AzTrials
AzTrials

Diffuse Large B-Cell LymphomaPhase 3NCT01287741

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 Phase 3 study testing Rituximab, Obinutuzumab and Cyclophosphamide in people with Diffuse Large B-Cell Lymphoma, run by Hoffmann-La Roche at 235 sites in 29 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B-Cell Lymphoma
What is being tested?
Rituximab, Obinutuzumab and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,418 participants
Where
235 sitesin 29 countries
Study dates
26 Jul 2011to 31 Jan 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

235 sites in 29 countries.

235 sites in 29 countries

United States36 sites

  • New York Oncology Hematology, P.C.

    Albany, New York, 12206

  • Texas Oncology, Pa - Amarillo

    Amarillo, Texas, 79106

  • Rocky Mountain Cancer Center - Aurora

    Aurora, Colorado, 80012

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-3300

  • Ironwood Cancer TX & Rsch Ctrs

    Chandler, Arizona, 85224

  • Medical University of SC (MUSC)

    Charleston, South Carolina, 29425

  • Mecklenburg Medical Group Charlotte

    Charlotte, North Carolina, 28204

  • Chattanooga Oncology and Hematology Associates, PC

    Chattanooga, Tennessee, 37404

  • South Carolina Oncology Associates - SCRI

    Columbia, South Carolina, 29210

  • California Cancer Associates for Research & Excellence, Inc.

    Encinitas, California, 92008

  • cCare

    Encinitas, California, 92024

  • Florida Cancer Specialists; Department of Oncology

    Fort Myers, Florida, 33901-8101

  • Texas Oncology-Fort Worth 12th Ave

    Fort Worth, Texas, 76104

  • Illinois Cancer Care, P.C. - Galesburg

    Galesburg, Illinois, 61401

  • MD Anderson Cancer Center Department of Lymphoma & Myeloma

    Houston, Texas, 77030

  • Joliet Oncology-Hematology; Associates, Ltd.

    Joliet, Illinois, 60435

  • UCLA - School of Medicine; Division of Hematology/Oncology

    Los Angeles, California, 90095-6984

  • Central Georgia Cancer Care PC

    Macon, Georgia, 31201

  • Signal Point Clinical; Research Center, LLC

    Middletown, Ohio, 45042

  • Tennessee Onc., PLLC - SCRI

    Nashville, Tennessee, 37203

  • Cancer Care Centers of South Texas-HOAST - San Antonio

    New Braunfels, Texas, 78130

  • Cancer Care & Hematology; Specialists of Chicagoland

    Niles, Illinois, 60714

  • Mercy Oncology / Hematology Center; Oncology

    Portland, Maine, 04102

  • Virginia Cancer Institute

    Richmond, Virginia, 23226

  • Blue Ridge Cancer Care

    Roanoke, Virginia, 24014

  • Park Nicollet Clin-Cancer Ctr

    Saint Louis Park, Minnesota, 55426

  • Cleveland CL N Coast Cancer Cr

    Sandusky, Ohio, 44870

  • Willamette Valley Cancer Insitute and Research Center

    Springfield, Oregon, 97477

  • Florida Cancer Specialists; Saint Petersburg

    St. Petersburg, Florida, 33719

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • Arizona Oncology

    Tucson, Arizona, 85704

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Wenatchee Valley Hospital & Clinics

    Wenatchee, Washington, 98801

  • Virginia Cancer Specialists - Winchester

    Winchester, Virginia, 22601

  • Forsyth Regional Cancer Center; Piedmont Hematology/Oncology Associates

    Winston-Salem, North Carolina, 27103

  • Minnesota Oncology Hematology Woodbury

    Woodbury, Minnesota, 55125

Other trials in United States

Italy31 sites

  • Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia

    Alessandria, Piedmont, 15121

  • Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica

    Bari, Apulia, 70124

  • A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna

    Bologna, Emilia-Romagna, 40138

  • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia

    Brescia, Lombardy, 25123

  • Azienda Ospedaliero Univ

    Catania, Sicily, 95124

  • Azienda Ospedaliera Univ

    Florence, Tuscany, 50141

  • A.O. Universitaria S. Martino Di Genova; Ematologia 1

    Genoa, Liguria, 16132

  • Ospedali Riuniti del Canavese

    Ivrea, Piedmont, 10015

  • Az. Osp. Papardo; Struttura Complessa Di Ematologia

    Messina, Sicily, 98165

  • Hospital San Raffaele

    Milan, Lombardy, 20132

  • Ist. Nazionale Per Lo Studio E Cura Dei Tumori; Div. Ematologia Trapianto Midollo Osseo Allogenico

    Milan, Lombardy, 20133

  • Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia

    Milan, Lombardy, 20141

  • Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica

    Naples, Campania, 80131

  • Nuovo Policlinico, Ii Facolta; Divisione Di Ematologia

    Naples, Campania, 80131

  • Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad

    Novara, Piedmont, 28100

  • Az. Osp. S. Luigi Gonzaga; S.C.D.U. Medicina Interna Ii

    Orbassano, Piedmont, 10043

  • Ospedale "A.Tortora" - Ematologia; Dipartimento Di Ematologia

    Pagani (Sa), Campania, 84016

  • Irccs Policlinico San Matteo; Divisione Di Ematologia

    Pavia, Lombardy, 27100

  • Ospedale Santa Chiara; Unita Operativa Di Ematologia

    Pisa, Tuscany, 56100

  • Ospedale Riuniti; Divisione Di Ematologia

    Reggio Calabria, Calabria, 89100

  • AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia

    Reggio Emilia, Emilia-Romagna, 42100

  • Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol

    Rome, Lazio, 00161

  • IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo

    San Giovanni Rotondo, Apulia, 71013

  • Az. Osp. S. Maria; Dept. Di Oncologia Medica

    Terni, Umbria, 05100

  • Ospedale Ca Foncello; Ematologia

    Treviso, Veneto, 31100

  • Az. Osp. C. Panico; Rep. Ematologia E Trapianto

    Tricase - LE, Apulia, 73039

  • A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1

    Turin, Piedmont, 10126

  • A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia

    Turin, Piedmont, 10126

  • A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica

    Udine, Friuli Venezia Giulia, 33100

  • Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia

    Verona, Veneto, 37130

  • Ospedale Di Vicenza; Nefrologia, Ematologia

    Vicenza, Veneto, 36100

Other trials in Italy

China28 sites

  • Cancer Hospital Chinese Academy of Medical Sciences.

    Beijing, 100021

  • Peking University First Hospital

    Beijing, 100034

  • The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)

    Beijing, 100071

  • Beijing Cancer Hospital

    Beijing, 100142

  • Beijing Hospital of Ministry of Health; Hematology

    Beijing, 100730

  • General Hospital of Chinese PLA; Department of Hematology

    Beijing, 100853

  • the First Hospital of Jilin University

    Changchun, 130021

  • Hu Nan Provincial Cancer Hospital

    Changsha, 410006

  • Fujian Medical University Union Hospital

    Fujian, 350001

  • Fujian Cancer Hospital

    Fuzhou, 350014

  • Sun Yet-sen University Cancer Center

    Guangzhou, 510060

  • Guangdong General Hospital

    Guangzhou, 510080

  • The First Affiliated Hospital of College of Medicine, Zhejiang University

    Hangzhou, 310003

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • The Second Affiliated Hospital to Nanchang University

    Nanchang, 330006

  • Jiangsu Cancer Hospital

    Nanjing, 210009

  • Jiangsu Province Hospital

    Nanjing, 210036

  • The First Affiliate Hospital of Guangxi Medical University

    Nanning, 530021

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, 200025

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Changhai Hospital of Shanghai

    Shanghai, 200433

  • First Hospital of China Medical University

    Shenyang, 110001

  • The Second Affiliated Hospital of Soochow University

    Suzhou, 215004

  • First Affiliated Hospital of Soochow University

    Suzhou, 215006

  • Tianjin Cancer Hospital

    Tianjin, 300060

  • Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology

    Wuhan, 430022

  • Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center

    Wuhan, 430023

  • The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)

