Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML
Launched by DAIICHI SANKYO · Aug 27, 2024
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of a medication called Quizartinib compared to a placebo (a substance with no active medication) when used alongside standard chemotherapy in patients who have recently been diagnosed with a type of leukemia known as acute myeloid leukemia (AML) that does not have a specific mutation called FLT3-ITD. The goal is to see if Quizartinib can improve treatment outcomes for these patients.
To be eligible for this trial, participants must be at least 18 years old and newly diagnosed with AML as confirmed by medical testing. They should be able to understand and sign a consent form, and their overall health should be rated as good to fair. Participants will receive standard chemotherapy treatment during the trial and will be monitored closely by healthcare professionals. This study is currently recruiting individuals, and it's important for potential participants to discuss their eligibility and any questions with their doctor.
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • Must be competent and able to comprehend, sign, and date an Ethics Committee (EC)- or Institutional Review Board (IRB)-approved Informed Consent Form (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 receiving standard "7+3" induction chemotherapy regimen as specified in the protocol
- 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 for other neoplasms or autoimmune/rheumatologic conditions.
- • Diagnosis of AML secondary to myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS/MPNs including CMML, aCML, 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:
- • 1. Leukapheresis;
- • 2. Treatment for hyperleukocytosis with hydroxyurea;
- • 3. Cranial radiotherapy for central nervous system (CNS) leukostasis;
- • 4. Prophylactic intrathecal chemotherapy;
- • 5. Growth factor/cytokine support.
About Daiichi Sankyo
Daiichi Sankyo is a global healthcare company headquartered in Tokyo, Japan, dedicated to the research, development, and commercialization of innovative pharmaceuticals and vaccines. With a strong focus on oncology, cardiovascular diseases, and rare disorders, Daiichi Sankyo leverages advanced technologies and a robust pipeline to address unmet medical needs worldwide. Committed to fostering collaboration and scientific excellence, the company engages in clinical trials that aim to bring transformative therapies to patients while adhering to the highest standards of safety and efficacy. Through its comprehensive approach to drug development, Daiichi Sankyo strives to improve patient outcomes and enhance the quality of life for individuals around the globe.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Philadelphia, Pennsylvania, United States
Milwaukee, Wisconsin, United States
Providence, Rhode Island, United States
Caen, , France
Saskatoon, , Canada
Detroit, Michigan, United States
Cleveland, Ohio, United States
Hackensack, New Jersey, United States
Madrid, , Spain
Valencia, , Spain
Baltimore, Maryland, United States
Houston, Texas, United States
Torino, , Italy
Murcia, , Spain
Oxford, , United Kingdom
Saint Louis, Missouri, United States
Brugge, , Belgium
Cincinnati, Ohio, United States
Tampa, Florida, United States
Chapel Hill, North Carolina, United States
Pittsburgh, Pennsylvania, United States
New Haven, Connecticut, United States
Rozzano, , Italy
Essen, , Germany
Tucson, Arizona, United States
Maidstone, , United Kingdom
Denver, Colorado, United States
Charlottesville, Virginia, United States
Houston, Texas, United States
Sapporo, , Japan
Valencia, , Spain
London, , United Kingdom
Fukuoka, , Japan
Lyon, , France
Beijing, , China
Cordoba, , Spain
Taipei, , Taiwan
Tampa, Florida, United States
Milano, , Italy
Kumamoto, , Japan
Adelaide, , Australia
Manchester, , United Kingdom
Heidelberg, , Germany
Perth, , Australia
Leuven, , Belgium
Augusta, Georgia, United States
Akita, , Japan
Chicago, Illinois, United States
Beijing, Beijing, China
Caceres, , Spain
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Busan, , Korea, Republic Of
Oslo, , Norway
Woolloongabba, , Australia
Bucuresti, , Romania
Hradec Kralove, , Czechia
Daegu, , Korea, Republic Of
Uppsala, , Sweden
Guangzhou, Guangdong, China
Praha 10, , Czechia
Seongnam Si, , Korea, Republic Of
Seoul, , Korea, Republic Of
Warszawa, , Poland
Barcelona, , Spain
Columbus, Ohio, United States
Phoenix, Arizona, United States
Belgrade, , Serbia
Melbourne, , Australia
Bucuresti, , Romania
Portland, Oregon, United States
Pleven, , Bulgaria
Ottawa, , Canada
Jinan, , China
Incheon, , Korea, Republic Of
Bergen, , Norway
Liverpool, , Australia
Brno, , Czechia
Novara, , Italy
Budapest, , Hungary
Taipei, , Taiwan
Beijing, Beijing, China
Albacete, , Spain
Münster, , Germany
Bari, , Italy
Changchun, , China
Singapore, , Singapore
Kiel, , Germany
Kanazawa, , Japan
Chicago, Illinois, United States
Changsha, , China
Concord, , Australia
Kaohsiung, , Taiwan
Beijing, , China
Taoyuan County, , Taiwan
Changsha, , China
Oslo, , Norway
Zhengzhou, Henan, China
Seoul, , Korea, Republic Of
Nis, , Serbia
Torquay, , United Kingdom
Jacksonville, Florida, United States
Nanchang, Jiangxi, China
Roeselare, , Belgium
Anderlecht, , Belgium
Valencia, , Spain
Chongqing, Chongqing, China
Malaga, , Spain
Madrid, , Spain
Suzhou, Jiangsu, China
Ostrava Poruba, , Czechia
Suwon, , Korea, Republic Of
Lexington, Kentucky, United States
Hong Kong, , Hong Kong
Nantong, , China
Santiago De Compostela, , Spain
Murdoch, , Australia
Lublin, , Poland
Zagreb, , Croatia
Daegu, , Korea, Republic Of
Seoul, , Korea, Republic Of
Debrecen, , Hungary
Bucuresti, , Romania
London, , Canada
Bunkyo Ku, , Japan
Daegu, , Korea, Republic Of
Dresden, , Germany
Rijeka, , Croatia
Lisboa, , Portugal
Torun, , Poland
Tianjin, Tianjin, China
San Giovanni Rotondo, , Italy
Ulsan, , Korea, Republic Of
Buffalo, New York, United States
London, , United Kingdom
Busan, , Korea, Republic Of
Belgrade, , Serbia
Wuxi, , China
Szeged, , Hungary
Bern, , Switzerland
Braunschweig, , Germany
Paris Cedex 10, , France
Nantes Cedex 1, , France
Box Hill, , Australia
Sofia, , Bulgaria
Seoul, , Korea, Republic Of
Palermo, , Italy
Zagreb, , Croatia
Porto, , Portugal
Madrid, , Spain
Rome, , Italy
Palma De Mallorca, , Spain
Craiova, , Romania
New York, New York, United States
Milano, , Italy
Wenzhou, , China
Plzen, , Czechia
Nagoya, , Japan
Porto Alegre, , Brazil
New Orleans, Louisiana, United States
Tampa, Florida, United States
Antwerpen, , Belgium
Syracuse, New York, United States
Brescia, , Italy
Hannover, , Germany
Roma, , Italy
Nashville, Tennessee, United States
Porto Alegre, , Brazil
Madrid, , Spain
Curitiba, , Brazil
Pozuelo De Alarcon, , Spain
Matsuyama, , Japan
Jau, , Brazil
Hwasun Gun, , Korea, Republic Of
Majadahonda, , Spain
Botucatu, , Brazil
Toronto, , Canada
Praha 2, , Czechia
Shengyang, , China
Passo Fundo, , Brazil
Yantai, , China
Fukuyama, , Japan
Jeonju Si, , Korea, Republic Of
Shanghai, , China
Taichung, , Taiwan
Cluj Napoca, , Romania
Santander, , Spain
Rennes Cedex 09, , France
Tenri, , Japan
Gifu, , Japan
Stara Zagora, , Bulgaria
Salouel, , France
Sao Jose Rio Preto, , Brazil
Ann Arbor, Michigan, United States
Plovdiv, , Bulgaria
Beijing, Beijing, China
Gyor, , Hungary
Bedford Park, , Australia
Liege, , Belgium
Florianăłpolis, , Brazil
Săło Paulo, , Brazil
Săło Paulo, , Brazil
Xi'an, , China
Tainan, , Taiwan
Douglas, , Australia
Goodyear, Arizona, United States
Liege, , Belgium
Florianăłpolis, , Brazil
Săło Paulo, , Brazil
Xi'an, , China
Jaú, , Brazil
Porto Alegre, , Brazil
Las Palmas, , Spain
Qingdao, Shandong, China
San Francisco, California, United States
Stanford, California, United States
Kissimmee, Florida, United States
Minneapolis, Minnesota, United States
Haddonfield, New Jersey, United States
Austin, Texas, United States
Richmond, Virginia, United States
Darlinghurst, , Australia
Linz, , Austria
Salzburg, , Austria
Wien, , Austria
Campinas, , Brazil
Curitiba, , Brazil
Fortaleza, , Brazil
Goiania, , Brazil
Passo Fundo, , Brazil
Porto Alegre, , Brazil
Porto Alegre, , Brazil
Rio De Janeiro, , Brazil
Săło Paulo, , Brazil
Sofia, , Bulgaria
Sofia, , Bulgaria
Guangzhou, , China
Nanjing, , China
Shenzhen, , China
Tianjin, , China
Angers, , France
Grenoble, , France
Le Chesnay Cedex, , France
Lille Cedex, , France
Marseille Cedex 05, , France
Nice, , France
Paris Cedex 10, , France
Pessac Cedex, , France
Pierre Băšnite, , France
Strasbourg, , France
Toulouse, , France
Alzenau, , Germany
Leipzig, , Germany
Shatin, , Hong Kong
Meldola, , Italy
Torino, , Italy
Varese, , Italy
Chiba Shi, , Japan
Hamamatsu, , Japan
Kamogawa Shi, , Japan
Maebashi, , Japan
Osaka Shi, , Japan
Sapporo, , Japan
Tromsă¸, , Norway
Olsztyn, , Poland
Singapore, , Singapore
Seville, , Spain
Găśteborg, , Sweden
Lund, , Sweden
Salzburg, , Austria
Curitiba, , Brazil
Fortaleza, , Brazil
Goiania, , Brazil
Passo Fundo, , Brazil
Porto Alegre, , Brazil
Rio De Janeiro, , Brazil
Sofia, , Bulgaria
Angers, , France
Grenoble, , France
Nice, , France
Paris Cedex 10, , France
Pessac Cedex, , France
Strasbourg, , France
Leipzig, , Germany
Olsztyn, , Poland
Aomori, , Japan
Osakar, , Japan
Taoyuan County, , Taiwan
Shanghai, Shanghai, China
Goiania, , Brazil
Columbus, Ohio, United States
Sao Paulo, , Brazil
Fortaleza, , Brazil
Florianopolis, , Brazil
Rio De Janeiro, , Brazil
Sao Paulo, , Brazil
Sao Paulo, , Brazil
La Tronche, , France
Gasteborg, , Sweden
Patients applied
Trial Officials
Global Clinical Leader
Study Director
Daiichi Sankyo
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported