Clinical trial NCT04680052: A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Follicular Lymphoma
Marginal Zone Lymphoma
Keywords: MOR00208
INCMOR00208
tafasitamab
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2020-12-22
Enrollment: 654
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 is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL
* Willingness to avoid pregnancy or fathering children
* In the opinion of the investigator, be able and willing to receive adequate mandatory prophylaxis and/or therapy for thromboembolic events (eg, aspirin 70-325 mg daily or low-molecular-weight heparin)
* Previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy
* Documented relapsed, refractory, or PD after treatment with systemic therapy
* ECOG performance status of 0 to 2

Exclusion Criteria:

* Women who are pregnant or breastfeeding.
* Any histology other than FL and MZL or clinical evidence of transformed lymphoma
* Prior non-hematologic malignancy
* Congestive heart failure
* HCV positivity, chronic HBV infection or history of HIV infection
* Active systemic infection
* CNS lymphoma involvement
* Any systemic anti-lymphoma and/or investigational therapy within 28 days prior to the start of Cycle 1
* Prior use of lenalidomide in combination with rituximab

Primary outcomes:
measure: FL Population: Progression-free Survival (PFS) by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented Disease Progression (PD), or Death From Any Cause, Whichever Occurred First
timeFrame: up to approximately 34 months
measure: FL Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
timeFrame: up to 2 years
Secondary outcomes:
measure: Overall Population: PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
timeFrame: up to approximately 34 months
measure: Overall Population: Kaplan-Meier Estimates of PFS by Investigator Assessment, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
timeFrame: up to 2 years
measure: FDG-avid FL Population: Positron Emission Tomography-Complete Response (PET-CR) Rate by Investigator Assessment, Using the Lugano 2014 Criteria
timeFrame: up to approximately 34 months
measure: FL Population: Overall Survival
timeFrame: up to approximately 34 months
measure: FL Population: Kaplan-Meier Estimates of Overall Survival
timeFrame: up to 2 years
measure: FDG-avid Overall Population: PET-CR Rate by Investigator Assessment, Using the Lugano 2014 Criteria
timeFrame: up to approximately 34 months
measure: FL Population: Minimal Residual Disease (MRD)-Negativity Rate (at Threshold of 10^-5) at End of Treatment
timeFrame: up to approximately 34 months
measure: Overall Population: MRD-negativity Rate (at Threshold of 10-5) at End of Treatment
timeFrame: up to approximately 34 months
measure: FL Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per the Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by Investigator Assessment
timeFrame: up to approximately 34 months
measure: Overall Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by Investigator Assessment
timeFrame: up to approximately 34 months
measure: FL Population: Duration of Response (DOR; the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
timeFrame: up to approximately 34 months
measure: FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
timeFrame: up to 2 years
measure: Overall Population: DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
timeFrame: up to approximately 34 months
measure: Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by Investigator Assessment
timeFrame: up to 2 years
measure: Overall Population: Overall Survival
timeFrame: up to approximately 34 months
measure: Overall Population: Kaplan-Meier Estimates of Overall Survival
timeFrame: up to 2 years
measure: FL Population: PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
timeFrame: up to approximately 34 months
measure: FL Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
timeFrame: up to 2 years
measure: Overall Population: PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
timeFrame: up to approximately 34 months
measure: Overall Population: Kaplan-Meier Estimates of PFS by IRC Review, Using the Lugano 2014 Criteria, Defined as the Time From Randomization to the First Documented PD, or Death From Any Cause, Whichever Occurred First
timeFrame: up to 2 years
measure: FL Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per the Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by IRC Review
timeFrame: up to approximately 34 months
measure: Overall Population: Overall Response Rate (Percentage of Participants Who Achieved a CR/PR Per Lugano Classification at Any Time During the Study But Before the First PD and Before/at the Start of a New Antilymphoma Treatment) by IRC Review
timeFrame: up to approximately 34 months
measure: FL Population: DOR the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
timeFrame: up to approximately 34 months
measure: FL Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
timeFrame: up to 2 years
measure: Overall Population: DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
timeFrame: up to approximately 34 months
measure: Overall Population: Kaplan-Meier Estimates of DOR (the Time From the First Tumor Response [CR or PR as Per the Lugano 2014 Classification] Until the Time of the First Documented PD or Death From Any Cause, Whichever Was Earlier) by IRC Review
timeFrame: up to 2 years
measure: FL Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
timeFrame: up to approximately 34 months
measure: Overall Population: EORTC QLQ-C30 Scores at Baseline and End of Treatment
timeFrame: up to approximately 34 months