    Xi'an, 710038

Other trials in China

Japan21 sites

  • Nagoya Daini Red Cross Hospital; Hematology & Oncology

    Aichi, 466-8650

  • Chiba University Hospital; Hematology

    Chiba, 260-8670

  • Kyushu University Hospital; Hematology, Oncology & Cardiovascular medicine

    Fukuoka, 812-8582

  • Kurume University Hospital; Hematology and Oncology

    Fukuoka, 830-0011

  • Gifu University Hospital; First Department of Internal Medicine

    Gifu, 501-1194

  • Hokkaido University Hospital; Hematology

    Hokkaido, 060-8648

  • Kobe City Medical Center General Hospital; Hematology

    Hyōgo, 650-0047

  • Yokohama City University Hospital; Hematology, Rheumatology, Infectious Disease

    Kanagawa, 236-0004

  • Kyoto University Hospital; Department of Hematology/Oncology

    Kyoto, 606-8507

  • Niigata Cancer Center Hospital; Internal Medicine

    Niigata, 951-8566

  • Iwate Medical University Hospital;Hematology and Oncology

    Numakunai, 020-8505

  • Kurashiki Central Hospital; Hematology

    Okayama, 710-8602

  • Osaka City University Hospital; Hematology

    Osaka, 545-8586

  • Osaka University Hospital; Hematology and Oncology

    Osaka, 565-0871

  • Kindai University Hospital; Hematology and Rheumatology

    Osaka, 589-8511

  • Shimane University Hospital;Hematology

    Shimane, 693-8501

  • Jichi Medical University Hospital; Hematology

    Tochigi, 329-0498

  • National Cancer Center Hospital; Hematology

    Tokyo, 104-0045

  • Toranomon Hospital; Hematology

    Tokyo, 105-8470

  • Nippon Medical School Hospital; Hematology

    Tokyo, 113-8603

  • The Cancer Institute Hospital of JFCR; Hematology Oncology

    Tokyo, 135-8550

Other trials in Japan

Canada15 sites

  • Tom Baker Cancer Centre; Dept of Medicine

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Queen Elizabeth II Health Sciences Centre; Oncology

    Halifax, Nova Scotia, B3H 2Y9

  • Hopital Maisonneuve- Rosemont; Oncology

    Montreal, Quebec, H1T 2M4

  • Chum Hopital Notre Dame; Centre D'Oncologie

    Montreal, Quebec, H2L 4M1

  • Mcgill University - Royal Victoria Hospital; Oncology

    Montreal, Quebec, H3A 1A1

  • McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

    Montreal, Quebec, H3T 1E2

  • Ottawa General Hospital

    Ottawa, Ontario, K1H 8L6

  • Hopital de L'Enfant-Jesus; Hematology

    Québec, Quebec, G1J 1Z4

  • Centre de sante et de services sociaux Rimouski Neigette

    Rimouski, Quebec, G5L 5T1

  • Saskatoon Cancer Centre; Uni of Saskatoon Campus

    Saskatoon, Saskatchewan, S7N 4H4

  • North York General Hospital

    Toronto, Ontario, M2J 1V1

  • Humber River Hospital

    Toronto, Ontario, M3M 0B2

  • University Health Network; Princess Margaret Hospital; Medical Oncology Dept

    Toronto, Ontario, M5G 2M9

  • BCCA-Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Spain10 sites

  • Hospital del Mar; Servicio de Hematologia

    Barcelona, 08003

  • Hospital Universitari Vall d'Hebron; Servicio de Hematologia

    Barcelona, 08035

  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología

    Barcelona, 08036

  • Hospital Duran i Reynals; Servicio de Hematologia

    Barcelona, 08907

  • Hospital Ramon y Cajal; Servicio de Hematologia

    Madrid, 28034

  • Hospital de Navarra, Servicio de Hematología

    Pamplona, Navarre, 31008

  • Complejo Hospitalario de Pontevedra; Servicio de Oncologia

    Pontevedra, 36002

  • Hospital Universitari Sant Joan de Reus; Servicio de Oncologia

    Reus, Tarragona, 43204

  • Hospital Universitario Virgen Macarena; Servicio de Oncologia

    Seville, 41009

  • Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia

    Toledo, 45004

Other trials in Spain

Germany7 sites

  • Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stammz

    Aachen, 52074

  • Onkologische Schwerpunktpraxis Kurfürstendamm

    Berlin, 10707

  • Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I

    Dresden, 01307

  • Friedrich-Alexander-Universität Erlangen-Nürnberg; Medizinische Klinik V

    Erlangen, 91054

  • Klinik der Justus-Liebig-Universität; Innere Medizin

    Giessen, 35392

  • Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V

    Heidelberg, 69120

  • Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie

    Würzburg, 97080

Other trials in Germany

Hungary7 sites

  • Semmelweis University, First Dept of Medicine

    Budapest, 1083

  • National Institute of Oncology, A Dept of Internal Medicine

    Budapest, 1122

  • University of Debrecen Medical and Health Science Center, Institute of Internal medicine Building B

    Debrecen, 4032

  • Petz Aladar Megyei Korhaz; Hematologia

    Győr, 9024

  • Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology

    Kaposvár, 7400

  • University of Pecs, I st Dept of Internal Medicine

    Pécs, 7624

  • University of Szeged, II Dept of Internal Medicine

    Szeged, 6720

Other trials in Hungary

South Korea7 sites

  • National Cancer Center

    Gyeonggi-do, 10408

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center - Oncology

    Seoul, 05505

  • Yonsei University Severance Hospital; Medical Oncology

    Seoul, 120-752

  • St. Mary'S Hospital, the Catholic University School of Medicine; Internal Medicine

    Seoul, 137-701

  • Samsung Medical Center

    Seoul, 6351

Other trials in South Korea

Poland6 sites

  • Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny

    Brzozów, 36-200

  • Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii

    Gdansk, 80-952

  • Medical University of Lodz; Hematology

    Lodz, 93-510

  • Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie

    Lublin, 20-081

  • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego

    Warsaw, 02-781

  • Medical Uni of Wroclaw; Hematology

    Wroclaw, 50-367

Other trials in Poland

Russia6 sites

  • Clinical Oncology Dispensary of Ministry of Health of Tatarstan

    Kazan', 420029

  • Blokhin Cancer Research Center; Clinical Oncology

    Moscow, 115478

  • Regional Clinical Hospital N.A. Semashko; Hematology

    Nizhny Novgorod, 603126

  • Penza Regional Oncology Dispensary

    Penza, 440071

  • Republican Clinical Hospital n.a. Baranov; Haematology

    Petrozavodsk, 185019

  • Research Inst. of Hematology & Blood Transfusion ; Hematology

    Saint Petersburg, 191024

Other trials in Russia

Thailand6 sites

  • King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine

    Bangkok, 10330

  • National Cancer Inst.

    Bangkok, 10400

  • Rajavithi Hospital; Medicine

    Bangkok, 10400

  • Ramathibodi Hospital; Division of Hematology, Department of Medicine

    Bangkok, 10400

  • Siriraj Hospital; Division of Hematology, Department of Medicine

    Bangkok, 10700

  • Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine

    Khon Kaen, 40002

Other trials in Thailand

Brazil5 sites

  • Centro de Pesquisas Oncologicas - CEPON

    Florianópolis, Santa Catarina, 88034-000

  • Hospital Mae de Deus

    Porto Alegre, Rio Grande do Sul, 90470-340

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto de Ensino e Pesquisa Sao Lucas - IEP

