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

Source: https://onco.cc/trials/nct03793478/  
OnCo record `nct03793478` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 1/2 trial of Quizartinib, Fludarabine, Cytarabine and Etoposide in acute myeloid leukaemia, run by Daiichi Sankyo, active and no longer recruiting.

## Summary

Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood is a phase 1/2 interventional study registered as NCT03793478 by Daiichi Sankyo, with 65 participants enrolled, started 2018-08-15 and due to reach its primary completion in 2027-05-01. Interventions recorded: Quizartinib, Fludarabine, Cytarabine, Intrathecal (IT) triple chemotherapy prophylaxis and Etoposide.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT03793478
- Phase: 1/2
- Setting: A Phase 1/2, Multicenter, Dose-Escalating Study To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy Of Quizartinib Administered in Combination With Re-Induction Chemotherapy, and as a Single-Agent Continuation Therapy, in Pediatric Relapsed/Refractory AML Subjects Aged 1 Month to <18 Years (and Young Adults Aged up to 21 Years) With FLT3-ITD Mutations
- Sponsor: Daiichi Sankyo
- Enrolled: 65

## Sources

- ClinicalTrials.gov NCT03793478: https://clinicaltrials.gov/study/NCT03793478

## Connected records

- cancers: [Acute myeloid leukaemia](https://onco.cc/cancers/aml/)
- drugs: [Cytarabine](https://onco.cc/drugs/cytarabine/), [Etoposide](https://onco.cc/drugs/etoposide/), [Fludarabine](https://onco.cc/drugs/fludarabine/), [Quizartinib](https://onco.cc/drugs/quizartinib/)
- companies: [Daiichi Sankyo](https://onco.cc/companies/daiichi-sankyo/)

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