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

NCT ID: NCT01287741

Last Updated: 2019-04-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1418 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-26

Study Completion Date

2018-01-31

Brief Summary

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This open-label, randomized, parallel group study will evaluate the efficacy and safety of obinutuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy versus rituximab (MabThera/Rituxan) with CHOP in previously untreated participants with cluster of differentiation 20 (CD20)-positive diffuse large B-cell lymphoma (DLBCL). Participants will be randomized to receive either obinutuzumab 1000 milligrams (mg) intravenously (IV) every 21 days or rituximab 375 milligrams per square meter (mg/m\^2) IV every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy IV every 21 days. Participants randomized to the obinutuzumab arm will receive an additional two doses on Days 8 and 15 of Cycle 1. Anticipated time on study treatment is 24 weeks.

Detailed Description

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Conditions

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Diffuse Large B-Cell Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Rituximab

Intervention Type DRUG

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.

Cyclophosphamide

Intervention Type DRUG

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

Doxorubicin

Intervention Type DRUG

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

Vincristine

Intervention Type DRUG

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

Prednisone

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Obinutuzumab

Intervention Type DRUG

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

Intervention Type DRUG

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

Doxorubicin

Intervention Type DRUG

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

Vincristine

Intervention Type DRUG

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

Prednisone

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Cyclophosphamide

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

Intervention Type DRUG

Doxorubicin

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

Intervention Type DRUG

Vincristine

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

Intervention Type DRUG

Prednisone

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

Intervention Type DRUG

Other Intervention Names

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MabThera, Rituxan GA101, RO5072759

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Italiana Linfomi - ETS

OTHER

Sponsor Role collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Ironwood Cancer TX & Rsch Ctrs

Chandler, Arizona, United States

Site Status

Arizona Oncology

Tucson, Arizona, United States

Site Status

California Cancer Associates for Research & Excellence, Inc.

Encinitas, California, United States

Site Status

cCare

Encinitas, California, United States

Site Status

UCLA - School of Medicine; Division of Hematology/Oncology

Los Angeles, California, United States

Site Status

Rocky Mountain Cancer Center - Aurora

Aurora, Colorado, United States

Site Status

Florida Cancer Specialists; Department of Oncology

Fort Myers, Florida, United States

Site Status

Florida Cancer Specialists; Saint Petersburg

St. Petersburg, Florida, United States

Site Status

Central Georgia Cancer Care PC

Macon, Georgia, United States

Site Status

Illinois Cancer Care, P.C. - Galesburg

Galesburg, Illinois, United States

Site Status

Joliet Oncology-Hematology; Associates, Ltd.

Joliet, Illinois, United States

Site Status

Cancer Care & Hematology; Specialists of Chicagoland

Niles, Illinois, United States

Site Status

Carle Cancer Center

Urbana, Illinois, United States

Site Status

Mercy Oncology / Hematology Center; Oncology

Portland, Maine, United States

Site Status

Park Nicollet Clin-Cancer Ctr

Saint Louis Park, Minnesota, United States

Site Status

Minnesota Oncology Hematology Woodbury

Woodbury, Minnesota, United States

Site Status

New York Oncology Hematology, P.C.

Albany, New York, United States

Site Status

Mecklenburg Medical Group Charlotte

Charlotte, North Carolina, United States

Site Status

Forsyth Regional Cancer Center; Piedmont Hematology/Oncology Associates

Winston-Salem, North Carolina, United States

Site Status

Signal Point Clinical; Research Center, LLC

Middletown, Ohio, United States

Site Status

Cleveland CL N Coast Cancer Cr

Sandusky, Ohio, United States

Site Status

Willamette Valley Cancer Insitute and Research Center

Springfield, Oregon, United States

Site Status

Medical University of SC (MUSC)

