Quizartinib for FLT3-ITD (+) Acute Myeloid Leukemia Maintenance

This study is looking at two different doses of quizartinib to help prevent acute myeloid leukemia (AML) from coming back. AML is a type of blood cancer. This trial is for people with a specific type of AML called FLT3-ITD (+), who are in their first complete remission (meaning the cancer is not currently detectable) and have not had a stem cell transplant. Participants will receive either a higher or lower daily dose of quizartinib by mouth. The main goal is to track any serious side effects from the treatment. This study is also looking at how quizartinib might affect your heart rate. About 130 adults aged 18 and older are expected to join.

Study design
This is an interventional study comparing two doses of quizartinib in approximately 130 participants. It has two arms, meaning participants will be assigned to one of two treatment groups.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Serious side effects will be monitored from the first dose until 30 days after the last dose, for up to 87 months.

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NCT06824168

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Daiichi Sankyo
~130 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:Quizartinib High DoseQuizartinib Low Dose

At a glance

Recruiting sites
46 of 58 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Serious Treatment Emergent Adverse Events (TEAEs)
Measured over From date of first dose to 30 days after last dose, up to 87 months
Acute Myeloid Leukemia
Leukemia
58 sites across 9 states
China19
South Korea15
Brazil8
Australia7
New York4
Texas2
Maryland1
Massachusetts1

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  • Serious Treatment Emergent Adverse Events (TEAEs)From date of first dose to 30 days after last dose, up to 87 months

    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).