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

NCT06578247 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2026-04-30

No results posted yet for this study

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).

Conditions

Interventions

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).

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-19
Primary Completion
2030-06-26
Completion
2030-06-26
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06578247 on ClinicalTrials.gov