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Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) (QuANTUM-First)

Primary Purpose

Acute Myeloid Leukemia, Leukemia

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Chemotherapy
Quizartinib
Placebo
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring 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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Florida (UF) Health Shands Hospital
  • The University of Chicago Medical Center
  • Franciscan St. Francis Health Indianapolis
  • University of Kentucky Chandler Medical Center
  • John Theurer Cancer Center at Hackensack University Medical Center
  • NY Medical College - Hudson Valley Hematology Oncology Associates
  • Duke Clinical Research Institute
  • University Hospitals Seidman Cancer Center
  • Hospital of the University of Pennsylvania
  • Thomas Jefferson University Hospital
  • West Virginia University Hospitals, Inc.
  • Sanatorio Britanico
  • Sanatorio Allende
  • Calvary Mater Newcastle
  • Townsville Hospital (TTH)
  • Princess Alexandra Hospital
  • Fiona Stanley Hospital
  • AZ Sint-Jan Brugge-Oostende AV
  • Universitair Ziekenhuis Gent
  • UCL Mont-Godinne
  • Hospital Amaral Carvalho
  • Hospital do CEPON
  • Instituto do Cancer do Estado de São Paulo
  • Santa Casa de Misericórdia de Porto Alegre
  • Hospital da Cidade de Passo Fundo
  • Hospital de Clínicas de Porto Alegre
  • University Multiprofile Hospital for Active Treatment "Dr. G. Stranski" EAD
  • University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
  • Tom Baker Cancer Centre
  • University of Alberta Hospital
  • Vancouver General Hospital (VGH)
  • Princess Margaret Cancer Centre
  • Peking University First Hospital
  • The General Hospital of People's Liberation Army (301 Hospital)
  • Fujian Medical University Union Hospital
  • Guangdong General Hospital
  • Lanzhou University Second Hospital
  • Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School
  • West China Hospital, Sichuan University
  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
  • The First Affiliated Hospital of Wenzhou Medical University
  • Tang Du Hospital, Fourth Military Medical University
  • Henan Cancer Hospital
  • Klinička Bolnica Dubrava
  • Klinička Bolnica Merkur
  • Klinički Bolnički Centar Zagreb
  • Fakultní Nemocnice Hradec Králové
  • Fakultní Nemocnice Olomouc
  • Fakultní Nemocnice Ostrava
  • Fakultni Nemocnice Plzen
  • Vseobecna Fakultni Nemocnice, Ustav hematologie a krevni transfuze (UHKT)
  • Hospital A. Michallon
  • Centre Hospitalier de Versailles - Hôpital André Mignot
  • Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
  • Centre Léon Bérard
  • L'Institut Paoli - Calmettes
  • Hôpital de la Conception
  • CHRU Montpellier - Saint Eloi
  • Hôpital Saint-Antoine
  • Hôpital Saint-Louis
  • Hôpital Haut-Lévêque
  • Centre Hospitalier Lyon-Sud
  • Centre Henri Becquerel - Centre de Lutte Contre le Cancer
  • Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan
  • HELIOS Klinikum Bad Saarow
  • Charité - Universitätsmedizin Berlin
  • Städtisches Klinikum Braunschweig gGmbH
  • Marien Hospital Düsseldorf GmbH
  • Universitätsklinikum Essen
  • Universitätsklinikum Frankfurt
  • Universitätsklinikum Halle (Saale)
  • Evangelisches Krankenhaus Hamm gGmbH
  • Medizinische Hochschule Hannover (MHH)
  • Universitätsklinikum Münster
  • Universitätsklinikum Tübingen
  • Universitätsklinikum Heidelberg
  • Universitätsklinikum Leipzig
  • Stauferklinikum Schwäbisch Gmünd