measure: FL Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment
timeFrame: up to approximately 34 months
measure: Overall Population: Health State EQ-5D-5L Scores at Baseline and End of Treatment
timeFrame: up to approximately 34 months
measure: FL Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
timeFrame: up to approximately 34 months
measure: Overall Population: Number of Participants With the Indicated Scores for the Five EQ-5D-5L Domains/Questions at Baseline and End of Treatment
timeFrame: up to approximately 34 months
measure: FL Population: Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) Scores at Baseline and End of Treatment
timeFrame: up to approximately 34 months
measure: Overall Population: FACT-Lym Scores at Baseline and End of Treatment
timeFrame: up to approximately 34 months
Other outcomes:
Locations:
city: Concord
country: United States
facility: John Muir Health Clinical Research Center
state: California
city: Greenbrae
country: United States
facility: Marin Cancer Care
state: California
city: Pasadena
country: United States
facility: The Oncology Institute of Hope and Innovation
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Middletown
country: United States
facility: Middlesex Hospital Cancer Center
state: Connecticut
city: New Haven
country: United States
facility: Smilow Cancer Hospital
state: Connecticut
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Plantation
country: United States
facility: Brcr Medical Center, Inc
state: Florida
city: Weeki Wachee
country: United States
facility: Asclepes Research Centers
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers,P.C
state: Georgia
city: Honolulu
country: United States
facility: Straub Medical Center
state: Hawaii
city: Des Moines
country: United States
facility: Des Moines Oncology Research Association
state: Iowa
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland-Greenebaum Cancer Center
state: Maryland
city: Bethesda
country: United States
facility: Cancer Center For Blood Disorders
state: Maryland
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Hospital
state: Michigan
city: Saint Louis Park
country: United States
facility: Metro-Minnesota Community Oncology Reserch Consortium (Mmcorc)
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic Hematology
state: Mississippi
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Nyu Clinical Cancer Center
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Oklahoma City
country: United States
facility: Integris Cancer Institute
state: Oklahoma
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Upstate
state: South Carolina
city: Watertown
country: United States
facility: Prairie Lakes Health Care System, Inc.
state: South Dakota
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons
state: Texas
city: Fort Worth
country: United States
facility: The Center For Cancer and Blood Disorders
state: Texas
city: Houston
country: United States
facility: Lyndon B Johnson General Hospital
state: Texas
city: Houston
country: United States
facility: Md Anderson Cancer Center
state: Texas
city: Spring
country: United States
facility: Renovatio Clinical
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Olympia
country: United States
facility: Vista Oncology Inc Ps
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington-Seattle Cancer Care Alliance
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties Pllc
state: Washington
city: Kogarah
country: Australia
facility: St George Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Wollongong Hospital - Illawarra Regional Hospital
state: New South Wales
city: Southport
country: Australia
facility: Gold Coast Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Northern Hospital
state: Victoria
city: St. Albans
country: Australia
facility: Western Health
state: Victoria
city: West Perth
country: Australia
facility: Perth Blood Institute
state: Western Australia
city: Box Hill
country: Australia
facility: Eastern Health
city: Hobart
country: Australia
facility: Royal Hobart Hospital
city: Graz
country: Austria
facility: Landeskrankenhaus Universitatsklinikum Graz
city: Innsbruck
country: Austria
facility: Innsbruck University Hospital
city: Linz
country: Austria
facility: Kepler Universitat Klinikum
city: Wien
country: Austria
facility: *Krankenhaus*
city: Antwerpen
country: Belgium
facility: Zna Stuivenberg
city: Brugge
country: Belgium
facility: A.Z. St.-Jan-Dienst Hematologie
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Brussels
country: Belgium
facility: Cliniques Universitaires Ucl Saint-Luc
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen, Dienst Hematologie
city: Gent
country: Belgium
facility: Ghent University Hospital
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis (Uz) Leuven
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liege - Sart Tilman
city: Roeselare
country: Belgium
facility: AZ Delta
city: Yvoir
country: Belgium
facility: Chu Ucl Namur University Hospital Mont-Godinne
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth Ii Health Sciences Centre
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Montréal
country: Canada
facility: Hospital Maisonneuve Rosemont
state: Quebec
city: Montréal
country: Canada
facility: McGill University Jewish General Hospital
state: Quebec
city: Québec
country: Canada
facility: Chu de Quebec - Universite Laval (Chul)
state: Quebec
city: Brno
country: Czechia
facility: University
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
city: Prague
country: Czechia
facility: Vseobecna Fakultni Nemocnice
city: Praha
country: Czechia
facility: University Hospital Kralovkse Vinohrady
city: Praha
country: Czechia
facility: University Hospital Motol
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Roskilde
country: Denmark
facility: Sjaellands Universitetshospital Naestved
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Amiens
country: France
facility: Chu Amiens Picardie - Hopital Sud
city: Angers
country: France
facility: Chu Angers Hotel Dieu Nord
city: Bordeaux
country: France
facility: Groupe Bordeaux Nord Aquitaine Gbna Polycliniques - Polyclinique Bordeaux Nord Aquitaine Pbna
city: Dijon
country: France
facility: Centre Hospitalier Universitaire Chu Dijon Bourgogne - Hopital Francois Mitterrand
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles - Hopital Andre Mignot
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: Hospital Saint-Louis Service Oncologie Medicale
city: Paris
country: France
facility: A.P.H. Paris Hopital Cochin
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
city: Pontoise
country: France
facility: Centre Hospitalier de Pontoise
city: Pringy
country: France
facility: Centre Hospitalier Annecy-Genevois
city: Tours
country: France
facility: Chru Hopitaux de Tours Hospital Bretonneau
city: Amberg
country: Germany
facility: Klinikum St. Marien Amberg
city: Berlin
country: Germany
facility: Klinik Fur Innere Medizin Hamatologie and Onkologie
city: Essen
country: Germany
facility: Universitatsklinikum Essen
city: GIEßEN
country: Germany
facility: University Clinic Giessen Und Marburg Ukgm
city: Greifswald
country: Germany
facility: Universitaetsmedizin Greifswald
city: Landshut
country: Germany
facility: Statistics and Data Corporation (Sdc)
city: Mainz
country: Germany
facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
city: Mannheim
country: Germany
facility: Medizinische Fakultaet Mannheim Der Universitaet Heidelberg
city: Muenster
country: Germany
facility: Universitatsklinikum Munster
city: Oldenburg
country: Germany
facility: Onkologische Schwerpunktpraxis
city: ULM
country: Germany
facility: Universitarsfrauenklinik Ulm
city: Würzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
city: Athens
country: Greece
facility: 251 Air Force General Hospital
city: Athens
country: Greece
facility: General Hospital of Athens Laiko
city: Athens
country: Greece
facility: University Hospital of West Attica - Attikon
city: Patras
country: Greece
facility: University General Hospital of Patras
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: National Institute of Oncology
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika
city: Eger
country: Hungary
facility: Markhot Ferenc Korhaz
city: Győr
country: Hungary
facility: Petz Aladar County Teaching Hospital
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz
city: Szeged
country: Hungary
facility: University of Szeged
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Galway
country: Ireland
facility: University Hospital Galway
city: Afula
country: Israel
facility: Ha Emek Medical Center
city: Bear Sheva
country: Israel
facility: Soroka
city: Beer Yaaqov
country: Israel
facility: Shamir Medical Center Formerly Assaf Harofeh Medical Center
city: Holon
country: Israel
facility: Wolfson
city: Jerusalem
country: Israel
facility: Shaare Zedek Mc
city: Jerusalem
country: Israel
facility: "Laiko" General Hospital of Athens, Hematology of the First Propaedeutic Internal Medicine Clinic
city: Jerusalem
country: Israel
facility: Hadassah
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center - Beilinson Hospital
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
city: Bari
country: Italy
facility: Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
city: Brescia
country: Italy
facility: Divisione Clinicizzata Di Ematologia
city: Candiolo
country: Italy
facility: Fondazione Del Piemonte Per L Oncologia Ircc Candiolo
city: Catania
country: Italy
facility: Divisione Clinicizzata Di Ematologia
city: Lecce
country: Italy
facility: Presidio Ospedaliero Vito Fazzi
city: Milano
country: Italy
facility: Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
city: Naples
country: Italy
facility: Istituto Nazionale Tumori Irccs Fondazione Pascale
city: Napoli
country: Italy
facility: Universita Di Napoli Federico Ii
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara
city: Orbassano
country: Italy
facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
city: Pavia
country: Italy
facility: Fondazione Irccs Policlinico San Matteo
city: Piacenza
country: Italy
facility: Ausl Di Placenza Ospedale Guglielmo Da Saliceto
city: Pisa
country: Italy
facility: Uo Ematologia Univ - Aoup Santa Chiara Pisa
city: Ravenna
country: Italy
facility: Ospedale Santa Maria Delle Croci
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
city: Rimini
country: Italy
facility: Ausl Della Romagna
city: Roma
country: Italy
facility: Universita Degli Studi Di Roma La Sapienza - Umberto I Policlinico Di Roma - Centro Di Ematologia
city: Rome
country: Italy
facility: Ospedale Sant. Eugenio
city: San Martino
country: Italy
facility: Irccs Azienda Ospedaliera Universitaria San Martino
city: Torino
country: Italy
facility: Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza
city: Trieste
country: Italy
facility: Asugi Ospedale Maggiore
city: Fukuoka-shi
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Fukuyama-shi
country: Japan
facility: Chugoku Center Hospital
city: Gifu-shi
country: Japan
facility: Gifu Municipal Hospital
city: Kagoshima-shi
country: Japan
facility: Kagoshima University Hospital
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
city: Kitakyushu-shi
country: Japan
