Study Stopped
The study was closed by the Sponsor according to the protocol-specified minimum post-treatment follow-up period of 3 years.
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 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)
2 other identifiers
interventional
1,418
28 countries
232
Brief Summary
This open-label, randomized, parallel group study will evaluate the efficacy and safety of obinutuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy versus rituximab (MabThera/Rituxan) with CHOP in previously untreated participants with cluster of differentiation 20 (CD20)-positive diffuse large B-cell lymphoma (DLBCL). Participants will be randomized to receive either obinutuzumab 1000 milligrams (mg) intravenously (IV) every 21 days or rituximab 375 milligrams per square meter (mg/m\^2) IV every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy IV every 21 days. Participants randomized to the obinutuzumab arm will receive an additional two doses on Days 8 and 15 of Cycle 1. Anticipated time on study treatment is 24 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2011
Longer than P75 for phase_3
232 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2011
CompletedFirst Posted
Study publicly available on registry
February 1, 2011
CompletedStudy Start
First participant enrolled
July 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2016
CompletedResults Posted
Study results publicly available
August 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2018
CompletedApril 12, 2019
April 1, 2019
4.8 years
January 31, 2011
April 7, 2017
April 8, 2019
Conditions
Outcome Measures
Primary Outcomes (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).
Baseline up to approximately 6.5 years (up to 31 January 2018)
Secondary Outcomes (15)
Median Time to Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed
Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
Median Time to Overall Survival (OS)
Baseline up to approximately 6.5 years (up to 31 January 2018)
Overall Response Rate (ORR), Investigator-Assessed
Baseline up to approximately 6.5 years (up to 31 January 2018)
Overall Response Rate (ORR), IRC-Assessed
Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
Complete Response (CR) at the End of Treatment, Investigator-Assessed
Baseline up to approximately 6.5 years (up to 31 January 2018)
- +10 more secondary outcomes
Study Arms (2)
Rituximab+Chemotherapy
ACTIVE 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.
Obinutuzumab+Chemotherapy
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Cyclophosphamide 750 milligrams per square metre (mg/m\^2), administered intravenously (IV) on Day 1 of each 21-day cycle.
Doxorubicin 50 mg/m\^2 IV, administered on Day 1 of each 21-day cycle.
Vincristine 1.4 mg/m\^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle.
Prednisone 100 mg (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Fondazione Italiana Linfomi - ETScollaborator
Study Sites (235)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300, United States
Ironwood Cancer TX & Rsch Ctrs
Chandler, Arizona, 85224, United States
Arizona Oncology
Tucson, Arizona, 85704, United States
California Cancer Associates for Research & Excellence, Inc.
Encinitas, California, 92008, United States
cCare
Encinitas, California, 92024, United States
UCLA - School of Medicine; Division of Hematology/Oncology
Los Angeles, California, 90095-6984, United States
Rocky Mountain Cancer Center - Aurora
Aurora, Colorado, 80012, United States
Florida Cancer Specialists; Department of Oncology
Fort Myers, Florida, 33901-8101, United States
Florida Cancer Specialists; Saint Petersburg
St. Petersburg, Florida, 33719, United States
Central Georgia Cancer Care PC
Macon, Georgia, 31201, United States
Illinois Cancer Care, P.C. - Galesburg
Galesburg, Illinois, 61401, United States
Joliet Oncology-Hematology; Associates, Ltd.
Joliet, Illinois, 60435, United States
Cancer Care & Hematology; Specialists of Chicagoland
Niles, Illinois, 60714, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Mercy Oncology / Hematology Center; Oncology
Portland, Maine, 04102, United States
Park Nicollet Clin-Cancer Ctr
Saint Louis Park, Minnesota, 55426, United States
Minnesota Oncology Hematology Woodbury
Woodbury, Minnesota, 55125, United States
New York Oncology Hematology, P.C.
Albany, New York, 12206, United States
Mecklenburg Medical Group Charlotte
Charlotte, North Carolina, 28204, United States
Forsyth Regional Cancer Center; Piedmont Hematology/Oncology Associates
Winston-Salem, North Carolina, 27103, United States
Signal Point Clinical; Research Center, LLC
Middletown, Ohio, 45042, United States
Cleveland CL N Coast Cancer Cr
Sandusky, Ohio, 44870, United States
Willamette Valley Cancer Insitute and Research Center
Springfield, Oregon, 97477, United States
Medical University of SC (MUSC)
Charleston, South Carolina, 29425, United States
South Carolina Oncology Associates - SCRI
Columbia, South Carolina, 29210, United States
Chattanooga Oncology and Hematology Associates, PC
Chattanooga, Tennessee, 37404, United States
Tennessee Onc., PLLC - SCRI
Nashville, Tennessee, 37203, United States
Texas Oncology, Pa - Amarillo
Amarillo, Texas, 79106, United States
Texas Oncology-Fort Worth 12th Ave
Fort Worth, Texas, 76104, United States
MD Anderson Cancer Center Department of Lymphoma & Myeloma
Houston, Texas, 77030, United States
Cancer Care Centers of South Texas-HOAST - San Antonio
New Braunfels, Texas, 78130, United States
Virginia Cancer Institute
Richmond, Virginia, 23226, United States
Blue Ridge Cancer Care
Roanoke, Virginia, 24014, United States
Virginia Cancer Specialists - Winchester
Winchester, Virginia, 22601, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, 98801, United States
Instituto Damic
Córdoba, X5003DCE, Argentina
Sanatorio Britanico: Hematologia
Rosario, 2000, Argentina
Sanatorio Parque de Rosario
Rosario, S2000DSV, Argentina
Cairns Base Hospital; Cancer Care Centre
Cairns, Queensland, 4870, Australia
Frankston Hospital; Oncology/Haematology
Frankston, Victoria, 3199, Australia
Monash Medical Centre; Haematology
Melbourne, Victoria, 3168, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
Innsbruck, 6020, Austria
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg, 5020, Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie
Vienna, 1090, Austria
Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul, 90470-340, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Centro de Pesquisas Oncologicas - CEPON
Florianópolis, Santa Catarina, 88034-000, Brazil
Instituto de Ensino e Pesquisa Sao Lucas - IEP
São Paulo, São Paulo, 01236-030, Brazil
Hospital Santa Marcelina;Oncologia
São Paulo, São Paulo, 08270-070, Brazil
Tom Baker Cancer Centre; Dept of Medicine
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Queen Elizabeth II Health Sciences Centre; Oncology
Halifax, Nova Scotia, B3H 2Y9, Canada
Ottawa General Hospital
Ottawa, Ontario, K1H 8L6, Canada
North York General Hospital
Toronto, Ontario, M2J 1V1, Canada
Humber River Hospital
Toronto, Ontario, M3M 0B2, Canada
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario, M5G 2M9, Canada
Hopital Maisonneuve- Rosemont; Oncology
Montreal, Quebec, H1T 2M4, Canada
Chum Hopital Notre Dame; Centre D'Oncologie
Montreal, Quebec, H2L 4M1, Canada
Mcgill University - Royal Victoria Hospital; Oncology
Montreal, Quebec, H3A 1A1, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, H3T 1E2, Canada
Hopital de L'Enfant-Jesus; Hematology
Québec, Quebec, G1J 1Z4, Canada
Centre de sante et de services sociaux Rimouski Neigette
Rimouski, Quebec, G5L 5T1, Canada
Saskatoon Cancer Centre; Uni of Saskatoon Campus
Saskatoon, Saskatchewan, S7N 4H4, Canada
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, 100021, China
Peking University First Hospital
Beijing, 100034, China
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
Beijing, 100071, China
Beijing Cancer Hospital
Beijing, 100142, China
Beijing Hospital of Ministry of Health; Hematology
Beijing, 100730, China
General Hospital of Chinese PLA; Department of Hematology
Beijing, 100853, China
the First Hospital of Jilin University
Changchun, 130021, China
Hu Nan Provincial Cancer Hospital
Changsha, 410006, China
Fujian Medical University Union Hospital
Fujian, 350001, China
Fujian Cancer Hospital
Fuzhou, 350014, China
Sun Yet-sen University Cancer Center
Guangzhou, 510060, China
Guangdong General Hospital
Guangzhou, 510080, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, 310003, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
The Second Affiliated Hospital to Nanchang University
