# A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML

Source: https://onco.cc/trials/nct03591510/  
OnCo record `nct03591510` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2 trial of Midostaurin, Fludarabine, Cytarabine, Daunorubicin, Idarubicin and Mitoxantrone in acute myeloid leukaemia, run by Novartis Pharmaceuticals, active and no longer recruiting.

## Summary

A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML is a phase 2 interventional study registered as NCT03591510 by Novartis Pharmaceuticals, with 22 participants enrolled, started 2019-03-13 and due to reach its primary completion in 2029-05-18. Interventions recorded: Midostaurin, Fludarabine, Cytarabine, Daunorubicin or idarubicin, Mitoxantrone and Etoposide.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT03591510
- Phase: 2
- Setting: A Phase II, Open-label, Single Arm Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Twice Daily Midostaurin (PKC412) Combined With Standard Chemotherapy and as a Single Agent Post-consolidation Therapy in Children With Untreated FLT3-mutated AML
- Sponsor: Novartis Pharmaceuticals
- Enrolled: 22

## Sources

- ClinicalTrials.gov NCT03591510: https://clinicaltrials.gov/study/NCT03591510

## Connected records

- cancers: [Acute myeloid leukaemia](https://onco.cc/cancers/aml/)
- drugs: [Cytarabine](https://onco.cc/drugs/cytarabine/), [Daunorubicin](https://onco.cc/drugs/daunorubicin/), [Fludarabine](https://onco.cc/drugs/fludarabine/), [Idarubicin](https://onco.cc/drugs/idarubicin/), [Midostaurin](https://onco.cc/drugs/midostaurin/), [Mitoxantrone](https://onco.cc/drugs/mitoxantrone/)
- companies: [Advanced Accelerator Applications (Novartis)](https://onco.cc/companies/advanced-accelerator-applications/)

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