2026-09-17
minor
Trial sites expanded: 58 → 64 locations
2026-06-17
minor
Study Status, Contacts/Locations v5
Study sitesdetails revised at 27 of 58 sites
2025-12-02
minor
Study Status, Contacts/Locations v4
2025-08-27
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-06-27→confirmed 2025-07-18
Study sites4→57
2025-06-25
minor
Study Status, Contacts/Locations v2
Start date2025-05-21→2025-06-27
Study sites0→4
2025-02-26
minor
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v1
Start date2025-03-25→2025-05-21
InterventionsQuizartinib (Drug)→Quizartinib High Dose (Drug), Quizartinib Low Dose (Drug)
Eligibility criteria+724 characters
[...] articipant had received allo-HSCT as part of AML treatment.
Prior treatmentTreatment with any investigational drugstrong or devicemoderate withinCYP3A 30inducers days prior to randomization (within 2 weeks foror investigational5 half-lives of randomization whichever is longer
Uncontrolled or approvedsignificant immunotherapy)cardiovascular or currently participating in other investigational procedures.
Inadequate washout period before randomization, defined as: major surgery <4 weeks or
≤2 weeks for low-invasive cases (e.g., colostomy).
Has an active CNS leukemia involvementdisease, including [...]
Secondary endpoints3 entries, revised
Serious TEAEs
Primary endpoints1 entry, revised
Serious Treatment Emergent Adverse Events (TEAEs)
Study description+159 characters
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.
2025-02-07
minor
Original filing