Clinical trial NCT02668653: Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)
Official title: A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy, and Administered as Continuation Therapy in Subjects 18 to 75 Years Old With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (QuANTUM First)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Leukemia
Keywords: Newly diagnosed Acute Myeloid Leukemia
FLT3-ITD positive
Chemotherapy
Induction chemotherapy
Consolidation chemotherapy
Quizartinib
Feline McDonough sarcoma (FMS)-like tyrosine kinase 3
AC220
FLT3-ITD
AML
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2016-01-29
Enrollment: 539
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research.

Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML).

Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy.

Detailed description: This is a phase 3, randomized, double-blind, placebo-control global study. The purpose of this study is to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as continuation therapy for up to 36 cycles) on overall survival in subjects with FLT3-internal tandem duplication (ITD) positive AML.

Eligibility criteria: Inclusion Criteria:

1. Must be competent and able to comprehend, sign, and date an Ethics Committee (EC) or Institutional Review Board approved Informed Consent Form (ICF) before performance of any study-specific procedures or tests;
2. Is ≥18 years or the minimum legal adult age (whichever is greater) and ≤75 years (at Screening);
3. Newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm, based on the World Health Organization (WHO) 2008 classification (at Screening);
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (at the time the participant signs their first ICF);
5. Presence of FLT3-ITD activating mutation in bone marrow (allelic ratio of ≥3% FLT3-ITD/total FLT3);
6. Participant is receiving standard "7+3" induction chemotherapy regimen as specified in the protocol;
7. Adequate renal function defined as:

   a. Creatinine clearance \>50 mL/min, as calculated with the modified Cockcroft Gault equation
8. Adequate hepatic function defined as:

   1. Total serum bilirubin (TBL) ≤1.5 × upper limit of normal (ULN) unless the participant has documented Gilbert's syndrome or the increase is related to increased unconjugated (indirect) bilirubin due to hemolysis;
   2. Serum alkaline phosphatase, aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 × ULN;
9. Serum electrolytes within normal limits: potassium, calcium (total, or corrected for serum albumin in case of hypoalbuminemia or ionized calcium) and magnesium. If outside of normal limits, participant will be eligible when electrolytes are corrected;
10. If a woman of childbearing potential, must have a negative serum pregnancy test upon entry into this study and must be willing to use highly effective birth control upon enrollment, during the treatment period and for 6 months following the last dose of investigational drug or cytarabine, whichever is later. A woman is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months);
11. If male, must be surgically sterile or willing to use highly effective birth control upon enrollment, during the treatment period, and for 6 months following the last dose of investigational drug or cytarabine, whichever is later.

Exclusion Criteria:

1. Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or breakpoint cluster region-Abelson murine leukemia viral oncogene homolog 1 (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).
2. Diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms;
3. Prior treatment for AML, except for the following allowances:

   * Leukapheresis;
   * Treatment for hyperleukocytosis with hydroxyurea;
   * Cranial radiotherapy for central nervous system (CNS) leukostasis;
   * Prophylactic intrathecal chemotherapy;
   * Growth factor/cytokine support;
4. Prior treatment with quizartinib or other FLT3-ITD inhibitors;
5. Prior treatment with any investigational drug or device within 30 days prior to Randomization (within 2 weeks for investigational or approved immunotherapy) or currently participating in other investigational procedures;
6. History of known CNS leukemia, including cerebrospinal fluid positive for AML blasts; lumbar puncture is recommended for participants with symptoms of CNS leukemia to rule out extramedullary CNS involvement;
7. History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for at least 2 years;
8. Uncontrolled or significant cardiovascular disease, including any of the following:

   * Bradycardia of less than 50 beats per minute, unless the participant has a pacemaker;
   * Fridericia's Heart Rate Correction Formula (QTcF) interval \>450 msec;
   * Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);
   * Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg;
   * History of clinically relevant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes);
   * History of second (Mobitz II) or third degree heart block (participants with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker);
   * History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening;
   * History of New York Heart Association Class 3 or 4 heart failure;
   * Known history of left ventricular ejection fraction (LVEF) ≤45% or less than the institutional lower limit of normal;
   * Complete left bundle branch block;
9. Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy;
10. Known active clinically relevant liver disease (eg, active hepatitis B, or active hepatitis C);
11. Known history of human immunodeficiency virus (HIV). Participants should be tested for HIV prior to Randomization if required by local regulations or EC;
12. History of hypersensitivity to any excipients in the quizartinib/placebo tablets;
13. Females who are pregnant or breastfeeding;
14. Otherwise considered inappropriate for the study by the Investigator.

