Trial Title:
Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML
NCT ID:
NCT06578247
Condition:
Leukemia
Conditions: Official terms:
Leukemia
Cytarabine
Daunorubicin
Idarubicin
Quizartinib
Conditions: Keywords:
acute myeloid leukemia
quizartinib
FLT3
FLT3-ITD
Chemotherapy
FLT3-WT
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking description:
This study has a double-blind design. Neither the participants nor any of the
investigators, Sponsor, Independent Review Committee (IRC) or contract research
organizations (CROs) will be aware of the treatments received. An independent
biostatistician, not otherwise part of the Sponsor trial team, will generate the
randomization schedule.
Intervention:
Intervention type:
Drug
Intervention name:
Quizartinib
Description:
Participants will receive quizartinib at 60 mg/day orally once daily
Arm group label:
Arm A: Quizartinib + Chemotherapy
Arm group label:
Arm C: Quizartinib + Chemotherapy then Placebo Maintenance
Other name:
Test Product
Intervention type:
Drug
Intervention name:
Placebo
Description:
Participants will receive placebo at 60 mg/day orally once daily
Arm group label:
Arm B: Placebo + Chemotherapy
Arm group label:
Arm C: Quizartinib + Chemotherapy then Placebo Maintenance
Other name:
Placebo Control
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
Participants will receive commercially available cytarabine (cytosine arabinoside) and
anthracycline (daunorubicin or idarubicin).
Arm group label:
Arm A: Quizartinib + Chemotherapy
Arm group label:
Arm B: Placebo + Chemotherapy
Arm group label:
Arm C: Quizartinib + Chemotherapy then Placebo Maintenance
Other name:
Cytarabine, Daunorubicin or Idarubicin
Other name:
Standard Chemotherapy
Summary:
This study will compare the effects of Quizartinib versus placebo in combination with
chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3
(FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).
Detailed description:
This is a clinical trial to compare the effect of quizartinib versus placebo
(administered with standard induction and consolidation chemotherapy, then administered
as maintenance therapy for up to 36 cycles) on the primary endpoint of overall survival
(OS) in adult patients with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal
tandem duplication (ITD) negative acute myeloid leukemia (AML). Participants will be
tested for FLT3-ITD mutation status in a central laboratory using a validated assay.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Must be competent and able to comprehend, sign, and date an Ethics Committee (EC)-
or Institutional Review Board (IRB)-approved Informed Consent Form (ICF) before
performance of any trial-specific procedures or tests.
- ≥18 years or the minimum legal adult age (whichever is greater) and 70 years (at
Screening).
- Newly diagnosed, morphologically documented primary AML based on the World Health
Organization (WHO) 2016 classification (at Screening)
- Eastern Cooperative Oncology Group (ECOG) performance status (at the time the
participant signs their ICF) of 0-2.
- Participant is receiving standard "7+3" induction chemotherapy regimen as specified
in the protocol
Key Exclusion Criteria:
- Diagnosis of acute promyelocytic leukemia (APL), French-American-British
classification M3 or WHO classification of APL with translocation,
t(15;17)(q22;q12), or BCR-ABL positive leukemia (ie, chronic myelogenous leukemia in
blast crisis); participants who undergo diagnostic workup for APL and treatment with
all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible
(treatment with ATRA must be discontinued before starting induction chemotherapy).
- Diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms
or autoimmune/rheumatologic conditions.
- Diagnosis of AML secondary to myelodysplastic syndrome (MDS) or a myeloproliferative
neoplasm (MPN) or MDS/MPNs including CMML, aCML, JMML and others.
- Participants with newly diagnosed AML with FLT3-ITD mutations (FLT3-ITD [+]) present
at ≥5% VAF (or ≥0.05 SR) based on a validated FLT3 mutation assay.
- Prior treatment for AML, except for the following allowances:
1. Leukapheresis;
2. Treatment for hyperleukocytosis with hydroxyurea;
3. Cranial radiotherapy for central nervous system (CNS) leukostasis;
4. Prophylactic intrathecal chemotherapy;
5. Growth factor/cytokine support.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope Phoenix
Address:
City:
Goodyear
Zip:
85338
Country:
United States
Facility:
Name:
Mayo Clinic - Phoenix
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Facility:
Name:
University of Arizona Cancer Center
Address:
City:
Tucson
Zip:
85724
Country:
United States
Facility:
Name:
Ucsf - School of Medicine
Address:
City:
San Francisco
Zip:
94115
Country:
United States
Facility:
Name:
Stanford University School of Medicine- Parent
Address:
City:
Stanford
Zip:
94305
Country:
United States
Facility:
Name:
Colorado Blood Cancer Institute
Address:
City:
Denver
Zip:
80218
Country:
United States
Facility:
Name:
Yale University
Address:
City:
New Haven
Zip:
06510
Country:
United States
Facility:
Name:
Mayo Clinic Hospital
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Facility:
Name:
Florida Hospital Cancer Institute - Kissimmee
Address:
City:
Kissimmee
Zip:
34741
Country:
United States
Facility:
Name:
Moffit Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Facility:
Name:
Usf College of Medicine
Address:
City:
Tampa
Zip:
33612
Country:
United States
Facility:
Name:
Augusta University
Address:
City:
Augusta
Zip:
30912
Country:
United States
Facility:
Name:
University of Illinois Hospital & Health Sciences System
Address:
City:
Chicago
Zip:
60612
Country:
United States
Facility:
Name:
The University of Chicago Medical Center
Address:
City:
Chicago
Zip:
60637
Country:
United States
Facility:
Name:
University of Kentucky
Address:
City:
Lexington
Zip:
40504
Country:
United States
Facility:
Name:
Ochsner Medical Center - New Orleans
Address:
City:
New Orleans
Zip:
70121
Country:
United States
Facility:
Name:
Johns Hopkins Hospital
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Facility:
Name:
University of Michigan Comprehensive Cancer Center Michigan Medicine
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Facility:
Name:
Henry Ford Hospital
Address:
City:
Detroit
Zip:
48202
Country:
United States
Facility:
Name:
University of Minnesota Medical School - Twin Cities Campus
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55905
Country:
United States
Facility:
Name:
Washington University
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Facility:
Name:
Thomas Jefferson Univ Hosp
Address:
City:
Haddonfield
Zip:
08033
Country:
United States
Facility:
Name:
Roswell Park Comprehensive Cancer Center
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Cancer Center - Main
Address:
City:
New York
Zip:
10065
Country:
United States
Facility:
Name:
Upstate University Hospital
Address:
City:
Syracuse
Zip:
13210
Country:
United States
Facility:
Name:
University of North Carolina Hospitals
Address:
City:
Chapel Hill
Zip:
27514
Country:
United States
Facility:
Name:
University of Cincinnati
Address:
City:
Cincinnati
Zip:
45219
Country:
United States
Facility:
Name:
Cleveland Clinic Taussig Cancer Center
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Facility:
Name:
The James Cancer Hospital and Solove Research Institute
Address:
City:
Columbus
Zip:
43210
Country:
United States
Facility:
Name:
Oregon Health & Science University (Ohsu)
Address:
City:
Portland
Zip:
97239
Country:
United States
Facility:
Name:
University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Facility:
Name:
Upmc Hillman Cancer Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Facility:
Name:
Rhode Island Hospital
Address:
City:
Providence
Zip:
02903
Country:
United States
Facility:
Name:
Tristar Bone Marrow Transplant
Address:
City:
Nashville
Zip:
37203
Country:
United States
Facility:
Name:
South Austin Medical Center
Address:
City:
Austin
Zip:
78745
Country:
United States
Facility:
Name:
Houston Methodist Hospital
Address:
City:
Houston
Zip:
77030
Country:
United States
Facility:
Name:
The University of Texas Md Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Facility:
Name:
Uva Health System
Address:
City:
Charlottesville
Zip:
22908
Country:
United States
Facility:
Name:
Virginia Commonwealth University (Vcu) Massey Cancer Center
Address:
City:
Richmond
Zip:
23229
Country:
United States
Facility:
Name:
Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Facility:
Name:
Royal Adelaide Hospital
Address:
City:
Adelaide
Zip:
5000
Country:
Australia
Facility:
Name:
Flinders Medical Centre (Fmc)
Address:
City:
Bedford Park
Zip:
5042
Country:
Australia
Facility:
Name:
Box Hill Hospital
Address:
City:
Box Hill
Zip:
3128
Country:
Australia
Facility:
Name:
Concord Repatriation General Hospital
Address:
City:
Concord
Zip:
2139
Country:
Australia
Facility:
Name:
St Vincent'S Hospital Melbourne
Address:
City:
Darlinghurst
Zip:
2010
Country:
Australia
Facility:
Name:
Townsville University Hospital
Address:
City:
Douglas
Zip:
4814
Country:
Australia
Facility:
Name:
Liverpool Hospital
Address:
City:
Liverpool
Zip:
2170
Country:
Australia
Facility:
Name:
The Alfred Hospital
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Facility:
Name:
Fiona Stanley Hospital
Address:
City:
Murdoch
Zip:
6150
Country:
Australia
Facility:
Name:
Sir Charles Gairdner Hospital
Address:
City:
Perth
Zip:
6009
Country:
Australia
Facility:
Name:
Princess Alexandra Hospital
Address:
City:
Woolloongabba
Zip:
4102
Country:
Australia
Facility:
Name:
Ordensklinikum Linz Gmbh - Elisabethinen
Address:
City:
Linz
Zip:
4020
Country:
Austria
Facility:
Name:
Lkh - Universită"Tsklinikum Der Pmu Salzburg
Address:
City:
Salzburg
Zip:
5020
Country:
Austria
Facility:
Name:
Hanusch Krankenhaus Der Wgkk Wien
Address:
City:
Wien
Zip:
1140
Country:
Austria
Facility:
Name:
Institut Jules Bordet
Address:
City:
Anderlecht
Zip:
1070
Country:
Belgium
Facility:
Name:
ZNA
Address:
City:
Antwerpen
Zip:
2060
Country:
Belgium
Facility:
Name:
Az Sint-Jan
Address:
City:
Brugge
Zip:
8000
Country:
Belgium
Facility:
Name:
Uz Leuven
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Facility:
Name:
Chu de Liă Ge
Address:
City:
Liege
Zip:
4000
Country:
Belgium
Facility:
Name:
AZ DELTA
Address:
City:
Roeselare
Zip:
8800
Country:
Belgium
Facility:
Name:
Unesp - Faculdade de Medicina Da Universidade Estadual Paulista - Campus Botucatu
Address:
City:
Botucatu
Zip:
18618-686
Country:
Brazil
Facility:
Name:
Centro de Hematologia E Hemoterapia - Hemocentro de Campinas - Unicamp
Address:
City:
Campinas
Zip:
13083-878
Country:
Brazil
Facility:
Name:
Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Că'Ncer
Address:
City:
Curitiba
Zip:
81520-060
Country:
Brazil
Facility:
Name:
Cepon - Centro de Pesquisas Oncolă"Gicas de Santa Catarina
Address:
City:
FlorianĂłpolis
Zip:
88034-000
Country:
Brazil
Facility:
Name:
Huwc - Ufc - Hospital Universită Rio Walter Cantă Dio - Universidade Federal Do Ceară
Address:
City:
Fortaleza
Zip:
60430-370
Country:
Brazil
Facility:
Name:
Hc-Ufg - Hospital Das Clă Nicas Da Universidade Federal de Goiă S
Address:
City:
Goiania
Zip:
74680160
Country:
Brazil
Facility:
Name:
Fundaã§Ã£O Doutor Amaral Carvalho
Address:
City:
Jaú
Zip:
17210-120
Country:
Brazil
Facility:
Name:
Hospital de Clă Nicas de Passo Fundo
Address:
City:
Passo Fundo
Zip:
99010-260
Country:
Brazil
Facility:
Name:
Santa Casa de Miserică"Rdia de Porto Alegre
Address:
City:
Porto Alegre
Zip:
90035-074
Country:
Brazil
Facility:
Name:
Hospital de Clă Nicas de Porto Alegre
Address:
City:
Porto Alegre
Zip:
90035-903
Country:
Brazil
Facility:
Name:
Hospital Ernesto Dornelles
Address:
City:
Porto Alegre
Zip:
90160-093
Country:
Brazil
Facility:
Name:
Inca - Instituto Nacional de Că'Ncer
Address:
City:
Rio de Janeiro
Zip:
20230-130
Country:
Brazil
Facility:
Name:
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
Address:
City:
Sao Jose Rio Preto
Zip:
15090-000
Country:
Brazil
Facility:
Name:
Icesp - Instituto Do Câncer Do Estado de São Paulo Octavio Frias de Oliveira
Address:
City:
SĂŁo Paulo
Zip:
01246-000
Country:
Brazil
Facility:
Name:
Hospital Benefică Ncia Portuguesa de Să O Paulo
Address:
City:
SĂŁo Paulo
Zip:
01323-001
Country:
Brazil
Facility:
Name:
Hospital Nove de Julho
Address:
City:
SĂŁo Paulo
Zip:
01409902
Country:
Brazil
Facility:
Name:
Umhat 'Dr. Georgi Stranski', Ead
Address:
City:
Pleven
Zip:
5800
Country:
Bulgaria
Facility:
Name:
Umhat 'Sv. Georgi', Ead
Address:
City:
Plovdiv
Zip:
4002
Country:
Bulgaria
Facility:
Name:
Umhat  Sv. Ivan Rilskiâ , Ead
Address:
City:
Sofia
Zip:
1431
Country:
Bulgaria
Facility:
Name:
Military Medical Academy - Mhat - Sofia
Address:
City:
Sofia
Zip:
1606
Country:
Bulgaria
Facility:
Name:
'Shathd' Ead Sofia
Address:
City:
Sofia
Zip:
1797
Country:
Bulgaria
Facility:
Name:
Umhat Prof. Dr. Stoyan Kirkovich Ad
Address:
City:
Stara Zagora
Zip:
6000
Country:
Bulgaria
Facility:
Name:
London Health Sciences Centre
Address:
City:
London
Zip:
N6A 5W9
Country:
Canada
Facility:
Name:
The Ottawa Hospital - General Campus
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Facility:
Name:
Saskatoon Cancer Centre
Address:
City:
Saskatoon
Zip:
S7N 4H4
Country:
Canada
Facility:
Name:
Princess Margaret Cancer Center
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Facility:
Name:
Peking University First Hospital
Address:
City:
Beijing
Zip:
100034
Country:
China
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Zip:
100191
Country:
China
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Facility:
Name:
The First Hospital of Jilin University
Address:
City:
Changchun
Zip:
130021
Country:
China
Facility:
Name:
Xiangya Hospital, Central South University
Address:
City:
Changsha
Zip:
410008
Country:
China
Facility:
Name:
The Second Xiangya Hospital of Central South University
Address:
City:
Changsha
Zip:
410011
Country:
China
Facility:
Name:
The First Affiliated Hospital of Chongqing Medical University
Address:
City:
Chongqing
Zip:
400016
Country:
China
Facility:
Name:
Sun Yat-Sen University, Cancer Center
Address:
City:
Guangzhou
Zip:
510060/510700
Country:
China
Facility:
Name:
Guangdong Provincial People'S Hospital
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Facility:
Name:
Qilu Hospital of Shandong University
Address:
City:
Jinan
Zip:
250012
Country:
China
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330006
Country:
China
Facility:
Name:
Zhong Da Hospital, Southeast University
Address:
City:
Nanjing
Zip:
210009
Country:
China
Facility:
Name:
Affiliated Hospital of Nantong University
Address:
City:
Nantong
Zip:
226001
Country:
China
Facility:
Name:
The Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Zip:
266071
Country:
China
Facility:
Name:
Shanghai Tongren Hospital
Address:
City:
Shanghai
Zip:
200050
Country:
China
Facility:
Name:
Shengjing Hospital of China Medical University
Address:
City:
Shengyang
Zip:
110004
Country:
China
Facility:
Name:
Shenzhen Second People'S Hospital
Address:
City:
Shenzhen
Zip:
518029
Country:
China
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Facility:
Name:
Institute of Hematology and Hospital of Blood Disease
Address:
City:
Tianjin
Zip:
300020
Country:
China
Facility:
Name:
Tianjin Medical University General Hospital
Address:
City:
Tianjin
Zip:
300052
Country:
China
Facility:
Name:
The First Affiliated Hospital of Wenzhou Medical University
Address:
City:
Wenzhou
Zip:
325015
Country:
China
Facility:
Name:
Wuxi People'S Hospital
Address:
City:
Wuxi
Zip:
214023
Country:
China
Facility:
Name:
The First Affiliated Hospital of Xiâ An Jiaotong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Facility:
Name:
Yantai Yuhuangding Hospital
Address:
City:
Yantai
Zip:
264000
Country:
China
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450008
Country:
China
Facility:
Name:
Clinical Hospital Centre Rijeka
Address:
City:
Rijeka
Zip:
51000
Country:
Croatia
Facility:
Name:
Clinical Hospital Centar Zagreb
Address:
City:
Zagreb
Zip:
10000
Country:
Croatia
Facility:
Name:
Clinical Hospital Dubrava
Address:
City:
Zagreb
Zip:
10000
Country:
Croatia
Facility:
Name:
Fakultni Nemocnice Brno
Address:
City:
Brno
Zip:
625 00
Country:
Czechia
Facility:
Name:
Fakultni Nemocnice Hradec Kralove
Address:
City:
Hradec Kralove
Zip:
50005
Country:
Czechia
Facility:
Name:
Fakultni Nemocnice Ostrava
Address:
City:
Ostrava - Poruba
Zip:
708 52
Country:
Czechia
Facility:
Name:
Fakultni Nemocnice Plzen
Address:
City:
Plzen
Zip:
304 60
Country:
Czechia
Facility:
Name:
Fakultni Nemocnice Kralovske Vinohrady
Address:
City:
Praha 10
Zip:
100 34
Country:
Czechia
Facility:
Name:
Ustav Hematologie A Krevni Transfuze
Address:
City:
Praha 2
Zip:
12800
Country:
Czechia
Facility:
Name:
Chu Angers - Hă"Pital Hă"Tel Dieu
Address:
City:
Angers
Zip:
49033
Country:
France
Facility:
Name:
Chu de Caen
Address:
City:
Caen
Zip:
14033
Country:
France
Facility:
Name:
Chu de Grenoble - Hă"Pital Albert Michallon
Address:
City:
Grenoble
Zip:
38043
Country:
France
Facility:
Name:
Centre Hospitalier de Versailles
Address:
City:
Le Chesnay Cedex
Zip:
78150
Country:
France
Facility:
Name:
Hopital Claude Huriez - Chru Lille
Address:
City:
Lille cedex
Zip:
59037
Country:
France
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Zip:
69008
Country:
France
Facility:
Name:
Hopital de La Conception - Aphm
Address:
City:
Marseille Cedex 05
Zip:
13005
Country:
France
Facility:
Name:
Chu de Nantes - Hotel Dieu
Address:
City:
Nantes cedex 1
Zip:
44093
Country:
France
Facility:
Name:
Chu Nice - Hă"Pital de L'Archet 1
Address:
City:
Nice
Zip:
06200
Country:
France
Facility:
Name:
Hă"Pital Saint-Louis
Address:
City:
Paris cedex 10
Zip:
75475
Country:
France
Facility:
Name:
Chu de Bordeaux - Hă"Pital Haut-Lă Vă Que
Address:
City:
Pessac cedex
Zip:
33604
Country:
France
Facility:
Name:
Centre Hospitalier Lyon Sud
Address:
City:
Pierre BĂŠnite
Zip:
69495
Country:
France
Facility:
Name:
Chu Rennes - Hopital Pontchaillou
Address:
City:
Rennes cedex 09
Zip:
35000
Country:
France
Facility:
Name:
Chu Amiens - Hopital Sud
Address:
City:
Salouel
Zip:
80480
Country:
France
Facility:
Name:
Institut de Cancă Rologie de Strasbourg Europe - Icans
Address:
City:
Strasbourg
Zip:
67200
Country:
France
Facility:
Name:
Institut Universitaire Du Cancer de Toulouse- Iuct-O
Address:
City:
Toulouse
Zip:
31059
Country:
France
Facility:
Name:
Klinikum Aschaffenburg-Alzenau
Address:
City:
Alzenau
Zip:
63755
Country:
Germany
Facility:
Name:
Staedtisches Klinikum Braunschweig Ggmbh
Address:
City:
Braunschweig
Zip:
38114
Country:
Germany
Facility:
Name:
Universitaetsklinikum Carl Gustav Carus Tu Dresden
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Facility:
Name:
Universitaetsklinikum Essen
Address:
City:
Essen
Zip:
45147
Country:
Germany
Facility:
Name:
Krh Klinikum Siloah
Address:
City:
Hannover
Zip:
30459
Country:
Germany
Facility:
Name:
Universitaetsklinikum Heidelberg
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Facility:
Name:
Universitaetsklinikum Schleswig-Holstein
Address:
City:
Kiel
Zip:
24105
Country:
Germany
Facility:
Name:
Universită"Tsklinikum Leipzig Klinik Fă R Hă"Matologie Internistische Onkologie Hă"Mostaseol
Address:
City:
Leipzig
Zip:
4103
Country:
Germany
Facility:
Name:
Universitaetsklinikum Muenster
Address:
City:
Münster
Zip:
48149
Country:
Germany
Facility:
Name:
The University of Hong Kong
Address:
City:
Hong kong
Country:
Hong Kong
Facility:
Name:
The Chinese University of Hong Kong (Cuhk)
Address:
City:
Shatin
Zip:
00000
Country:
Hong Kong
Facility:
Name:
Semmelweis Egyetem
Address:
City:
Budapest
Zip:
1088
Country:
Hungary
Facility:
Name:
Debreceni Egyetem
Address:
City:
Debrecen
Zip:
4032
Country:
Hungary
Facility:
Name:
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Address:
City:
Gyor
Zip:
9024
Country:
Hungary
Facility:
Name:
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Address:
City:
Szeged
Zip:
6725
Country:
Hungary
Facility:
Name:
Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari
Address:
City:
Bari
Zip:
70124
Country:
Italy
Facility:
Name:
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Spedali Civili)
Address:
City:
Brescia
Zip:
25100
Country:
Italy
Facility:
Name:
Irccs Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori 'Dino Amadori' - Irst
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Facility:
Name:
Ospedale San Raffaele
Address:
City:
Milano
Zip:
20132
Country:
Italy
Facility:
Name:
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Address:
City:
Milano
Zip:
20162
Country:
Italy
Facility:
Name:
Ospedale Maggiore Di Novara
Address:
City:
Novara
Zip:
28100
Country:
Italy
Facility:
Name:
Azienda Ospedaliera Vincenzo Cervello
Address:
City:
Palermo
Zip:
90146
Country:
Italy
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Address:
City:
Roma
Zip:
168
Country:
Italy
Facility:
Name:
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Address:
City:
Rome
Zip:
133
Country:
Italy
Facility:
Name:
Istituto Clinico Humanitas
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Facility:
Name:
Irccs Ospedale Casa Sollievo Della Sofferenza
Address:
City:
San Giovanni Rotondo
Zip:
71013
Country:
Italy
Facility:
Name:
Azienda Ospedaliero-Universitaria Cittă Della Salute E Della Scienza Di Torino
Address:
City:
Torino
Zip:
10126
Country:
Italy
Facility:
Name:
Ospedale Mauriziano Umberto I
Address:
City:
Torino
Zip:
10128
Country:
Italy
Facility:
Name:
Asst Dei Sette Laghi Ospedale Di Circolo E Fondazione Macchi Varese
Address:
City:
Varese
Zip:
21100
Country:
Italy
Facility:
Name:
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Address:
City:
Bunkyo-ku
Zip:
113-8677
Country:
Japan
Facility:
Name:
Chiba Aoba Municipal Hospital
Address:
City:
Chiba-shi
Zip:
260-0852
Country:
Japan
Facility:
Name:
Kyushu University Hospital
Address:
City:
Fukuoka
Zip:
812-8582
Country:
Japan
Facility:
Name:
Chugoku Central Hospital
Address:
City:
Fukuyama
Country:
Japan
Facility:
Name:
Gifu Municipal Hospital
Address:
City:
Gifu
Country:
Japan
Facility:
Name:
Hamamatsu University School of Medicine, University Hospital
Address:
City:
Hamamatsu
Zip:
431-3192
Country:
Japan
Facility:
Name:
Tesshokai Kameda General Hospital
Address:
City:
Kamogawa-shi
Zip:
296-8602
Country:
Japan
Facility:
Name:
National Hospital Organization Kumamoto Medical Center
Address:
City:
Kumamoto
Country:
Japan
Facility:
Name:
Saiseikai Maebashi Hospital
Address:
City:
Maebashi
Country:
Japan
Facility:
Name:
Ehime Prefectural Central Hospital
Address:
City:
Matsuyama
Country:
Japan
Facility:
Name:
Osaka Red Cross Hospital
Address:
City:
Osaka-shi
Zip:
543-8555
Country:
Japan
Facility:
Name:
Hokkaido University Hospital
Address:
City:
Sapporo
Zip:
060-8648
Country:
Japan
Facility:
Name:
Sapporo Hokuyu Hospital
Address:
City:
Sapporo
Country:
Japan
Facility:
Name:
Tenri Hospital
Address:
City:
Tenri
Zip:
632-8552
Country:
Japan
Facility:
Name:
Inje University Haeundae Paik Hospital
Address:
City:
Busan
Zip:
48108
Country:
Korea, Republic of
Facility:
Name:
Pusan National University Hospital
Address:
City:
Busan
Country:
Korea, Republic of
Facility:
Name:
Kyungpook National University Chilgok Hospital
Address:
City:
Daegu
Zip:
41404
Country:
Korea, Republic of
Facility:
Name:
Yeungnam University Hospital
Address:
City:
Daegu
Zip:
42415
Country:
Korea, Republic of
Facility:
Name:
Daegu Catholic University Medical Center
Address:
City:
Daegu
Zip:
42472
Country:
Korea, Republic of
Facility:
Name:
Chonnam National University Hwasun Hospital
Address:
City:
Hwasun-gun
Zip:
58128
Country:
Korea, Republic of
Facility:
Name:
Gachon University Gil Medical Center
Address:
City:
Incheon
Zip:
21565
Country:
Korea, Republic of
Facility:
Name:
Jeonbuk National University Hospital
Address:
City:
Jeonju-si
Zip:
54907
Country:
Korea, Republic of
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam-si
Zip:
13620
Country:
Korea, Republic of
Facility:
Name:
Severance Hospital, Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Facility:
Name:
The Catholic University of Korea, Seoul St. Mary'S Hospital
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Facility:
Name:
Korea University Guro Hospital
Address:
City:
Seoul
Zip:
08308
Country:
Korea, Republic of
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
110-744
Country:
Korea, Republic of
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
5505
Country:
Korea, Republic of
Facility:
Name:
Ajou University Hospital
Address:
City:
Suwon
Zip:
16499
Country:
Korea, Republic of
Facility:
Name:
Ulsan University Hospital
Address:
City:
Ulsan
Zip:
44033
Country:
Korea, Republic of
Facility:
Name:
Haukeland Universitetssykehus
Address:
City:
Bergen
Zip:
N-5021
Country:
Norway
Facility:
Name:
Oslo University Hospital
Address:
City:
Oslo
Zip:
0424
Country:
Norway
Facility:
Name:
University Hospital of North Norway
Address:
City:
Tromsø
Zip:
9019
Country:
Norway
Facility:
Name:
Klinika Hematoonkologii I Transplantacji Szpiku
Address:
City:
Lublin
Zip:
20-081
Country:
Poland
Facility:
Name:
Spzoz Msw Zwarmiĺ Sko-Mazurskimcen.Onko.Wolsztynie
Address:
City:
Olsztyn
Zip:
10-228
Country:
Poland
Facility:
Name:
Wojewodzki Szpital Zespolony Im. L. Rydygiera W Toruniu
Address:
City:
Torun
Zip:
87-100
Country:
Poland
Facility:
Name:
Instytut Hematologii I Transfuzjologii
Address:
City:
Warszawa
Zip:
02-776
Country:
Poland
Facility:
Name:
Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
Address:
City:
Lisboa
Zip:
1649-035
Country:
Portugal
Facility:
Name:
Instituto Português de Oncologia Do Porto Francisco Gentil, Epe
Address:
City:
Porto
Zip:
4200-072
Country:
Portugal
Facility:
Name:
Spitalul Clinic Colentina
Address:
City:
Bucuresti
Zip:
020125
Country:
Romania
Facility:
Name:
Institutul Clinic Fundeni
Address:
City:
Bucuresti
Zip:
022328
Country:
Romania
Facility:
Name:
Spitalul Clinic Coltea
Address:
City:
Bucuresti
Zip:
030171
Country:
Romania
Facility:
Name:
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
Address:
City:
Cluj-Napoca
Zip:
400015
Country:
Romania
Facility:
Name:
Spitalul Clinic Municipal Filantropia Craiova
Address:
City:
Craiova
Zip:
200143
Country:
Romania
Facility:
Name:
Military Medical Academy
Address:
City:
Belgrade
Zip:
11000
Country:
Serbia
Facility:
Name:
University Clinical Center of Serbia
Address:
City:
Belgrade
Zip:
11000
Country:
Serbia
Facility:
Name:
University Clinical Center Nis
Address:
City:
Nis
Zip:
18000
Country:
Serbia
Facility:
Name:
National University Hospital
Address:
City:
Singapore
Zip:
119228
Country:
Singapore
Facility:
Name:
Curie Oncology Pte Ltd
Address:
City:
Singapore
Zip:
329563
Country:
Singapore
Facility:
Name:
Complejo Hospitalario Universitario de Albacete
Address:
City:
Albacete
Zip:
02006
Country:
Spain
Facility:
Name:
Hospital de La Santa Creu I Sant Pau
Address:
City:
Barcelona
Zip:
8025
Country:
Spain
Facility:
Name:
Hospital San Pedro de Alcantara
Address:
City:
Caceres
Zip:
10003
Country:
Spain
Facility:
Name:
Hospital Universitario Reina Sofia
Address:
City:
Cordoba
Zip:
14004
Country:
Spain
Facility:
Name:
Hospital Universitario de Gran Canaria Dr. Negrin
Address:
City:
Las Palmas
Country:
Spain
Facility:
Name:
Clinica Universidad de Navarra
Address:
City:
Madrid
Zip:
28027
Country:
Spain
Facility:
Name:
Md Anderson Cancer Centre
Address:
City:
Madrid
Zip:
28033
Country:
Spain
Facility:
Name:
Hospital Universitario Fundacion Jimenez Diaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Facility:
Name:
Hospital Universitario Puerta de Hierro Majadahonda
Address:
City:
Majadahonda
Zip:
28220
Country:
Spain
Facility:
Name:
Hospital Regional Universitario de Malaga
Address:
City:
Malaga
Zip:
29010
Country:
Spain
Facility:
Name:
Hospital General Universitario Morales Meseguer
Address:
City:
Murcia
Zip:
30008
Country:
Spain
Facility:
Name:
Hospital Universitari Son Espases
Address:
City:
Palma de Mallorca
Zip:
07120
Country:
Spain
Facility:
Name:
Hospital Universitario Quironsalud Madrid
Address:
City:
Pozuelo de Alarcon
Zip:
28223
Country:
Spain
Facility:
Name:
Hospital Universitario Marques de Valdecilla
Address:
City:
Santander
Zip:
39012
Country:
Spain
Facility:
Name:
Complejo Hospitalario Universitario de Santiago
Address:
City:
Santiago de Compostela
Zip:
15706
Country:
Spain
Facility:
Name:
Hospital Universitario Virgen Del Rocio
Address:
City:
Seville
Zip:
41010
Country:
Spain
Facility:
Name:
Hospital Clinico Universitario de Valencia
Address:
City:
Valencia
Zip:
46010
Country:
Spain
Facility:
Name:
Hospital Universitario Dr. Peset
Address:
City:
Valencia
Zip:
46017
Country:
Spain
Facility:
Name:
Hospital Universitari I Politecnic La Fe
Address:
City:
Valencia
Zip:
46026
Country:
Spain
Facility:
Name:
Sahlgrenska Universitetssjukhuset
Address:
City:
GĂśteborg
Zip:
41345
Country:
Sweden
Facility:
Name:
Skă Nes Universitetssjukhus, Lund
Address:
City:
Lund
Zip:
22185
Country:
Sweden
Facility:
Name:
Akademiska Sjukhuset
Address:
City:
Uppsala
Zip:
75185
Country:
Sweden
Facility:
Name:
Inselspital - Universitaetsspital Bern
Address:
City:
Bern
Zip:
3010
Country:
Switzerland
Facility:
Name:
Kaohsiung Chang Gung Memorial Hospital
Address:
City:
Kaohsiung
Zip:
833
Country:
Taiwan
Facility:
Name:
China Medical University Hospital
Address:
City:
Taichung
Zip:
404327
Country:
Taiwan
Facility:
Name:
National Cheng Kung University Hospitalx
Address:
City:
Tainan
Zip:
70403
Country:
Taiwan
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Zip:
11217
Country:
Taiwan
Facility:
Name:
Chang Gung Memorial Hospital
Address:
City:
Taoyuan County
Zip:
333
Country:
Taiwan
Facility:
Name:
King'S College Hospital
Address:
City:
London
Zip:
SE5 9NU
Country:
United Kingdom
Facility:
Name:
Hammersmith Hospital
Address:
City:
London
Zip:
W12 0HS
Country:
United Kingdom
Facility:
Name:
Maidstone Hospital
Address:
City:
Maidstone
Zip:
ME16 9QQ
Country:
United Kingdom
Facility:
Name:
Manchester Royal Infirmary
Address:
City:
Manchester
Zip:
M13 9WL
Country:
United Kingdom
Facility:
Name:
Churchill Hospital
Address:
City:
Oxford
Zip:
OX3 7LJ
Country:
United Kingdom
Facility:
Name:
Torbay Hospital
Address:
City:
Torquay
Zip:
TQ2 7AA
Country:
United Kingdom
Start date:
October 30, 2024
Completion date:
June 26, 2030
Lead sponsor:
Agency:
Daiichi Sankyo
Agency class:
Industry
Source:
Daiichi Sankyo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06578247
