AzTrials
AzTrials

LeukemiaPhase 3QuANTUM-WILDNCT06578247

Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML

A Phase 3 study testing Quizartinib and Chemotherapy in people with Leukemia, run by Daiichi Sankyo at 284 sites in 28 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Leukemia
What is being tested?
Quizartinib and Chemotherapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
700 participants
Where
284 sitesin 28 countries
Study dates
19 Nov 2024to 26 Jun 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 70 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 (IRB)-approved ICF before performance of any trial-specific procedures or tests.
  • ≥18 years or the minimum legal adult age (whichever is greater) and ≤70 years (at Screening).
  • Newly diagnosed, morphologically documented primary AML based on the World Health Organization (WHO) 2016 classification (at Screening)
  • Eastern Cooperative Oncology Group (ECOG) performance status (at the time the participant signs their ICF) of 0-2.
  • Participant is a candidate for standard "7+3" induction chemotherapy regimen as specified in the protocol per investigator assessment

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 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.
  • Diagnosis of AML with known antecedent myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS/MPNs including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and others.
  • Participants with newly diagnosed AML with FLT3-ITD mutations (FLT3-ITD [+]) present at ≥5% VAF (or ≥0.05 SR) based on a validated FLT3 mutation assay.
  • Prior treatment for AML, except for the following allowances prior to Day 1 of chemotherapy:
  • Leukapheresis;
Show all 9Show fewer
  • Treatment for hyperleukocytosis with hydroxyurea;
  • Cranial radiotherapy for central nervous system (CNS) leukostasis;
  • Prophylactic intrathecal chemotherapy

Trial locations and contacts

284 sites in 28 countries.

284 sites in 28 countries

United States52 sites

  • University of Michigan Comprehensive Cancer Center Michigan Medicine

    Ann Arbor, Michigan, 48109

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • Augusta University

    Augusta, Georgia, 30912

  • South Austin Medical Center

    Austin, Texas, 78745

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263

  • University of North Carolina Hospitals

    Chapel Hill, North Carolina, 27514

  • Uva Health System

    Charlottesville, Virginia, 22908

  • Robert H Lurie Comprehensive Cancer Center Northwestern University

    Chicago, Illinois, 60611

  • University of Illinois Hospital & Health Sciences System

    Chicago, Illinois, 60612

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • The James Cancer Hospital and Solove Research Institute

    Columbus, Ohio, 43210

  • Ohio Health Research Institute

    Columbus, Ohio, 43214

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Duke Cancer Institute - Sarcoma Research

    Durham, North Carolina, 27710

  • City of Hope Phoenix

    Goodyear, Arizona, 85338

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Thomas Jefferson Univ Hosp

    Haddonfield, New Jersey, 08033

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030

  • Mayo Clinic Hospital

    Jacksonville, Florida, 32224

  • Florida Hospital Cancer Institute - Kissimmee

    Kissimmee, Florida, 34741

  • University of Kentucky

    Lexington, Kentucky, 40504

  • Memorial Sloan Kettering Cancer Center - Main

    Long Island City, New York, 11101

  • David Geffen School of Medicine

    Los Angeles, California, 90095

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Minnesota Medical School - Twin Cities Campus

    Minneapolis, Minnesota, 55455

  • Tristar Bone Marrow Transplant

    Nashville, Tennessee, 37203

  • Yale University

    New Haven, Connecticut, 06510

  • Ochsner Medical Center - New Orleans

    New Orleans, Louisiana, 70121

  • Memorial Sloan Kettering Cancer Center - Main

    New York, New York, 10065

  • Peggy & Charles Stephenson Oklahoma Cancer Ctr

    Oklahoma City, Oklahoma, 73104

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic - Phoenix

    Phoenix, Arizona, 85054

  • Upmc Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health & Science University (Ohsu)

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Virginia Commonwealth University (Vcu) Massey Cancer Center

    Richmond, Virginia, 23229

  • Mayo Clinic

    Rochester, Minnesota, 55902

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of California Davis Health System

    Sacramento, California, 95817

  • Ucsf Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • Washington University

    St Louis, Missouri, 63110

  • Stanford University School of Medicine- Parent

    Stanford, California, 94305

  • Upstate University Hospital

    Syracuse, New York, 13210

  • Tampa General Hospital

    Tampa, Florida, 33606

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • University of Arizona Cancer Center

    Tucson, Arizona, 85724

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

Other trials in United States

China26 sites

  • Peking University First Hospital

    Beijing, 100034

  • Peking University Third Hospital

    Beijing, 100191

  • Peking Union Medical College Hospital

    Beijing, 100730

  • The First Hospital of Jilin University

    Changchun, 130021

  • Xiangya Hospital, Central South University

    Changsha, 410008

  • The Second Xiangya Hospital of Central South University

    Changsha, 410011

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 400016

  • Sun Yat-Sen University, Cancer Center

    Guangzhou, 510060/510700

  • Guangdong Provincial People'S Hospital

    Guangzhou, 510080

  • Qilu Hospital of Shandong University

    Jinan, 250012

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330006

  • Zhong Da Hospital, Southeast University

    Nanjing, 210009

  • Affiliated Hospital of Nantong University

    Nantong, 226001

  • The Affiliated Hospital of Qingdao University

    Qingdao, 266071

  • Shanghai Tongren Hospital

    Shanghai, 200050

  • Shengjing Hospital of China Medical University

    Shengyang, 110004

  • Shenzhen Second People'S Hospital

    Shenzhen, 518029

  • The Second Hospital of Hebei Medicical University

    Shijiazhuang

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215006

  • Institute of Hematology and Hospital of Blood Disease

    Tianjin, 300020

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325015

  • Wuxi People'S Hospital

    Wuxi, 214023

  • The First Affiliated Hospital of Xiâan Jiaotong University

    Xi'an, 710061

  • Yantai Yuhuangding Hospital

    Yantai, 264000

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

Spain26 sites

  • Complejo Hospitalario Universitario de Albacete

    Albacete, 02006

  • Hospital General Universitario Doctor Balmis

    Alicante, 03010

  • Ico Badalona - Hospital Universitari Germans Trias I Pujol

    Badalona

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 8025

  • Hospital Universitari Vall D'Hebron

    Barcelona

  • Hospital Universitario De Burgos

    Burgos

  • Hospital San Pedro de Alcantara

    Cáceres, 10003

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Universitario de Gran Canaria Dr. Negrin

    Las Palmas

  • Clinica Universidad de Navarra

    Madrid, 28027

  • Md Anderson Cancer Centre

    Madrid, 28033

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, 28220

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008

  • Hospital Universitari Son Espases

    Palma de Mallorca, 07120

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, 28223

  • Hospital Clinico Universitario de Salamanca

    Salamanca

  • Hospital Universitario Marques de Valdecilla

    Santander, 39012

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, 15706

  • Hospital Universitario Virgen Del Rocio

    Seville, 41010

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitario Dr. Peset

    Valencia, 46017

  • Hospital Universitari I Politecnic La Fe

    Valencia, 46026

Other trials in Spain

France18 sites

  • Chu Angers - Hăpital Hătel Dieu

    Angers, 49033

  • Chu de Caen

    Caen, 14033

  • Chu de Grenoble - Hospital Albert Michallon

    La Tronche, 38700

  • Centre Hospitalier de Versailles

    Le Chesnay, 78150

  • Hopital Claude Huriez - Chru Lille

    Lille, 59037

  • Centre Léon Bérard

    Lyon, 69008

  • Hopital de La Conception - Aphm

    Marseille, 13005

  • Chu de Nantes - Hotel Dieu

    Nantes, 44093

  • CHU Nice - Hôpital de l'Archet 1

    Nice, 06200

  • Hospital Saint-Louis

    Paris, 75475

  • Chu de Bordeaux - Hăpital Haut-Lăvăque

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre BĂŠnite, 69495

  • Chu Rennes - Hopital Pontchaillou

    Rennes, 35000

  • Chu Amiens - Hopital Sud

    Salouël, 80480

  • Institut de Cancérologie de Strasbourg Europe - ICANS

    Strasbourg, 67200

  • Institut de Cancărologie de Strasbourg Europe - Icans

    Strasbourg, 67200

  • Institut Universitaire Du Cancer de Toulouse- Iuct-O

    Toulouse, 31059

  • Institut Gustave Roussy

    Villejuif

Other trials in France

Japan18 sites

  • Akita University Hospital

    Akita, 010-8543

  • Aomori Prefetural Central Hospital

    Aomori, 030-8553

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    Bunkyō City, 113-8677

  • Chiba Aoba Municipal Hospital

    Chiba, 260-0852

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Chugoku Central Hospital

    Fukuyama

  • Gifu Municipal Hospital

    Gifu

  • Hamamatsu University School of Medicine, University Hospital

    Hamamatsu, 431-3192

  • Tesshokai Kameda General Hospital

    Kamogawa-shi, 296-8602

  • Kanazawa University Hospital

    Kanazawa, 920-8641

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto

  • Saiseikai Maebashi Hospital

    Maebashi

  • Ehime Prefectural Central Hospital

    Matsuyama

  • Nagoya University Hospital

    Nagoya, 466-8560

  • Osaka Red Cross Hospital

    Osakar, 543-8555

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • Sapporo Hokuyu Hospital

    Sapporo

  • Tenri Hospital

    Tenri, 632-8552

Other trials in Japan

Brazil17 sites

  • Cetus Hospital Dia Oncologia

    Belo Horizonte

  • Unesp - Faculdade de Medicina Da Universidade Estadual Paulista - Campus Botucatu

    Botucatu, 18618-686

  • Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP

    Campinas, 13083-878

  • Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

    Curitiba, 81520-060

  • Cepon - Centro De Pesquisas Oncolagicas de Santa Catarina

    Florianópolis

  • HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

    Fortaleza, 60430-370

  • HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

    Goiânia, 74680160

  • Fundacao Doutor Amaral Carvalho

    Jaú, 17210-120

  • Hospital de Clínicas de Passo Fundo

    Passo Fundo, 99010-260

  • Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, 90035-074

  • Hospital de Clănicas de Porto Alegre

    Porto Alegre, 90035-903

  • INCA - Instituto Nacional de Cancer

    Rio de Janeiro

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

    Sao Jose Rio Preto, 15090-000

  • ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

    São Paulo, 01246-000

  • Hospital Beneficencia Portuguesa da Sao Paulo

    São Paulo, 01323-001

  • Hospital Nove de Julho

    São Paulo, 01409902

  • Sírio-Libanês Brasilia-Centro de Oncologia-Asa Sul

    São Paulo

Other trials in Brazil

South Korea17 sites

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Pusan National University Hospital

    Busan

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • Yeungnam University Hospital

    Daegu, 42415

  • Daegu Catholic University Medical Center

    Daegu, 42472

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, 58128

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Jeonbuk National University Hospital

    Jeonju, 54907

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Samsung Medical Center

    Seoul, 06351

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

    Seoul, 06591

  • Korea University Guro Hospital

    Seoul, 08308

  • Seoul National University Hospital

    Seoul, 110-744

  • Asan Medical Center

    Seoul, 5505

  • Ajou University Hospital

    Suwon, 16499

  • Ulsan University Hospital

    Ulsan, 44033

Other trials in South Korea

Italy15 sites

  • Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari

    Bari, 70124

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Spedali Civili)

    Brescia, 25100

  • Irccs Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori 'Dino Amadori' - Irst

    Meldola, 47014

  • Ospedale San Raffaele

    Milan, 20132

  • Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

    Milan, 20162

  • Ospedale Maggiore Di Novara

    Novara

  • Azienda Ospedaliera Vincenzo Cervello

    Palermo, 90146

  • Fondazione Policlinico Universitario Agostino Gemelli Irccs

    Roma, 168

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Rome, 133

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Rome

  • Istituto Clinico Humanitas

    Rozzano, 20089

  • Irccs Ospedale Casa Sollievo Della Sofferenza

    San Giovanni Rotondo, 71013

  • Azienda Ospedaliero-Universitaria Cittă Della Salute E Della Scienza Di Torino

    Torino, 10126

  • Ospedale Mauriziano Umberto I

    Torino, 10128

  • Asst Dei Sette Laghi Ospedale Di Circolo E Fondazione Macchi Varese

    Varese, 21100

Other trials in Italy

Australia12 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • Flinders Medical Centre (Fmc)

    Bedford Park, 5042

  • Flinders Medical Centre (Fmc)

    Bedford Park

  • Box Hill Hospital

    Box Hill, 3128

  • Concord Repatriation General Hospital

    Concord, 2139

  • St Vincent'S Hospital Melbourne

    Darlinghurst, 2010

  • Townsville University Hospital

    Douglas, 4814

  • Liverpool Hospital

    Liverpool, 2170

  • The Alfred Hospital

    Melbourne, 3004

  • Fiona Stanley Hospital

    Murdoch, 6150

  • Sir Charles Gairdner Hospital

    Perth, 6009

  • Princess Alexandra Hospital

    Woolloongabba, 4102

Other trials in Australia

Germany11 sites

  • Klinikum Aschaffenburg-Alzenau

    Alzenau in Unterfranken, 63755

  • Charité Campus Virchow-Klinikum

    Berlin

  • Staedtisches Klinikum Braunschweig Ggmbh

    Braunschweig, 38114

  • Universitaetsklinikum Carl Gustav Carus Tu Dresden

    Dresden, 01307

  • Universitaetsklinikum Essen

    Essen, 45147

  • Krh Klinikum Siloah

    Hanover, 30459

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Universitaetsklinikum Heidelberg

    Heidelberg

  • Universitaetsklinikum Schleswig-Holstein

    Kiel, 24105

  • Universitătsklinikum Leipzig Klinik Făr Hămatologie Internistische Onkologie Hămostaseol

    Leipzig, 4103

  • Universitaetsklinikum Muenster

    Münster

Other trials in Germany

United Kingdom8 sites

  • Queen Elizabeth Hospital

    Birmingham

  • Northwick Park Hospital

    Harrow, HA1 3UJ

  • King'S College Hospital

    London, SE5 9NU

  • Hammersmith Hospital

    London, W12 0HS

  • Maidstone Hospital

    Maidstone, ME16 9QQ

  • Manchester Royal Infirmary

    Manchester, M13 9WL

  • Churchill Hospital

    Oxford, OX3 7LJ

  • Torbay Hospital

    Torquay, TQ2 7AA

Other trials in United Kingdom

Belgium7 sites

  • Institut Jules Bordet

    Anderlecht, 1070

  • ZNA

    Antwerp, 2060

  • Az Sint-Jan

    Bruges, 8000

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Uz Leuven

    Leuven, 3000

  • Chu de Liage

    Liège, 4000

  • AZ DELTA

    Roeselare, 8800

Other trials in Belgium

Bulgaria6 sites

  • Umhat 'Dr. Georgi Stranski', Ead

    Pleven, 5800

  • Umhat 'Sv. Georgi', Ead

    Plovdiv, 4002

  • Umhat Âsv. Ivan Rilskiâ, Ead

    Sofia, 1431

  • Military Medical Academy - Mhat - Sofia

    Sofia, 1606

  • 'Shathd' Ead Sofia

    Sofia, 1797

  • Umhat Prof. Dr. Stoyan Kirkovich Ad

    Stara Zagora, 6000

Other trials in Bulgaria

Czechia6 sites

  • Fakultni Nemocnice Brno

    Brno, 625 00

  • Fakultni Nemocnice Hradec Kralove

    Hradec Králové, 50005

  • Fakultni Nemocnice Plzen

    Pilsen, 304 60

  • Fakultni Nemocnice Ostrava

    Poruba, 708 52

  • Fakultni Nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Ustav Hematologie A Krevni Transfuze

    Prague, 12800

Other trials in Czechia

Taiwan6 sites

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

  • China Medical University Hospital

    Taichung, 404327

  • National Cheng Kung University Hospitalx

    Tainan, 70403

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Memorial Hospital

    Taoyuan County, 00333

Other trials in Taiwan

Canada5 sites

  • London Health Sciences Centre

    London, N6A 5W9

  • McGill University - Dept. Oncology Clinical Research Program

    Montreal

  • The Ottawa Hospital - General Campus

    Ottawa, K1H 8L6

  • Saskatoon Cancer Centre

    Saskatoon, S7N 4H4

  • Princess Margaret Cancer Center

    Toronto, M5G 2M9

Other trials in Canada

Romania5 sites

  • Spitalul Clinic Colentina

    Bucharest, 020125

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • Spitalul Clinic Coltea

    Bucharest, 030171

  • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca

    Cluj-Napoca, 400015

  • Spitalul Clinic Municipal Filantropia Craiova

    Craiova, 200143

Other trials in Romania

Hungary4 sites

  • Semmelweis Egyetem

    Budapest, 1088

  • Debreceni Egyetem

    Debrecen, 4032

  • Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz

    Győr, 9024

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 6725

Other trials in Hungary

Austria3 sites

  • Ordensklinikum Linz Gmbh - Elisabethinen

    Linz, 4020

  • LKH - Universitätsklinikum der PMU Salzburg

    Salzburg, 5020

  • Hanusch Krankenhaus Der Wgkk Wien

    Vienna, 1140

Other trials in Austria

Croatia3 sites

  • Clinical Hospital Centre Rijeka

    Rijeka, 51000

  • Clinical Hospital Centar Zagreb

    Zagreb, 10000

  • Clinical Hospital Dubrava

    Zagreb, 10000

Other trials in Croatia

Norway3 sites

  • Haukeland Universitetssykehus

    Bergen, N-5021

  • Oslo University Hospital Rikshospitalet Clinical Research Unit

    Oslo

  • University Hospital of North Norway

    Tromsø, 9019

Other trials in Norway

Serbia3 sites

  • Military Medical Academy

    Belgrade, 11000

  • University Clinical Center of Serbia

    Belgrade, 11000

  • University Clinical Center Nis

    Niš, 18000

Other trials in Serbia

Sweden3 sites

  • Sahlgrenska Universitetssjukhuset

    Gasteborg, 41345

  • Skă Nes Universitetssjukhus, Lund

    Lund, 22185

  • Akademiska Sjukhuset

    Uppsala, 75185

Other trials in Sweden

Hong Kong2 sites

  • The University of Hong Kong

    Hong Kong

  • The Chinese University of Hong Kong (Cuhk)

    Shatin, 00000

Other trials in Hong Kong

Poland2 sites

  • Klinika Hematoonkologii I Transplantacji Szpiku

    Lublin, 20-081

  • Instytut Hematologii I Transfuzjologii

    Warsaw, 02-776

Other trials in Poland

Portugal2 sites

  • Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria

    Lisbon, 1649-035

  • Instituto Portugues De Oncologia do Porto Francisco Gentil, EPE

    Porto, 4200-072

Other trials in Portugal

Singapore2 sites

  • National University Hospital

    Singapore, 119228

  • Curie Oncology Pte Ltd

    Singapore, 329563

Other trials in Singapore

Switzerland2 sites

  • Inselspital - Universitaetsspital Bern

    Bern, 3010

  • Luzerner Kantonsspital - Luzern

    Lazern 16

Other trials in Switzerland

About this study

Official title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial Of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy and Administered as Maintenance Therapy in Adult Patients With Newly Diagnosed FLT3-ITD Negative Acute Myeloid Leukemia

This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).

Read the detailed description

This is a clinical trial to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as maintenance therapy for up to 36 cycles) on the primary endpoint of overall survival (OS) in adult patients with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML). Participants will be tested for FLT3-ITD mutation status in a central laboratory using a validated assay.

Conditions
Leukemia
Being tested
Quizartinib, Placebo, Chemotherapy
Keywords
acute myeloid leukemia, quizartinib, FLT3, FLT3-ITD, Chemotherapy, FLT3-WT
Medical subject headings
Leukemia, Leukemia, Myeloid, Acute

What participants receive

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

  • QuizartinibDrug

    Also called Test Product

    Participants will receive quizartinib at 60 mg/day orally once daily

  • PlaceboDrug

    Also called Placebo Control

    Participants will receive placebo at 60 mg/day orally once daily

  • ChemotherapyDrug

    Also called Cytarabine, Daunorubicin or Idarubicin, Standard Chemotherapy

    Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin or idarubicin).

Study groups in NCT06578247
Study groupRoleWhat they receive
Arm A: Quizartinib + ChemotherapyExperimentalParticipants will receive quizartinib at 60 mg/day orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive quizartinib at 60 mg/day orally once daily for up to 36 cycles (28-day cycle)
Receives: Drug: Quizartinib; Drug: Chemotherapy
Arm B: Placebo + ChemotherapyPlacebo comparatorParticipants will receive placebo at 60 mg/day orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive placebo at 60 mg/day orally once daily for up to 36 cycles (28-day cycle)
Receives: Drug: Placebo; Drug: Chemotherapy
Arm C: Quizartinib + Chemotherapy then Placebo MaintenanceExperimentalParticipants will receive quizartinib at 60 mg/day orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive placebo at 60 mg/day orally once daily for up to 36 cycles (28-day cycle)
Receives: Drug: Quizartinib; Drug: Placebo; Drug: Chemotherapy

What is being measured

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

  1. Overall Survival (Arm A vs Arm B)

    Overall survival (OS) is defined as the time from randomization until death from any cause.

    Measured: Date of first patient randomized to the target number of deaths reached, up to approximately 42 months

Secondary outcomes (6)

  1. Event-free survival (Arm A vs. Arm B)

    Event-free survival (EFS) is defined as time from randomization to date of failure to achieve CR at end of induction, relapse after CR, or death due to any cause, whichever occurs first

    Measured: Date of randomization up to approximately 42 months

  2. Duration of complete response (Arm A vs. Arm B)

    Duration of complete response (DoCR) is defined as time from the first documented CR until documented relapse or death due to any cause, whichever comes first. As assessed by Independent Review Committee.

    Measured: Date of randomization up to approximately 42 months

  3. Relapse-free survival (Arm A vs. Arm B)

    Relapse-free survival (RFS) is defined as time from randomization, for participants who achieve CR in the Induction Phase, until relapse or death due to any cause, whichever comes first. As assessed by Independent Review Committee .

    Measured: Date of randomization up to approximately 42 months

  4. Complete remission rate (Arm A vs. Arm B)

    Complete remission rate (CR) is defined as proportion of of participants who achieved a CR. As assessed by Independent Review Committee.

    Measured: At end of Induction Phase, up to approximately 120 days

  5. Complete remission rate with minimal or measurable residual disease (Arm A vs. Arm B)

    Proportion of participants achieving CR with minimal or measurable residual disease (MRD) negativity. As assessed by Independent Review Committee.

    Measured: At end of Induction Phase (Cycle 2 or Cycles 1 and 2), up to approximately 120 days

  6. Number of Participants With Treatment-emergent Adverse Events (Arm A vs. Arm B)

    Treatment-emergent adverse events (TEAE) are defined as those AEs with start or worsening date during the on-treatment period (from the first dose date of quizartinib/placebo to 30 days after the last dose date of quizartinib/placebo).

    Measured: Date of first dose up to 30 days after last dose, up to approximately 42 months

Timeline

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

  1. First posted29 Aug 2024
  2. Study start19 Nov 2024
  3. Primary completion26 Jun 2030 (estimated)
  4. Study completion26 Jun 2030 (estimated)

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, Care provider, Investigator
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06578247
Sponsor's protocol ID
AC220-168
Other IDs
2023-507936-20-00, 2023
Acronym
QuANTUM-WILD
Status last verified
Jun 2026
First submitted
14 Aug 2024
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) on completed studies 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, Altman JK, Bullinger L, Cheong JW, Fathi AT, Levis MJ, Luger S, Miyamoto T, Oliva EN, Perl AE, Recher C, Veiga RR, Wang J, Zeidan AM, Liu L, Duong Y, Rohrbach JEC, Inghirami G, Alexis K, Gosberg A, Nahar A, Burns K, Daver N, Erba HP. QuANTUM-Wild: a Phase III, randomized trial of quizartinib in newly diagnosed FLT3-ITD-negative acute myeloid leukemia. Future Oncol. 2026 Jul;22(16):1913-1924. doi: 10.1080/14796694.2026.2689464. Epub 2026 Jul 11.

    PubMed 42434847

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Quizartinib and Chemotherapy in people with Leukemia, run by Daiichi Sankyo at 284 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 5 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 284 sites in United States, China, Spain, France, Japan 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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 (Arm A vs Arm B) (time frame: Date of first patient randomized to the target number of deaths reached, up to approximately 42 months). 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 NCT06578247, which also lists 1 linked publication.

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 2 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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