Primary outcomes:
measure: Overall Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
timeFrame: Date of randomization to the date of death due to any cause, up to approximately 3 years after enrollment
Secondary outcomes:
measure: Event-free Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
timeFrame: Date of randomization to the date of refractory disease, relapse, or death, up to approximately 3 years after enrollment
measure: Complete Remission (CR) Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
timeFrame: Approximately Cycle 1 Day 21 (Induction) to end of Induction, up to approximately 120 days (each Induction cycle is up to 60 days)
measure: Composite CR Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
timeFrame: Approximately Cycle 1 Day 21 (Induction) to end of Induction, up to approximately 120 days (each Induction cycle is up to 60 days)
measure: Number of Participants With Treatment-emergent Adverse Events Occurring in ≥10% Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
timeFrame: Date of first dose up to 30 days after last dose, up to 36 cycles following continuation (approximately 6 years 11 months, each cycle is 28 days)
measure: Number of Participants Achieving CR With FLT3-ITD Minimal Residual Disease Negativity at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
timeFrame: Approximately Cycle 1 Day 21 (Induction phase) to end of Induction phase, up to approximately 120 days (each Induction cycle is up to 60 days)
measure: Number of Participants Achieving Composite CR With FLT3-ITD Minimal Residual Disease Negativity at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
timeFrame: Approximately Cycle 1 Day 21 (Induction phase) to end of Induction phase, up to approximately 120 days (each Induction cycle is up to 60 days)
measure: Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve at Steady State
timeFrame: Induction Cycle 1: Day 8, predose, 2-4 hours (hr) postdose on Days 8, 15, 21; Consolidation Cycle 1: Day 6, predose, 2-4 hr postdose on Days 6, 13, 19; Continuation Cycle 1: 2-4 hr postdose, Days 1, 8, 15; Cycle 2 Days 1 and 15 (each cycle, 28 days)
measure: Pharmacokinetic Parameter Steady State, Maximum Plasma Concentration (Css,Max)
timeFrame: Induction Cycle 1: Day 8, predose, 2-4 hours (hr) postdose on Days 8, 15, 21; Consolidation Cycle 1: Day 6, predose, 2-4 hr postdose on Days 6, 13, 19; Continuation Cycle 1: 2-4 hr postdose, Days 1, 8, 15; Cycle 2 Days 1 and 15 (each cycle, 28 days)
measure: Pharmacokinetic Parameter Time to Maximum Plasma Concentration Steady State (Tmax,ss)
timeFrame: Induction Cycle 1: Day 8, predose, 2-4 hours (hr) postdose on Days 8, 15, 21; Consolidation Cycle 1: Day 6, predose, 2-4 hr postdose on Days 6, 13, 19; Continuation Cycle 1: 2-4 hr postdose, Days 1, 8, 15; Cycle 2 Days 1 and 15 (each cycle, 28 days)
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida (UF) Health Shands Hospital
state: Florida
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Franciscan St. Francis Health Indianapolis
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Valhalla
country: United States
facility: NY Medical College - Hudson Valley Hematology Oncology Associates
state: New York
city: Durham
country: United States
facility: Duke Clinical Research Institute
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Seidman Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Morgantown
country: United States
facility: West Virginia University Hospitals, Inc.
state: West Virginia
city: Rosario
country: Argentina
facility: Sanatorio Britanico
state: Santa Fe
city: Córdoba
country: Argentina
facility: Sanatorio Allende
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Douglas
country: Australia
facility: Townsville Hospital (TTH)
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge-Oostende AV
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Yvoir
country: Belgium
facility: UCL Mont-Godinne
city: Brasília
country: Brazil
facility: Hospital Amaral Carvalho
city: Brasília
country: Brazil
facility: Hospital do CEPON
city: Brasília
country: Brazil
facility: Instituto do Cancer do Estado de São Paulo
city: Brasília
country: Brazil
facility: Santa Casa de Misericórdia de Porto Alegre
city: Passo Fundo
country: Brazil
facility: Hospital da Cidade de Passo Fundo
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
city: Pleven
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Dr. G. Stranski" EAD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital (VGH)
state: British Columbia
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: The General Hospital of People's Liberation Army (301 Hospital)
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
city: Guangzhou
country: China
facility: Guangdong General Hospital
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School
city: Taiyuan
country: China
facility: West China Hospital, Sichuan University
city: Tianjin
country: China
facility: Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
city: Xi'an
country: China
facility: Tang Du Hospital, Fourth Military Medical University
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Zagreb
country: Croatia
facility: Klinička Bolnica Dubrava
city: Zagreb
country: Croatia
facility: Klinička Bolnica Merkur
city: Zagreb
country: Croatia
facility: Klinički Bolnički Centar Zagreb
city: Hradec Kralove
country: Czechia
facility: Fakultní Nemocnice Hradec Králové
city: Olomouc
country: Czechia
facility: Fakultní Nemocnice Olomouc
city: Ostrava
country: Czechia
facility: Fakultní Nemocnice Ostrava
city: Plzen
country: Czechia
facility: Fakultni Nemocnice Plzen
city: Praha 2
country: Czechia
facility: Vseobecna Fakultni Nemocnice, Ustav hematologie a krevni transfuze (UHKT)
city: Grenoble
country: France
facility: Hospital A. Michallon
city: Le Chesnay
country: France
facility: Centre Hospitalier de Versailles - Hôpital André Mignot
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marguerittes
country: France
facility: L'Institut Paoli - Calmettes
city: Marseille
country: France
facility: Hôpital de la Conception
city: Montpellier
country: France
facility: CHRU Montpellier - Saint Eloi
city: Paris
country: France
facility: Hôpital Saint-Antoine
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Pessac
country: France
facility: Hôpital Haut-Lévêque
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon-Sud
city: Rouen
country: France
facility: Centre Henri Becquerel - Centre de Lutte Contre le Cancer
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan
city: Bad Saarow
country: Germany
facility: HELIOS Klinikum Bad Saarow
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Braunschweig
country: Germany
facility: Städtisches Klinikum Braunschweig gGmbH
city: Düsseldorf
country: Germany
facility: Marien Hospital Düsseldorf GmbH
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt
city: Halle
country: Germany
facility: Universitätsklinikum Halle (Saale)
city: Hamm
country: Germany
facility: Evangelisches Krankenhaus Hamm gGmbH
city: Hannöver
country: Germany
facility: Medizinische Hochschule Hannover (MHH)
city: Heidelberg
country: Germany
facility: Universitätsklinikum Münster
city: Heidelberg
country: Germany
facility: Universitätsklinikum Tübingen
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Mutlangen
country: Germany
facility: Stauferklinikum Schwäbisch Gmünd
city: Wuppertal
country: Germany
facility: HELIOS Klinikum Wuppertal
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
city: Budapest
country: Hungary
facility: Markusovszky Egyetemi Oktatókórház
city: Budapest
country: Hungary
facility: Szegedi Tudományegyetem
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ
city: Pécs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Központ
city: Szombathely
country: Hungary
facility: Markusovszky Egyetemi Oktatókórház
city: Be'er Ya'aqov
country: Israel
facility: Assaf Harofeh Medical Center
state: Tsifrin
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Medical Center
city: Petaẖ Tiqwa
country: Israel
facility: Rabin Medical Center - Beilinson Hospital
city: Ramat-Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Alessandria
country: Italy
facility: Azienda Ospedaliera Nazionale SS.Antonio e Biagio e Cesare Arrigo
city: Ascoli Piceno
country: Italy
facility: Azienda Sanitaria Locale 13 - Ospedale "C. e G. Mazzoni"- Ascoli Piceno
city: Bari
country: Italy
facility: Azienda Ospedaliero - Universitaria Consorziale Policlinico di Bari
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
city: Genova
country: Italy
facility: IRCCS AOU San Martino - IST
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Napoli
country: Italy
facility: A.O.R.N. "A. Cardarelli"
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
city: Orbassano
country: Italy
facility: Azienda Ospedaliero - Universitaria San Luigi Gonzaga
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
city: Ravenna
country: Italy
facility: Ospedale S. Maria delle Croci - Ravenna
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
city: Roma
country: Italy
facility: Ospedale S. Eugenio
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Roma
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Roma
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Roma
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria "Federico II"
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Salerno
country: Italy
facility: Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi d'Aragona
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
city: Torino
country: Italy
facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette
city: Torino
country: Italy
facility: Azienda Ospedaliera Ordine Mauriziano di Torino
city: Varese
country: Italy
facility: ASST dei Sette Laghi - Ospedale di Circolo e Fondazione Macchi Varese
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Toyohashi
country: Japan
facility: Toyohashi Municipal Hospital
state: Aichi
city: Matsuyama
country: Japan
facility: Ehime Prefectural Central Hospital
state: Ehime
city: Yoshida
country: Japan
facility: University of Fukui Hospital
state: Fukui
city: Higashi
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Maebashi
country: Japan
facility: Gunmaken Saiseikai Maebashi Hospital
state: Gunma
city: Maebashi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Fukuyama
country: Japan
facility: Chugoku Central Hospital
state: Hiroshima
city: Sapporo
country: Japan
facility: Sapporo Hokuyu Hospital
state: Hokkaido
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
state: Kanagawa
city: Sendai
country: Japan
facility: National Hospital Organization Sendai Medical Center
state: Miagi
city: Tenri
country: Japan
facility: Tenri Hospital
state: Nara
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Bunkyō-Ku
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital
state: Tokyo
city: Minato-Ku
country: Japan
facility: The Jikei University Hospital
state: Tokyo
city: Akita
country: Japan
facility: Akita University Hospital
city: Aomori
country: Japan
facility: Aomori Prefectural Central Hospital
city: Chiba
country: Japan
facility: Chiba Aoba Municipal Hospital
city: Chiba
country: Japan
facility: Kameda Medical Center - Kameda General Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Gifu
country: Japan
facility: Gifu Municipal Hospital
city: Kagoshima
country: Japan
facility: National Hospital Organization Kagoshima Medical Center
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
city: Kumamoto
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Osaka
country: Japan
facility: Osaka City General Hospital
city: Osaka
country: Japan
facility: Osaka Red Cross Hospital
city: Tokyo
country: Japan
facility: NTT Medical Center Tokyo
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: SoonChunHyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Sŏwŏn
country: Korea, Republic of
facility: Ajou University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital (UUH)
city: Kraków
country: Poland
facility: Szpital Uniwersytecki w Krakowie
city: Słupsk
country: Poland
facility: Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka
city: Warszawa
country: Poland
facility: Instytut Hematologii i Transfuzjologi
city: Warszawa
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr. 1 we Wrocławiu
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Central, EPE - Hospital Santo António dos Capuchos
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto, EPE - Hospital Geral de Santo António
city: Porto
country: Portugal
facility: Instituto Português Oncologia do Porto Francisco Gentil, EPE
city: Porto
country: Portugal
facility: Centro Hospitalar de São João, EPE - Hospital de São João
city: Bucuresti
country: Romania
facility: Institutul Regional de Oncologie Iași
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina
city: Bucuresti
country: Romania
facility: Spitalul Clinic Coltea
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Bucuresti
city: Bucuresti
country: Romania
facility: Institutul Clinic Fundeni
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic "Prof. Dr. Ion Chiricuţă" Cluj Napoca
city: Craiova
country: Romania
facility: Spitalul Clinic Municipal Filantropia Craiova
city: Târgu-Mureş
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Târgu-Mureş (4005)
city: Târgu-Mureş
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Târgu-Mureş (4008)
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhny Novgorod Regional Clinical Hospital
city: Penza
country: Russian Federation
facility: Penza Regional Oncology Dispensary
city: Petrozavodsk
country: Russian Federation
facility: Republican Hospital n.a.V.A. Baranov
city: Ryazan'
country: Russian Federation
facility: Ryazan Regional Clinical Hospital
city: Saint Petersburg
country: Russian Federation
facility: Almazov Federal North-West Medical Research Centre
city: Saratov
country: Russian Federation
facility: Saratov State Medical University named after V.I. Razumovsky
city: St. Petersburg
country: Russian Federation
facility: Russian Research Institute of Hematology and Blood Transfusion
city: St. Petersburg
country: Russian Federation
facility: Leningrad Regional Clinic and Hospital
city: Tula
country: Russian Federation
facility: Tula Regional Clinical Hospital
city: Belgrade
country: Serbia
facility: Klinički Centar Srbije
city: Nis
country: Serbia
facility: Klinički Centar Niš
city: Novi Sad
country: Serbia
facility: Klinički Centar Vojvodine
city: Singapore
country: Singapore
facility: National University Hospital (S) Pte Ltd
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Palma
country: Spain
facility: Hospital Universitari Son Espases
state: Mallorca
city: Albacete
country: Spain
facility: Complejo Hospitalario Universitario de Albacete - Hospital General Universitario
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Badalona
country: Spain
facility: Catalan Institute of Oncology (ICO)
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Barcelona
country: Spain
facility: Hospital Duran i Reynals
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Girona
country: Spain
facility: Hospital Universitari de Girona Doctor Josep Trueta
city: Granada
country: Spain
facility: Complejo Hospitalario Universitario Granada
city: La Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Dr. Negrín
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Quirón Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga - Hospital General
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Pamplona
country: Spain
facility: Fundación Jiménez Díaz
city: Pamplona
country: Spain
facility: Hospital Clínico Universitario "Lozano Blesa"
city: Pamplona
country: Spain
facility: Hospital General Universitario Morales Meseguer
city: Pamplona
country: Spain
facility: Hospital Universitario Miguel Servet
city: Pamplona
country: Spain
facility: Hospital Álvaro Cunqueiro
city: Salamanca
country: Spain
facility: Hosp Universitario Salamanca
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Santiago de Compostela
country: Spain
facility: Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clínico Universitario
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Tarragona
country: Spain
facility: Hospital Universitari Joan XXIII de Tarragona
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation - Kaohsiung Branch
state: Niaosong District
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation - Linkou Branch
city: Cherkasy
country: Ukraine
facility: Cherkasy Regional Oncology Dispensary
city: Poltava
country: Ukraine
facility: Poltava Regional Clinical Hospital named after M. V. Sklifosovskoho
city: Vinnytsia
country: Ukraine
facility: Vinnitsa Regional Clinical Hospital im. N.I. Pirogov
city: Zhytomyr
country: Ukraine
facility: Zhitomir Regional Clinical Hospital
city: Maidstone
country: United Kingdom
facility: Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References:
citation: Cortes J, Perl AE, Dohner H, Kantarjian H, Martinelli G, Kovacsovics T, Rousselot P, Steffen B, Dombret H, Estey E, Strickland S, Altman JK, Baldus CD, Burnett A, Kramer A, Russell N, Shah NP, Smith CC, Wang ES, Ifrah N, Gammon G, Trone D, Lazzaretto D, Levis M. Quizartinib, an FLT3 inhibitor, as monotherapy in patients with relapsed or refractory acute myeloid leukaemia: an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2018 Jul;19(7):889-903. doi: 10.1016/S1470-2045(18)30240-7. Epub 2018 May 31.