Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML (QuANTUM-WILD)

April 28, 2026 updated by: Daiichi Sankyo

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).

Study Overview

Status

Recruiting

Conditions

Leukemia

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

700

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Daiichi Sankyo Contact for Clinical Trial Information
Phone Number: 908-992-6400
Email: CTRinfo_us@daiichisankyo.com

Study Locations

Australia
- - Adelaide, Australia, 5000
    - Not yet recruiting
    - Royal Adelaide Hospital
  - Bedford Park, Australia, 5042
    - Not yet recruiting
    - Flinders Medical Centre (Fmc)
  - Bedford Park, Australia
    - Recruiting
    - Flinders Medical Centre (Fmc)
  - Box Hill, Australia, 3128
    - Not yet recruiting
    - Box Hill Hospital
  - Concord, Australia, 2139
    - Not yet recruiting
    - Concord Repatriation General Hospital
  - Darlinghurst, Australia, 2010
    - Recruiting
    - St Vincent's Hospital Melbourne
  - Douglas, Australia, 4814
    - Not yet recruiting
    - Townsville University Hospital
  - Liverpool, Australia, 2170
    - Recruiting
    - Liverpool Hospital
  - Melbourne, Australia, 3004
    - Recruiting
    - The Alfred Hospital
  - Murdoch, Australia, 6150
    - Recruiting
    - Fiona Stanley Hospital
  - Perth, Australia, 6009
    - Recruiting
    - Sir Charles Gairdner Hospital
  - Woolloongabba, Australia, 4102
    - Recruiting
    - Princess Alexandra Hospital
Austria
- - Linz, Austria, 4020
    - Recruiting
    - Ordensklinikum Linz Gmbh - Elisabethinen
  - Salzburg, Austria, 5020
    - Recruiting
    - LKH - Universitätsklinikum der PMU Salzburg
  - Vienna, Austria, 1140
    - Not yet recruiting
    - Hanusch Krankenhaus Der Wgkk Wien
Belgium
- - Anderlecht, Belgium, 1070
    - Recruiting
    - Institut Jules Bordet
  - Antwerp, Belgium, 2060
    - Recruiting
    - ZNA
  - Bruges, Belgium, 8000
    - Recruiting
    - AZ Sint-Jan
  - Brussels, Belgium, 1200
    - Recruiting
    - Cliniques Universitaires Saint-luc
  - Leuven, Belgium, 3000
    - Recruiting
    - UZ Leuven
  - Liège, Belgium, 4000
    - Recruiting
    - Chu of Liège
  - Roeselare, Belgium, 8800
    - Recruiting
    - AZ Delta
Brazil
- - Belo Horizonte, Brazil
    - Active, not recruiting
    - Cetus Hospital Dia Oncologia
  - Botucatu, Brazil, 18618-686
    - Active, not recruiting
    - UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
  - Campinas, Brazil, 13083-878
    - Active, not recruiting
    - Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP
  - Curitiba, Brazil, 81520-060
    - Active, not recruiting
    - Hospital Erasto Gaertner - Liga Paranaense de Combate Ao Cancer
  - Florianópolis, Brazil
    - Active, not recruiting
    - Cepon - Centro de Pesquisas Oncolăgicas de Santa Catarina
  - Fortaleza, Brazil, 60430-370
    - Active, not recruiting
    - HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
  - Goiânia, Brazil, 74680160
    - Active, not recruiting
    - HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
  - Jaú, Brazil, 17210-120
    - Active, not recruiting
    - Fundacao Doutor Amaral Carvalho
  - Passo Fundo, Brazil, 99010-260
    - Active, not recruiting
    - Hospital de Clinicas de Passo Fundo
  - Porto Alegre, Brazil, 90035-074
    - Active, not recruiting
    - Santa Casa de Misericordia de Porto Alegre
  - Porto Alegre, Brazil, 90035-903
    - Active, not recruiting
    - Hospital de Clănicas de Porto Alegre
  - Rio de Janeiro, Brazil
    - Active, not recruiting
    - INCA - Instituto Nacional de Cancer
  - Sao Jose Rio Preto, Brazil, 15090-000
    - Active, not recruiting
    - Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
  - São Paulo, Brazil, 01246-000
    - Active, not recruiting
    - ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
  - São Paulo, Brazil, 01323-001
    - Active, not recruiting
    - Hospital Beneficencia Portuguesa da Sao Paulo
  - São Paulo, Brazil, 01409902
    - Active, not recruiting
    - Hospital Nove de Julho
  - São Paulo, Brazil
    - Active, not recruiting
    - Sírio-Libanês Brasilia-Centro de Oncologia-Asa Sul
Bulgaria
- - Pleven, Bulgaria, 5800
    - Recruiting
    - UMHAT 'Dr. Georgi Stranski', EAD
  - Plovdiv, Bulgaria, 4002
    - Not yet recruiting
    - Umhat 'Sv. Georgi', Ead
  - Sofia, Bulgaria, 1606
    - Not yet recruiting
    - Military Medical Academy - MHAT - Sofia
  - Sofia, Bulgaria, 1431
    - Recruiting
    - Umhat Âsv. Ivan Rilskiâ, Ead
  - Sofia, Bulgaria, 1797
    - Recruiting
    - 'Shathd' Ead Sofia
  - Stara Zagora, Bulgaria, 6000
    - Recruiting
    - UMHAT Prof. Dr. Stoyan Kirkovich AD
Canada
- - London, Canada, N6A 5W9
    - Recruiting
    - London Health Sciences Centre
  - Montreal, Canada
    - Recruiting
    - McGill University - Dept. Oncology Clinical Research Program
  - Ottawa, Canada, K1H 8L6
    - Recruiting
    - The Ottawa Hospital - General Campus
  - Saskatoon, Canada, S7N 4H4
    - Not yet recruiting
    - Saskatoon Cancer Centre
  - Toronto, Canada, M5G 2M9
    - Recruiting
    - Princess Margaret Cancer Center
China
- - Beijing, China, 100191
    - Active, not recruiting
    - Peking University Third Hospital
  - Beijing, China, 100730
    - Active, not recruiting
    - Peking Union Medical College Hospital
  - Beijing, China, 100034
    - Active, not recruiting
    - Peking University First Hospital
  - Changchun, China, 130021
    - Active, not recruiting
    - The First Hospital of Jilin University
  - Changsha, China, 410011
    - Active, not recruiting
    - The second Xiangya hospital of central south university
  - Changsha, China, 410008
    - Active, not recruiting
    - Xiangya Hospital, Central South University
  - Chongqing, China, 400016
    - Active, not recruiting
    - The First Affiliated Hospital of Chongqing Medical University
  - Guangzhou, China, 510080
    - Active, not recruiting
    - Guangdong Provincial People's Hospital
  - Guangzhou, China, 510060/510700
    - Active, not recruiting
    - Sun Yat-Sen University, Cancer Center
  - Jinan, China, 250012
    - Active, not recruiting
    - Qilu Hospital of Shandong University
  - Nanchang, China, 330006
    - Active, not recruiting
    - The First Affiliated Hospital of NanChang University
  - Nanjing, China, 210009
    - Active, not recruiting
    - Zhong Da Hospital, Southeast University
  - Nantong, China, 226001
    - Active, not recruiting
    - Affiliated Hospital of Nantong University
  - Qingdao, China, 266071
    - Active, not recruiting
    - The Affiliated Hospital of Qingdao University
  - Shanghai, China, 200050
    - Active, not recruiting
    - Shanghai Tongren Hospital
  - Shengyang, China, 110004
    - Active, not recruiting
    - Shengjing Hospital Of China Medical University
  - Shenzhen, China, 518029
    - Active, not recruiting
    - Shenzhen Second People's Hospital
  - Shijiazhuang, China
    - Active, not recruiting
    - The Second Hospital of Hebei Medicical University
  - Suzhou, China, 215006
    - Active, not recruiting
    - The First Affiliated Hospital of Soochow University
  - Tianjin, China, 300052
    - Active, not recruiting
    - Tianjin Medical University General Hospital
  - Tianjin, China, 300020
    - Active, not recruiting
    - Institute of Hematology and Hospital of Blood Disease
  - Wenzhou, China, 325015
    - Active, not recruiting
    - The First Affiliated Hospital of Wenzhou Medical University
  - Wuxi, China, 214023
    - Active, not recruiting
    - Wuxi People's Hospital
  - Xi'an, China, 710061
    - Active, not recruiting
    - The First Affiliated Hospital of Xiâan Jiaotong University
  - Yantai, China, 264000
    - Active, not recruiting
    - Yantai Yuhuangding Hospital
  - Zhengzhou, China, 450008
    - Active, not recruiting
    - Henan Cancer Hospital
Croatia
- - Rijeka, Croatia, 51000
    - Recruiting
    - Clinical Hospital Centre Rijeka
  - Zagreb, Croatia, 10000
    - Recruiting
    - Clinical Hospital Dubrava
  - Zagreb, Croatia, 10000
    - Recruiting
    - Clinical Hospital Centar Zagreb
Czechia
- - Brno, Czechia, 625 00
    - Recruiting
    - Fakultni nemocnice Brno
  - Hradec Králové, Czechia, 50005
    - Not yet recruiting
    - Fakultni nemocnice Hradec Kralove
  - Pilsen, Czechia, 304 60
    - Recruiting
    - Fakultni nemocnice Plzen
  - Poruba, Czechia, 708 52
    - Recruiting
    - Fakultni Nemocnice Ostrava
  - Prague, Czechia, 100 34
    - Recruiting
    - Fakultni nemocnice Kralovske Vinohrady
  - Prague, Czechia, 12800
    - Not yet recruiting
    - Ustav Hematologie A Krevni Transfuze
France
- - Angers, France, 49033
    - Not yet recruiting
    - Chu Angers - Hăpital Hătel Dieu
  - Caen, France, 14033
    - Recruiting
    - CHU de Caen
  - La Tronche, France, 38700
    - Recruiting
    - Chu de Grenoble - Hospital Albert Michallon
  - Le Chesnay, France, 78150
    - Recruiting
    - Centre Hospitalier De Versailles
  - Lille, France, 59037
    - Recruiting
    - Hopital Claude Huriez - CHRU Lille
  - Lyon, France, 69008
    - Recruiting
    - Centre Léon Bérard
  - Marseille, France, 13005
    - Recruiting
    - Hopital de la Conception - APHM
  - Nantes, France, 44093
    - Recruiting
    - CHU de Nantes - Hôtel Dieu
  - Nice, France, 06200
    - Recruiting
    - CHU Nice - Hôpital de l'Archet 1
  - Paris, France, 75475
    - Recruiting
    - Hospital Saint-Louis
  - Pessac, France, 33604
    - Not yet recruiting
    - Chu de Bordeaux - Hăpital Haut-Lăvăque
  - Pierre BĂŠnite, France, 69495
    - Recruiting
    - Centre Hospitalier Lyon Sud
  - Rennes, France, 35000
    - Recruiting
    - CHU Rennes - Hôpital Pontchaillou
  - Salouël, France, 80480
    - Recruiting
    - CHU Amiens - Hopital Sud
  - Strasbourg, France, 67200
    - Recruiting
    - Institut de Cancérologie de Strasbourg Europe - ICANS
  - Strasbourg, France, 67200
    - Not yet recruiting
    - Institut de Cancărologie de Strasbourg Europe - Icans
  - Toulouse, France, 31059
    - Recruiting
    - Institut Universitaire Du Cancer de Toulouse- Iuct-O
  - Villejuif, France
    - Recruiting
    - Institut Gustave Roussy
Germany
- - Alzenau in Unterfranken, Germany, 63755
    - Not yet recruiting
    - Klinikum Aschaffenburg-Alzenau
  - Berlin, Germany
    - Recruiting
    - Charité Campus Virchow-Klinikum
  - Braunschweig, Germany, 38114
    - Recruiting
    - Staedtisches Klinikum Braunschweig Ggmbh
  - Dresden, Germany, 01307
    - Recruiting
    - Universitaetsklinikum Carl Gustav Carus TU Dresden
  - Essen, Germany, 45147
    - Recruiting
    - Universitaetsklinikum Essen
  - Hanover, Germany, 30459
    - Recruiting
    - KRH Klinikum Siloah
  - Heidelberg, Germany, 69120
    - Not yet recruiting
    - Universitaetsklinikum Heidelberg
  - Heidelberg, Germany
    - Recruiting
    - Universitaetsklinikum Heidelberg
  - Kiel, Germany, 24105
    - Not yet recruiting
    - Universitaetsklinikum Schleswig-Holstein
  - Leipzig, Germany, 4103
    - Not yet recruiting
    - Universitătsklinikum Leipzig Klinik Făr Hămatologie Internistische Onkologie Hămostaseol
  - Münster, Germany
    - Recruiting
    - Universitaetsklinikum Muenster
Hong Kong
- - Hong Kong, Hong Kong
    - Recruiting
    - The University of Hong Kong
  - Shatin, Hong Kong, 00000
    - Recruiting
    - The Chinese University of Hong Kong (Cuhk)
Hungary
- - Budapest, Hungary, 1088
    - Not yet recruiting
    - Semmelweis Egyetem
  - Debrecen, Hungary, 4032
    - Not yet recruiting
    - Debreceni Egyetem
  - Győr, Hungary, 9024
    - Not yet recruiting
    - Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
  - Szeged, Hungary, 6725
    - Not yet recruiting
    - Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Italy
- - Bari, Italy, 70124
    - Not yet recruiting
    - Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
  - Brescia, Italy, 25100
    - Recruiting
    - Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
  - Meldola, Italy, 47014
    - Recruiting
    - Irccs Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori 'Dino Amadori' - Irst
  - Milan, Italy, 20132
    - Recruiting
    - Ospedale San Raffaele
  - Milan, Italy, 20162
    - Not yet recruiting
    - Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
  - Novara, Italy
    - Recruiting
    - Ospedale Maggiore di Novara
  - Palermo, Italy, 90146
    - Recruiting
    - Azienda Ospedaliera Vincenzo Cervello
  - Roma, Italy, 168
    - Recruiting
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  - Rome, Italy, 133
    - Not yet recruiting
    - Azienda Ospedaliera Universitaria Policlinico Tor Vergata
  - Rome, Italy
    - Recruiting
    - Azienda Ospedaliera Universitaria Policlinico Tor Vergata
  - Rozzano, Italy, 20089
    - Recruiting
    - Istituto Clinico Humanitas
  - San Giovanni Rotondo, Italy, 71013
    - Recruiting
    - IRCCS Ospedale Casa Sollievo della Sofferenza
  - Torino, Italy, 10126
    - Recruiting
    - Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
  - Torino, Italy, 10128
    - Recruiting
    - Ospedale Mauriziano Umberto I
  - Varese, Italy, 21100
    - Recruiting
    - Asst Dei Sette Laghi Ospedale Di Circolo E Fondazione Macchi Varese
Japan
- - Akita, Japan, 010-8543
    - Recruiting
    - Akita University Hospital
  - Aomori, Japan, 030-8553
    - Recruiting
    - Aomori Prefetural Central Hospital
  - Bunkyō City, Japan, 113-8677
    - Recruiting
    - Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
  - Chiba, Japan, 260-0852
    - Recruiting
    - Chiba Aoba Municipal Hospital
  - Fukuoka, Japan, 812-8582
    - Recruiting
    - Kyushu University Hospital
  - Fukuyama, Japan
    - Recruiting
    - Chugoku Central Hospital
  - Gifu, Japan
    - Recruiting
    - Gifu Municipal Hospital
  - Hamamatsu, Japan, 431-3192
    - Recruiting
    - Hamamatsu University School of Medicine, University Hospital
  - Kamogawa-shi, Japan, 296-8602
    - Recruiting
    - Tesshokai Kameda General Hospital
  - Kanazawa, Japan, 920-8641
    - Recruiting
    - Kanazawa University Hospital
  - Kumamoto, Japan
    - Recruiting
    - National Hospital Organization Kumamoto Medical Center
  - Maebashi, Japan
    - Recruiting
    - Saiseikai Maebashi Hospital
  - Matsuyama, Japan
    - Recruiting
    - Ehime Prefectural Central Hospital
  - Nagoya, Japan, 466-8560
    - Recruiting
    - Nagoya University Hospital
  - Osakar, Japan, 543-8555
    - Recruiting
    - Japan RED CROSS OSAKA HOSPITAL
  - Sapporo, Japan, 060-8648
    - Recruiting
    - Hokkaido University Hospital
  - Sapporo, Japan
    - Recruiting
    - Sapporo Hokuyu Hospital
  - Tenri, Japan, 632-8552
    - Recruiting
    - Tenri Hospital
Norway
- - Bergen, Norway, N-5021
    - Recruiting
    - Haukeland Universitetssykehus
  - Oslo, Norway
    - Recruiting
    - Oslo University Hospital
  - TromsĂ¸, Norway, 9019
    - Not yet recruiting
    - University Hospital of North Norway
Poland
- - Lublin, Poland, 20-081
    - Not yet recruiting
    - Klinika Hematoonkologii I Transplantacji Szpiku
  - Olsztyn, Poland, 10-228
    - Withdrawn
    - Spzoz Msw Zwarmiĺsko-Mazurskimcen.Onko.Wolsztynie
  - Torun, Poland, 87-100
    - Withdrawn
    - Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu
  - Warsaw, Poland, 02-776
    - Not yet recruiting
    - Instytut Hematologii i Transfuzjologii
Portugal
- - Lisbon, Portugal, 1649-035
    - Not yet recruiting
    - Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
  - Porto, Portugal, 4200-072
    - Recruiting
    - Instituto Português de Oncologia do Porto Francisco Gentil, EPE
Romania
- - Bucharest, Romania, 022328
    - Recruiting
    - Institutul Clinic Fundeni
  - Bucharest, Romania, 030171
    - Recruiting
    - Spitalul Clinic Coltea
  - Bucharest, Romania, 020125
    - Recruiting
    - Spitalul Clinic Colentina
  - Cluj-Napoca, Romania, 400015
    - Recruiting
    - Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
  - Craiova, Romania, 200143
    - Recruiting
    - Spitalul Clinic Municipal Filantropia Craiova
Serbia
- - Belgrade, Serbia, 11000
    - Not yet recruiting
    - University Clinical Center of Serbia
  - Belgrade, Serbia, 11000
    - Not yet recruiting
    - Military Medical Academy
  - Niš, Serbia, 18000
    - Not yet recruiting
    - University Clinical Center Niš
Singapore
- - Singapore, Singapore, 119228
    - Not yet recruiting
    - National University Hospital
  - Singapore, Singapore, 329563
    - Recruiting
    - Curie Oncology Pte Ltd
South Korea
- - Busan, South Korea, 48108
    - Active, not recruiting
    - Inje University Haeundae Paik Hospital
  - Busan, South Korea
    - Active, not recruiting
    - Pusan National University Hospital
  - Daegu, South Korea, 41404
    - Active, not recruiting
    - Kyungpook National University Chilgok Hospital
  - Daegu, South Korea, 42415
    - Active, not recruiting
    - Yeungnam University Hospital
  - Daegu, South Korea, 42472
    - Active, not recruiting
    - Daegu Catholic University Medical Center
  - Hwasun-gun, South Korea, 58128
    - Active, not recruiting
    - Chonnam National University Hwasun Hospital
  - Incheon, South Korea, 21565
    - Active, not recruiting
    - Gachon University Gil Medical Center
  - Jeonju, South Korea, 54907
    - Active, not recruiting
    - Jeonbuk National University Hospital
  - Seongnam-si, South Korea, 13620
    - Active, not recruiting
    - Seoul National University Bundang Hospital
  - Seoul, South Korea, 06351
    - Active, not recruiting
    - Samsung Medical Center
  - Seoul, South Korea, 08308
    - Active, not recruiting
    - Korea University Guro Hospital
  - Seoul, South Korea, 03722
    - Active, not recruiting
    - Severance Hospital, Yonsei University Health System
  - Seoul, South Korea, 06591
    - Active, not recruiting
    - The Catholic University of Korea, Seoul St. Mary's Hospital
  - Seoul, South Korea, 110-744
    - Active, not recruiting
    - Seoul National University Hospital
  - Seoul, South Korea, 5505
    - Active, not recruiting
    - Asan Medical Center
  - Suwon, South Korea, 16499
    - Active, not recruiting
    - Ajou University Hospital
  - Ulsan, South Korea, 44033
    - Active, not recruiting
    - Ulsan University Hospital
Spain
- - Albacete, Spain, 02006
    - Recruiting
    - Complejo Hospitalario Universitario de Albacete
  - Alicante, Spain, 03010
    - Recruiting
    - Hospital General Universitario Doctor Balmis
  - Badalona, Spain
    - Recruiting
    - ICO Badalona - Hospital Universitari Germans Trias i Pujol
  - Barcelona, Spain
    - Recruiting
    - Hospital Universitari Vall d'Hebron
  - Barcelona, Spain, 8025
    - Recruiting
    - Hospital de la Santa Creu i Sant Pau
  - Burgos, Spain
    - Recruiting
    - Hospital Universitario de Burgos
  - Cáceres, Spain, 10003
    - Recruiting
    - Hospital San Pedro De Alcantara
  - Córdoba, Spain, 14004
    - Recruiting
    - Hospital Universitario Reina Sofia
  - Las Palmas, Spain
    - Recruiting
    - Hospital Universitario de Gran Canaria Dr. Negrin
  - Madrid, Spain, 28041
    - Recruiting
    - Hospital Universitario 12 de Octubre
  - Madrid, Spain, 28027
    - Recruiting
    - Clinica Universidad de Navarra
  - Madrid, Spain
    - Recruiting
    - Hospital Universitario La Paz
  - Madrid, Spain, 28040
    - Recruiting
    - Hospital Universitario Fundacion Jimenez Diaz
  - Madrid, Spain, 28033
    - Recruiting
    - Md Anderson Cancer Centre
  - Majadahonda, Spain, 28220
    - Recruiting
    - Hospital Universitario Puerta de Hierro Majadahonda
  - Murcia, Spain, 30008
    - Recruiting
    - Hospital General Universitario Morales Meseguer
  - Málaga, Spain, 29010
    - Recruiting
    - Hospital Regional Universitario de Malaga
  - Palma de Mallorca, Spain, 07120
    - Recruiting
    - Hospital Universitari Son Espases
  - Pozuelo de Alarcón, Spain, 28223
    - Recruiting
    - Hospital Universitario Quirónsalud Madrid
  - Salamanca, Spain
    - Recruiting
    - Hospital Clínico Universitario de Salamanca
  - Santander, Spain, 39012
    - Recruiting
    - Hospital Universitario Marqués de Valdecilla
  - Santiago de Compostela, Spain, 15706
    - Recruiting
    - Complejo Hospitalario Universitario de Santiago
  - Seville, Spain, 41010
    - Recruiting
    - Hospital Universitario Virgen del Rocio
  - Valencia, Spain, 46010
    - Recruiting
    - Hospital Clínico Universitario de Valencia
  - Valencia, Spain, 46026
    - Recruiting
    - Hospital Universitari i Politecnic La Fe
  - Valencia, Spain, 46017
    - Recruiting
    - Hospital Universitario Dr. Peset
Sweden
- - Gasteborg, Sweden, 41345
    - Recruiting
    - Sahlgrenska Universitetssjukhuset
  - Lund, Sweden, 22185
    - Recruiting
    - Skă Nes Universitetssjukhus, Lund
  - Uppsala, Sweden, 75185
    - Not yet recruiting
    - Akademiska Sjukhuset
Switzerland
- - Bern, Switzerland, 3010
    - Recruiting
    - Inselspital - Universitaetsspital Bern
  - Bern, Switzerland, 3010
    - Not yet recruiting
    - Inselspital - Universitaetsspital Bern
  - Lazern 16, Switzerland
    - Recruiting
    - Luzerner Kantonsspital - Luzern
Taiwan
- - Kaohsiung City, Taiwan, 833
    - Active, not recruiting
    - Kaohsiung Chang Gung Memorial Hospital
  - Taichung, Taiwan, 404327
    - Active, not recruiting
    - China Medical University Hospital
  - Tainan, Taiwan, 70403
    - Active, not recruiting
    - National Cheng Kung University Hospitalx
  - Taipei, Taiwan, 11217
    - Active, not recruiting
    - Taipei Veterans General Hospital
  - Taipei, Taiwan, 10002
    - Active, not recruiting
    - National Taiwan University Hospital
  - Taoyuan County, Taiwan, 00333
    - Active, not recruiting
    - Chang Gung Memorial Hospital
United Kingdom
- - Birmingham, United Kingdom
    - Recruiting
    - Queen Elizabeth Hospital
  - Harrow, United Kingdom, HA1 3UJ
    - Recruiting
    - Northwick Park Hospital
  - London, United Kingdom, W12 0HS
    - Recruiting
    - Hammersmith Hospital
  - London, United Kingdom, SE5 9NU
    - Not yet recruiting
    - King's College Hospital
  - Maidstone, United Kingdom, ME16 9QQ
    - Not yet recruiting
    - Maidstone Hospital
  - Manchester, United Kingdom, M13 9WL
    - Recruiting
    - Manchester Royal Infirmary
  - Oxford, United Kingdom, OX3 7LJ
    - Recruiting
    - Churchill Hospital
  - Torquay, United Kingdom, TQ2 7AA
    - Not yet recruiting
    - Torbay Hospital
United States
- Arizona
  - Goodyear, Arizona, United States, 85338
    - Recruiting
    - City of Hope Phoenix
  - Phoenix, Arizona, United States, 85054
    - Recruiting
    - Mayo Clinic - Phoenix
  - Tucson, Arizona, United States, 85724
    - Recruiting
    - University of Arizona Cancer Center
- California
  - Los Angeles, California, United States, 90095
    - Recruiting
    - David Geffen School of Medicine
  - Sacramento, California, United States, 95817
    - Recruiting
    - University of California Davis Health System
  - San Francisco, California, United States, 94115
    - Recruiting
    - Ucsf - School of Medicine
  - Stanford, California, United States, 94305
    - Recruiting
    - Stanford University School of Medicine- Parent
- Colorado
  - Denver, Colorado, United States, 80218
    - Recruiting
    - Colorado Blood Cancer Institute
- Connecticut
  - New Haven, Connecticut, United States, 06510
    - Recruiting
    - Yale University
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20016
    - Recruiting
    - Sibley Memorial Hospital
- Florida
  - Jacksonville, Florida, United States, 32224
    - Recruiting
    - Mayo Clinic Hospital
  - Kissimmee, Florida, United States, 34741
    - Recruiting
    - Florida Hospital Cancer Institute - Kissimmee
  - Tampa, Florida, United States, 33606
    - Recruiting
    - Tampa General Hospital
  - Tampa, Florida, United States, 33612
    - Recruiting
    - Moffitt Cancer Center
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Recruiting
    - Winship Cancer Institute of Emory University
  - Augusta, Georgia, United States, 30912
    - Not yet recruiting
    - Augusta University
- Illinois
  - Chicago, Illinois, United States, 60637
    - Recruiting
    - The University of Chicago Medical Center
  - Chicago, Illinois, United States, 60612
    - Recruiting
    - University of Illinois Hospital & Health Sciences System
  - Chicago, Illinois, United States, 60611
    - Recruiting
    - Robert H Lurie Comprehensive Cancer Center Northwestern University
- Kentucky
  - Lexington, Kentucky, United States, 40504
    - Recruiting
    - University Of Kentucky
- Louisiana
  - New Orleans, Louisiana, United States, 70121
    - Not yet recruiting
    - Ochsner Medical Center - New Orleans
- Maryland
  - Baltimore, Maryland, United States, 21287
    - Recruiting
    - Johns Hopkins Hospital
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Recruiting
    - Massachusetts General Hospital
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Recruiting
    - University of Michigan Comprehensive Cancer Center Michigan Medicine
  - Detroit, Michigan, United States, 48202
    - Recruiting
    - Henry Ford Hospital
- Minnesota
  - Minneapolis, Minnesota, United States, 55455
    - Recruiting
    - University of Minnesota Medical School - Twin Cities Campus
  - Rochester, Minnesota, United States, 55905
    - Not yet recruiting
    - Mayo Clinic
  - Rochester, Minnesota, United States, 55902
    - Recruiting
    - Mayo Clinic
- Missouri
  - St Louis, Missouri, United States, 63110
    - Not yet recruiting
    - Washington University
- New Jersey
  - Hackensack, New Jersey, United States, 07601
    - Recruiting
    - Hackensack University Medical Center
  - Haddonfield, New Jersey, United States, 08033
    - Recruiting
    - Thomas Jefferson Univ Hosp
- New York
  - Buffalo, New York, United States, 14263
    - Recruiting
    - Roswell Park Comprehensive Cancer Center
  - Long Island City, New York, United States, 11101
    - Recruiting
    - Memorial Sloan Kettering Cancer Center - MAIN
  - New York, New York, United States, 10065
    - Not yet recruiting
    - Memorial Sloan Kettering Cancer Center - MAIN
  - Syracuse, New York, United States, 13210
    - Not yet recruiting
    - Upstate University Hospital
- North Carolina
  - Chapel Hill, North Carolina, United States, 27514
    - Recruiting
    - University of North Carolina Hospitals
  - Durham, North Carolina, United States, 27710
    - Recruiting
    - Duke Cancer Institute - Sarcoma Research
- Ohio
  - Cincinnati, Ohio, United States, 45219
    - Not yet recruiting
    - University of Cincinnati
  - Cleveland, Ohio, United States, 44195
    - Recruiting
    - Cleveland Clinic Taussig Cancer Center
  - Columbus, Ohio, United States, 43210
    - Recruiting
    - The James Cancer Hospital and Solove Research Institute
  - Columbus, Ohio, United States, 43214
    - Recruiting
    - Ohio Health Marion Area Physicians
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - Recruiting
    - Peggy & Charles Stephenson Oklahoma Cancer Ctr
- Oregon
  - Portland, Oregon, United States, 97239
    - Recruiting
    - Oregon Health & Science University (OHSU)
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104
    - Recruiting
    - University of Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15232
    - Not yet recruiting
    - UPMC Hillman Cancer Center
- Rhode Island
  - Providence, Rhode Island, United States, 02903
    - Recruiting
    - Rhode Island Hospital
- Tennessee
  - Nashville, Tennessee, United States, 37203
    - Recruiting
    - TriStar Bone Marrow Transplant
- Texas
  - Austin, Texas, United States, 78745
    - Not yet recruiting
    - South Austin Medical Center
  - Houston, Texas, United States, 77030
    - Recruiting
    - Houston Methodist Hospital
  - Houston, Texas, United States, 77030
    - Recruiting
    - The University of Texas MD Anderson Cancer Center
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - Not yet recruiting
    - UVA Health System
  - Richmond, Virginia, United States, 23229
    - Recruiting
    - Virginia Commonwealth University (VCU) Massey Cancer Center
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - Recruiting
    - Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Key Inclusion Criteria:

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

Key Exclusion Criteria:

Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or BCR-ABL positive leukemia (ie, chronic myelogenous leukemia in blast crisis); participants who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy).
Diagnosis of AML secondary to prior chemotherapy or radiotherapy.
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:
1. Leukapheresis;
2. Treatment for hyperleukocytosis with hydroxyurea;
3. Cranial radiotherapy for central nervous system (CNS) leukostasis;
4. Prophylactic intrathecal chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Quizartinib + Chemotherapy Participants 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)	Drug: Quizartinib Participants will receive quizartinib at 60 mg/day orally once daily Other Names: Test Product Drug: Chemotherapy Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin or idarubicin). Other Names: Standard Chemotherapy Cytarabine, Daunorubicin or Idarubicin
Placebo Comparator: Arm B: Placebo + Chemotherapy Participants 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)	Drug: Chemotherapy Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin or idarubicin). Other Names: Standard Chemotherapy Cytarabine, Daunorubicin or Idarubicin Drug: Placebo Participants will receive placebo at 60 mg/day orally once daily Other Names: Placebo Control
Experimental: Arm C: Quizartinib + Chemotherapy then Placebo Maintenance Participants 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)	Drug: Quizartinib Participants will receive quizartinib at 60 mg/day orally once daily Other Names: Test Product Drug: Chemotherapy Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin or idarubicin). Other Names: Standard Chemotherapy Cytarabine, Daunorubicin or Idarubicin Drug: Placebo Participants will receive placebo at 60 mg/day orally once daily Other Names: Placebo Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Overall survival (OS) is defined as the time from randomization until death from any cause.	Date of first patient randomized to the target number of deaths reached, up to approximately 42 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (Arm A vs. Arm B) Time Frame: Date of first dose up to 30 days after last dose, up to approximately 42 months	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).	Date of first dose up to 30 days after last dose, up to approximately 42 months
Event-free survival (Arm A vs. Arm B) Time Frame: Date of randomization up to approximately 42 months	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	Date of randomization up to approximately 42 months
Duration of complete response (Arm A vs. Arm B) Time Frame: Date of randomization up to approximately 42 months	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.	Date of randomization up to approximately 42 months
Relapse-free survival (Arm A vs. Arm B) Time Frame: Date of randomization up to approximately 42 months	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 .	Date of randomization up to approximately 42 months
Complete remission rate (Arm A vs. Arm B) Time Frame: At end of Induction Phase, up to approximately 120 days	Complete remission rate (CR) is defined as proportion of of participants who achieved a CR. As assessed by Independent Review Committee.	At end of Induction Phase, up to approximately 120 days
Complete remission rate with minimal or measurable residual disease (Arm A vs. Arm B) Time Frame: At end of Induction Phase (Cycle 2 or Cycles 1 and 2), up to approximately 120 days	Proportion of participants achieving CR with minimal or measurable residual disease (MRD) negativity. As assessed by Independent Review Committee.	At end of Induction Phase (Cycle 2 or Cycles 1 and 2), up to approximately 120 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daiichi Sankyo

Investigators

Study Director: Global Clinical Leader, Daiichi Sankyo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2024

Primary Completion (Estimated)

June 26, 2030

Study Completion (Estimated)

June 26, 2030

Study Registration Dates

First Submitted

August 14, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

AC220-168
2023-507936-20-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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/

IPD Sharing Time Frame

Completed studies that has reached a global end or completion with all data set collected and analyzed, and 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 on completed 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 Supporting Information Type

STUDY_PROTOCOL
SAP
ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Leukemia

Stanford University

Terminated

Allogeneic Transplantation for Patients With Acute Leukemia or Chronic Myelogenous Leukemia (CML)

Leukemia | Leukemia, Lymphocytic, Acute | Leukemia Acute Promyelocytic Leukemia (APL) | Leukemia Acute Lymphoid Leukemia (ALL) | Leukemia Chronic Myelogenous Leukemia (CML) | Leukemia Acute Myeloid Leukemia (AML) | Leukemia Chronic Lymphocytic Leukemia (CLL)

United States
Massachusetts General Hospital
Celgene Corporation

Terminated

Lenalidomide in Combination With Microtransplantation as Post-remission Therapy in AML

Acute Myelogenous Leukemia | Acute Myeloid Leukemia (AML) | Acute Myelocytic Leukemia | Acute Granulocytic Leukemia | Acute Non-Lymphocytic Leukemia

United States
Institute of Hematology & Blood Diseases Hospital
Bejing Institute for Stem Cell and Regenerative Medicine; Institute for Stem...

Recruiting

Safety and Preliminary Efficacy of JK500 Cell Injection in Relapsed/Refractory Pediatric Acute Myeloid Leukemia

Refractory Leukemia | Relapsed Leukemia | Acute Myeloid Leukemia, Childhood

China
Betta Pharmaceuticals Co., Ltd.

Not yet recruiting

A Study of MRX2843 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

Acute Myeloid Leukemia Leukemia

China
Children's Oncology Group
National Cancer Institute (NCI)

Completed

Studying Biomarkers in Samples From Younger Patients With Acute Myeloid Leukemia

Childhood Acute Monoblastic Leukemia (M5a) | Childhood Acute Monocytic Leukemia (M5b) | Childhood Acute Myeloblastic Leukemia Without Maturation (M1) | Childhood Acute Myelomonocytic Leukemia (M4) | Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies

United States
Hybrigenics Corporation

Unknown

Efficacy Study of Inecalcitol With Decitabine in Acute Myeloid Leukemia Patients Unfit for Standard Chemotherapy

Acute Myelogenous Leukemia

United States, France
Massachusetts General Hospital

Completed

Alisertib for Acute Myeloid Leukemia

Acute Myelogenous Leukemia

United States
Kinex Pharmaceuticals Inc.

Completed

Evaluation of KX2-391 in Elderly Subjects With Acute Myeloid Leukemia (AML)

Acute Myelogenous Leukemia

United States
National Cancer Institute (NCI)

Terminated

Idarubicin and Cytarabine With or Without Bevacizumab in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Adult Acute Megakaryoblastic Leukemia (M7) | Adult Acute Minimally Differentiated Myeloid Leukemia (M0) | Adult Acute Monoblastic Leukemia (M5a) | Adult Acute Monocytic Leukemia (M5b) | Adult Acute Myeloblastic Leukemia With Maturation (M2) | Adult Acute Myeloblastic Leukemia Without Maturation... and other conditions

United States
Sidney Kimmel Comprehensive Cancer Center at Johns...

Completed

Red Cell Transfusion Goals in Patients With Acute Leukemias

Acute Lymphoblastic Leukemia | Acute Myelogenous Leukemia (AML) | Acute Lymphocytic Leukemia (ALL) | Acute Promyelocytic Leukemia (APL)

United States

Clinical Trials on Quizartinib

Daiichi Sankyo, Inc.

No longer available

Expanded Treatment Protocol for Adults With FLT3-ITD Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) to Receive Quizartinib

Acute Myeloid Leukemia With Gene Mutations
Daiichi Sankyo, Inc.
Quotient Sciences

Completed

A Study to Determine the Absolute Oral Bioavailability of Quizartinib Using a Radiolabeled Microtracer in Healthy Subjects

Healthy Subjects

United Kingdom
Daiichi Sankyo, Inc.

Completed

A Study of Quizartinib Pharmacokinetics in Participants With Moderate Hepatic Impairment

Hepatic Impairment | Moderate Impaired Hepatic Function

United States
Daiichi Sankyo Co., Ltd.
Daiichi Sankyo, Inc.

Completed

Phase 2 Study of Quizartinib in Participants With Acute Myeloid Leukemia (AML) FLT3 Internal Tandem Duplication (FLT3/ITD) Mutation

Leukemia, Myeloid, Acute

Japan
Daiichi Sankyo, Inc.
Ambit Biosciences Corporation

Completed

Open Label Study to Evaluate Safety and Efficacy of 2 Doses of Quizartinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Leukemia, Myeloid, Acute

United States, France, Italy, United Kingdom
Daiichi Sankyo Co., Ltd.

Completed

Study of Quizartinib in Combination With Standard Therapies in Chinese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)

Acute Myeloid Leukemia (AML)

China
Daiichi Sankyo

Recruiting

Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission

Acute Myeloid Leukemia | Leukemia

Brazil, China, United States, Australia, South Korea
Daiichi Sankyo, Inc.

Terminated

Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia (AML)

Acute Myeloid Leukemia

United States
M.D. Anderson Cancer Center

Recruiting

Dose Escalation and Expansion of Ziftomenib in Combination With Quizartinib in Acute Myeloid Leukemia

Acute Myeloid Leukemia

United States
Daiichi Sankyo

Recruiting

Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment

Hepatic Impairment

United States

Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML (QuANTUM-WILD)

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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Leukemia

Clinical Trials on Quizartinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations