Clinical trial NCT01287741: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diffuse Large B-Cell Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Fondazione Italiana Linfomi - ETS
First posted: 2011-02-01
Enrollment: 1418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Median Time to Progression-Free Survival (PFS), Investigator-Assessed
timeFrame: Baseline up to approximately 6.5 years (up to 31 January 2018)
Secondary outcomes:
measure: Median Time to Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed
timeFrame: Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
measure: Median Time to Overall Survival (OS)
timeFrame: Baseline up to approximately 6.5 years (up to 31 January 2018)
measure: Overall Response Rate (ORR), Investigator-Assessed
timeFrame: Baseline up to approximately 6.5 years (up to 31 January 2018)
measure: Overall Response Rate (ORR), IRC-Assessed
timeFrame: Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
measure: Complete Response (CR) at the End of Treatment, Investigator-Assessed
timeFrame: Baseline up to approximately 6.5 years (up to 31 January 2018)
measure: Complete Response (CR) at the End of Treatment, IRC-Assessed
timeFrame: Baseline up to approximately 4 years and 9 months (up to 29 April 2016)
measure: Median Time to Event-Free Survival (EFS), Investigator-Assessed
timeFrame: 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)
measure: Median Time to Disease-Free Survival (DFS), Investigator-Assessed
timeFrame: Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)
measure: Duration of Response (DOR), Investigator-Assessed
timeFrame: Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018)
measure: Time to Next Anti-Lymphoma Treatment (TTNALT)
timeFrame: 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)
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Baseline up to approximately 6.5 years (up to 31 January 2018)
measure: Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab
timeFrame: 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)
measure: Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score
timeFrame: 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)
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores
timeFrame: 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)
measure: Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
timeFrame: 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)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Chandler
country: United States
facility: Ironwood Cancer TX & Rsch Ctrs
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology
state: Arizona
city: Encinitas
country: United States
facility: California Cancer Associates for Research & Excellence, Inc.
state: California
city: Encinitas
country: United States
facility: cCare
state: California
city: Los Angeles
country: United States
facility: UCLA - School of Medicine; Division of Hematology/Oncology
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Center - Aurora
state: Colorado
city: Fort Myers
country: United States
facility: Florida Cancer Specialists; Department of Oncology
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists; Saint Petersburg
state: Florida
city: Macon
country: United States
facility: Central Georgia Cancer Care PC
state: Georgia
city: Galesburg
country: United States
facility: Illinois Cancer Care, P.C. - Galesburg
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology-Hematology; Associates, Ltd.
state: Illinois
city: Niles
country: United States
facility: Cancer Care & Hematology; Specialists of Chicagoland
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Portland
country: United States
facility: Mercy Oncology / Hematology Center; Oncology
state: Maine
city: Saint Louis Park
country: United States
facility: Park Nicollet Clin-Cancer Ctr
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Oncology Hematology Woodbury
state: Minnesota
city: Albany
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: Charlotte
country: United States
facility: Mecklenburg Medical Group Charlotte
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Regional Cancer Center; Piedmont Hematology/Oncology Associates
state: North Carolina
city: Middletown
country: United States
facility: Signal Point Clinical; Research Center, LLC
state: Ohio
city: Sandusky
country: United States
facility: Cleveland CL N Coast Cancer Cr
state: Ohio
city: Springfield
country: United States
facility: Willamette Valley Cancer Insitute and Research Center
state: Oregon
city: Charleston
country: United States
facility: Medical University of SC (MUSC)
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Oncology Associates - SCRI
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Oncology and Hematology Associates, PC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Onc., PLLC - SCRI
state: Tennessee
city: Amarillo
country: United States
facility: Texas Oncology, Pa - Amarillo
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology-Fort Worth 12th Ave
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center Department of Lymphoma & Myeloma
state: Texas
city: New Braunfels
country: United States
facility: Cancer Care Centers of South Texas-HOAST - San Antonio
state: Texas
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Roanoke
country: United States
facility: Blue Ridge Cancer Care
state: Virginia
city: Winchester
country: United States
facility: Virginia Cancer Specialists - Winchester
state: Virginia
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospital & Clinics
state: Washington
city: Cordoba
country: Argentina
facility: Instituto Damic
city: Rosario
country: Argentina
facility: Sanatorio Britanico: Hematologia
city: Rosario
country: Argentina
facility: Sanatorio Parque de Rosario
city: Cairns
country: Australia
facility: Cairns Base Hospital; Cancer Care Centre
state: Queensland
city: Frankston
country: Australia
facility: Frankston Hospital; Oncology/Haematology
state: Victoria
city: Melbourne
country: Australia
facility: Monash Medical Centre; Haematology
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Innsbruck
country: Austria
facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
city: Salzburg
country: Austria
facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
city: Wien
country: Austria
facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie
city: Porto Alegre
country: Brazil
facility: Hospital Mae de Deus
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: RS
city: Florianopolis
country: Brazil
facility: Centro de Pesquisas Oncologicas - CEPON
state: SC
city: Sao Paulo
country: Brazil
facility: Instituto de Ensino e Pesquisa Sao Lucas - IEP
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Santa Marcelina;Oncologia
state: SP
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre; Dept of Medicine
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Vancouver
country: Canada
facility: BCCA-Vancouver Cancer Centre
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre; Oncology
state: Nova Scotia
city: Ottawa
country: Canada
facility: Ottawa General Hospital
state: Ontario
city: Toronto
country: Canada
facility: North York General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Humber River Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept
state: Ontario
city: Montreal
country: Canada
facility: Hopital Maisonneuve- Rosemont; Oncology
state: Quebec
city: Montreal
country: Canada
facility: Chum Hopital Notre Dame; Centre D'Oncologie
state: Quebec
city: Montreal
country: Canada
facility: Mcgill University - Royal Victoria Hospital; Oncology
state: Quebec
city: Montreal
country: Canada
facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
state: Quebec
city: Quebec City
country: Canada
facility: Hopital de L'Enfant-Jesus; Hematology
state: Quebec
city: Rimouski
country: Canada
facility: Centre de sante et de services sociaux Rimouski Neigette
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre; Uni of Saskatoon Campus
state: Saskatchewan
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences.
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Beijing Hospital of Ministry of Health; Hematology
city: Beijing
country: China
facility: General Hospital of Chinese PLA; Department of Hematology
city: Changchun
country: China
facility: the First Hospital of Jilin University
city: Changsha
country: China
facility: Hu Nan Provincial Cancer Hospital
city: Fujian
country: China
facility: Fujian Medical University Union Hospital
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Guangzhou
country: China
facility: Sun Yet-sen University Cancer Center
city: Guangzhou
country: China
facility: Guangdong General Hospital
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Nanchang
country: China
facility: The Second Affiliated Hospital to Nanchang University
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Nanning
country: China
facility: The First Affiliate Hospital of Guangxi Medical University
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Changhai Hospital of Shanghai
city: Shenyang
country: China
facility: First Hospital of China Medical University
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
city: Suzhou
country: China
facility: First Affiliated Hospital of Soochow University
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
city: Wuhan
country: China
facility: Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center
city: Xi'an
country: China
facility: The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
city: Bogota
country: Colombia
facility: Fundacion Cardioinfantil
city: Bogota
country: Colombia
facility: Organizacion Sanitas Internacional
city: Floridablanca
country: Colombia
facility: FOSCAL
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika
city: Hradec Kralove
country: Czechia
facility: Fn Hr. Kralove; IV. Interni Hematologicka Klinika
city: Praha 2
country: Czechia
facility: Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK
city: København Ø
country: Denmark
facility: Rigshospitalet; Hæmatologisk Klinik
city: Roskilde
country: Denmark
facility: Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium
city: Århus
country: Denmark
facility: Aarhus Universitetshospital, Hæmatologisk Afdeling R
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stammz
city: Berlin
country: Germany
facility: Onkologische Schwerpunktpraxis Kurfürstendamm
city: Dresden
country: Germany
facility: Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I
city: Erlangen
country: Germany
facility: Friedrich-Alexander-Universität Erlangen-Nürnberg; Medizinische Klinik V
city: Gießen
country: Germany
facility: Klinik der Justus-Liebig-Universität; Innere Medizin
city: Heidelberg
country: Germany
facility: Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital; Department of Medicine
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital; Dept of Medicine
city: Budapest
country: Hungary
facility: Semmelweis University, First Dept of Medicine
city: Budapest
country: Hungary
facility: National Institute of Oncology, A Dept of Internal Medicine
city: Debrecen
country: Hungary
facility: University of Debrecen Medical and Health Science Center, Institute of Internal medicine Building B
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Korhaz; Hematologia
city: Kaposvar
country: Hungary
facility: Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology
city: Pecs
country: Hungary
facility: University of Pecs, I st Dept of Internal Medicine
city: Szeged
country: Hungary
facility: University of Szeged, II Dept of Internal Medicine
city: Reggio Calabria
country: Italy
facility: Ospedale Riuniti; Divisione Di Ematologia
state: Calabria
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica
state: Campania
city: Napoli
country: Italy
facility: Nuovo Policlinico, Ii Facolta; Divisione Di Ematologia
state: Campania
city: Pagani (Sa)
country: Italy
facility: Ospedale "A.Tortora" - Ematologia; Dipartimento Di Ematologia
state: Campania
city: Bologna
country: Italy
facility: A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
facility: AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia
state: Emilia-Romagna
city: Udine
country: Italy
facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol
state: Lazio
city: Genova
country: Italy
facility: A.O. Universitaria S. Martino Di Genova; Ematologia 1
state: Liguria
city: Brescia
country: Italy
facility: A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
state: Lombardia
city: Milano
country: Italy
facility: Hospital San Raffaele
state: Lombardia
city: Milano
country: Italy
facility: Ist. Nazionale Per Lo Studio E Cura Dei Tumori; Div. Ematologia Trapianto Midollo Osseo Allogenico
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia
state: Lombardia
city: Pavia
country: Italy
facility: Irccs Policlinico San Matteo; Divisione Di Ematologia
state: Lombardia
city: Alessandria
country: Italy
facility: Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia
state: Piemonte
city: Ivrea
country: Italy
facility: Ospedali Riuniti del Canavese
state: Piemonte
city: Novara
country: Italy
facility: Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad
state: Piemonte
city: Orbassano
country: Italy
facility: Az. Osp. S. Luigi Gonzaga; S.C.D.U. Medicina Interna Ii
state: Piemonte
city: Torino
country: Italy
facility: A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
state: Piemonte
city: Torino
country: Italy
facility: A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia
state: Piemonte
city: Bari
country: Italy
facility: Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
state: Puglia
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo
state: Puglia
city: Tricase - LE
country: Italy
facility: Az. Osp. C. Panico; Rep. Ematologia E Trapianto
state: Puglia
city: Catania
country: Italy
facility: Azienda Ospedaliero Univ
state: Sicilia
city: Messina
country: Italy
facility: Az. Osp. Papardo; Struttura Complessa Di Ematologia
state: Sicilia
city: Firenze
country: Italy
facility: Azienda Ospedaliera Univ
state: Toscana
city: Pisa
country: Italy
facility: Ospedale Santa Chiara; Unita Operativa Di Ematologia
state: Toscana
city: Terni
country: Italy
facility: Az. Osp. S. Maria; Dept. Di Oncologia Medica
state: Umbria
city: Treviso
country: Italy
facility: Ospedale Ca Foncello; Ematologia
state: Veneto
city: Verona
country: Italy
facility: Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia
state: Veneto
city: Vicenza
country: Italy
facility: Ospedale Di Vicenza; Nefrologia, Ematologia
state: Veneto
city: Aichi
country: Japan
facility: Nagoya Daini Red Cross Hospital; Hematology & Oncology
city: Chiba
country: Japan
facility: Chiba University Hospital; Hematology
city: Fukuoka
country: Japan
facility: Kyushu University Hospital; Hematology, Oncology & Cardiovascular medicine
city: Fukuoka
country: Japan
facility: Kurume University Hospital; Hematology and Oncology
city: Gifu
country: Japan
facility: Gifu University Hospital; First Department of Internal Medicine
city: Hokkaido
country: Japan
facility: Hokkaido University Hospital; Hematology
city: Hyogo
country: Japan
facility: Kobe City Medical Center General Hospital; Hematology
city: Iwate
country: Japan
facility: Iwate Medical University Hospital;Hematology and Oncology
city: Kanagawa
country: Japan
facility: Yokohama City University Hospital; Hematology, Rheumatology, Infectious Disease
city: Kyoto
country: Japan
facility: Kyoto University Hospital; Department of Hematology/Oncology
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital; Internal Medicine
city: Okayama
country: Japan
facility: Kurashiki Central Hospital; Hematology
city: Osaka
country: Japan
facility: Osaka City University Hospital; Hematology
city: Osaka
country: Japan
facility: Osaka University Hospital; Hematology and Oncology
city: Osaka
country: Japan
facility: Kindai University Hospital; Hematology and Rheumatology
city: Shimane
country: Japan
facility: Shimane University Hospital;Hematology
city: Tochigi
country: Japan
facility: Jichi Medical University Hospital; Hematology
city: Tokyo
country: Japan
facility: National Cancer Center Hospital; Hematology
city: Tokyo
country: Japan
facility: Toranomon Hospital; Hematology
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital; Hematology
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR; Hematology Oncology
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center - Oncology
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital; Medical Oncology
city: Seoul
country: Korea, Republic of
facility: St. Mary'S Hospital, the Catholic University School of Medicine; Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Chihuahua
country: Mexico
facility: Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose E. Gonzalez; Haematology
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization
city: Queretaro
country: Mexico
facility: Centro de Estudios Clinicos de Queretaro, SC
city: Panama
country: Panama
facility: Centro Hemato Oncologico Panama
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas
city: Lima
country: Peru
facility: Instituto;Oncologico Miraflores
city: Lima
country: Peru
facility: Clinica de Especialidades Medicas
city: Brzozów
country: Poland
facility: Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii
city: Lodz
country: Poland
facility: Medical University of Lodz; Hematology
city: Lublin
country: Poland
facility: Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie
city: Warszawa
country: Poland
facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego
city: Wroclaw
country: Poland
facility: Medical Uni of Wroclaw; Hematology
city: Kazan
country: Russian Federation
facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan
city: Moscow
country: Russian Federation
facility: Blokhin Cancer Research Center; Clinical Oncology
city: Nizhny Novgorod
country: Russian Federation
facility: Regional Clinical Hospital N.A. Semashko; Hematology
city: Penza
country: Russian Federation
facility: Penza Regional Oncology Dispensary
city: Petrozavodsk
country: Russian Federation
facility: Republican Clinical Hospital n.a. Baranov; Haematology
city: St Petersburg
country: Russian Federation
facility: Research Inst. of Hematology & Blood Transfusion ; Hematology
city: Belgrade
country: Serbia
facility: Institute of Hematology
city: Novi Sad
country: Serbia
facility: Clinical Center Vojvodine; Clinic for Hematology
city: Bratislava
country: Slovakia
facility: National Oncology Inst. ; Dept. of Haematology
city: Cape Town
country: South Africa
facility: Constantiaberg Medical Clinic; Dept. of Haematology & Bone Marrow Translant
city: Groenkloof
country: South Africa
facility: Mary Potter Oncology Centre
city: Johannesburg
country: South Africa
facility: Medical Oncology Centre of Rosebank; Oncology
city: Parktown, Johannesburg
country: South Africa
facility: Wits Donald Gordon Clinical Trial Centre; Medical Oncology
city: Pretoria
country: South Africa
facility: Drs Thomson, Brittain an Partners Inc
city: Pamplona
country: Spain
facility: Hospital de Navarra, Servicio de Hematología
state: Navarra
city: Reus
country: Spain
facility: Hospital Universitari Sant Joan de Reus; Servicio de Oncologia
state: Tarragona
city: Barcelona
country: Spain
facility: Hospital del Mar; Servicio de Hematologia
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología
city: Barcelona
country: Spain
facility: Hospital Duran i Reynals; Servicio de Hematologia
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal; Servicio de Hematologia
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra; Servicio de Oncologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia
city: Toledo
country: Spain
facility: Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau; Zentrum Für Onkologie, Hämatologie & Transfusionsmedizin
city: Bellinzona
country: Switzerland
facility: Ospedale San Giovanni; Oncologia
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden;Onkologie und Hämatologie
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
city: Taipei
country: Taiwan
facility: Veterans General Hospital; Division of Oncology
city: Taipei
country: Taiwan
facility: National Taiwan Universtiy Hospital; Division of Hematology
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine
city: Bangkok
country: Thailand
facility: National Cancer Inst.
city: Bangkok
country: Thailand
facility: Rajavithi Hospital; Medicine
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital; Division of Hematology, Department of Medicine
city: Bangkok
country: Thailand
facility: Siriraj Hospital; Division of Hematology, Department of Medicine
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary; Haematology - Ward 16
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital; Department of Haematology
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital; Haematology
city: Leicester
country: United Kingdom
facility: The HOPE Clinical Trials Unit
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital; Dept. Of Haematology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
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