facility: Hospital of the University of Occupation and Environmental Health
city: Kobe-shi
country: Japan
facility: Kobe City Medical Center General Hospital
city: Nagoya-shi
country: Japan
facility: Japanese Red Cross Nagoya Daini Hospital
city: Narita City
country: Japan
facility: Iuhw Narita Hospital
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital
city: Saitama
country: Japan
facility: Saitama Medical University Hospital
city: Suita-shi
country: Japan
facility: Osaka University Hospital
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Tsu-shi
country: Japan
facility: Mie University Hospital
city: Yamagata-shi
country: Japan
facility: Yamagata University Hospital
city: Busan-si
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Busan-si
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University
city: Incheon
country: Korea, Republic of
facility: Gacheon University Gil Medical Center
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Yeoido St.Mary'S Hospital
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Centre
city: Arnhem
country: Netherlands
facility: Hospital Rijnstate
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Leidschendam
country: Netherlands
facility: HMC
city: Brumunddal
country: Norway
facility: Innlandet Hospital Trust
city: Trondheim
country: Norway
facility: Universitetssykehuset I Trondheim - St. Olavs Hospital
city: Brzozow
country: Poland
facility: Szpital Spec Brzozowiepoland
city: Katowice
country: Poland
facility: Pratia Poznan
city: Krakow
country: Poland
facility: Pratia McM Krakow
city: Krakow
country: Poland
facility: Sp Zoz Szpital Uniwersytecki
city: Lodz
country: Poland
facility: Uniwersytet Medyczny W Lodzi - Klinika Hematologii
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1
city: Tomaszow Mazowiecki
country: Poland
facility: Specjalistyczny Szpital Onkologiczny
city: Warszawa
country: Poland
facility: Maria Sklodowska-Curie National Research Institute of Oncology
city: Warszawa
country: Poland
facility: Institute of Hematology and Transfusion Medicine
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego
city: Rostov-on-don
country: Russian Federation
facility: Rostov State Medical University
city: St.petersburg
country: Russian Federation
facility: Pavlov First Saint Petersburg State Medical University
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruna
city: Alicante
country: Spain
facility: Hospital General Unviersitario de Alicante
city: Badalona
country: Spain
facility: Ico Hospital Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Barcelona
country: Spain
facility: Hospital General Universitario Vall D Hebron
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Gijon
country: Spain
facility: Hospital Universitario de Cabuenes
city: Hospitalet de Llobregat
country: Spain
facility: Institut Catala Doncologia Ico - Hospital Duran I Reynals Location
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Ramon Y Cajal
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz University Hospital
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Quironsalud Madrid
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de La Victoria
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de La Arrixaca
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
city: Sabadell
country: Spain
facility: Consorci Hospitalari Parc Tauli de Sabadell
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio Sevilla
city: Terrassa
country: Spain
facility: Hospital Universitari Mutua Terrassa
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
city: Valencia
country: Spain
facility: Hospital Universitari I Politecnic La Fe
city: Vitoria-gasteiz
country: Spain
facility: Hospital Universitario de Alava
city: Solna
country: Sweden
facility: Karolinska University Hospital Solna
city: Uddevalla
country: Sweden
facility: Goetalandsregionen - Uddevalla Sjukhus Us
city: Uppsala
country: Sweden
facility: Uppsala Universitet - Akademiska Sjukhuset
city: Basel
country: Switzerland
facility: University Hospital of Basel Department of Oncology
city: Bellinzona
country: Switzerland
facility: Oncological Institute of Southern Switzerland
city: Bern
country: Switzerland
facility: Inselspital - Universitaetsspital Bern
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Zurich
country: Switzerland
facility: Universitatsspital Zurich
city: Kaohsiung City
country: Taiwan
facility: E-Da Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University (Ncku) Hospital
city: Taipei City
country: Taiwan
facility: Hematology and Medical Oncology Too Foundation Sun Yat Sen Cancer Center
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Tri Service General Hospital
city: Taipei
country: Taiwan
facility: Institutional Review Board Taipei Veterans General Hospital
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Hastanesi
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Istanbul
country: Turkey
facility: Acibadem Maslak Hospital
city: Kharkiv
country: Ukraine
facility: Communal Non-Profit Enterprise Regional Center of Oncology
city: Kyiv
country: Ukraine
facility: National Cancer Institute of Ministry of Health
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham Nhs Foundation Trust
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: The Royal Marsden Nhs Foundation Trust - Chelsea
city: Manchester
country: United Kingdom
facility: The Christie Nhs Foundation Trust Uk
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
city: Sutton
country: United Kingdom
facility: The Royal Marsden Nhs Foundation Trust - Sutton
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton Nhs Trust
Study officials:
References: