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

Primary Purpose

Diffuse Large B-Cell Lymphoma

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rituximab
Obinutuzumab
Cyclophosphamide
Doxorubicin
Vincristine
Prednisone
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Ironwood Cancer TX & Rsch Ctrs
  • Arizona Oncology
  • California Cancer Associates for Research & Excellence, Inc.
  • cCare
  • UCLA - School of Medicine; Division of Hematology/Oncology
  • Rocky Mountain Cancer Center - Aurora
  • Florida Cancer Specialists; Department of Oncology
  • Florida Cancer Specialists; Saint Petersburg
  • Central Georgia Cancer Care PC
  • Illinois Cancer Care, P.C. - Galesburg
  • Joliet Oncology-Hematology; Associates, Ltd.
  • Cancer Care & Hematology; Specialists of Chicagoland
  • Carle Cancer Center
  • Mercy Oncology / Hematology Center; Oncology
  • Park Nicollet Clin-Cancer Ctr
  • Minnesota Oncology Hematology Woodbury
  • New York Oncology Hematology, P.C.
  • Mecklenburg Medical Group Charlotte
  • Forsyth Regional Cancer Center; Piedmont Hematology/Oncology Associates
  • Signal Point Clinical; Research Center, LLC
  • Cleveland CL N Coast Cancer Cr
  • Willamette Valley Cancer Insitute and Research Center
  • Medical University of SC (MUSC)
  • South Carolina Oncology Associates - SCRI
  • Chattanooga Oncology and Hematology Associates, PC
  • Tennessee Onc., PLLC - SCRI
  • Texas Oncology, Pa - Amarillo
  • Texas Oncology-Fort Worth 12th Ave
  • MD Anderson Cancer Center Department of Lymphoma & Myeloma
  • Cancer Care Centers of South Texas-HOAST - San Antonio
  • Virginia Cancer Institute
  • Blue Ridge Cancer Care
  • Virginia Cancer Specialists - Winchester
  • Northwest Medical Specialties
  • Wenatchee Valley Hospital & Clinics
  • Instituto Damic
  • Sanatorio Britanico: Hematologia
  • Sanatorio Parque de Rosario
  • Cairns Base Hospital; Cancer Care Centre
  • Frankston Hospital; Oncology/Haematology
  • Monash Medical Centre; Haematology
  • Fiona Stanley Hospital
  • Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
  • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
  • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie
  • Hospital Mae de Deus
  • Hospital Sao Lucas - PUCRS
  • Centro de Pesquisas Oncologicas - CEPON
  • Instituto de Ensino e Pesquisa Sao Lucas - IEP
  • Hospital Santa Marcelina;Oncologia
  • Tom Baker Cancer Centre; Dept of Medicine
  • Cross Cancer Institute
  • BCCA-Vancouver Cancer Centre
  • Queen Elizabeth II Health Sciences Centre; Oncology
  • Ottawa General Hospital
  • North York General Hospital
  • Humber River Hospital
  • University Health Network; Princess Margaret Hospital; Medical Oncology Dept
  • Hopital Maisonneuve- Rosemont; Oncology
  • Chum Hopital Notre Dame; Centre D'Oncologie
  • Mcgill University - Royal Victoria Hospital; Oncology
  • McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
  • Hopital de L'Enfant-Jesus; Hematology
  • Centre de sante et de services sociaux Rimouski Neigette
  • Saskatoon Cancer Centre; Uni of Saskatoon Campus
  • Cancer Hospital Chinese Academy of Medical Sciences.
  • Peking University First Hospital
  • The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
  • Beijing Cancer Hospital
  • Beijing Hospital of Ministry of Health; Hematology
  • General Hospital of Chinese PLA; Department of Hematology
  • the First Hospital of Jilin University
  • Hu Nan Provincial Cancer Hospital
  • Fujian Medical University Union Hospital
  • Fujian Cancer Hospital
  • Sun Yet-sen University Cancer Center
  • Guangdong General Hospital
  • The First Affiliated Hospital of College of Medicine, Zhejiang University
  • Harbin Medical University Cancer Hospital
  • The Second Affiliated Hospital to Nanchang University
  • Jiangsu Cancer Hospital
  • Jiangsu Province Hospital
  • The First Affiliate Hospital of Guangxi Medical University
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  • Fudan University Shanghai Cancer Center
