NCT06824168

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Acute Myeloid Leukemia
• Leukemia

Interventions

Type	Name	Description
DRUG	Quizartinib High Dose	Participants in Arm 1 will receive oral daily higher dose of quizartinib,
DRUG	Quizartinib Low Dose	Participants in Arm 2 will receive oral daily lower dose of quizartinib

Timeline

• Start date: 2025-07-18
• Primary completion: 2028-06-06
• Completion: 2032-07-14
• First posted: 2025-02-13
• Last updated: 2025-12-04

Locations

58 sites across 5 countries: United States, Australia, Brazil, China, South Korea

Regulatory

• FDA-regulated drug study