NCT06578247

Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial Of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy and Administered as Maintenance Therapy in Adult Patients With Newly Diagnosed FLT3-ITD Negative Acute Myeloid Leukemia

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the effects of Quizartinib versus placebo in combination with chemotherapy in participants with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML).

Detailed description

This is a clinical trial to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as maintenance therapy for up to 36 cycles) on the primary endpoint of overall survival (OS) in adult patients with newly diagnosed FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukemia (AML). Participants will be tested for FLT3-ITD mutation status in a central laboratory using a validated assay.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	Quizartinib	Participants will receive quizartinib at 60 mg/day orally once daily
DRUG	Placebo	Participants will receive placebo at 60 mg/day orally once daily
DRUG	Chemotherapy	Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin or idarubicin).

Timeline

• Start date: 2024-11-19
• Primary completion: 2030-06-26
• Completion: 2030-06-26
• First posted: 2024-08-29
• Last updated: 2026-03-31

Locations

292 sites across 28 countries: United States, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czechia, France, Germany, Hong Kong, Hungary, Italy, Japan, Norway, Poland, Portugal, Romania, Serbia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study