    São Paulo, São Paulo, 01236-030

  • Hospital Santa Marcelina;Oncologia

    São Paulo, São Paulo, 08270-070

Other trials in Brazil

South Africa5 sites

  • Constantiaberg Medical Clinic; Dept. of Haematology & Bone Marrow Translant

    Cape Town, 7800

  • Mary Potter Oncology Centre

    Groenkloof, 0181

  • Medical Oncology Centre of Rosebank; Oncology

    Johannesburg, 2196

  • Wits Donald Gordon Clinical Trial Centre; Medical Oncology

    Parktown, Johannesburg, 2193

  • Drs Thomson, Brittain an Partners Inc

    Pretoria, 0044

Other trials in South Africa

United Kingdom5 sites

  • Aberdeen Royal Infirmary; Haematology - Ward 16

    Aberdeen, AB25 2ZN

  • Birmingham Heartlands Hospital; Department of Haematology

    Birmingham, B9 5SS

  • Addenbrookes Hospital; Haematology

    Cambridge, CB2 0QQ

  • The HOPE Clinical Trials Unit

    Leicester, LE1 5WW

  • New Cross Hospital; Dept. Of Haematology

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Australia4 sites

  • Cairns Base Hospital; Cancer Care Centre

    Cairns, Queensland, 4870

  • Frankston Hospital; Oncology/Haematology

    Frankston, Victoria, 3199

  • Monash Medical Centre; Haematology

    Melbourne, Victoria, 3168

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

Other trials in Australia

Mexico4 sites

  • Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre

    Chihuahua City, 31000

  • Hospital Universitario Dr. Jose E. Gonzalez; Haematology

    Monterrey, 64460

  • Oaxaca Site Management Organization

    Oaxaca City, 68000

  • Centro de Estudios Clinicos de Queretaro, SC

    Querétaro, 76000

Other trials in Mexico

Switzerland4 sites

  • Kantonsspital Aarau; Zentrum Für Onkologie, Hämatologie & Transfusionsmedizin

    Aarau, 5001

  • Ospedale San Giovanni; Oncologia

    Bellinzona, 6500

  • Kantonsspital Graubünden;Onkologie und Hämatologie

    Chur, 7000

  • UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

    Zurich, 8091

Other trials in Switzerland

Taiwan4 sites

  • Veterans General Hospital; Division of Oncology

    Taipei, 00112

  • National Taiwan Universtiy Hospital; Division of Hematology

    Taipei, 100

  • Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

    Taipei, 112

  • Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology

    Taoyuan, 333

Other trials in Taiwan

Argentina3 sites

  • Instituto Damic

    Córdoba, X5003DCE

  • Sanatorio Britanico: Hematologia

    Rosario, 2000

  • Sanatorio Parque de Rosario

    Rosario, S2000DSV

Other trials in Argentina

Austria3 sites

  • Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie

    Innsbruck, 6020

  • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

    Salzburg, 5020

  • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie

    Vienna, 1090

Other trials in Austria

Colombia3 sites

  • Fundacion Cardioinfantil

    Bogotá

  • Organizacion Sanitas Internacional

    Bogotá

  • FOSCAL

    Floridablanca

Other trials in Colombia

Czechia3 sites

  • Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

    Brno, 625 00

  • Fn Hr. Kralove; IV. Interni Hematologicka Klinika

    Hradec Králové, 500 05

  • Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK

    Prague, 128 08

Other trials in Czechia

Denmark3 sites

  • Aarhus Universitetshospital, Hæmatologisk Afdeling R

    Aarhus, 8000

  • Rigshospitalet; Hæmatologisk Klinik

    København Ø, 2100

  • Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium

    Roskilde, 4000

Other trials in Denmark

Peru3 sites

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, 15038

  • Instituto;Oncologico Miraflores

    Lima, 18

  • Clinica de Especialidades Medicas

    Lima, Lima 41

Other trials in Peru

Hong Kong2 sites

  • Pamela Youde Nethersole Eastern Hospital; Department of Medicine

    Hong Kong

  • Queen Mary Hospital; Dept of Medicine

    Hong Kong

Other trials in Hong Kong

Serbia2 sites

  • Institute of Hematology

    Belgrade, 11000

  • Clinical Center Vojvodine; Clinic for Hematology

    Novi Sad, 21000

Other trials in Serbia

Panama1 site

  • Centro Hemato Oncologico Panama

    Panama City, 0832

Other trials in Panama

Slovakia1 site

  • National Oncology Inst. ; Dept. of Haematology

    Bratislava, 833 10

Other trials in Slovakia

About this study

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)

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.

Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Also called MabThera, Rituxan

    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.

  • ObinutuzumabDrug

    Also called GA101, RO5072759

    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.

  • CyclophosphamideDrug

    Cyclophosphamide 750 milligrams per square metre (mg/m^2), administered intravenously (IV) on Day 1 of each 21-day cycle.

  • DoxorubicinDrug

    Doxorubicin 50 mg/m^2 IV, administered on Day 1 of each 21-day cycle.

  • VincristineDrug

    Vincristine 1.4 mg/m^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle.

  • PrednisoneDrug

    Prednisone 100 mg (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle.

Study groups in NCT01287741
Study groupRoleWhat they receive
Rituximab+ChemotherapyActive comparatorParticipants 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.
Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone
Obinutuzumab+ChemotherapyExperimentalParticipants 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.
Receives: Drug: Obinutuzumab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median Time to Progression-Free Survival (PFS), Investigator-Assessed

    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).

    Measured: Baseline up to approximately 6.5 years (up to 31 January 2018)

Secondary outcomes (15)

  1. Median Time to Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed

    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.

    Measured: Baseline up to approximately 4 years and 9 months (up to 29 April 2016)

  2. Median Time to Overall Survival (OS)

    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.

    Measured: Baseline up to approximately 6.5 years (up to 31 January 2018)

  3. Overall Response Rate (ORR), Investigator-Assessed

    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.

    Measured: Baseline up to approximately 6.5 years (up to 31 January 2018)

  4. Overall Response Rate (ORR), IRC-Assessed

    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.

    Measured: Baseline up to approximately 4 years and 9 months (up to 29 April 2016)

  5. Complete Response (CR) at the End of Treatment, Investigator-Assessed

    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.

    Measured: Baseline up to approximately 6.5 years (up to 31 January 2018)

  6. Complete Response (CR) at the End of Treatment, IRC-Assessed

    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.

    Measured: Baseline up to approximately 4 years and 9 months (up to 29 April 2016)

  7. Median Time to Event-Free Survival (EFS), Investigator-Assessed

    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.

    Measured: 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)

  8. Median Time to Disease-Free Survival (DFS), Investigator-Assessed

    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.

    Measured: Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)

  9. Duration of Response (DOR), Investigator-Assessed

    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%.

    Measured: Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)

  10. Time to Next Anti-Lymphoma Treatment (TTNALT)

    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.

    Measured: 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)

  11. Percentage of Participants With Adverse Events (AEs)

    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.

    Measured: Baseline up to approximately 6.5 years (up to 31 January 2018)

  12. Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab

    The presence of HAHAs to obinutuzumab was assessed in the first 100 randomized participants.

    Measured: 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)

  13. Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score

    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.

    Measured: 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)

  14. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores

    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.

    Measured: 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)

  15. Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)

    Serum samples for assessment of obinutuzumab serum concentrations were collected only from a subset of Japanese participants following administration of 1000 mg obinutuzumab.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2011 (estimated)
  2. Study start26 Jul 2011
  3. Primary completion29 Apr 2016
  4. Study completion31 Jan 2018

Why it stopped: The study was closed by the Sponsor according to the protocol-specified minimum post-treatment follow-up period of 3 years.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,418 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01287741
Sponsor's protocol ID
BO21005
Other IDs
2010-024194-39
Status last verified
Apr 2019
First submitted
31 Jan 2011
Last updated
12 Apr 2019

Publications

  • Morschhauser F, Lenz G, Herrera AF, Flowers CR, Trneny M, Burke JM, Hou JZ, Staber PB, Hawkes EA, Izutsu K, Le Gouill S, Belada D, Tucci A, Yan M, Harris W, Lu K, Bolen CR, Hirata J, Lee C, Jiang Y, Jardin F, Hatzi K. Low lymphoma macrophage infiltration predicts poor outcomes for R-CHOP- but not Pola-R-CHP-treated patients with DLBCL. Blood Neoplasia. 2026 Jul 2;3(4):100264. doi: 10.1016/j.bneo.2026.100264. eCollection 2026 Nov.

    PubMed 42699559

  • Torkaman M, Jemaa S, Fredrickson J, Fernandez Coimbra A, De Crespigny A, Carano RAD. Comparative analysis of intestinal tumor segmentation in PET CT scans using organ based and whole body deep learning. BMC Med Imaging. 2025 Feb 17;25(1):52. doi: 10.1186/s12880-025-01587-3.

    PubMed 39962481

  • Jemaa S, Ounadjela S, Wang X, El-Galaly TC, Kostakoglu L, Knapp A, Ku G, Musick L, Sahin D, Wei MC, Yin S, Bengtsson T, De Crespigny A, Carano RAD. Automated Lugano Metabolic Response Assessment in 18F-Fluorodeoxyglucose-Avid Non-Hodgkin Lymphoma With Deep Learning on 18F-Fluorodeoxyglucose-Positron Emission Tomography. J Clin Oncol. 2024 Sep 1;42(25):2966-2977. doi: 10.1200/JCO.23.01978. Epub 2024 Jun 6.

    PubMed 38843483

  • Yan JT, Bel C, Trask PC, Lo E. Are changes in patient-reported outcomes prognostic for diffuse large B-Cell lymphoma survival? Results from the GOYA trial. J Patient Rep Outcomes. 2024 Mar 18;8(1):31. doi: 10.1186/s41687-024-00708-w.

    PubMed 38498084

  • Ho RS, Launonen A. Comparison of statistical methods for extrapolating survival in previously untreated diffuse large B-cell lymphoma: results based on the POLARIX study. J Med Econ. 2023 Jan-Dec;26(1):1178-1189. doi: 10.1080/13696998.2023.2259107. Epub 2023 Sep 13.

    PubMed 37702406

  • Jemaa S, Paulson JN, Hutchings M, Kostakoglu L, Trotman J, Tracy S, de Crespigny A, Carano RAD, El-Galaly TC, Nielsen TG, Bengtsson T. Full automation of total metabolic tumor volume from FDG-PET/CT in DLBCL for baseline risk assessments. Cancer Imaging. 2022 Aug 12;22(1):39. doi: 10.1186/s40644-022-00476-0.

    PubMed 35962459

  • Nowicka M, Hilton LK, Ashton-Key M, Hargreaves CE, Lee C, Foxall R, Carter MJ, Beers SA, Potter KN, Bolen CR, Klein C, Knapp A, Mir F, Rose-Zerilli M, Burton C, Klapper W, Scott DW, Sehn LH, Vitolo U, Martelli M, Trneny M, Rushton CK, Slack GW, Farinha P, Strefford JC, Oestergaard MZ, Morin RD, Cragg MS. Prognostic significance of FCGR2B expression for the response of DLBCL patients to rituximab or obinutuzumab treatment. Blood Adv. 2021 Aug 10;5(15):2945-2957. doi: 10.1182/bloodadvances.2021004770.

    PubMed 34323958

  • Strefford JC, Nowicka M, Hargreaves CE, Burton C, Davies A, Ganderton R, Hiddemann W, Iriyama C, Klapper W, Latham KV, Martelli M, Mir F, Parker H, Potter KN, Rose-Zerilli MJJ, Sehn LH, Trneny M, Vitolo U, Bolen CR, Klein C, Knapp A, Oestergaard MZ, Cragg MS. Single-nucleotide Fcgamma receptor polymorphisms do not impact obinutuzumab/rituximab outcome in patients with lymphoma. Blood Adv. 2021 Aug 10;5(15):2935-2944. doi: 10.1182/bloodadvances.2020003985.

    PubMed 34323957

  • Kostakoglu L, Martelli M, Sehn LH, Belada D, Carella AM, Chua N, Gonzalez-Barca E, Hong X, Pinto A, Shi Y, Tatsumi Y, Knapp A, Mattiello F, Nielsen T, Sahin D, Sellam G, Oestergaard MZ, Vitolo U, Trneny M. End-of-treatment PET/CT predicts PFS and OS in DLBCL after first-line treatment: results from GOYA. Blood Adv. 2021 Mar 9;5(5):1283-1290. doi: 10.1182/bloodadvances.2020002690.

    PubMed 33651099

  • Bolen CR, Klanova M, Trneny M, Sehn LH, He J, Tong J, Paulson JN, Kim E, Vitolo U, Di Rocco A, Fingerle-Rowson G, Nielsen T, Lenz G, Oestergaard MZ. Prognostic impact of somatic mutations in diffuse large B-cell lymphoma and relationship to cell-of-origin: data from the phase III GOYA study. Haematologica. 2020 Sep 1;105(9):2298-2307. doi: 10.3324/haematol.2019.227892.

    PubMed 33054054

  • Sehn LH, Martelli M, Trneny M, Liu W, Bolen CR, Knapp A, Sahin D, Sellam G, Vitolo U. A randomized, open-label, Phase III study of obinutuzumab or rituximab plus CHOP in patients with previously untreated diffuse large B-Cell lymphoma: final analysis of GOYA. J Hematol Oncol. 2020 Jun 6;13(1):71. doi: 10.1186/s13045-020-00900-7.

    PubMed 32505213

  • Klanova M, Oestergaard MZ, Trneny M, Hiddemann W, Marcus R, Sehn LH, Vitolo U, Bazeos A, Goede V, Zeuner H, Knapp A, Sahin D, Spielewoy N, Bolen CR, Cardona A, Klein C, Venstrom JM, Nielsen T, Fingerle-Rowson G. Prognostic Impact of Natural Killer Cell Count in Follicular Lymphoma and Diffuse Large B-cell Lymphoma Patients Treated with Immunochemotherapy. Clin Cancer Res. 2019 Aug 1;25(15):4634-4643. doi: 10.1158/1078-0432.CCR-18-3270. Epub 2019 May 3.

    PubMed 31053601

  • McCord R, Bolen CR, Koeppen H, Kadel EE 3rd, Oestergaard MZ, Nielsen T, Sehn LH, Venstrom JM. PD-L1 and tumor-associated macrophages in de novo DLBCL. Blood Adv. 2019 Feb 26;3(4):531-540. doi: 10.1182/bloodadvances.2018020602.

    PubMed 30770362

  • Klanova M, Sehn LH, Bence-Bruckler I, Cavallo F, Jin J, Martelli M, Stewart D, Vitolo U, Zaja F, Zhang Q, Mattiello F, Sellam G, Punnoose EA, Szafer-Glusman E, Bolen CR, Oestergaard MZ, Fingerle-Rowson GR, Nielsen T, Trneny M. Integration of cell of origin into the clinical CNS International Prognostic Index improves CNS relapse prediction in DLBCL. Blood. 2019 Feb 28;133(9):919-926. doi: 10.1182/blood-2018-07-862862. Epub 2019 Jan 7.

    PubMed 30617197

  • Kusumoto S, Arcaini L, Hong X, Jin J, Kim WS, Kwong YL, Peters MG, Tanaka Y, Zelenetz AD, Kuriki H, Fingerle-Rowson G, Nielsen T, Ueda E, Piper-Lepoutre H, Sellam G, Tobinai K. Risk of HBV reactivation in patients with B-cell lymphomas receiving obinutuzumab or rituximab immunochemotherapy. Blood. 2019 Jan 10;133(2):137-146. doi: 10.1182/blood-2018-04-848044. Epub 2018 Oct 19.

    PubMed 30341058

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab, Obinutuzumab and Cyclophosphamide in people with Diffuse Large B-Cell Lymphoma, run by Hoffmann-La Roche at 235 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 235 sites in United States, Italy, China, Japan, Canada and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Time to Progression-Free Survival (PFS), Investigator-Assessed (time frame: Baseline up to approximately 6.5 years (up to 31 January 2018)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01287741, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.

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