  • Changhai Hospital of Shanghai
  • First Hospital of China Medical University
  • The Second Affiliated Hospital of Soochow University
  • First Affiliated Hospital of Soochow University
  • Tianjin Cancer Hospital
  • Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
  • Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center
  • The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
  • Fundacion Cardioinfantil
  • Organizacion Sanitas Internacional
  • FOSCAL
  • Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika
  • Fn Hr. Kralove; IV. Interni Hematologicka Klinika
  • Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK
  • Rigshospitalet; Hæmatologisk Klinik
  • Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium
  • Aarhus Universitetshospital, Hæmatologisk Afdeling R
  • Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stammz
  • Onkologische Schwerpunktpraxis Kurfürstendamm
  • Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I
  • Friedrich-Alexander-Universität Erlangen-Nürnberg; Medizinische Klinik V
  • Klinik der Justus-Liebig-Universität; Innere Medizin
  • Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V
  • Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie
  • Pamela Youde Nethersole Eastern Hospital; Department of Medicine
  • Queen Mary Hospital; Dept of Medicine
  • Semmelweis University, First Dept of Medicine
  • National Institute of Oncology, A Dept of Internal Medicine
  • University of Debrecen Medical and Health Science Center, Institute of Internal medicine Building B
  • Petz Aladar Megyei Korhaz; Hematologia
  • Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology
  • University of Pecs, I st Dept of Internal Medicine
  • University of Szeged, II Dept of Internal Medicine
  • Ospedale Riuniti; Divisione Di Ematologia
  • Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica
  • Nuovo Policlinico, Ii Facolta; Divisione Di Ematologia
  • Ospedale "A.Tortora" - Ematologia; Dipartimento Di Ematologia
  • A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
  • AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia
  • A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica
  • Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol
  • A.O. Universitaria S. Martino Di Genova; Ematologia 1
  • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
  • Hospital San Raffaele
  • Ist. Nazionale Per Lo Studio E Cura Dei Tumori; Div. Ematologia Trapianto Midollo Osseo Allogenico
  • Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia
  • Irccs Policlinico San Matteo; Divisione Di Ematologia
  • Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia
  • Ospedali Riuniti del Canavese
  • Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad
  • Az. Osp. S. Luigi Gonzaga; S.C.D.U. Medicina Interna Ii
  • A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
  • A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia
  • Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
  • IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo
  • Az. Osp. C. Panico; Rep. Ematologia E Trapianto
  • Azienda Ospedaliero Univ
  • Az. Osp. Papardo; Struttura Complessa Di Ematologia
  • Azienda Ospedaliera Univ
  • Ospedale Santa Chiara; Unita Operativa Di Ematologia
  • Az. Osp. S. Maria; Dept. Di Oncologia Medica
  • Ospedale Ca Foncello; Ematologia
  • Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia
  • Ospedale Di Vicenza; Nefrologia, Ematologia
  • Nagoya Daini Red Cross Hospital; Hematology & Oncology
  • Chiba University Hospital; Hematology
  • Kyushu University Hospital; Hematology, Oncology & Cardiovascular medicine
  • Kurume University Hospital; Hematology and Oncology
  • Gifu University Hospital; First Department of Internal Medicine
  • Hokkaido University Hospital; Hematology
  • Kobe City Medical Center General Hospital; Hematology
  • Iwate Medical University Hospital;Hematology and Oncology
  • Yokohama City University Hospital; Hematology, Rheumatology, Infectious Disease
  • Kyoto University Hospital; Department of Hematology/Oncology
  • Niigata Cancer Center Hospital; Internal Medicine
  • Kurashiki Central Hospital; Hematology
  • Osaka City University Hospital; Hematology
  • Osaka University Hospital; Hematology and Oncology
  • Kindai University Hospital; Hematology and Rheumatology
  • Shimane University Hospital;Hematology
  • Jichi Medical University Hospital; Hematology
  • National Cancer Center Hospital; Hematology
  • Toranomon Hospital; Hematology
  • Nippon Medical School Hospital; Hematology
  • The Cancer Institute Hospital of JFCR; Hematology Oncology
  • National Cancer Center
  • Chonnam National University Hwasun Hospital
  • Seoul National University Hospital
  • Asan Medical Center - Oncology
  • Yonsei University Severance Hospital; Medical Oncology
  • St. Mary'S Hospital, the Catholic University School of Medicine; Internal Medicine
  • Samsung Medical Center
  • Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre
  • Hospital Universitario Dr. Jose E. Gonzalez; Haematology
  • Oaxaca Site Management Organization
  • Centro de Estudios Clinicos de Queretaro, SC
  • Centro Hemato Oncologico Panama
  • Instituto Nacional de Enfermedades Neoplasicas
  • Instituto;Oncologico Miraflores
  • Clinica de Especialidades Medicas
  • Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny
  • Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii
  • Medical University of Lodz; Hematology
  • Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie
  • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego
  • Medical Uni of Wroclaw; Hematology
  • Clinical Oncology Dispensary of Ministry of Health of Tatarstan
  • Blokhin Cancer Research Center; Clinical Oncology
  • Regional Clinical Hospital N.A. Semashko; Hematology
  • Penza Regional Oncology Dispensary
  • Republican Clinical Hospital n.a. Baranov; Haematology
  • Research Inst. of Hematology & Blood Transfusion ; Hematology
  • Institute of Hematology
  • Clinical Center Vojvodine; Clinic for Hematology
  • National Oncology Inst. ; Dept. of Haematology
  • Constantiaberg Medical Clinic; Dept. of Haematology & Bone Marrow Translant
  • Mary Potter Oncology Centre
  • Medical Oncology Centre of Rosebank; Oncology
  • Wits Donald Gordon Clinical Trial Centre; Medical Oncology
  • Drs Thomson, Brittain an Partners Inc
  • Hospital de Navarra, Servicio de Hematología
  • Hospital Universitari Sant Joan de Reus; Servicio de Oncologia
  • Hospital del Mar; Servicio de Hematologia
  • Hospital Universitari Vall d'Hebron; Servicio de Hematologia
  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología
  • Hospital Duran i Reynals; Servicio de Hematologia
  • Hospital Ramon y Cajal; Servicio de Hematologia
  • Complejo Hospitalario de Pontevedra; Servicio de Oncologia
  • Hospital Universitario Virgen Macarena; Servicio de Oncologia
  • Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
  • Kantonsspital Aarau; Zentrum Für Onkologie, Hämatologie & Transfusionsmedizin
  • Ospedale San Giovanni; Oncologia
  • Kantonsspital Graubünden;Onkologie und Hämatologie
  • UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
  • Veterans General Hospital; Division of Oncology
  • National Taiwan Universtiy Hospital; Division of Hematology
  • Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
  • Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
  • King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine
  • National Cancer Inst.
  • Rajavithi Hospital; Medicine
  • Ramathibodi Hospital; Division of Hematology, Department of Medicine
  • Siriraj Hospital; Division of Hematology, Department of Medicine
  • Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine
  • Aberdeen Royal Infirmary; Haematology - Ward 16
  • Birmingham Heartlands Hospital; Department of Haematology
  • Addenbrookes Hospital; Haematology
  • The HOPE Clinical Trials Unit
  • New Cross Hospital; Dept. Of Haematology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Rituximab+Chemotherapy

Obinutuzumab+Chemotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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%.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 31, 2011
Last Updated
April 8, 2019
Sponsor
Hoffmann-La Roche
Collaborators
Fondazione Italiana Linfomi - ETS
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1. Study Identification

Unique Protocol Identification Number
NCT01287741
Brief Title
A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)
Official Title
A Phase III, Multicenter, Open-Label Randomized Trial Comparing the Efficacy of GA101 (RO5072759) in Combination With CHOP (G-CHOP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With CD20-Positive Diffuse Large B-Cell Lymphoma (DLBCL)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
The study was closed by the Sponsor according to the protocol-specified minimum post-treatment follow-up period of 3 years.
Study Start Date
July 26, 2011 (Actual)
Primary Completion Date
April 29, 2016 (Actual)
Study Completion Date
January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Fondazione Italiana Linfomi - ETS

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1418 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rituximab+Chemotherapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Obinutuzumab+Chemotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
MabThera, Rituxan
Intervention Description
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
Intervention Name(s)
Obinutuzumab
Other Intervention Name(s)
GA101, RO5072759
Intervention Description
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
Intervention Name(s)
Cyclophosphamide
Intervention Description
Cyclophosphamide 750 milligrams per square metre (mg/m^2), administered intravenously (IV) on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Doxorubicin 50 mg/m^2 IV, administered on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
Vincristine 1.4 mg/m^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone 100 mg (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle.
Primary Outcome Measure Information:
Title
Median Time to Progression-Free Survival (PFS), Investigator-Assessed
Description
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).
Time Frame
Baseline up to approximately 6.5 years (up to 31 January 2018)
Secondary Outcome Measure Information:
Title
Median Time to Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed
Description
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.
Time Frame
Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
Title
Median Time to Overall Survival (OS)
Description
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.
Time Frame
Baseline up to approximately 6.5 years (up to 31 January 2018)
Title
Overall Response Rate (ORR), Investigator-Assessed
Description
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.
Time Frame
Baseline up to approximately 6.5 years (up to 31 January 2018)
Title
Overall Response Rate (ORR), IRC-Assessed
Description
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.
Time Frame
Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
Title
Complete Response (CR) at the End of Treatment, Investigator-Assessed
Description
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.
Time Frame
Baseline up to approximately 6.5 years (up to 31 January 2018)
Title
Complete Response (CR) at the End of Treatment, IRC-Assessed
Description
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.
Time Frame
Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
Title
Median Time to Event-Free Survival (EFS), Investigator-Assessed
Description
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.
Time Frame
Baseline up to death or disease progression, or initiation of new anti-lymphoma treatment (NALT), whichever occurred first, approximately 6.5 years (up to 31 January 2018)
Title
Median Time to Disease-Free Survival (DFS), Investigator-Assessed
Description
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.
Time Frame
Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)
Title
Duration of Response (DOR), Investigator-Assessed
Description
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%.
Time Frame
Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)
Title
Time to Next Anti-Lymphoma Treatment (TTNALT)
Description
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.
Time Frame
Baseline up to start of next anti-lymphoma treatment or death due to any cause, whichever occurred first, approximately 6.5 years (31 January 2018)
Title
Percentage of Participants With Adverse Events (AEs)
Description
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.
Time Frame
Baseline up to approximately 6.5 years (up to 31 January 2018)
Title
Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
Description
The presence of HAHAs to obinutuzumab was assessed in the first 100 randomized participants.
Time Frame
Pre-dose (Hour 0) on Cycle (C) 4 Day (D) 1, at end of treatment/early termination (up to Month 6), every 6 months thereafter for 30 months (cycle length = 21 days)
Title
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score
Description
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.
Time Frame
Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to approximately 6.5 years, (cycle length = 21 days)
Title
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
Description
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.
Time Frame
Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to data cut-off, up to approximately 6.5 years, (cycle length = 21 days)
Title
Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Description
Serum samples for assessment of obinutuzumab serum concentrations were collected only from a subset of Japanese participants following administration of 1000 mg obinutuzumab.
Time Frame
C1: D1 post-infusion and 20-28 and 66-80 hours after end of infusion, D8 and D15 pre-and post-infusion; C2: D1 pre- and post-infusion; C4: D1 pre- and post-infusion; C6: D1 pre- and post-infusion; C8: D1 pre- and post-infusion (cycle length = 21 days)

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
35962459
Citation
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.
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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.
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PubMed Identifier
34323957
Citation
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.
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PubMed Identifier
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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.
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PubMed Identifier
33054054
Citation
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A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)

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