Nanchang, 330006, China
Jiangsu Cancer Hospital
Nanjing, 210009, China
Jiangsu Province Hospital
Nanjing, 210036, China
The First Affiliate Hospital of Guangxi Medical University
Nanning, 530021, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200025, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Changhai Hospital of Shanghai
Shanghai, 200433, China
First Hospital of China Medical University
Shenyang, 110001, China
The Second Affiliated Hospital of Soochow University
Suzhou, 215004, China
First Affiliated Hospital of Soochow University
Suzhou, 215006, China
Tianjin Cancer Hospital
Tianjin, 300060, China
Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
Wuhan, 430022, China
Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center
Wuhan, 430023, China
The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
Xi'an, 710038, China
Fundacion Cardioinfantil
Bogotá, Colombia
Organizacion Sanitas Internacional
Bogotá, Colombia
FOSCAL
Floridablanca, Colombia
Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika
Brno, 625 00, Czechia
Fn Hr. Kralove; IV. Interni Hematologicka Klinika
Hradec Králové, 500 05, Czechia
Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK
Prague, 128 08, Czechia
Aarhus Universitetshospital, Hæmatologisk Afdeling R
Aarhus, 8000, Denmark
Rigshospitalet; Hæmatologisk Klinik
København Ø, 2100, Denmark
Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium
Roskilde, 4000, Denmark
Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stammz
Aachen, 52074, Germany
Onkologische Schwerpunktpraxis Kurfürstendamm
Berlin, 10707, Germany
Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I
Dresden, 01307, Germany
Friedrich-Alexander-Universität Erlangen-Nürnberg; Medizinische Klinik V
Erlangen, 91054, Germany
Klinik der Justus-Liebig-Universität; Innere Medizin
Giessen, 35392, Germany
Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V
Heidelberg, 69120, Germany
Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie
Würzburg, 97080, Germany
Pamela Youde Nethersole Eastern Hospital; Department of Medicine
Hong Kong, Hong Kong
Queen Mary Hospital; Dept of Medicine
Hong Kong, Hong Kong
Semmelweis University, First Dept of Medicine
Budapest, 1083, Hungary
National Institute of Oncology, A Dept of Internal Medicine
Budapest, 1122, Hungary
University of Debrecen Medical and Health Science Center, Institute of Internal medicine Building B
Debrecen, 4032, Hungary
Petz Aladar Megyei Korhaz; Hematologia
Győr, 9024, Hungary
Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology
Kaposvár, 7400, Hungary
University of Pecs, I st Dept of Internal Medicine
Pécs, 7624, Hungary
University of Szeged, II Dept of Internal Medicine
Szeged, 6720, Hungary
Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
Bari, Apulia, 70124, Italy
IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo
San Giovanni Rotondo, Apulia, 71013, Italy
Az. Osp. C. Panico; Rep. Ematologia E Trapianto
Tricase - LE, Apulia, 73039, Italy
Ospedale Riuniti; Divisione Di Ematologia
Reggio Calabria, Calabria, 89100, Italy
Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica
Napoli, Campania, 80131, Italy
Nuovo Policlinico, Ii Facolta; Divisione Di Ematologia
Napoli, Campania, 80131, Italy
Ospedale "A.Tortora" - Ematologia; Dipartimento Di Ematologia
Pagani (Sa), Campania, 84016, Italy
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
Bologna, Emilia-Romagna, 40138, Italy
AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia
Reggio Emilia, Emilia-Romagna, 42100, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica
Udine, Friuli Venezia Giulia, 33100, Italy
Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol
Rome, Lazio, 00161, Italy
A.O. Universitaria S. Martino Di Genova; Ematologia 1
Genoa, Liguria, 16132, Italy
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
Brescia, Lombardy, 25123, Italy
Hospital San Raffaele
Milan, Lombardy, 20132, Italy
Ist. Nazionale Per Lo Studio E Cura Dei Tumori; Div. Ematologia Trapianto Midollo Osseo Allogenico
Milan, Lombardy, 20133, Italy
Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia
Milan, Lombardy, 20141, Italy
Irccs Policlinico San Matteo; Divisione Di Ematologia
Pavia, Lombardy, 27100, Italy
Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia
Alessandria, Piedmont, 15121, Italy
Ospedali Riuniti del Canavese
Ivrea, Piedmont, 10015, Italy
Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad
Novara, Piedmont, 28100, Italy
Az. Osp. S. Luigi Gonzaga; S.C.D.U. Medicina Interna Ii
Orbassano, Piedmont, 10043, Italy
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
Turin, Piedmont, 10126, Italy
A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia
Turin, Piedmont, 10126, Italy
Azienda Ospedaliero Univ
Catania, Sicily, 95124, Italy
Az. Osp. Papardo; Struttura Complessa Di Ematologia
Messina, Sicily, 98165, Italy
Azienda Ospedaliera Univ
Florence, Tuscany, 50141, Italy
Ospedale Santa Chiara; Unita Operativa Di Ematologia
Pisa, Tuscany, 56100, Italy
Az. Osp. S. Maria; Dept. Di Oncologia Medica
Terni, Umbria, 05100, Italy
Ospedale Ca Foncello; Ematologia
Treviso, Veneto, 31100, Italy
Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia
Verona, Veneto, 37130, Italy
Ospedale Di Vicenza; Nefrologia, Ematologia
Vicenza, Veneto, 36100, Italy
Nagoya Daini Red Cross Hospital; Hematology & Oncology
Aichi, 466-8650, Japan
Chiba University Hospital; Hematology
Chiba, 260-8670, Japan
Kyushu University Hospital; Hematology, Oncology & Cardiovascular medicine
Fukuoka, 812-8582, Japan
Kurume University Hospital; Hematology and Oncology
Fukuoka, 830-0011, Japan
Gifu University Hospital; First Department of Internal Medicine
Gifu, 501-1194, Japan
Hokkaido University Hospital; Hematology
Hokkaido, 060-8648, Japan
Kobe City Medical Center General Hospital; Hematology
Hyōgo, 650-0047, Japan
Yokohama City University Hospital; Hematology, Rheumatology, Infectious Disease
Kanagawa, 236-0004, Japan
Kyoto University Hospital; Department of Hematology/Oncology
Kyoto, 606-8507, Japan
Niigata Cancer Center Hospital; Internal Medicine
Niigata, 951-8566, Japan
Iwate Medical University Hospital;Hematology and Oncology
Numakunai, 020-8505, Japan
Kurashiki Central Hospital; Hematology
Okayama, 710-8602, Japan
Osaka City University Hospital; Hematology
Osaka, 545-8586, Japan
Osaka University Hospital; Hematology and Oncology
Osaka, 565-0871, Japan
Kindai University Hospital; Hematology and Rheumatology
Osaka, 589-8511, Japan
Shimane University Hospital;Hematology
Shimane, 693-8501, Japan
Jichi Medical University Hospital; Hematology
Tochigi, 329-0498, Japan
National Cancer Center Hospital; Hematology
Tokyo, 104-0045, Japan
Toranomon Hospital; Hematology
Tokyo, 105-8470, Japan
Nippon Medical School Hospital; Hematology
Tokyo, 113-8603, Japan
The Cancer Institute Hospital of JFCR; Hematology Oncology
Tokyo, 135-8550, Japan
Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre
Chihuahua City, 31000, Mexico
Hospital Universitario Dr. Jose E. Gonzalez; Haematology
Monterrey, 64460, Mexico
Oaxaca Site Management Organization
Oaxaca City, 68000, Mexico
Centro de Estudios Clinicos de Queretaro, SC
Querétaro, 76000, Mexico
Centro Hemato Oncologico Panama
Panama City, 0832, Panama
Instituto Nacional de Enfermedades Neoplasicas
Lima, 15038, Peru
Instituto;Oncologico Miraflores
Lima, 18, Peru
Clinica de Especialidades Medicas
Lima, Lima 41, Peru
Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny
Brzozów, 36-200, Poland
Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii
Gdansk, 80-952, Poland
Medical University of Lodz; Hematology
Lodz, 93-510, Poland
Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie
Lublin, 20-081, Poland
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego
Warsaw, 02-781, Poland
Medical Uni of Wroclaw; Hematology
Wroclaw, 50-367, Poland
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
Kazan', 420029, Russia
Blokhin Cancer Research Center; Clinical Oncology
Moscow, 115478, Russia
Regional Clinical Hospital N.A. Semashko; Hematology
Nizhny Novgorod, 603126, Russia
Penza Regional Oncology Dispensary
Penza, 440071, Russia
Republican Clinical Hospital n.a. Baranov; Haematology
Petrozavodsk, 185019, Russia
Research Inst. of Hematology & Blood Transfusion ; Hematology
Saint Petersburg, 191024, Russia
Institute of Hematology
Belgrade, 11000, Serbia
Clinical Center Vojvodine; Clinic for Hematology
Novi Sad, 21000, Serbia
National Oncology Inst. ; Dept. of Haematology
Bratislava, 833 10, Slovakia
Constantiaberg Medical Clinic; Dept. of Haematology & Bone Marrow Translant
Cape Town, 7800, South Africa
Mary Potter Oncology Centre
Groenkloof, 0181, South Africa
Medical Oncology Centre of Rosebank; Oncology
Johannesburg, 2196, South Africa
Wits Donald Gordon Clinical Trial Centre; Medical Oncology
Parktown, Johannesburg, 2193, South Africa
Drs Thomson, Brittain an Partners Inc
Pretoria, 0044, South Africa
National Cancer Center
Gyeonggi-do, 10408, South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center - Oncology
Seoul, 05505, South Korea
Yonsei University Severance Hospital; Medical Oncology
Seoul, 120-752, South Korea
St. Mary'S Hospital, the Catholic University School of Medicine; Internal Medicine
Seoul, 137-701, South Korea
Samsung Medical Center
Seoul, 6351, South Korea
Hospital de Navarra, Servicio de Hematología
Pamplona, Navarre, 31008, Spain
Hospital Universitari Sant Joan de Reus; Servicio de Oncologia
Reus, Tarragona, 43204, Spain
Hospital del Mar; Servicio de Hematologia
Barcelona, 08003, Spain
Hospital Universitari Vall d'Hebron; Servicio de Hematologia
Barcelona, 08035, Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, 08036, Spain
Hospital Duran i Reynals; Servicio de Hematologia
Barcelona, 08907, Spain
Hospital Ramon y Cajal; Servicio de Hematologia
Madrid, 28034, Spain
Complejo Hospitalario de Pontevedra; Servicio de Oncologia
Pontevedra, 36002, Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Seville, 41009, Spain
Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
Toledo, 45004, Spain
Kantonsspital Aarau; Zentrum Für Onkologie, Hämatologie & Transfusionsmedizin
Aarau, 5001, Switzerland
Ospedale San Giovanni; Oncologia
Bellinzona, 6500, Switzerland
Kantonsspital Graubünden;Onkologie und Hämatologie
Chur, 7000, Switzerland
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
Zurich, 8091, Switzerland
Veterans General Hospital; Division of Oncology
Taipei, 00112, Taiwan
National Taiwan Universtiy Hospital; Division of Hematology
Taipei, 100, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
Taipei, 112, Taiwan
Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
Taoyuan District, 333, Taiwan
King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine
Bangkok, 10330, Thailand
National Cancer Inst.
Bangkok, 10400, Thailand
Rajavithi Hospital; Medicine
Bangkok, 10400, Thailand
Ramathibodi Hospital; Division of Hematology, Department of Medicine
Bangkok, 10400, Thailand
Siriraj Hospital; Division of Hematology, Department of Medicine
Bangkok, 10700, Thailand
Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine
Khon Kaen, 40002, Thailand
Aberdeen Royal Infirmary; Haematology - Ward 16
Aberdeen, AB25 2ZN, United Kingdom
Birmingham Heartlands Hospital; Department of Haematology
Birmingham, B9 5SS, United Kingdom
Addenbrookes Hospital; Haematology
Cambridge, CB2 0QQ, United Kingdom
The HOPE Clinical Trials Unit
Leicester, LE1 5WW, United Kingdom
New Cross Hospital; Dept. Of Haematology
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (14)
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.
PMID: 39962481DERIVEDJemaa 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.
PMID: 38843483DERIVEDYan 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.
PMID: 38498084DERIVEDHo 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.
PMID: 37702406DERIVEDJemaa 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.
PMID: 35962459DERIVEDNowicka 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.
PMID: 34323958DERIVEDStrefford 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.
PMID: 34323957DERIVEDKostakoglu 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.
PMID: 33651099DERIVEDBolen 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.
PMID: 33054054DERIVEDSehn 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.
PMID: 32505213DERIVEDKlanova 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.
PMID: 31053601DERIVEDMcCord 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.
PMID: 30770362DERIVEDKlanova 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.
PMID: 30617197DERIVEDKusumoto 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.
PMID: 30341058DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2011
First Posted
February 1, 2011
Study Start
July 26, 2011
Primary Completion
April 29, 2016
Study Completion
January 31, 2018
Last Updated
April 12, 2019
Results First Posted
August 17, 2017
Record last verified: 2019-04