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Search / Trial NCT06578247

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 June 27, 2025

Recruiting

Keywords

Acute Myeloid Leukemia Quizartinib Flt3 Flt3 Itd Chemotherapy Flt3 Wt

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.

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

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

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

Patients applied

0 patients applied

Trial Officials

Global Clinical Leader

Study Director

Daiichi Sankyo

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported