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Acute Myeloid LeukemiaPhase 2NCT06824168

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

A Phase 2 study testing Quizartinib High Dose and Quizartinib Low Dose in people with Acute Myeloid Leukemia and Leukemia, run by Daiichi Sankyo at 64 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This clinical two-arm trial is designed to evaluate two doses of quizartinib as maintenance therapy after induction/consolidation in participants with FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) (+) acute myeloid leukemia (AML) in first complete remission (CR) who have not received allogeneic… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia, Leukemia
What is being tested?
Quizartinib High Dose and Quizartinib Low Dose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
64 sitesin 5 countries
Study dates
18 Jul 2025to 14 Jul 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
  • 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.
  • 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.
  • 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
  • Participant must meet the following prior therapy requirements:
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  • 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.
  • Has not received more than four cycles of consolidation therapy. Regimens may contain conventional agents only.
  • 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.
  • Able to begin the maintenance phase within 60 days of D1 of the last consolidation cycle received.
  • Eastern Cooperative Oncology Group (ECOG) PS of 0 to 2.

Who cannot join

  • 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).
  • Diagnosis of AML secondary to prior chemotherapy or radiotherapy for other neoplasms.
  • Prior treatment for AML, except for the following allowances:
  • Induction and consolidation therapy, as previously described (inclusion criterion #5)
  • Leukapheresis
  • Hydroxyurea to treat hyperleukocytosis
Show all 24Show fewer
  • Cranial radiotherapy for central nervous system (CNS) leukostasis
  • Prophylactic intrathecal chemotherapy
  • Growth factor/cytokine support
  • Participant had received allo-HSCT as part of AML treatment.
  • Treatment with any strong or moderate CYP3A inducers within 2 weeks or 5 half-lives of randomization whichever is longer
  • Uncontrolled or significant cardiovascular disease, including the following:
  • QTcF interval >450 ms (based on average of triplicate ECG at Screening)
  • Diagnosed or suspected congenital long QT syndrome or known family history of congenital long QT syndrome
  • History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes
  • Participant has bradycardia of less than 50 beats per minute (bpm; as determined by central reading), unless the participant has a pacemaker
  • 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.
  • Myocardial infarction within 6 months prior to screening
  • Uncontrolled angina pectoris within 6 months prior to screening
  • New York Heart Association Class 3 or 4 congestive heart failure
  • LVEF ≤45% or institutional lower limit of normal
  • Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg despite optimal medical management)
  • Complete left or right bundle branch block
  • Severe aortic stenosis

Trial locations and contacts

64 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Contact for Trial Information contact

908-992-6400

CTRinfo_us@daiichisankyo.com

64 sites in 5 countries

China19 sites, 18 recruiting

  • Peking Union Medical College Hospital

    Beijing

    Recruiting

  • Peking University Third Hospital

    Beijing

    Recruiting

  • The First Hospital of Jilin University

    Changchun

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou

    Recruiting

  • Nanfang Hospital of Southern Medical University

    Guangzhou

    Recruiting

  • Sun Yat-sen University Cancer center

    Guangzhou

    Recruiting

  • The First Affiliated Hosptial of Zhejiang University School of Medicine

    Hangzhou

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang

    Recruiting

  • Zhong Da Hospital, Southeast University

    Nanjing

    Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao

    Recruiting

  • Huashan Hospital, Fudan University

    Shanghai

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou

    Recruiting

  • Hematology Hospital of the Chinese Academy of Medical Sciences

    Tianjin

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou

    Withdrawn

  • The First Affiliated Hospital of Jiaotong University

    Xi'an

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen

    Recruiting

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Recruiting

Other trials in China

United States15 sites, 12 recruiting

  • John Hopkins School of Medicine

    Baltimore, Maryland, 21287

    Not yet recruiting

  • University of Alabama - Birmingham

    Birmingham, Alabama, 35294

    Not yet recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Withdrawn

  • Novant Health Clinical Research

    Charlotte, North Carolina, 28204

    Not yet recruiting

  • Spoknwrd Clinical Trials Inc.

    Easton, Pennsylvania, 18045

    Recruiting

  • East Carolina University

    Greenville, North Carolina, 27834

    Not yet recruiting

  • John Theurer Cancer Center at Hackensack UMC

    Hackensack, New Jersey, 07601

    Not yet recruiting

  • The Methodist Hospital Research Institute

    Houston, Texas, 77030

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Not yet recruiting

  • Weill Cornell

    New York, New York, 10021-9800

    Recruiting

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

    Not yet recruiting

  • Westchester Medical College

    Valhalla, New York, 10595

    Withdrawn

  • Clinical Research Allicance

    Westbury, New York, 11590

    Recruiting

  • Umass Memorial Health Care Systems

    Worcester, Massachusetts, 01655

    Withdrawn

Other trials in United States

South Korea15 sites, 13 recruiting

  • Inje University Haeundae Paik Hospital

    Busan

    Recruiting

  • Pusan National University Hospital

    Busan

    Recruiting

  • Kyungpook National University Hospital

    Daegu

    Recruiting

  • Yeungnam University Hospital

    Daegu

    Recruiting

  • National Cancer Center

    Goyang-si, 10408

    Recruiting

  • Gachon University Gil Medical Center

    Incheon

    Withdrawn

  • Jeonbuk National University Hospital

    Jeonju

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam

    Recruiting

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

    Seoul, 6591

    Withdrawn

  • Samsung Medical Center

    Seoul

    Recruiting

  • Seoul National University Hospital

    Seoul

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul

    Recruiting

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

    Seoul

    Not yet recruiting

  • Ajou University Hospital

    Suwon

    Recruiting

  • Ulsan University Hospital

    Ulsan

    Recruiting

Other trials in South Korea

Brazil8 sites, 8 recruiting

  • Hospital Erasto Gaertner - Liga Paranaense de Combate ao Cancer

    Curitiba

    Recruiting

  • Cetus Hospital Dia Oncologia

    Minas Gerai

    Recruiting

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre

    Recruiting

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

    Porto Alegre

    Recruiting

  • INCA - Instituto Nacional de Câncer

    Rio de Janeiro

    Recruiting

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

    San Jose Rio Preto

    Recruiting

  • Hospital Santa Marcelina

    São Paulo

    Recruiting

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

    São Paulo

    Recruiting

Other trials in Brazil

Australia7 sites, 7 recruiting

  • Royal Adelaide Hospital

    Adelaide

    Recruiting

  • Austin Health

    Australia

    Recruiting

  • St. Vincent's Hospital Melbourne

    Darlinghurst

    Recruiting

  • The Alfred Hospital

    Melbourne

    Recruiting

  • Royal Perth Hospital

    Perth

    Recruiting

  • Gold Coast University Hospital

    Southport

    Recruiting

  • Westmead Hospital

    Sydney

    Recruiting

Other trials in Australia

About this study

Official title: A Phase 2, Multicenter, Randomized, Open-label Trial to Evaluate Safety and Efficacy of Two Dose Levels of Quizartinib as Maintenance for Adult Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia in Complete Remission

This clinical two-arm trial is designed to evaluate two doses of quizartinib as maintenance therapy after induction/consolidation in participants with FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) (+) acute myeloid leukemia (AML) in first complete remission (CR) who have not received allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Read the detailed description

This study also involves the Holter sub-study, which is designed to assess the impact of rapid acceleration in heart rate on the cardiac safety of quizartinib.

Being tested
Quizartinib High Dose, Quizartinib Low Dose
Keywords
acute myeloid leukemia, quizartinib, FLT3, allo-HSCT, leukemia
Medical subject headings
Leukemia, Myeloid, Acute, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quizartinib High DoseDrug

    Also called VANFLYTA®

    Participants in Arm 1 will receive oral daily higher dose of quizartinib,

  • Quizartinib Low DoseDrug

    Also called VANFLYTA®

    Participants in Arm 2 will receive oral daily lower dose of quizartinib

Study groups in NCT06824168
Study groupRoleWhat they receive
Arm 1ExperimentalParticipants will receive higher dose of quizartinib
Receives: Drug: Quizartinib High Dose
Arm 2ExperimentalParticipants will receive lower dose of quizartinib
Receives: Drug: Quizartinib Low Dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serious Treatment Emergent Adverse Events (TEAEs)

    TEAEs are defined as AEs with start or worsening date during the on-treatment period (from the first dose date of trial treatment to 30 days after the last dose date of trial treatment).

    Measured: From date of first dose to 30 days after last dose, up to 87 months

Secondary outcomes (3)

  1. TEAEs

    TEAEs are defined as AEs with start or worsening date during the on-treatment period (from the first dose date of trial treatment to 30 days after the last dose date of trial treatment).

    Measured: From date of first dose to 30 days after last dose, up to 87 months

  2. Overall Survival (OS)

    OS is defined as the time from randomization until death from any cause.

    Measured: From date of randomization to death from any cause, up to 87 months

  3. Relapse-free Survival (RFS)

    RFS is defined as the time from randomization until documented relapse or death from any cause, whichever comes first

    Measured: From date of randomization to documented relapse or death from any cause, whichever comes first, up to 87 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2025
  2. Study start18 Jul 2025
  3. Primary completion6 Jun 2028 (estimated)
  4. Study completion14 Jul 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06824168
Sponsor's protocol ID
AC220-167
Status last verified
Sep 2026
First submitted
7 Feb 2025
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Quizartinib High Dose and Quizartinib Low Dose in people with Acute Myeloid Leukemia and Leukemia, run by Daiichi Sankyo at 64 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in China, United States, South Korea, Brazil, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Contact for Trial Information (908-992-6400, CTRinfo_us@daiichisankyo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serious Treatment Emergent Adverse Events (TEAEs) (time frame: From date of first dose to 30 days after last dose, up to 87 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06824168.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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