Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML (QuANTUM-WILD)
June 30, 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
Active, not recruiting
Conditions
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 Locations
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Adelaide, Australia, 5000
- Royal Adelaide Hospital
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Bedford Park, Australia
- Flinders Medical Centre (Fmc)
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Bedford Park, Australia, 5042
- Flinders Medical Centre (Fmc)
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Box Hill, Australia, 3128
- Box Hill Hospital
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Concord, Australia, 2139
- Concord Repatriation General Hospital
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Darlinghurst, Australia, 2010
- St Vincent's Hospital Melbourne
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Douglas, Australia, 4814
- Townsville University Hospital
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Liverpool, Australia, 2170
- Liverpool Hospital
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Melbourne, Australia, 3004
- The Alfred Hospital
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Murdoch, Australia, 6150
- Fiona Stanley Hospital
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Perth, Australia, 6009
- Sir Charles Gairdner Hospital
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Woolloongabba, Australia, 4102
- Princess Alexandra Hospital
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Linz, Austria, 4020
- Ordensklinikum Linz Gmbh - Elisabethinen
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Salzburg, Austria, 5020
- Lkh - Universitatsklinikum Der Pmu Salzburg
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Vienna, Austria, 1140
- Hanusch Krankenhaus Der Wgkk Wien
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Anderlecht, Belgium, 1070
- Institut Jules Bordet
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Antwerp, Belgium, 2060
- ZNA
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Bruges, Belgium, 8000
- AZ Sint-Jan
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Brussels, Belgium, 1200
- Cliniques universitaires Saint-Luc
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Leuven, Belgium, 3000
- UZ Leuven
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Liège, Belgium, 4000
- Chu de Liăge
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Roeselare, Belgium, 8800
- AZ Delta
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Belo Horizonte, Brazil
- Cetus Hospital Dia Oncologia
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Botucatu, Brazil, 18618-686
- UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
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Campinas, Brazil, 13083-878
- Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP
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Curitiba, Brazil, 81520-060
- Hospital Erasto Gaertner - Liga Paranaense de Combate ao Cancer
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Florianópolis, Brazil
- Cepon - Centro de Pesquisas Oncolăgicas de Santa Catarina
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Fortaleza, Brazil, 60430-370
- HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
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Goiânia, Brazil, 74680160
- HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
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Jaú, Brazil, 17210-120
- Fundacao Doutor Amaral Carvalho
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Passo Fundo, Brazil, 99010-260
- Hospital de Clínicas de Passo Fundo
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Porto Alegre, Brazil, 90035-074
- Santa Casa de Misericórdia de Porto Alegre
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Porto Alegre, Brazil, 90035-903
- Hospital de Clănicas de Porto Alegre
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Rio de Janeiro, Brazil
- INCA - Instituto Nacional de Câncer
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Sao Jose Rio Preto, Brazil, 15090-000
- Fundação Faculdade Regional de Medicina de São José do Rio Preto
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São Paulo, Brazil, 01246-000
- ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira
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São Paulo, Brazil, 01409902
- Hospital Nove de Julho
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São Paulo, Brazil, 01323-001
- Hospital Beneficencia Portuguesa da Sao Paulo
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São Paulo, Brazil
- Sírio-Libanês Brasilia-Centro de Oncologia-Asa Sul
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Pleven, Bulgaria, 5800
- UMHAT 'Dr. Georgi Stranski', EAD
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Plovdiv, Bulgaria, 4002
- Umhat 'Sv. Georgi', Ead
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Sofia, Bulgaria, 1606
- Military Medical Academy - MHAT - Sofia
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Sofia, Bulgaria, 1797
- 'Shathd' Ead Sofia
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Sofia, Bulgaria, 1431
- Umhat Âsv. Ivan Rilskiâ, Ead
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Stara Zagora, Bulgaria, 6000
- UMHAT Prof. Dr. Stoyan Kirkovich AD
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London, Canada, N6A 5W9
- London Health Sciences Centre
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Montreal, Canada
- McGill University - Dept. Oncology Clinical Research Program
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Ottawa, Canada, K1H 8L6
- The Ottawa Hospital - General Campus
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Saskatoon, Canada, S7N 4H4
- Saskatoon Cancer Centre
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Toronto, Canada, M5G 2M9
- Princess Margaret Cancer Center
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Beijing, China, 100730
- Peking Union Medical College Hospital
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Beijing, China, 100191
- Peking University Third Hospital
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Beijing, China, 100034
- Peking University First Hospital
