AzTrials
AzTrials

Acute Myeloid LeukemiaPhase 3QuANTUM-FirstNCT02668653

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

A Phase 3 study testing Chemotherapy and Quizartinib in people with Acute Myeloid Leukemia and Leukemia, run by Daiichi Sankyo at 244 sites in 28 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Myeloid Leukemia, Leukemia
What is being tested?
Chemotherapy and Quizartinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
539 participants
Where
244 sitesin 28 countries
Study dates
1 Sep 2016to 16 Jun 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • Adequate renal function defined as:
  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

244 sites in 28 countries.

244 sites in 28 countries

Spain37 sites

  • Complexo Hospitalario Universitario A Coruña

    A Coruña, 15006

  • Complejo Hospitalario Universitario de Albacete - Hospital General Universitario

    Albacete, 2006

  • Hospital General Universitario de Alicante

    Alicante, 3010

  • Catalan Institute of Oncology (ICO)

    Badalona, 8916

  • Hospital del Mar

    Barcelona, 8003

  • Hospital Universitario Vall d'Hebron

    Barcelona, 8035

  • Hospital Clinic i Provincial

    Barcelona, 8036

  • Hospital Duran i Reynals

    Barcelona, 8907

  • Hospital de Basurto

    Bilbao, 48013

  • Hospital San Pedro de Alcántara

    Cáceres, 10002

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Hospital Universitari de Girona Doctor Josep Trueta

    Girona, 17007

  • Complejo Hospitalario Universitario Granada

    Granada, 18014

  • Hospital Dr. Negrín

    Las Palmas de Gran Canaria, 35010

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Quirón Madrid

    Madrid, 28223

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, 28222

  • Hospital Regional Universitario de Málaga - Hospital General

    Málaga, 29010

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Hospital Universitari Son Espases

    Palma, Mallorca, 7014

  • Complejo Hospitalario de Navarra

    Pamplona, 31008

  • Fundación Jiménez Díaz

    Pamplona, 31008

  • Hospital Clínico Universitario "Lozano Blesa"

    Pamplona, 31008

  • Hospital General Universitario Morales Meseguer

    Pamplona, 31008

  • Hospital Universitario Miguel Servet

    Pamplona, 31008

  • Hospital Álvaro Cunqueiro

    Pamplona, 31008

  • Hosp Universitario Salamanca

    Salamanca, 37007

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clínico Universitario

    Santiago de Compostela, 15706

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Hospital Universitari Joan XXIII de Tarragona

    Tarragona, 43005

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitario Dr. Peset

    Valencia, 46017

  • Hospital Universitari i Politècnic La Fe

    Valencia, CP 46026

Other trials in Spain

Japan29 sites

  • Akita University Hospital

    Akita, 010-8543

  • Aomori Prefectural Central Hospital

    Aomori, 030-8553

  • Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital

    Bunkyō-Ku, Tokyo, 113-8677

  • Chiba Aoba Municipal Hospital

    Chiba, 260-0852

  • Kameda Medical Center - Kameda General Hospital

    Chiba, 296-0041

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Chugoku Central Hospital

    Fukuyama, Hiroshima, 720-0001

  • Gifu Municipal Hospital

    Gifu, 500-8513

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3192

  • Kyushu University Hospital

    Higashi, Fukuoka, 812-8582

  • National Hospital Organization Kagoshima Medical Center

    Kagoshima, 892-0853

  • Kobe City Medical Center General Hospital

    Kobe, 650-0047

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, 860-0008

  • Gunmaken Saiseikai Maebashi Hospital

    Maebashi, Gunma, 371-0821

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511

  • Ehime Prefectural Central Hospital

    Matsuyama, Ehime, 790-0024

  • The Jikei University Hospital

    Minato-Ku, Tokyo, 105-0003

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • National Hospital Organization Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

  • Osaka City General Hospital

    Osaka, 534-0021

  • Osaka Red Cross Hospital

    Osaka, 543-8555

  • Sapporo Hokuyu Hospital

    Sapporo, Hokkaido, 003-0006

  • National Hospital Organization Sendai Medical Center

    Sendai, Miagi, 983-8520

  • Tenri Hospital

    Tenri, Nara, 632-8552

  • NTT Medical Center Tokyo

    Tokyo, 141-8625

  • Toyohashi Municipal Hospital

    Toyohashi, Aichi-ken, 441-8570

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004

  • University of Fukui Hospital

    Yoshida, Fukui, 910-1193

Other trials in Japan

Italy24 sites

  • Azienda Ospedaliera Nazionale SS.Antonio e Biagio e Cesare Arrigo

    Alessandria, 15121

  • Azienda Sanitaria Locale 13 - Ospedale "C. e G. Mazzoni"- Ascoli Piceno

    Ascoli Piceno, 63100

  • Azienda Ospedaliero - Universitaria Consorziale Policlinico di Bari

    Bari, 70124

  • Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi

    Bologna, 40138

  • IRCCS AOU San Martino - IST

    Genova, 16132

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • A.O.R.N. "A. Cardarelli"

    Naples, 80131

  • Azienda Ospedaliero Universitaria Maggiore della Carità di Novara

    Novara, 28100

  • Azienda Ospedaliero - Universitaria San Luigi Gonzaga

    Orbassano, 10043

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

    Palermo, 90146

  • Ospedale S. Maria delle Croci - Ravenna

    Ravenna, 48121

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 133

  • Ospedale S. Eugenio

    Roma, 133

  • Policlinico Tor Vergata

    Roma, 133

  • IRCCS Ospedale San Raffaele

    Roma, 20132

  • Azienda Ospedaliero-Universitaria Careggi

    Roma, 50134

  • Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara

    Roma, 56126

  • Azienda Ospedaliera Universitaria "Federico II"

    Roma, 80131

  • Istituto Clinico Humanitas

    Rozzano, 20089

  • Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi d'Aragona

    Salerno, 84131

  • Azienda Ospedaliera Universitaria Senese

    Siena, 53100

  • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette

    Torino, 10126

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino, 10128

  • ASST dei Sette Laghi - Ospedale di Circolo e Fondazione Macchi Varese

    Varese, 21100

Other trials in Italy

South Korea18 sites

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Pusan National University Hospital

    Busan, 49241

  • Kyungpook National University Hospital

    Daegu, 41944

  • Yeungnam University Medical Center

    Daegu, 42415

  • Daegu Catholic University Medical Center

    Daegu, 42472

  • Chonnam National University Hwasun Hospital

    Hwasun, 58128

  • Gachon University Gil Hospital

    Incheon, 21565

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Seoul National University Hospital

    Seoul, 3080

  • Severance Hospital

    Seoul, 3722

  • SoonChunHyang University Seoul Hospital

    Seoul, 4401

  • Konkuk University Medical Center

    Seoul, 5030

  • Asan Medical Center

    Seoul, 5505

  • Samsung Medical Center

    Seoul, 6351

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 6591

  • Korea University Guro Hospital

    Seoul, 8308

  • Ajou University Hospital

    Sŏwŏn, 16499

  • Ulsan University Hospital (UUH)

    Ulsan, 44033

Other trials in South Korea

Germany15 sites

  • HELIOS Klinikum Bad Saarow

    Bad Saarow, 15526

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

  • Städtisches Klinikum Braunschweig gGmbH

    Braunschweig, 38114

  • Marien Hospital Düsseldorf GmbH

    Düsseldorf, 40479

  • Universitätsklinikum Essen

    Essen, 45122

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60590

  • Universitätsklinikum Halle (Saale)

    Halle, 6120

  • Evangelisches Krankenhaus Hamm gGmbH

    Hamm, 59063

  • Medizinische Hochschule Hannover (MHH)

    Hannover, 30625

  • Universitätsklinikum Münster

    Heidelberg, 69115

  • Universitätsklinikum Tübingen

    Heidelberg, 69115

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Universitätsklinikum Leipzig

    Leipzig, 4103

  • Stauferklinikum Schwäbisch Gmünd

    Mutlangen, 73557

  • HELIOS Klinikum Wuppertal

    Wuppertal, 42283

Other trials in Germany

France13 sites

  • Hospital A. Michallon

    Grenoble, 38043

  • Centre Hospitalier de Versailles - Hôpital André Mignot

    Le Chesnay, 78150

  • Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

    Lille, 59037

  • Centre Léon Bérard

    Lyon, 69373

  • L'Institut Paoli - Calmettes

    Marguerittes, 13009

  • Hôpital de la Conception

    Marseille, 13385

  • CHRU Montpellier - Saint Eloi

    Montpellier, 34295

  • Hôpital Saint-Antoine

    Paris, 75012

  • Hôpital Saint-Louis

    Paris, 75475

  • Hôpital Haut-Lévêque

    Pessac, 33604

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69495

  • Centre Henri Becquerel - Centre de Lutte Contre le Cancer

    Rouen, 76038

  • Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan

    Toulouse, 31059

Other trials in France

United States11 sites

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

  • University Hospitals Seidman Cancer Center

    Cleveland, Ohio, 44106

  • Duke Clinical Research Institute

    Durham, North Carolina, 27710

  • University of Florida (UF) Health Shands Hospital

    Gainesville, Florida, 90095

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Franciscan St. Francis Health Indianapolis

    Indianapolis, Indiana, 46237

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536

  • West Virginia University Hospitals, Inc.

    Morgantown, West Virginia, 26506

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • NY Medical College - Hudson Valley Hematology Oncology Associates

    Valhalla, New York, 10595

Other trials in United States

China11 sites

  • Peking University First Hospital

    Beijing, 100034

  • The General Hospital of People's Liberation Army (301 Hospital)

    Beijing, 100853

  • Fujian Medical University Union Hospital

    Fuzhou, 350001

  • Guangdong General Hospital

    Guangzhou, 510030

  • Lanzhou University Second Hospital

    Lanzhou, 730030

  • Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School

    Shanghai, 200025

  • West China Hospital, Sichuan University

    Taiyuan, 30001

  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

    Tianjin, 300020

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325015

  • Tang Du Hospital, Fourth Military Medical University

    Xi'an, 710038

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Romania9 sites

  • Institutul Regional de Oncologie Iași

    Bucharest, 20125

  • Spitalul Clinic Colentina

    Bucharest, 20125

  • Spitalul Clinic Coltea

    Bucharest, 20125

  • Spitalul Universitar de Urgenta Bucuresti

    Bucharest, 20125

  • Institutul Clinic Fundeni

    Bucharest, 22328

  • Institutul Oncologic "Prof. Dr. Ion Chiricuţă" Cluj Napoca

    Cluj-Napoca, 400124

  • Spitalul Clinic Municipal Filantropia Craiova

    Craiova, 200143

  • Spitalul Clinic Judetean de Urgenta Târgu-Mureş (4005)

    Târgu Mureş, 540042

  • Spitalul Clinic Judetean de Urgenta Târgu-Mureş (4008)

    Târgu Mureş, 540136

Other trials in Romania

Russia9 sites

  • Nizhny Novgorod Regional Clinical Hospital

    Nizhny Novgorod, 603126

  • Penza Regional Oncology Dispensary

    Penza, 440071

  • Republican Hospital n.a.V.A. Baranov

    Petrozavodsk, 185019

  • Ryazan Regional Clinical Hospital

    Ryazan, 390039

  • Russian Research Institute of Hematology and Blood Transfusion

    Saint Petersburg, 191024

  • Leningrad Regional Clinic and Hospital

    Saint Petersburg, 194291

  • Almazov Federal North-West Medical Research Centre

    Saint Petersburg, 197341

  • Saratov State Medical University named after V.I. Razumovsky

    Saratov, 410012

  • Tula Regional Clinical Hospital

    Tula, 300053

Other trials in Russia

Israel7 sites

  • Assaf Harofeh Medical Center

    Be’er Ya‘aqov, Tsifrin, 70300

  • Bnai Zion Medical Center

    Haifa, 31048

  • Rambam Medical Center

    Haifa, 31096

  • Hadassah University Medical Center

    Jerusalem, 91120

  • Rabin Medical Center - Beilinson Hospital

    Petah Tikva, 49100

  • The Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Brazil6 sites

  • Hospital Amaral Carvalho

    Brasília, 70750-521

  • Hospital do CEPON

    Brasília, 70750-521

  • Instituto do Cancer do Estado de São Paulo

    Brasília, 70750-521

  • Santa Casa de Misericórdia de Porto Alegre

    Brasília, 70750-521

  • Hospital da Cidade de Passo Fundo

    Passo Fundo, 99010-260

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, 90035-903

Other trials in Brazil

Hungary6 sites

  • Markusovszky Egyetemi Oktatókórház

    Budapest, 1051

  • Szegedi Tudományegyetem

    Budapest, 1051

  • Semmelweis Egyetem

    Budapest, 1083

  • Debreceni Egyetem Klinikai Központ

    Debrecen, 4032

  • Pecsi Tudomanyegyetem Klinikai Központ

    Pécs, 7624

  • Markusovszky Egyetemi Oktatókórház

    Szombathely, 9700

Other trials in Hungary

Taiwan6 sites

  • Chang Gung Medical Foundation - Kaohsiung Branch

    Kaohsiung City, Niaosong District, 83301

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Medical Foundation - Linkou Branch

    Taoyuan, 33305

Other trials in Taiwan

Czechia5 sites

  • Fakultní Nemocnice Hradec Králové

    Hradec Králové, 500 05

  • Fakultní Nemocnice Olomouc

    Olomouc, 775 20

  • Fakultní Nemocnice Ostrava

    Ostrava, 708 52

  • Fakultni Nemocnice Plzen

    Pilsen, 304 60

  • Vseobecna Fakultni Nemocnice, Ustav hematologie a krevni transfuze (UHKT)

    Prague, 128 20

Other trials in Czechia

Portugal5 sites

  • Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra

    Coimbra, 3000-075

  • Centro Hospitalar Lisboa Central, EPE - Hospital Santo António dos Capuchos

    Lisbon, 1169050

  • Centro Hospitalar do Porto, EPE - Hospital Geral de Santo António

    Porto, 4099-001

  • Instituto Português Oncologia do Porto Francisco Gentil, EPE

    Porto, 4200-072

  • Centro Hospitalar de São João, EPE - Hospital de São João

    Porto, 4200-319

Other trials in Portugal

Australia4 sites

  • Townsville Hospital (TTH)

    Douglas, Queensland, 4814

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada4 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • University of Alberta Hospital

    Edmonton, Alberta, T6G-3G3

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 1X5

  • Vancouver General Hospital (VGH)

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Poland4 sites

  • Szpital Uniwersytecki w Krakowie

    Krakow, 31-501

  • Wojewódzki Szpital Specjalistyczny im. Janusza Korczaka

    Słupsk, 76-200

  • Instytut Hematologii i Transfuzjologi

    Warsaw, 00-957

  • Samodzielny Publiczny Szpital Kliniczny Nr. 1 we Wrocławiu

    Warsaw, 50367

Other trials in Poland

Ukraine4 sites

  • Cherkasy Regional Oncology Dispensary

    Cherkasy, 18009

  • Poltava Regional Clinical Hospital named after M. V. Sklifosovskoho

    Poltava, 36011

  • Vinnitsa Regional Clinical Hospital im. N.I. Pirogov

    Vinnytsia, 21018

  • Zhitomir Regional Clinical Hospital

    Zhytomyr, 10002

Other trials in Ukraine

Belgium3 sites

  • AZ Sint-Jan Brugge-Oostende AV

    Bruges, 8000

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • UCL Mont-Godinne

    Yvoir, 5530

Other trials in Belgium

Croatia3 sites

  • Klinička Bolnica Dubrava

    Zagreb, 10000

  • Klinička Bolnica Merkur

    Zagreb, 10000

  • Klinički Bolnički Centar Zagreb

    Zagreb, 10000

Other trials in Croatia

Serbia3 sites

  • Klinički Centar Srbije

    Belgrade, 11000

  • Klinički Centar Niš

    Niš, 18000

  • Klinički Centar Vojvodine

    Novi Sad, 21101

Other trials in Serbia

Argentina2 sites

  • Sanatorio Allende

    Córdoba, X5000JHQ

  • Sanatorio Britanico

    Rosario, Santa Fe Province, S2000CVB

Other trials in Argentina

Bulgaria2 sites

  • University Multiprofile Hospital for Active Treatment "Dr. G. Stranski" EAD

    Pleven, 5800

  • University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD

    Sofia, 1000

Other trials in Bulgaria

Singapore2 sites

  • National University Hospital (S) Pte Ltd

    Singapore, 119074

  • Singapore General Hospital

    Singapore, 138543

Other trials in Singapore

Hong Kong1 site

  • Prince of Wales Hospital

    Shatin

Other trials in Hong Kong

United Kingdom1 site

  • Maidstone and Tunbridge Wells NHS Trust - Maidstone Hospital

    Maidstone, ME16 9QQ

Other trials in United Kingdom

About this study

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)

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.

Read the 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.

Being tested
Chemotherapy, Quizartinib, Placebo
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
Medical subject headings
Leukemia, Myeloid, Acute, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChemotherapyDrug

    Also called Cytarabine, Daunorubicin, Idarubicin

  • QuizartinibDrug

    Also called Test Product

  • PlaceboDrug

    Also called Placebo Control

Study groups in NCT02668653
Study groupRoleWhat they receive
Chemotherapy plus quizartinibExperimentalInduction: 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
Receives: Drug: Chemotherapy; Drug: Quizartinib
Chemotherapy plus placeboActive comparatorInduction: 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
Receives: Drug: Chemotherapy; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Date of randomization to the date of death due to any cause, up to approximately 3 years after enrollment

Secondary outcomes (9)

  1. 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.

    Measured: Date of randomization to the date of refractory disease, relapse, or death, up to approximately 3 years after enrollment

  2. 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 <5% blasts, >1000 neutrophils, >100,000 platelets, and other [defined as absence of extramedullary disease [EMD], blasts with rods, and leukemic blasts], after induction

    Measured: Approximately Cycle 1 Day 21 (Induction) to end of Induction, up to approximately 120 days (each Induction cycle is up to 60 days)

  3. 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 <5% blasts, >1000 neutrophils, >100,000 platelets, and other [defined as absence of extramedullary disease [EMD], blasts with rods, and leukemic blasts], or CR with incomplete neutrophil or platelet recovery (CRi) at the end of first Induction cycle.

    Measured: Approximately Cycle 1 Day 21 (Induction) to end of Induction, up to approximately 120 days (each Induction cycle is up to 60 days)

  4. 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.

    Measured: 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)

  5. 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 <5% blasts, >1000 neutrophils, >100,000 platelets, and other [defined as absence of extramedullary disease [EMD], blasts with rods, and leukemic blasts]. 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.

    Measured: 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)

  6. 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 <5% blasts, >1000 neutrophils, >100,000 platelets, and other [defined as absence of extramedullary disease [EMD], blasts with rods, and leukemic blasts], 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.

    Measured: 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)

  7. Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve at Steady State

    AUCss was assessed by population Pharmacokinetic (PK) analysis during Cycle 1 of each phase.

    Measured: 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)

  8. Pharmacokinetic Parameter Steady State, Maximum Plasma Concentration (Css,Max)

    Css,max was assessed by population PK analysis during Cycle 1 of each phase.

    Measured: 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)

  9. 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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2016 (estimated)
  2. Study start1 Sep 2016
  3. Primary completion13 Aug 2021
  4. Study completion16 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
539 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02668653
Sponsor's protocol ID
AC220-A-U302
Other IDs
2015-004856-24, 173667, 2015
Acronym
QuANTUM-First
Status last verified
Jul 2024
First submitted
22 Jan 2016
Last updated
6 Aug 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/

Publications

  • Montesinos P, Levis MJ, Patkowska E, Cortes J, Perl AE, Sekeres MA, Dombret H, Wang J, Schlenk RF, Liu L, Khan N, Rohrbach JEC, Nahar A, Burns K, Erba HP. Quizartinib in older patients (aged >/=60 years) with newly diagnosed FLT3-ITDpositive acute myeloid leukemia: subgroup analyses from QuANTUM-First. Haematologica. 2026 Oct 29. doi: 10.3324/haematol.2026.301241. Online ahead of print.

    PubMed 42952446

  • Levis MJ, Erba HP, Montesinos P, Patkowska E, Cortes J, Perl AE, Dombret H, Amadori S, Wang J, Schlenk RF, Liu L, Mostafa Kamel Y, Imadalou K, Laadem A, Burns K, Sekeres MA. Quizartinib for patients with newly diagnosed FLT3-ITD-positive AML who received maintenance therapy in QuANTUM-First. Blood Adv. 2026 Jun 23;10(12):4144-4159. doi: 10.1182/bloodadvances.2025017738.

    PubMed 41949390

  • Oliva EN, Cottone F, Unni S, Correges A, Hansen JB, Marston XL, Cortes J, Sekeres MA. Patient-reported outcomes in newly diagnosed patients with FLT3-internal-tandem-duplication-positive acute myeloid leukaemia receiving standard chemotherapy plus quizartinib or placebo (QuANTUM-First): a global, randomised, placebo-controlled, phase 3 trial. Lancet Haematol. 2026 Mar;13(3):e169-e180. doi: 10.1016/S2352-3026(25)00361-8.

    PubMed 41791832

  • Levis MJ, Erba HP, Montesinos P, Kim HJ, Vrhovac R, Patkowska E, Zak P, Wang PN, Connolly Rohrbach JE, Chang KCN, Liu L, Mostafa Kamel Y, Imadalou K, Lesegretain A, Cortes J, Sekeres MA, Dombret H, Amadori S, Wang J, Schlenk RF, Perl AE. FLT3-ITD measurable residual disease from the QuANTUM-First trial. Blood Adv. 2026 Feb 10;10(3):917-928. doi: 10.1182/bloodadvances.2025016444.

    PubMed 41052406

  • Schlenk RF, Montesinos P, Kim HJ, Romero-Aguilar A, Vrhovac R, Patkowska E, Zak P, Wang PN, Hanyok J, Liu L, Kamel YM, Imadalou K, Lesegretain A, Cortes J, Sekeres MA, Dombret H, Amadori S, Wang J, Perl AE, Levis MJ, Erba HP. Impact of hematopoietic cell transplantation and quizartinib in newly diagnosed patients with acute myeloid leukemia and FMS-like tyrosine kinase 3-internal tandem duplications in the QuANTUM-First trial. Haematologica. 2025 Sep 1;110(9):2024-2039. doi: 10.3324/haematol.2024.286623. Epub 2025 Mar 13.

    PubMed 40079105

  • Erba HP, Montesinos P, Kim HJ, Patkowska E, Vrhovac R, Zak P, Wang PN, Mitov T, Hanyok J, Kamel YM, Rohrbach JEC, Liu L, Benzohra A, Lesegretain A, Cortes J, Perl AE, Sekeres MA, Dombret H, Amadori S, Wang J, Levis MJ, Schlenk RF; QuANTUM-First Study Group. Quizartinib plus chemotherapy in newly diagnosed patients with FLT3-internal-tandem-duplication-positive acute myeloid leukaemia (QuANTUM-First): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 May 13;401(10388):1571-1583. doi: 10.1016/S0140-6736(23)00464-6. Epub 2023 Apr 25.

    PubMed 37116523

  • 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.

    PubMed 29859851

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Chemotherapy and Quizartinib in people with Acute Myeloid Leukemia and Leukemia, run by Daiichi Sankyo at 244 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 244 sites in Spain, Japan, Italy, South Korea, Germany and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival in Participants With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (time frame: Date of randomization to the date of death due to any cause, up to approximately 3 years after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02668653, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.

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