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Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood

NCT03793478 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-04-01

No results posted yet for this study

Summary

Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research.

Children or young adults with a certain kind of blood cancer (FLT3-ITD AML) might be able to join this study if it has come back after remission or is not responding to treatment.

Conditions

Interventions

DRUG

Quizartinib

Administered orally once daily starting on Day 6 and continuing through Day 28; Optional low intensity consolidation with chemotherapy: Administered orally once daily starting on Day 1 and continuing through Day 28

DRUG

Fludarabine

30 mg/m\^2/day IV infusion given over 30 minutes on Days 1 through 5 (administered based on body weight)

DRUG

Cytarabine

2000 mg/m\^2/day IV infusion given over 3 hours on Days 1 through 5 (begin 4 hours after the start of fludarabine) (administered in accordance with standard of care); Optional high intensity consolidation with chemotherapy and quizartinib: 500 mg/m\^2/day as a continuous 96-hour IV infusion on Days 1 through 4; Optional low intensity consolidation with chemotherapy: 75 mg/m\^2/day as once daily subcutaneous or IV on Days 1 through 4 and Days 15 through 18

DRUG

Intrathecal (IT) triple chemotherapy prophylaxis

IT cytarabine, methotrexate, and either prednisolone or hydrocortisone; doses are based on the participant's age and standard practice at each site

DRUG

Etoposide

Optional high intensity consolidation with chemotherapy and quizartinib: 100 mg/m\^2/dose once daily as an IV infusion over 3 hours on Days 1 through 5

Sponsors & Collaborators

  • Innovative Therapies For Children with Cancer Consortium

    collaborator OTHER

  • Children's Oncology Group

    collaborator NETWORK

  • Daiichi Sankyo

    lead INDUSTRY

Principal Investigators

  • Global Clinical Leader · Daiichi Sankyo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Month
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-15
Primary Completion
2027-05-01
Completion
2027-05-01
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Denmark
  • France
  • Israel
  • Italy
  • Netherlands
  • Spain
  • Sweden

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 NCT03793478 on ClinicalTrials.gov