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Changchun, China, 130021
- The First Hospital of Jilin University
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Changsha, China, 410008
- Xiangya Hospital, Central South University
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Changsha, China, 410011
- The Second Xiangya Hospital of Central South University
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Chongqing, China, 400016
- The First Affiliated Hospital of Chongqing Medical University
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Guangzhou, China, 510080
- Guangdong Provincial People's Hospital
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Guangzhou, China, 510060/510700
- Sun Yat-Sen University, Cancer Center
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Jinan, China, 250012
- Qilu Hospital of Shandong University
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Nanchang, China, 330006
- The First Affiliated Hospital of Nanchang University
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Nanjing, China, 210009
- Zhong Da Hospital, Southeast University
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Nantong, China, 226001
- Affiliated Hospital of Nantong University
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Qingdao, China, 266071
- The Affiliated Hospital of Qingdao University
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Shanghai, China, 200050
- Shanghai Tongren Hospital
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Shengyang, China, 110004
- Shengjing Hospital of China Medical University
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Shenzhen, China, 518029
- Shenzhen Second People's Hospital
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Shijiazhuang, China
- The Second Hospital of Hebei Medicical University
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Suzhou, China, 215006
- The First Affiliated Hospital of Soochow University
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Tianjin, China, 300052
- Tianjin Medical University General Hospital
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Tianjin, China, 300020
- Institute of Hematology and Hospital of Blood Disease
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Wenzhou, China, 325015
- The First Affiliated Hospital of Wenzhou Medical University
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Wuxi, China, 214023
- Wuxi People's Hospital
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Xi'an, China, 710061
- The First Affiliated Hospital of Xiâan Jiaotong University
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Yantai, China, 264000
- Yantai YuHuangDing Hospital
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Zhengzhou, China, 450008
- Henan Cancer Hospital
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Rijeka, Croatia, 51000
- Clinical Hospital Centre Rijeka
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Zagreb, Croatia, 10000
- Clinical Hospital Dubrava
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Zagreb, Croatia, 10000
- Clinical Hospital Centar Zagreb
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Brno, Czechia, 625 00
- Fakultni nemocnice Brno
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Hradec Králové, Czechia, 50005
- Fakultni nemocnice Hradec Kralove
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Pilsen, Czechia, 304 60
- Fakultni Nemocnice Plzen
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Poruba, Czechia, 708 52
- Fakultni Nemocnice Ostrava
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Prague, Czechia, 100 34
- Fakultni nemocnice Kralovske Vinohrady
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Prague, Czechia, 12800
- Ustav hematologie a krevni transfuze
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Angers, France, 49033
- Chu Angers - Hăpital Hătel Dieu
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Caen, France, 14033
- CHU de Caen
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La Tronche, France, 38700
- Chu de Grenoble - Hospital Albert Michallon
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Le Chesnay, France, 78150
- Centre Hospitalier De Versailles
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Lille, France, 59037
- Hopital Claude Huriez - CHRU Lille
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Lyon, France, 69008
- Centre Léon Bérard
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Marseille, France, 13005
- Hopital de la Conception - APHM
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Nantes, France, 44093
- CHU de Nantes - Hôtel Dieu
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Nice, France, 06200
- CHU Nice - Hôpital de l'Archet 1
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Paris, France, 75475
- Hospital Saint-Louis
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Pessac, France, 33604
- Chu de Bordeaux - Hăpital Haut-Lăvăque
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Pierre BĂŠnite, France, 69495
- Centre Hospitalier LYON SUD
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Rennes, France, 35000
- CHU Rennes - Hôpital Pontchaillou
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Salouël, France, 80480
- CHU Amiens - Hopital Sud
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Strasbourg, France, 67200
- Institut de Cancérologie de Strasbourg Europe - ICANS
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Strasbourg, France, 67200
- Institut de Cancărologie de Strasbourg Europe - Icans
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Toulouse, France, 31059
- Institut Universitaire Du Cancer de Toulouse- Iuct-O
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Villejuif, France
- Institut Gustave Roussy
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Alzenau in Unterfranken, Germany, 63755
- Klinikum Aschaffenburg-Alzenau
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Berlin, Germany
- Charité Campus Virchow-Klinikum
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Braunschweig, Germany, 38114
- Staedtisches Klinikum Braunschweig gGmbH
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Dresden, Germany, 01307
- Universitaetsklinikum Carl Gustav Carus TU Dresden
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Essen, Germany, 45147
- Universitaetsklinikum Essen
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Hanover, Germany, 30459
- KRH Klinikum Siloah
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Heidelberg, Germany, 69120
- Universitaetsklinikum Heidelberg
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Heidelberg, Germany
- Universitaetsklinikum Heidelberg
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Kiel, Germany, 24105
- Universitaetsklinikum Schleswig-Holstein
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Leipzig, Germany, 4103
- Universitătsklinikum Leipzig Klinik Făr Hămatologie Internistische Onkologie Hămostaseol
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Münster, Germany
- Universitaetsklinikum Muenster
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Hong Kong, Hong Kong
- The University of Hong Kong
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Shatin, Hong Kong, 00000
- The Chinese University of Hong Kong (Cuhk)
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Budapest, Hungary, 1088
- Semmelweis Egyetem
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Debrecen, Hungary, 4032
- Debreceni Egyetem
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Győr, Hungary, 9024
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
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Szeged, Hungary, 6725
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
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Bari, Italy, 70124
- Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
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Brescia, Italy, 25100
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
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Meldola, Italy, 47014
- Irccs Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori 'Dino Amadori' - Irst
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Milan, Italy, 20132
- Ospedale San Raffaele
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Milan, Italy, 20162
- Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
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Novara, Italy
- Ospedale Maggiore di Novara
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Palermo, Italy, 90146
- Azienda Ospedaliera Vincenzo Cervello
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Roma, Italy, 168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Rome, Italy, 133
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata
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Rome, Italy
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata
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Rozzano, Italy, 20089
- Istituto Clinico Humanitas
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San Giovanni Rotondo, Italy, 71013
- IRCCS Ospedale Casa Sollievo della Sofferenza
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Torino, Italy, 10128
- Ospedale Mauriziano Umberto I
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Torino, Italy, 10126
- Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
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Varese, Italy, 21100
- Asst Dei Sette Laghi Ospedale Di Circolo E Fondazione Macchi Varese
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Akita, Japan, 010-8543
- Akita University Hospital
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Aomori, Japan, 030-8553
- Aomori Prefetural Central Hospital
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Bunkyō City, Japan, 113-8677
- Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
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Chiba, Japan, 260-0852
- Chiba Aoba Municipal Hospital
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Fukuoka, Japan, 812-8582
- Kyushu University Hospital
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Fukuyama, Japan
- Chugoku Central Hospital
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Gifu, Japan
- Gifu Municipal Hospital
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Hamamatsu, Japan, 431-3192
- Hamamatsu University School of Medicine, University Hospital
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Kamogawa-shi, Japan, 296-8602
- Tesshokai Kameda General Hospital
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Kanazawa, Japan, 920-8641
- Kanazawa University Hospital
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Kumamoto, Japan
- National Hospital Organization Kumamoto Medical Center
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Maebashi, Japan
- Saiseikai Maebashi Hospital
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Matsuyama, Japan
- Ehime Prefectural Central Hospital
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Nagoya, Japan, 466-8560
- Nagoya University Hospital
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Osakar, Japan, 543-8555
- Osaka Red Cross Hospital
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Sapporo, Japan, 060-8648
- Hokkaido University Hospital
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Sapporo, Japan
- Sapporo Hokuyu Hospital
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Tenri, Japan, 632-8552
- Tenri Hospital
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Bergen, Norway, N-5021
- Haukeland Universitetssykehus
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Oslo, Norway
- Oslo University Hospital Rikshospitalet Clinical Research Unit
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Tromsø, Norway, 9019
- University Hospital of North Norway
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Lublin, Poland, 20-081
- Klinika Hematoonkologii I Transplantacji Szpiku
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Warsaw, Poland, 02-776
- Instytut Hematologii i Transfuzjologii
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Lisbon, Portugal, 1649-035
- Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria
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Porto, Portugal, 4200-072
- Instituto Português de Oncologia do Porto Francisco Gentil, EPE
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Bucharest, Romania, 022328
- Institutul Clinic Fundeni
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Bucharest, Romania, 030171
- Spitalul Clinic Coltea
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Bucharest, Romania, 020125
- Spitalul Clinic Colentina
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Cluj-Napoca, Romania, 400015
- Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
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Craiova, Romania, 200143
- Spitalul Clinic Municipal Filantropia Craiova
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Belgrade, Serbia, 11000
- Military Medical Academy
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Belgrade, Serbia, 11000
- University Clinical Center of Serbia
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Niš, Serbia, 18000
- University Clinical Center Nis
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Singapore, Singapore, 119228
- National University Hospital
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Singapore, Singapore, 329563
- Curie Oncology Pte Ltd
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Busan, South Korea, 48108
- Inje University Haeundae Paik Hospital
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Busan, South Korea
- Pusan National University Hospital
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Daegu, South Korea, 41404
- Kyungpook National University Chilgok Hospital
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Daegu, South Korea, 42472
- Daegu Catholic University Medical Center
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Daegu, South Korea, 42415
- Yeungnam University Hospital
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Hwasun-gun, South Korea, 58128
- Chonnam National University Hwasun Hospital
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Incheon, South Korea, 21565
- Gachon University Gil Medical Center
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Jeonju, South Korea, 54907
- Jeonbuk National University Hospital
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Seongnam-si, South Korea, 13620
- Seoul National University Bundang Hospital
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Seoul, South Korea, 06351
- Samsung Medical Center
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Seoul, South Korea, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, South Korea, 06591
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Seoul, South Korea, 110-744
- Seoul National University Hospital
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Seoul, South Korea, 08308
- Korea University Guro Hospital
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Seoul, South Korea, 5505
- Asan Medical Center
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Suwon, South Korea, 16499
- Ajou University Hospital
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Ulsan, South Korea, 44033
- Ulsan University Hospital
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Albacete, Spain, 02006
- Complejo Hospitalario Universitario de Albacete
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Alicante, Spain, 03010
- Hospital General Universitario Doctor Balmis
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Badalona, Spain
- ICO Badalona - Hospital Universitari Germans Trias i Pujol
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Barcelona, Spain
- Hospital Universitari Vall d'Hebron
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Barcelona, Spain, 8025
- Hospital de La Santa Creu i Sant Pau
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Burgos, Spain
- Hospital Universitario de Burgos
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Cáceres, Spain, 10003
- Hospital San Pedro De Alcantara
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Córdoba, Spain, 14004
- Hospital Universitario Reina Sofia
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Las Palmas, Spain
- Hospital Universitario de Gran Canaria Dr. Negrín
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Madrid, Spain, 28040
- Hospital Universitario Fundación Jiménez Díaz
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Madrid, Spain, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Spain
- Hospital Universitario La Paz
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Madrid, Spain, 28027
- Clinica Universidad de Navarra
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Madrid, Spain, 28033
- MD Anderson Cancer Centre
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Majadahonda, Spain, 28220
- Hospital Universitario Puerta de Hierro Majadahonda
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Murcia, Spain, 30008
- Hospital General Universitario Morales Meseguer
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Málaga, Spain, 29010
- Hospital Regional Universitario de Málaga
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Palma de Mallorca, Spain, 07120
- Hospital Universitari Son Espases
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Pozuelo de Alarcón, Spain, 28223
- Hospital Universitario Quironsalud Madrid
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Salamanca, Spain
- Hospital Clinico Universitario de Salamanca
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Santander, Spain, 39012
- Hospital Universitario Marqués de Valdecilla
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Santiago de Compostela, Spain, 15706
- Complejo Hospitalario Universitario de Santiago
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Seville, Spain, 41010
- Hospital Universitario Virgen del Rocío
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Valencia, Spain, 46026
- Hospital Universitari i Politecnic La Fe
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Valencia, Spain, 46010
- Hospital Clínico Universitario de Valencia
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Valencia, Spain, 46017
- Hospital Universitario Dr. Peset
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Gasteborg, Sweden, 41345
- Sahlgrenska Universitetssjukhuset
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Lund, Sweden, 22185
- Skă Nes Universitetssjukhus, Lund
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Uppsala, Sweden, 75185
- Akademiska Sjukhuset
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Bern, Switzerland, 3010
- Inselspital - Universitaetsspital Bern
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Lazern 16, Switzerland
- Luzerner Kantonsspital - Luzern
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Kaohsiung City, Taiwan, 833
- Kaohsiung Chang Gung Memorial Hospital
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Taichung, Taiwan, 404327
- China Medical University Hospital
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Tainan, Taiwan, 70403
- National Cheng Kung University Hospitalx
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Taipei, Taiwan, 10002
- National Taiwan University Hospital
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Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
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Taoyuan County, Taiwan, 00333
- Chang Gung Memorial Hospital
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Birmingham, United Kingdom
- Queen Elizabeth Hospital
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Harrow, United Kingdom, HA1 3UJ
- Northwick Park Hospital
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London, United Kingdom, W12 0HS
- Hammersmith Hospital
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London, United Kingdom, SE5 9NU
- King's College Hospital
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Maidstone, United Kingdom, ME16 9QQ
- Maidstone Hospital
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Manchester, United Kingdom, M13 9WL
- Manchester Royal Infirmary
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Oxford, United Kingdom, OX3 7LJ
- Churchill Hospital
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Torquay, United Kingdom, TQ2 7AA
- Torbay Hospital
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Arizona
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Goodyear, Arizona, United States, 85338
- City of Hope Phoenix
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Phoenix, Arizona, United States, 85054
- Mayo Clinic - Phoenix
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Tucson, Arizona, United States, 85724
- University of Arizona Cancer Center
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California
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Los Angeles, California, United States, 90095
- David Geffen School of Medicine
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Sacramento, California, United States, 95817
- University Of California Davis Health System
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San Francisco, California, United States, 94115
- UCSF Helen Diller Family Comprehensive Cancer Center
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Stanford, California, United States, 94305
- Stanford University School of Medicine- Parent
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Colorado
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Denver, Colorado, United States, 80218
- Colorado Blood Cancer Institute
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale University
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District of Columbia
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Washington D.C., District of Columbia, United States, 20016
- Sibley Memorial Hospital
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Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic Hospital
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Kissimmee, Florida, United States, 34741
- Florida Hospital Cancer Institute - Kissimmee
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Tampa, Florida, United States, 33606
- Tampa General Hospital
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Tampa, Florida, United States, 33612
- Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, United States, 30322
- Winship Cancer Institute of Emory University
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Augusta, Georgia, United States, 30912
- Augusta University
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Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois Hospital & Health Sciences System
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Chicago, Illinois, United States, 60637
- The University of Chicago Medical Center
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Chicago, Illinois, United States, 60611
- Robert H Lurie Comprehensive Cancer Center Northwestern University
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Kentucky
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Lexington, Kentucky, United States, 40504
- University of Kentucky
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Louisiana
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New Orleans, Louisiana, United States, 70121
- Ochsner Medical Center - New Orleans
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Comprehensive Cancer Center Michigan Medicine
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Medical School - Twin Cities Campus
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Rochester, Minnesota, United States, 55902
- Mayo Clinic
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Missouri
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St Louis, Missouri, United States, 63110
- Washington University
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
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Haddonfield, New Jersey, United States, 08033
- Thomas Jefferson Univ Hosp
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New York
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Buffalo, New York, United States, 14263
- Roswell Park Comprehensive Cancer Center
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Long Island City, New York, United States, 11101
- Memorial Sloan Kettering Cancer Center - MAIN
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center - MAIN
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Syracuse, New York, United States, 13210
- Upstate University Hospital
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- University of North Carolina Hospitals
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Durham, North Carolina, United States, 27710
- Duke Cancer Institute - Sarcoma Research
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Ohio
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Cincinnati, Ohio, United States, 45219
- University of Cincinnati
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, United States, 43214
- Ohio Health Research Institute
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Columbus, Ohio, United States, 43210
- The James Cancer Hospital and Solove Research Institute
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Peggy & Charles Stephenson Oklahoma Cancer Ctr
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University (OHSU)
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15232
- UPMC Hillman Cancer Center
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
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Tennessee
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Nashville, Tennessee, United States, 37203
- TriStar Bone Marrow Transplant
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Texas
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Austin, Texas, United States, 78745
- South Austin Medical Center
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Houston, Texas, United States, 77030
- Houston Methodist Hospital
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Houston, Texas, United States, 77030
- The University of Texas MD Anderson Cancer Center
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Virginia
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Charlottesville, Virginia, United States, 22908
- UVA Health System
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Richmond, Virginia, United States, 23229
- Virginia Commonwealth University (Vcu) Massey Cancer Center
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
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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
No
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:
- Leukapheresis;
- Treatment for hyperleukocytosis with hydroxyurea;
- Cranial radiotherapy for central nervous system (CNS) leukostasis;
- 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
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)
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Participants will receive quizartinib at 60 mg/day orally once daily
Other Names:
Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin or idarubicin).
Other Names:
|
|
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)
|
Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin or idarubicin).
Other Names:
Participants will receive placebo at 60 mg/day orally once daily
Other Names:
|
|
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)
|
Participants will receive quizartinib at 60 mg/day orally once daily
Other Names:
Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin or idarubicin).
Other Names:
Participants will receive placebo at 60 mg/day orally once daily
Other Names:
|
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
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Overall survival (OS) is defined as the time from randomization until death from any cause.
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Date of first patient randomized to the target number of deaths reached, up to approximately 42 months
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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
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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).
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Date of first dose up to 30 days after last dose, up to approximately 42 months
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Event-free survival (Arm A vs. Arm B)
Time Frame: Date of randomization up to approximately 42 months
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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
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Date of randomization up to approximately 42 months
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|
Duration of complete response (Arm A vs. Arm B)
Time Frame: Date of randomization up to approximately 42 months
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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.
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Date of randomization up to approximately 42 months
|
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Relapse-free survival (Arm A vs. Arm B)
Time Frame: Date of randomization up to approximately 42 months
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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 .
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Date of randomization up to approximately 42 months
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Complete remission rate (Arm A vs. Arm B)
Time Frame: At end of Induction Phase, up to approximately 120 days
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Complete remission rate (CR) is defined as proportion of of participants who achieved a CR.
As assessed by Independent Review Committee.
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At end of Induction Phase, up to approximately 120 days
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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
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Proportion of participants achieving CR with minimal or measurable residual disease (MRD) negativity.
As assessed by Independent Review Committee.
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At end of Induction Phase (Cycle 2 or Cycles 1 and 2), up to approximately 120 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
July 2, 2026
Last Update Submitted That Met QC Criteria
June 30, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Histologic Type
- Hematologic Diseases
- Leukemia, Myeloid
- Hemic and Lymphatic Diseases
- Leukemia
- Leukemia, Myeloid, Acute
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Therapeutics
- Nucleic Acids, Nucleotides, and Nucleosides
- Hydrocarbons
- Hydrocarbons, Cyclic
- Carbohydrates
- Polycyclic Aromatic Hydrocarbons
- Hydrocarbons, Aromatic
- Polycyclic Compounds
- Glycosides
- Cytidine
- Pyrimidine Nucleosides
- Pyrimidines
- Nucleosides
- Arabinonucleosides
- Anthracyclines
- Naphthacenes
- Aminoglycosides
- Cytarabine
- Daunorubicin
- Idarubicin
- Drug Therapy
- quizartinib
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
No
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.