)

April 12, 2019

Last Update Submitted That Met QC Criteria

April 8, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BO21005
  • 2010-024194-39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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