  • HELIOS Klinikum Wuppertal
  • Prince of Wales Hospital
  • Markusovszky Egyetemi Oktatókórház
  • Szegedi Tudományegyetem
  • Semmelweis Egyetem
  • Debreceni Egyetem Klinikai Központ
  • Pecsi Tudomanyegyetem Klinikai Központ
  • Markusovszky Egyetemi Oktatókórház
  • Assaf Harofeh Medical Center
  • Bnai Zion Medical Center
  • Rambam Medical Center
  • Hadassah University Medical Center
  • Rabin Medical Center - Beilinson Hospital
  • The Chaim Sheba Medical Center
  • Tel Aviv Sourasky Medical Center
  • Azienda Ospedaliera Nazionale SS.Antonio e Biagio e Cesare Arrigo
  • Azienda Sanitaria Locale 13 - Ospedale "C. e G. Mazzoni"- Ascoli Piceno
  • Azienda Ospedaliero - Universitaria Consorziale Policlinico di Bari
  • Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
  • IRCCS AOU San Martino - IST
  • ASST Grande Ospedale Metropolitano Niguarda
  • A.O.R.N. "A. Cardarelli"
  • Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
  • Azienda Ospedaliero - Universitaria San Luigi Gonzaga
  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
  • Ospedale S. Maria delle Croci - Ravenna
  • Fondazione Policlinico Universitario Agostino Gemelli
  • Ospedale S. Eugenio
  • Policlinico Tor Vergata
  • IRCCS Ospedale San Raffaele
  • Azienda Ospedaliero-Universitaria Careggi
  • Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara
  • Azienda Ospedaliera Universitaria "Federico II"
  • Istituto Clinico Humanitas
  • Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi d'Aragona
  • Azienda Ospedaliera Universitaria Senese
  • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette
  • Azienda Ospedaliera Ordine Mauriziano di Torino
  • ASST dei Sette Laghi - Ospedale di Circolo e Fondazione Macchi Varese
  • National Hospital Organization Nagoya Medical Center
  • Nagoya University Hospital
  • Toyohashi Municipal Hospital
  • Ehime Prefectural Central Hospital
  • University of Fukui Hospital
  • Kyushu University Hospital
  • Gunmaken Saiseikai Maebashi Hospital
  • Gunma University Hospital
  • Chugoku Central Hospital
  • Sapporo Hokuyu Hospital
  • Yokohama City University Hospital
  • National Hospital Organization Sendai Medical Center
  • Tenri Hospital
  • Hamamatsu University Hospital
  • Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital
  • The Jikei University Hospital
  • Akita University Hospital
  • Aomori Prefectural Central Hospital
  • Chiba Aoba Municipal Hospital
  • Kameda Medical Center - Kameda General Hospital
  • National Hospital Organization Kyushu Cancer Center
  • Gifu Municipal Hospital
  • National Hospital Organization Kagoshima Medical Center
  • Kobe City Medical Center General Hospital
  • National Hospital Organization Kumamoto Medical Center
  • Nagasaki University Hospital
  • Osaka City General Hospital
  • Osaka Red Cross Hospital
  • NTT Medical Center Tokyo
  • Inje University Haeundae Paik Hospital
  • Pusan National University Hospital
  • Kyungpook National University Hospital
  • Yeungnam University Medical Center
  • Daegu Catholic University Medical Center
  • Chonnam National University Hwasun Hospital
  • Gachon University Gil Hospital
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Severance Hospital
  • SoonChunHyang University Seoul Hospital
  • Konkuk University Medical Center
  • Asan Medical Center
  • Samsung Medical Center
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Korea University Guro Hospital
  • Ajou University Hospital
  • Ulsan University Hospital (UUH)
  • Szpital Uniwersytecki w Krakowie
  • Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka
  • Instytut Hematologii i Transfuzjologi
  • Samodzielny Publiczny Szpital Kliniczny Nr. 1 we Wrocławiu
  • Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra
  • Centro Hospitalar Lisboa Central, EPE - Hospital Santo António dos Capuchos
  • Centro Hospitalar do Porto, EPE - Hospital Geral de Santo António
  • Instituto Português Oncologia do Porto Francisco Gentil, EPE
  • Centro Hospitalar de São João, EPE - Hospital de São João
  • Institutul Regional de Oncologie Iași
  • Spitalul Clinic Colentina
  • Spitalul Clinic Coltea
  • Spitalul Universitar de Urgenta Bucuresti
  • Institutul Clinic Fundeni
  • Institutul Oncologic "Prof. Dr. Ion Chiricuţă" Cluj Napoca
  • Spitalul Clinic Municipal Filantropia Craiova
  • Spitalul Clinic Judetean de Urgenta Târgu-Mureş (4005)
  • Spitalul Clinic Judetean de Urgenta Târgu-Mureş (4008)
  • Nizhny Novgorod Regional Clinical Hospital
  • Penza Regional Oncology Dispensary
  • Republican Hospital n.a.V.A. Baranov
  • Ryazan Regional Clinical Hospital
  • Almazov Federal North-West Medical Research Centre
  • Saratov State Medical University named after V.I. Razumovsky
  • Russian Research Institute of Hematology and Blood Transfusion
  • Leningrad Regional Clinic and Hospital
  • Tula Regional Clinical Hospital
  • Klinički Centar Srbije
  • Klinički Centar Niš
  • Klinički Centar Vojvodine
  • National University Hospital (S) Pte Ltd
  • Singapore General Hospital
  • Hospital Universitari Son Espases
  • Complejo Hospitalario Universitario de Albacete - Hospital General Universitario
  • Hospital General Universitario de Alicante
  • Catalan Institute of Oncology (ICO)
  • Hospital del Mar
  • Hospital Universitario Vall d'Hebron
  • Hospital Clinic i Provincial
  • Hospital Duran i Reynals
  • Hospital de Basurto
  • Hospital San Pedro de Alcántara
  • Hospital Universitario Reina Sofía
  • Hospital Universitari de Girona Doctor Josep Trueta
  • Complejo Hospitalario Universitario Granada
  • Complexo Hospitalario Universitario A Coruña
  • Hospital Dr. Negrín
  • Hospital General Universitario Gregorio Marañón
  • Hospital Universitario Ramón y Cajal
  • Hospital Clínico San Carlos
  • Hospital Universitario 12 de Octubre
  • Hospital Quirón Madrid
  • Hospital Universitario Puerta de Hierro - Majadahonda
  • Hospital Regional Universitario de Málaga - Hospital General
  • Hospital Universitario Central de Asturias
  • Complejo Hospitalario de Navarra
  • Fundación Jiménez Díaz
  • Hospital Clínico Universitario "Lozano Blesa"
  • Hospital General Universitario Morales Meseguer
  • Hospital Universitario Miguel Servet
  • Hospital Álvaro Cunqueiro
  • Hosp Universitario Salamanca
  • Hospital Universitario Marqués de Valdecilla
  • Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clínico Universitario
  • Hospital Universitario Virgen del Rocío
  • Hospital Universitari Joan XXIII de Tarragona
  • Hospital Clinico Universitario de Valencia
  • Hospital Universitario Dr. Peset
  • Hospital Universitari i Politècnic La Fe
  • Chang Gung Medical Foundation - Kaohsiung Branch
  • China Medical University Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Chang Gung Medical Foundation - Linkou Branch
  • Cherkasy Regional Oncology Dispensary
  • Poltava Regional Clinical Hospital named after M. V. Sklifosovskoho
  • Vinnitsa Regional Clinical Hospital im. N.I. Pirogov
  • Zhitomir Regional Clinical Hospital
  • Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chemotherapy plus quizartinib

Chemotherapy plus placebo

Arm Description

Induction: up to 2 cycles with cytarabine and daunorubicin/idarubicin, followed by the experimental drug quizartinib Consolidation: up to 4 cycles of cytarabine followed by the experimental drug quizartinib and/or hematopoeitic stem cell transplant Continuation: up to 36 cycles with the experimental drug quizartinib

Induction: up to 2 cycles with cytarabine and daunorubicin/idarubicin, followed by placebo Consolidation: up to 4 cycles of cytarabine followed by placebo and/or hematopoeitic stem cell transplant Continuation: up to 36 cycles with placebo

Outcomes

Primary Outcome Measures

Overall Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Overall survival is defined as the time from randomization until death from any cause.

Secondary Outcome Measures

Event-free Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Event-free survival (EFS) is the time from randomization to the earliest date of either refractory disease (or treatment failure [TF]), relapse, or death from any cause. Refractory disease is defined as complete remission never achieved during Induction (CR: >1000 neutrophils, >100,000 platelets, <5% blasts, and other [defined as absence of extramedullary disease [EMD], blasts with rods, and leukemic blasts]). For refractory disease, EFS event date is Day 1 (randomization). Relapse after CR is defined as ≥5% blasts, leukemic blasts, extramedullary leukemia, and presence of rods. This analysis is based on a response assessment with TF defined as not achieving response of CR, using a 42- day window from the start of the last cycle in Induction for CR evaluation.
Complete Remission (CR) Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Complete remission (CR) rate is defined as the percentage of participants achieving CR, defined as a disappearance of all target lesions, after Induction.
Composite CR Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Composite complete remission (CRc) rate is defined as the percentage of participants whose best response is complete remission (CR), defined as a disappearance of all target lesions, or CR with incomplete neutrophil or platelet recovery (CRi) at the end of first Induction cycle.
Number of Participants With Treatment-emergent Adverse Events Occurring in ≥10% Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
A treatment-emergent adverse event (TEAE) is defined as an adverse event that occur, having been absent before first dose of quizartinib or placebo, or have worsened in severity after initiating quizartinib or placebo. Adverse events collected more than 30 days after the last dose of quizartinib/placebo will not be considered TEAEs unless they are considered drug-related.
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
Complete remission (CR) is defined as participants achieving CR defined as a disappearance of all target lesions. Minimal or measurable residual disease is the presence of a small number of leukemic cells in the bone marrow of patients with AML below the level of detection using conventional morphologic assessment.
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
Composite complete remission (CRc) is defined as participants achieving complete remission (CR), defined as a disappearance of all target lesions, or CR with incomplete neutrophil or platelet recovery (CRi). Minimal or measurable residual disease is the presence of a small number of leukemic cells in the bone marrow of patients with AML below the level of detection using conventional morphologic assessment.
Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve at Steady State
AUCss was assessed by population PK analysis during Cycle 1 of each phase.
Pharmacokinetic Parameter Steady State, Maximum Plasma Concentration (Css,Max)
Css,max was assessed by population PK analysis during Cycle 1 of each phase.
Pharmacokinetic Parameter Time to Maximum Plasma Concentration Steady State (Tmax,ss)
Tmax,ss was assessed by population PK analysis during Cycle 1 of each phase.

Full Information

First Posted
January 22, 2016
Last Updated
November 23, 2022
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02668653
Brief Title
Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)
Acronym
QuANTUM-First
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2016 (Actual)
Primary Completion Date
August 13, 2021 (Actual)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
539 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy plus quizartinib
Arm Type
Experimental
Arm Description
Induction: up to 2 cycles with cytarabine and daunorubicin/idarubicin, followed by the experimental drug quizartinib Consolidation: up to 4 cycles of cytarabine followed by the experimental drug quizartinib and/or hematopoeitic stem cell transplant Continuation: up to 36 cycles with the experimental drug quizartinib
Arm Title
Chemotherapy plus placebo
Arm Type
Active Comparator
Arm Description
Induction: up to 2 cycles with cytarabine and daunorubicin/idarubicin, followed by placebo Consolidation: up to 4 cycles of cytarabine followed by placebo and/or hematopoeitic stem cell transplant Continuation: up to 36 cycles with placebo
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
Cytarabine, Daunorubicin, Idarubicin
Intervention Type
Drug
Intervention Name(s)
Quizartinib
Other Intervention Name(s)
Test Product
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Control
Primary Outcome Measure Information:
Title
Overall Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Description
Overall survival is defined as the time from randomization until death from any cause.
Time Frame
Date of randomization to the date of death due to any cause, up to approximately 3 years after enrollment
Secondary Outcome Measure Information:
Title
Event-free Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Description
Event-free survival (EFS) is the time from randomization to the earliest date of either refractory disease (or treatment failure [TF]), relapse, or death from any cause. Refractory disease is defined as complete remission never achieved during Induction (CR: >1000 neutrophils, >100,000 platelets, <5% blasts, and other [defined as absence of extramedullary disease [EMD], blasts with rods, and leukemic blasts]). For refractory disease, EFS event date is Day 1 (randomization). Relapse after CR is defined as ≥5% blasts, leukemic blasts, extramedullary leukemia, and presence of rods. This analysis is based on a response assessment with TF defined as not achieving response of CR, using a 42- day window from the start of the last cycle in Induction for CR evaluation.
Time Frame
Date of randomization to the date of refractory disease, relapse, or death, up to approximately 3 years after enrollment
Title
Complete Remission (CR) Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Description
Complete remission (CR) rate is defined as the percentage of participants achieving CR, defined as a disappearance of all target lesions, after Induction.
Time Frame
Approximately Cycle 1 Day 21 (Induction) to end of Induction, up to approximately 120 days (each Induction cycle is up to 60 days)
Title
Composite CR Rate at the End of Induction in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Description
Composite complete remission (CRc) rate is defined as the percentage of participants whose best response is complete remission (CR), defined as a disappearance of all target lesions, or CR with incomplete neutrophil or platelet recovery (CRi) at the end of first Induction cycle.
Time Frame
Approximately Cycle 1 Day 21 (Induction) to end of Induction, up to approximately 120 days (each Induction cycle is up to 60 days)
Title
Number of Participants With Treatment-emergent Adverse Events Occurring in ≥10% Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Description
A treatment-emergent adverse event (TEAE) is defined as an adverse event that occur, having been absent before first dose of quizartinib or placebo, or have worsened in severity after initiating quizartinib or placebo. Adverse events collected more than 30 days after the last dose of quizartinib/placebo will not be considered TEAEs unless they are considered drug-related.
Time Frame
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)
Title
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
Description
Complete remission (CR) is defined as participants achieving CR defined as a disappearance of all target lesions. Minimal or measurable residual disease is the presence of a small number of leukemic cells in the bone marrow of patients with AML below the level of detection using conventional morphologic assessment.
Time Frame
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)
Title
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
Description
Composite complete remission (CRc) is defined as participants achieving complete remission (CR), defined as a disappearance of all target lesions, or CR with incomplete neutrophil or platelet recovery (CRi). Minimal or measurable residual disease is the presence of a small number of leukemic cells in the bone marrow of patients with AML below the level of detection using conventional morphologic assessment.
Time Frame
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)
Title
Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve at Steady State
Description
AUCss was assessed by population PK analysis during Cycle 1 of each phase.
Time Frame
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)
Title
Pharmacokinetic Parameter Steady State, Maximum Plasma Concentration (Css,Max)
Description
Css,max was assessed by population PK analysis during Cycle 1 of each phase.
Time Frame
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)
Title
Pharmacokinetic Parameter Time to Maximum Plasma Concentration Steady State (Tmax,ss)
Description
Tmax,ss was assessed by population PK analysis during Cycle 1 of each phase.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Is ≥18 years or the minimum legal adult age (whichever is greater) and ≤75 years (at Screening); 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); Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (at the time the participant signs their first ICF); Presence of FLT3-ITD activating mutation in bone marrow (allelic ratio of ≥3% FLT3-ITD/total FLT3); Participant is receiving standard "7+3" induction chemotherapy regimen as specified in the protocol; Adequate renal function defined as: a. Creatinine clearance >50 mL/min, as calculated with the modified Cockcroft Gault equation Adequate hepatic function defined as: 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; Serum alkaline phosphatase, aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 × ULN; 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; 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); 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: 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). Diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms; 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; Prior treatment with quizartinib or other FLT3-ITD inhibitors; 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; 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; 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; 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; Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy; Known active clinically relevant liver disease (eg, active hepatitis B, or active hepatitis C); Known history of human immunodeficiency virus (HIV). Participants should be tested for HIV prior to Randomization if required by local regulations or EC; History of hypersensitivity to any excipients in the quizartinib/placebo tablets; Females who are pregnant or breastfeeding; Otherwise considered inappropriate for the study by the Investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Florida (UF) Health Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
90095-7170
Country
United States
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Franciscan St. Francis Health Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0293
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
NY Medical College - Hudson Valley Hematology Oncology Associates
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Duke Clinical Research Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University Hospitals Seidman Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-4307
Country
United States
Facility Name
West Virginia University Hospitals, Inc.
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Sanatorio Britanico
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000CVB
Country
Argentina
Facility Name
Sanatorio Allende
City
Córdoba
ZIP/Postal Code
X5000JHQ
Country
Argentina
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Townsville Hospital (TTH)
City
Douglas
State/Province
Queensland
ZIP/Postal Code
4814
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
AZ Sint-Jan Brugge-Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UCL Mont-Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Hospital Amaral Carvalho
City
Brasília
ZIP/Postal Code
70750-521
Country
Brazil
Facility Name
Hospital do CEPON
City
Brasília
ZIP/Postal Code
70750-521
Country
Brazil
Facility Name
Instituto do Cancer do Estado de São Paulo
City
Brasília
ZIP/Postal Code
70750-521
Country
Brazil
Facility Name
Santa Casa de Misericórdia de Porto Alegre
City
Brasília
ZIP/Postal Code
70750-521
Country
Brazil
Facility Name
Hospital da Cidade de Passo Fundo
City
Passo Fundo
ZIP/Postal Code
99010-260
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
University Multiprofile Hospital for Active Treatment "Dr. G. Stranski" EAD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G-3G3
Country
Canada
Facility Name
Vancouver General Hospital (VGH)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
The General Hospital of People's Liberation Army (301 Hospital)
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
ZIP/Postal Code
350001
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
ZIP/Postal Code
510030
Country
China
Facility Name
Lanzhou University Second Hospital
City
Lanzhou
ZIP/Postal Code
730030
Country
China
Facility Name
Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
West China Hospital, Sichuan University
City
Taiyuan
ZIP/Postal Code
30001
Country
China
Facility Name
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
City
Tianjin
ZIP/Postal Code
300020
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
ZIP/Postal Code
325015
Country
China
Facility Name
Tang Du Hospital, Fourth Military Medical University
City
Xi'an
ZIP/Postal Code
710038
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Facility Name
Klinička Bolnica Dubrava
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinička Bolnica Merkur
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Klinički Bolnički Centar Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Fakultní Nemocnice Hradec Králové
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultní Nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Fakultní Nemocnice Ostrava
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Fakultni Nemocnice Plzen
City
Plzen
ZIP/Postal Code
304 60
Country
Czechia
Facility Name
Vseobecna Fakultni Nemocnice, Ustav hematologie a krevni transfuze (UHKT)
City
Praha 2
ZIP/Postal Code
128 20
Country
Czechia
Facility Name
Hospital A. Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Centre Hospitalier de Versailles - Hôpital André Mignot
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Facility Name
Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
L'Institut Paoli - Calmettes
City
Marguerittes
ZIP/Postal Code
13009
Country
France
Facility Name
Hôpital de la Conception
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CHRU Montpellier - Saint Eloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hôpital Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hôpital Haut-Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier Lyon-Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Henri Becquerel - Centre de Lutte Contre le Cancer
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
HELIOS Klinikum Bad Saarow
City
Bad Saarow
ZIP/Postal Code
15526
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Städtisches Klinikum Braunschweig gGmbH
City
Braunschweig
ZIP/Postal Code
38114
Country
Germany
Facility Name
Marien Hospital Düsseldorf GmbH
City
Düsseldorf
ZIP/Postal Code
40479
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitätsklinikum Halle (Saale)
City
Halle
ZIP/Postal Code
6120
Country
Germany
Facility Name
Evangelisches Krankenhaus Hamm gGmbH
City
Hamm
ZIP/Postal Code
59063
Country
Germany
Facility Name
Medizinische Hochschule Hannover (MHH)
City
Hannöver
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
4103
Country
Germany
Facility Name
Stauferklinikum Schwäbisch Gmünd
City
Mutlangen
ZIP/Postal Code
73557
Country
Germany
Facility Name
HELIOS Klinikum Wuppertal
City
Wuppertal
ZIP/Postal Code
42283
Country
Germany
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong
Facility Name
Markusovszky Egyetemi Oktatókórház
City
Budapest
ZIP/Postal Code
1051
Country
Hungary
Facility Name
Szegedi Tudományegyetem
City
Budapest
ZIP/Postal Code
1051
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Központ
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Pecsi Tudomanyegyetem Klinikai Központ
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Markusovszky Egyetemi Oktatókórház
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Assaf Harofeh Medical Center
City
Be'er Ya'aqov
State/Province
Tsifrin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah University Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center - Beilinson Hospital
City
Petaẖ Tiqwa
ZIP/Postal Code
49100
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Azienda Ospedaliera Nazionale SS.Antonio e Biagio e Cesare Arrigo
City
Alessandria
ZIP/Postal Code
15121
Country
Italy
Facility Name
Azienda Sanitaria Locale 13 - Ospedale "C. e G. Mazzoni"- Ascoli Piceno
City
Ascoli Piceno
ZIP/Postal Code
63100
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria Consorziale Policlinico di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
IRCCS AOU San Martino - IST
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
A.O.R.N. "A. Cardarelli"
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Ospedale S. Maria delle Croci - Ravenna
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
133
Country
Italy
Facility Name
Ospedale S. Eugenio
City
Roma
ZIP/Postal Code
133
Country
Italy
Facility Name
Policlinico Tor Vergata
City
Roma
ZIP/Postal Code
133
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele
City
Roma
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Careggi
City
Roma
ZIP/Postal Code
50134
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara
City
Roma
ZIP/Postal Code
56126
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria "Federico II"
City
Roma
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi d'Aragona
City
Salerno
ZIP/Postal Code
84131
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Azienda Ospedaliera Ordine Mauriziano di Torino
City
Torino
ZIP/Postal Code
10128
Country
Italy
Facility Name
ASST dei Sette Laghi - Ospedale di Circolo e Fondazione Macchi Varese
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
National Hospital Organization Nagoya Medical Center
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Facility Name
Nagoya University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Toyohashi Municipal Hospital
City
Toyohashi
State/Province
Aichi
ZIP/Postal Code
441-8570
Country
Japan
Facility Name
Ehime Prefectural Central Hospital
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
790-0024
Country
Japan
Facility Name
University of Fukui Hospital
City
Yoshida
State/Province
Fukui
ZIP/Postal Code
910-1193
Country
Japan
Facility Name
Kyushu University Hospital
City
Higashi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Gunmaken Saiseikai Maebashi Hospital
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-0821
Country
Japan
Facility Name
Gunma University Hospital
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Chugoku Central Hospital
City
Fukuyama
State/Province
Hiroshima
ZIP/Postal Code
720-0001
Country
Japan
Facility Name
Sapporo Hokuyu Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0006
Country
Japan
Facility Name
Yokohama City University Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
National Hospital Organization Sendai Medical Center
City
Sendai
State/Province
Miagi
ZIP/Postal Code
983-8520
Country
Japan
Facility Name
Tenri Hospital
City
Tenri
State/Province
Nara
ZIP/Postal Code
632-8552
Country
Japan
Facility Name
Hamamatsu University Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital
City
Bunkyō-Ku
State/Province
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
The Jikei University Hospital
City
Minato-Ku
State/Province
Tokyo
ZIP/Postal Code
105-0003
Country
Japan
Facility Name
Akita University Hospital
City
Akita
ZIP/Postal Code
010-8543
Country
Japan
Facility Name
Aomori Prefectural Central Hospital
City
Aomori
ZIP/Postal Code
030-8553
Country
Japan
Facility Name
Chiba Aoba Municipal Hospital
City
Chiba
ZIP/Postal Code
260-0852
Country
Japan
Facility Name
Kameda Medical Center - Kameda General Hospital
City
Chiba
ZIP/Postal Code
296-0041
Country
Japan
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Gifu Municipal Hospital
City
Gifu
ZIP/Postal Code
500-8513
Country
Japan
Facility Name
National Hospital Organization Kagoshima Medical Center
City
Kagoshima
ZIP/Postal Code
892-0853
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
National Hospital Organization Kumamoto Medical Center
City
Kumamoto
ZIP/Postal Code
860-0008
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Osaka City General Hospital
City
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Osaka Red Cross Hospital
City
Osaka
ZIP/Postal Code
543-8555
Country
Japan
Facility Name
NTT Medical Center Tokyo
City
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Daegu Catholic University Medical Center
City
Daegu
ZIP/Postal Code
42472
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Gachon University Gil Hospital
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
3722
Country
Korea, Republic of
Facility Name
SoonChunHyang University Seoul Hospital
City
Seoul
ZIP/Postal Code
4401
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
5030
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
6351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
6591
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
8308
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Sŏwŏn
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Ulsan University Hospital (UUH)
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
Facility Name
Szpital Uniwersytecki w Krakowie
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka
City
Słupsk
ZIP/Postal Code
76-200
Country
Poland
Facility Name
Instytut Hematologii i Transfuzjologi
City
Warszawa
ZIP/Postal Code
00-957
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr. 1 we Wrocławiu
City
Warszawa
ZIP/Postal Code
50367
Country
Poland
Facility Name
Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Centro Hospitalar Lisboa Central, EPE - Hospital Santo António dos Capuchos
City
Lisboa
ZIP/Postal Code
1169050
Country
Portugal
Facility Name
Centro Hospitalar do Porto, EPE - Hospital Geral de Santo António
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Instituto Português Oncologia do Porto Francisco Gentil, EPE
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Centro Hospitalar de São João, EPE - Hospital de São João
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Institutul Regional de Oncologie Iași
City
Bucuresti
ZIP/Postal Code
20125
Country
Romania
Facility Name
Spitalul Clinic Colentina
City
Bucuresti
ZIP/Postal Code
20125
Country
Romania
Facility Name
Spitalul Clinic Coltea
City
Bucuresti
ZIP/Postal Code
20125
Country
Romania
Facility Name
Spitalul Universitar de Urgenta Bucuresti
City
Bucuresti
ZIP/Postal Code
20125
Country
Romania
Facility Name
Institutul Clinic Fundeni
City
Bucuresti
ZIP/Postal Code
22328
Country
Romania
Facility Name
Institutul Oncologic "Prof. Dr. Ion Chiricuţă" Cluj Napoca
City
Cluj-Napoca
ZIP/Postal Code
400124
Country
Romania
Facility Name
Spitalul Clinic Municipal Filantropia Craiova
City
Craiova
ZIP/Postal Code
200143
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Târgu-Mureş (4005)
City
Târgu-Mureş
ZIP/Postal Code
540042
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Târgu-Mureş (4008)
City
Târgu-Mureş
ZIP/Postal Code
540136
Country
Romania
Facility Name
Nizhny Novgorod Regional Clinical Hospital
City
Nizhny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Penza Regional Oncology Dispensary
City
Penza
ZIP/Postal Code
440071
Country
Russian Federation
Facility Name
Republican Hospital n.a.V.A. Baranov
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Ryazan Regional Clinical Hospital
City
Ryazan'
ZIP/Postal Code
390039
Country
Russian Federation
Facility Name
Almazov Federal North-West Medical Research Centre
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Saratov State Medical University named after V.I. Razumovsky
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
Russian Research Institute of Hematology and Blood Transfusion
City
St. Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
Leningrad Regional Clinic and Hospital
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Tula Regional Clinical Hospital
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
Facility Name
Klinički Centar Srbije
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Klinički Centar Niš
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
Klinički Centar Vojvodine
City
Novi Sad
ZIP/Postal Code
21101
Country
Serbia
Facility Name
National University Hospital (S) Pte Ltd
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
138543
Country
Singapore
Facility Name
Hospital Universitari Son Espases
City
Palma
State/Province
Mallorca
ZIP/Postal Code
7014
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Albacete - Hospital General Universitario
City
Albacete
ZIP/Postal Code
2006
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
3010
Country
Spain
Facility Name
Catalan Institute of Oncology (ICO)
City
Badalona
ZIP/Postal Code
8916
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital Clinic i Provincial
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Hospital Duran i Reynals
City
Barcelona
ZIP/Postal Code
8907
Country
Spain
Facility Name
Hospital de Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital San Pedro de Alcántara
City
Cáceres
ZIP/Postal Code
10002
Country
Spain
Facility Name
Hospital Universitario Reina Sofía
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitari de Girona Doctor Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Complejo Hospitalario Universitario Granada
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Complexo Hospitalario Universitario A Coruña
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Dr. Negrín
City
Las Palmas De Gran Canaria
ZIP/Postal Code
35010
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Quirón Madrid
City
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro - Majadahonda
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Regional Universitario de Málaga - Hospital General
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Fundación Jiménez Díaz
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Clínico Universitario "Lozano Blesa"
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital General Universitario Morales Meseguer
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Álvaro Cunqueiro
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hosp Universitario Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clínico Universitario
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitari Joan XXIII de Tarragona
City
Tarragona
ZIP/Postal Code
43005
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitario Dr. Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Hospital Universitari i Politècnic La Fe
City
Valencia
ZIP/Postal Code
CP 46026
Country
Spain
Facility Name
Chang Gung Medical Foundation - Kaohsiung Branch
City
Kaohsiung
State/Province
Niaosong District
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Chang Gung Medical Foundation - Linkou Branch
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Cherkasy Regional Oncology Dispensary
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Poltava Regional Clinical Hospital named after M. V. Sklifosovskoho
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
Vinnitsa Regional Clinical Hospital im. N.I. Pirogov
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Zhitomir Regional Clinical Hospital
City
Zhytomyr
ZIP/Postal Code
10002
Country
Ukraine
Facility Name
Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital
City
Maidstone
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD Sharing Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD Sharing Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/
Citations:
PubMed Identifier
29859851
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.
Results Reference
derived

Learn more about this trial

Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)

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