Clinical Trial

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

Recruiting Phase 2
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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 hematopoietic stem cell transplantation (allo-HSCT).
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-02-07; most recent amendment 2026-06-17.
Status change: Not Yet Recruiting → Recruiting 2025-08-27
Trial Details
NCT Number NCT06824168
Lead Sponsor Daiichi Sankyo
Conditions Acute Myeloid Leukemia, Leukemia
Enrollment 130 participants
Start Date 2025-07-18
Primary Completion 2028-06-06 (estimated)
Study Completion 2032-07-14 (estimated)
Updated on ClinicalTrials.gov 2026-06-22