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New hope for AML patients: quizartinib maintenance trial launches

NCT ID NCT06824168

Disease control Sponsor: Daiichi Sankyo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times

Summary

This study tests two different doses of the drug quizartinib as a maintenance therapy for adults with a specific type of acute myeloid leukemia (FLT3-ITD positive) who are in their first complete remission after initial treatment and have not had a stem cell transplant. The goal is to see which dose is safer and more effective at preventing the cancer from coming back. About 130 participants will be randomly assigned to receive either a higher or lower dose of quizartinib.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 130 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jul 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Adults ≥18 years of age or the minimum legal adult age (whichever is greater) on the day of signing the ICF (no upper limit of age). 2. Newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm based on the World Health Organization (WHO) 2008/2016 classification. 3. Participant has confirmed FLT3-ITD-positive (≥0.05 SR or ≥5% VAF) activating mutation from initial diagnosis in bone marrow or peripheral blood as determined by a local institution's validated molecular testing. 4. Participants must have confirmed, morphologically documented CR1, on the most recent BMA, based on the local laboratory results, performed within 28 days prior to C1D1 of maintenance therapy. Complete remission will be defined as \<5% blasts in the bone marrow with no morphologic characteristics of acute leukemia (e.g., Auer Rods), no evidence of extramedullary disease, and no leukemic blasts in the peripheral blood. Complete blood count recovery is required with absolute neutrophil count of more than 1.000 × 109/L and platelets more than 100 × 109/L (IWG criteria).27 5. Participant must meet the following prior therapy requirements: 1. Has received at least one cycle of induction therapy but no more than two to achieve CR1. The induction cycles can be the same regimen or different regimens and may contain conventional agents only (e.g., cytarabine + daunorubicin or idarubicin: "7 + 3" or "5 + 2"), or a combination with FLT3 inhibitors. 2. Has not received more than four cycles of consolidation therapy. Regimens may contain conventional agents only. 3. FLT3 inhibitors are permitted as part of the induction or consolidation treatment. Participants who received FLT3 inhibitors before enrollment in the trial will need a washout period of 14 days. 6. Able to begin the maintenance phase within 60 days of D1 of the last consolidation cycle received. 7. Eastern Cooperative Oncology Group (ECOG) PS of 0 to 2. Key Exclusion Criteria: 1. 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 (i.e., 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). 2. Diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms. 3. Prior treatment for AML, except for the following allowances: 1. Induction and consolidation therapy, as previously described (inclusion criterion #5) 2. Leukapheresis 3. Hydroxyurea to treat hyperleukocytosis 4. Cranial radiotherapy for central nervous system (CNS) leukostasis 5. Prophylactic intrathecal chemotherapy 6. Growth factor/cytokine support 4. Participant had received allo-HSCT as part of AML treatment. 5. Treatment with any strong or moderate CYP3A inducers within 2 weeks or 5 half-lives of randomization whichever is longer 6. Uncontrolled or significant cardiovascular disease, including the following: 1. QTcF interval \>450 ms (based on average of triplicate ECG at Screening) 2. Diagnosed or suspected congenital long QT syndrome or known family history of congenital long QT syndrome 3. History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes 4. Participant has bradycardia of less than 50 beats per minute (bpm; as determined by central reading), unless the participant has a pacemaker 5. History of second- or third-degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers and have no history of fainting or clinically relevant arrhythmia with pacemakers. 6. Myocardial infarction within 6 months prior to screening 7. Uncontrolled angina pectoris within 6 months prior to screening 8. New York Heart Association Class 3 or 4 congestive heart failure 9. LVEF ≤45% or institutional lower limit of normal 10. Uncontrolled hypertension (resting systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg despite optimal medical management) 11. Complete left or right bundle branch block 12. Severe aortic stenosis

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia acute myeloid leukemia, FLT3 internal tandem duplication leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia Leukemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    58 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • "Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto CIP - Centro Integrado de Pesquisa"

    RECRUITING

    San Jose Rio Preto, Brazil

  • Ajou University Hospital

    RECRUITING

    Suwon, South Korea

  • Austin Health

    RECRUITING

    Australia, Australia

  • Cetus Hospital Dia Oncologia

    RECRUITING

    Minas Gerai, Brazil

  • Clinical Research Allicance

    RECRUITING

    Westbury, New York, 11590, United States

  • East Carolina University

    NOT_YET_RECRUITING

    Greenville, North Carolina, 27834, United States

  • Gachon University Gil Medical Center

    WITHDRAWN

    Incheon, South Korea

  • Gold Coast University Hospital

    RECRUITING

    Southport, Australia

  • Guangdong Provincial People's Hospital

    RECRUITING

    Guangzhou, China

  • Hematology Hospital of the Chinese Academy of Medical Sciences

    RECRUITING

    Tianjin, China

  • Hospital Erasto Gaertner - Liga Paranaense de Combate ao Cancer

    RECRUITING

    Curitiba, Brazil

  • Hospital Santa Marcelina

    RECRUITING

    São Paulo, Brazil

  • Hospital de Clínicas de Porto Alegre

    RECRUITING

    Porto Alegre, Brazil

  • Huashan Hospital, Fudan University

    RECRUITING

    Shanghai, China

  • Huntsman Cancer Institute

    NOT_YET_RECRUITING

    Salt Lake City, Utah, 84112, United States

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

    RECRUITING

    São Paulo, Brazil

  • INCA - Instituto Nacional de Câncer

    RECRUITING

    Rio de Janeiro, Brazil

  • Inje University Haeundae Paik Hospital

    RECRUITING

    Busan, South Korea

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre Centro Multidisciplinar de Pesquisa

    RECRUITING

    Porto Alegre, Brazil

  • Jeonbuk National University Hospital

    RECRUITING

    Jeonju, South Korea

  • John Hopkins School of Medicine

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21287, United States

  • John Theurer Cancer Center at Hackensack UMC

    NOT_YET_RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Kyungpook National University Hospital

    RECRUITING

    Daegu, South Korea

  • Nanfang Hospital of Southern Medical University

    RECRUITING

    Guangzhou, China

  • National Cancer Center

    RECRUITING

    Goyang-si, 10408, South Korea

  • Novant Health Clinical Research

    NOT_YET_RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, China

  • Peking University Third Hospital

    RECRUITING

    Beijing, China

  • Pusan National University Hospital

    RECRUITING

    Busan, South Korea

  • Roswell Park Cancer Institute

    WITHDRAWN

    Buffalo, New York, 14263, United States

  • Royal Adelaide Hospital

    RECRUITING

    Adelaide, Australia

  • Royal Perth Hospital

    RECRUITING

    Perth, Australia

  • Samsung Medical Center

    RECRUITING

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, South Korea

  • Spoknwrd Clinical Trials Inc.

    RECRUITING

    Easton, Pennsylvania, 18045, United States

  • St. Vincent's Hospital Melbourne

    RECRUITING

    Darlinghurst, Australia

  • Sun Yat-sen University Cancer center

    RECRUITING

    Guangzhou, China

  • The Affiliated Hospital of Qingdao University

    RECRUITING

    Qingdao, China

  • The Affiliated Hospital of Xuzhou Medical College

    RECRUITING

    Xuzhou, China

  • The Alfred Hospital

    RECRUITING

    Melbourne, Australia

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

    WITHDRAWN

    Seoul, 6591, South Korea

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

    NOT_YET_RECRUITING

    Seoul, South Korea

  • The First Affiliated Hospital of Guangxi Medical University

    RECRUITING

    Nanning, China

  • The First Affiliated Hospital of Jiaotong University

    RECRUITING

    Xi'an, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, China

  • The First Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, China

  • The First Affiliated Hospital of Wenzhou Medical University

    WITHDRAWN

    Wenzhou, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, China

  • The First Affiliated Hosptial of Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, China

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, China

  • The Methodist Hospital Research Institute

    RECRUITING

    Houston, Texas, 77030, United States

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • USC Norris Comprehensive Cancer Center

    NOT_YET_RECRUITING

    Los Angeles, California, 90033, United States

  • Ulsan University Hospital

    RECRUITING

    Ulsan, South Korea

  • Umass Memorial Health Care Systems

    WITHDRAWN

    Worcester, Massachusetts, 01655, United States

  • University of Alabama - Birmingham

    NOT_YET_RECRUITING

    Birmingham, Alabama, 35294, United States

  • Weill Cornell

    RECRUITING

    New York, New York, 10021-9800, United States

  • Westchester Medical College

    WITHDRAWN

    Valhalla, New York, 10595, United States

  • Westmead Hospital

    RECRUITING

    Sydney, Australia

  • Yeungnam University Hospital

    RECRUITING

    Daegu, South Korea

  • Zhong Da Hospital, Southeast University

    RECRUITING

    Nanjing, China

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