Charleston, South Carolina, United States

Site Status

South Carolina Oncology Associates - SCRI

Columbia, South Carolina, United States

Site Status

Chattanooga Oncology and Hematology Associates, PC

Chattanooga, Tennessee, United States

Site Status

Tennessee Onc., PLLC - SCRI

Nashville, Tennessee, United States

Site Status

Texas Oncology, Pa - Amarillo

Amarillo, Texas, United States

Site Status

Texas Oncology-Fort Worth 12th Ave

Fort Worth, Texas, United States

Site Status

MD Anderson Cancer Center Department of Lymphoma & Myeloma

Houston, Texas, United States

Site Status

Cancer Care Centers of South Texas-HOAST - San Antonio

New Braunfels, Texas, United States

Site Status

Virginia Cancer Institute

Richmond, Virginia, United States

Site Status

Blue Ridge Cancer Care

Roanoke, Virginia, United States

Site Status

Virginia Cancer Specialists - Winchester

Winchester, Virginia, United States

Site Status

Northwest Medical Specialties

Tacoma, Washington, United States

Site Status

Wenatchee Valley Hospital & Clinics

Wenatchee, Washington, United States

Site Status

Instituto Damic

Córdoba, , Argentina

Site Status

Sanatorio Britanico: Hematologia

Rosario, , Argentina

Site Status

Sanatorio Parque de Rosario

Rosario, , Argentina

Site Status

Cairns Base Hospital; Cancer Care Centre

Cairns, Queensland, Australia

Site Status

Frankston Hospital; Oncology/Haematology

Frankston, Victoria, Australia

Site Status

Monash Medical Centre; Haematology

Melbourne, Victoria, Australia

Site Status

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Site Status

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

Innsbruck, , Austria

Site Status

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

Salzburg, , Austria

Site Status

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

Vienna, , Austria

Site Status

Hospital Mae de Deus

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Centro de Pesquisas Oncologicas - CEPON

Florianópolis, Santa Catarina, Brazil

Site Status

Instituto de Ensino e Pesquisa Sao Lucas - IEP

São Paulo, São Paulo, Brazil

Site Status

Hospital Santa Marcelina;Oncologia

São Paulo, São Paulo, Brazil

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Tom Baker Cancer Centre; Dept of Medicine

Calgary, Alberta, Canada

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

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BCCA-Vancouver Cancer Centre

Vancouver, British Columbia, Canada

Site Status

Queen Elizabeth II Health Sciences Centre; Oncology

Halifax, Nova Scotia, Canada

Site Status

Ottawa General Hospital

Ottawa, Ontario, Canada

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North York General Hospital

Toronto, Ontario, Canada

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Humber River Hospital

Toronto, Ontario, Canada

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University Health Network; Princess Margaret Hospital; Medical Oncology Dept

Toronto, Ontario, Canada

Site Status

Hopital Maisonneuve- Rosemont; Oncology

Montreal, Quebec, Canada

Site Status

Chum Hopital Notre Dame; Centre D'Oncologie

Montreal, Quebec, Canada

Site Status

Mcgill University - Royal Victoria Hospital; Oncology

Montreal, Quebec, Canada

Site Status

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

Montreal, Quebec, Canada

Site Status

Hopital de L'Enfant-Jesus; Hematology

Québec, Quebec, Canada

Site Status

Centre de sante et de services sociaux Rimouski Neigette

Rimouski, Quebec, Canada

Site Status

Saskatoon Cancer Centre; Uni of Saskatoon Campus

Saskatoon, Saskatchewan, Canada

Site Status

Cancer Hospital Chinese Academy of Medical Sciences.

Beijing, , China

Site Status

Peking University First Hospital

Beijing, , China

Site Status

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

Beijing, , China

Site Status

Beijing Cancer Hospital

Beijing, , China

Site Status

Beijing Hospital of Ministry of Health; Hematology

Beijing, , China

Site Status

General Hospital of Chinese PLA; Department of Hematology

Beijing, , China

Site Status

the First Hospital of Jilin University

Changchun, , China

Site Status

Hu Nan Provincial Cancer Hospital

Changsha, , China

Site Status

Fujian Medical University Union Hospital

Fujian, , China

Site Status

Fujian Cancer Hospital

Fuzhou, , China

Site Status

Sun Yet-sen University Cancer Center

Guangzhou, , China

Site Status

Guangdong General Hospital

Guangzhou, , China

Site Status

The First Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, , China

Site Status

Harbin Medical University Cancer Hospital

Harbin, , China

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The Second Affiliated Hospital to Nanchang University

Nanchang, , China

Site Status

Jiangsu Cancer Hospital

Nanjing, , China

Site Status

Jiangsu Province Hospital

Nanjing, , China

Site Status

The First Affiliate Hospital of Guangxi Medical University

Nanning, , China

Site Status

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, , China

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Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status

Changhai Hospital of Shanghai

Shanghai, , China

Site Status

First Hospital of China Medical University

Shenyang, , China

Site Status

The Second Affiliated Hospital of Soochow University

Suzhou, , China

Site Status

First Affiliated Hospital of Soochow University

Suzhou, , China

Site Status

Tianjin Cancer Hospital

Tianjin, , China

Site Status

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

Wuhan, , China

Site Status

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

Wuhan, , China

Site Status

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

Xi'an, , China

Site Status

Fundacion Cardioinfantil

Bogotá, , Colombia

Site Status

Organizacion Sanitas Internacional

Bogotá, , Colombia

Site Status

FOSCAL

Floridablanca, , Colombia

Site Status

Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

Brno, , Czechia

Site Status

Fn Hr. Kralove; IV. Interni Hematologicka Klinika

Hradec Králové, , Czechia

Site Status

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

Prague, , Czechia

Site Status

Aarhus Universitetshospital, Hæmatologisk Afdeling R

Aarhus, , Denmark

Site Status

Rigshospitalet; Hæmatologisk Klinik

København Ø, , Denmark

Site Status

Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium

Roskilde, , Denmark

Site Status

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

Aachen, , Germany

Site Status

Onkologische Schwerpunktpraxis Kurfürstendamm

Berlin, , Germany

Site Status

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

Dresden, , Germany

Site Status

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

Erlangen, , Germany

Site Status

Klinik der Justus-Liebig-Universität; Innere Medizin

Giessen, , Germany

Site Status

Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V

Heidelberg, , Germany

Site Status

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

Würzburg, , Germany

Site Status

Pamela Youde Nethersole Eastern Hospital; Department of Medicine

Hong Kong, , Hong Kong

Site Status

Queen Mary Hospital; Dept of Medicine

Hong Kong, , Hong Kong

Site Status

Semmelweis University, First Dept of Medicine

Budapest, , Hungary

Site Status

National Institute of Oncology, A Dept of Internal Medicine

Budapest, , Hungary

Site Status

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

Debrecen, , Hungary

Site Status

Petz Aladar Megyei Korhaz; Hematologia

Győr, , Hungary

Site Status

Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology

Kaposvár, , Hungary

Site Status

University of Pecs, I st Dept of Internal Medicine

Pécs, , Hungary

Site Status

University of Szeged, II Dept of Internal Medicine

Szeged, , Hungary

Site Status

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

Bari, Apulia, Italy

Site Status

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

San Giovanni Rotondo, Apulia, Italy

Site Status

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

Tricase - LE, Apulia, Italy

Site Status

Ospedale Riuniti; Divisione Di Ematologia

Reggio Calabria, Calabria, Italy

Site Status

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

Napoli, Campania, Italy

Site Status

Nuovo Policlinico, Ii Facolta; Divisione Di Ematologia

Napoli, Campania, Italy

Site Status

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

Pagani (Sa), Campania, Italy

Site Status

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

Bologna, Emilia-Romagna, Italy

Site Status

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

Reggio Emilia, Emilia-Romagna, Italy

Site Status

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

Udine, Friuli Venezia Giulia, Italy

Site Status

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

Rome, Lazio, Italy

Site Status

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

Genoa, Liguria, Italy

Site Status

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

Brescia, Lombardy, Italy

Site Status

Hospital San Raffaele

Milan, Lombardy, Italy

Site Status

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

Milan, Lombardy, Italy

Site Status

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

Milan, Lombardy, Italy

Site Status

Irccs Policlinico San Matteo; Divisione Di Ematologia

Pavia, Lombardy, Italy

Site Status

Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia

Alessandria, Piedmont, Italy

Site Status

Ospedali Riuniti del Canavese

Ivrea, Piedmont, Italy

Site Status

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

Novara, Piedmont, Italy

Site Status

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

Orbassano, Piedmont, Italy

Site Status

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

Turin, Piedmont, Italy

Site Status

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

Turin, Piedmont, Italy

Site Status

Azienda Ospedaliero Univ

Catania, Sicily, Italy

Site Status

Az. Osp. Papardo; Struttura Complessa Di Ematologia

Messina, Sicily, Italy

Site Status

Azienda Ospedaliera Univ

Florence, Tuscany, Italy

Site Status

Ospedale Santa Chiara; Unita Operativa Di Ematologia

Pisa, Tuscany, Italy

Site Status

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

Terni, Umbria, Italy

Site Status

Ospedale Ca Foncello; Ematologia

Treviso, Veneto, Italy

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

Verona, Veneto, Italy

Site Status

Ospedale Di Vicenza; Nefrologia, Ematologia

Vicenza, Veneto, Italy

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Nagoya Daini Red Cross Hospital; Hematology & Oncology

Aichi, , Japan

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Chiba University Hospital; Hematology

Chiba, , Japan

Site Status

Kyushu University Hospital; Hematology, Oncology & Cardiovascular medicine

Fukuoka, , Japan

Site Status

Kurume University Hospital; Hematology and Oncology

Fukuoka, , Japan

Site Status

Gifu University Hospital; First Department of Internal Medicine

Gifu, , Japan

Site Status

Hokkaido University Hospital; Hematology

Hokkaido, , Japan

Site Status

Kobe City Medical Center General Hospital; Hematology

Hyōgo, , Japan

Site Status

Yokohama City University Hospital; Hematology, Rheumatology, Infectious Disease

Kanagawa, , Japan

Site Status

Kyoto University Hospital; Department of Hematology/Oncology

Kyoto, , Japan

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Niigata Cancer Center Hospital; Internal Medicine

Niigata, , Japan

Site Status

Iwate Medical University Hospital;Hematology and Oncology

Numakunai, , Japan

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Kurashiki Central Hospital; Hematology

Okayama, , Japan

Site Status

Osaka City University Hospital; Hematology

Osaka, , Japan

Site Status

Osaka University Hospital; Hematology and Oncology

Osaka, , Japan

Site Status

Kindai University Hospital; Hematology and Rheumatology

Osaka, , Japan

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Shimane University Hospital;Hematology

Shimane, , Japan

Site Status

Jichi Medical University Hospital; Hematology

Tochigi, , Japan

Site Status

National Cancer Center Hospital; Hematology

Tokyo, , Japan

Site Status

Toranomon Hospital; Hematology

Tokyo, , Japan

Site Status

Nippon Medical School Hospital; Hematology

Tokyo, , Japan

Site Status

The Cancer Institute Hospital of JFCR; Hematology Oncology

Tokyo, , Japan

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

Chihuahua City, , Mexico

Site Status

Hospital Universitario Dr. Jose E. Gonzalez; Haematology

Monterrey, , Mexico

Site Status

Oaxaca Site Management Organization

Oaxaca City, , Mexico

Site Status

Centro de Estudios Clinicos de Queretaro, SC

Querétaro, , Mexico

Site Status

Centro Hemato Oncologico Panama

Panama City, , Panama

Site Status

Instituto Nacional de Enfermedades Neoplasicas

Lima, , Peru

Site Status

Instituto;Oncologico Miraflores

Lima, , Peru

Site Status

Clinica de Especialidades Medicas

Lima, , Peru

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Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny

Brzozów, , Poland

Site Status

Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii

Gdansk, , Poland

Site Status

Medical University of Lodz; Hematology

Lodz, , Poland

Site Status

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

Lublin, , Poland

Site Status

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

Warsaw, , Poland

Site Status

Medical Uni of Wroclaw; Hematology

Wroclaw, , Poland

Site Status

Clinical Oncology Dispensary of Ministry of Health of Tatarstan

Kazan', , Russia

Site Status

Blokhin Cancer Research Center; Clinical Oncology

Moscow, , Russia

Site Status

Regional Clinical Hospital N.A. Semashko; Hematology

Nizhny Novgorod, , Russia

Site Status

Penza Regional Oncology Dispensary

Penza, , Russia

Site Status

Republican Clinical Hospital n.a. Baranov; Haematology

Petrozavodsk, , Russia

Site Status

Research Inst. of Hematology & Blood Transfusion ; Hematology

Saint Petersburg, , Russia

Site Status

Institute of Hematology

Belgrade, , Serbia

Site Status

Clinical Center Vojvodine; Clinic for Hematology

Novi Sad, , Serbia

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National Oncology Inst. ; Dept. of Haematology

Bratislava, , Slovakia

Site Status

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

Cape Town, , South Africa

Site Status

Mary Potter Oncology Centre

Groenkloof, , South Africa

Site Status

Medical Oncology Centre of Rosebank; Oncology

Johannesburg, , South Africa

Site Status

Wits Donald Gordon Clinical Trial Centre; Medical Oncology

Parktown, Johannesburg, , South Africa

Site Status

Drs Thomson, Brittain an Partners Inc

Pretoria, , South Africa

Site Status

National Cancer Center

Gyeonggi-do, , South Korea

Site Status

Chonnam National University Hwasun Hospital

Jeollanam-do, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Asan Medical Center - Oncology

Seoul, , South Korea

Site Status

Yonsei University Severance Hospital; Medical Oncology

Seoul, , South Korea

Site Status

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

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Hospital de Navarra, Servicio de Hematología

Pamplona, Navarre, Spain

Site Status

Hospital Universitari Sant Joan de Reus; Servicio de Oncologia

Reus, Tarragona, Spain

Site Status

Hospital del Mar; Servicio de Hematologia

Barcelona, , Spain

Site Status

Hospital Universitari Vall d'Hebron; Servicio de Hematologia

Barcelona, , Spain

Site Status

Hospital Clínic i Provincial; Servicio de Hematología y Oncología

Barcelona, , Spain

Site Status

Hospital Duran i Reynals; Servicio de Hematologia

Barcelona, , Spain

Site Status

Hospital Ramon y Cajal; Servicio de Hematologia

Madrid, , Spain

Site Status

Complejo Hospitalario de Pontevedra; Servicio de Oncologia

Pontevedra, , Spain

Site Status

Hospital Universitario Virgen Macarena; Servicio de Oncologia

Seville, , Spain

Site Status

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

Toledo, , Spain

Site Status

Kantonsspital Aarau; Zentrum Für Onkologie, Hämatologie & Transfusionsmedizin

Aarau, , Switzerland

Site Status

Ospedale San Giovanni; Oncologia

Bellinzona, , Switzerland

Site Status

Kantonsspital Graubünden;Onkologie und Hämatologie

Chur, , Switzerland

Site Status

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

Zurich, , Switzerland

Site Status

Veterans General Hospital; Division of Oncology

Taipei, , Taiwan

Site Status

National Taiwan Universtiy Hospital; Division of Hematology

Taipei, , Taiwan

Site Status

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

Taipei, , Taiwan

Site Status

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

Taoyuan District, , Taiwan

Site Status

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

Bangkok, , Thailand

Site Status

National Cancer Inst.

Bangkok, , Thailand

Site Status

Rajavithi Hospital; Medicine

Bangkok, , Thailand

Site Status

Ramathibodi Hospital; Division of Hematology, Department of Medicine

Bangkok, , Thailand

Site Status

Siriraj Hospital; Division of Hematology, Department of Medicine

Bangkok, , Thailand

Site Status

Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine

Khon Kaen, , Thailand

Site Status

Aberdeen Royal Infirmary; Haematology - Ward 16

Aberdeen, , United Kingdom

Site Status

Birmingham Heartlands Hospital; Department of Haematology

Birmingham, , United Kingdom

Site Status

Addenbrookes Hospital; Haematology

Cambridge, , United Kingdom

Site Status

The HOPE Clinical Trials Unit

Leicester, , United Kingdom

Site Status

New Cross Hospital; Dept. Of Haematology

Wolverhampton, , United Kingdom

Site Status

Countries

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United States Argentina Australia Austria Brazil Canada China Colombia Czechia Denmark Germany Hong Kong Hungary Italy Japan Mexico Panama Peru Poland Russia Serbia Slovakia South Africa South Korea Spain Switzerland Taiwan Thailand United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39962481 (View on PubMed)

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.

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PMID: 38843483 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38498084 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37702406 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35962459 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34323958 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34323957 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33651099 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33054054 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32505213 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31053601 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30770362 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30617197 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30341058 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2010-024194-39

Identifier Type: -

Identifier Source: secondary_id

BO21005

Identifier Type: -

Identifier Source: org_study_id

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