# A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation

> **NCT02421939** · PHASE3 · COMPLETED · sponsor: **Astellas Pharma Global Development, Inc.** · enrollment: 371 (actual)

## Conditions studied

- Leukemia, Acute Myeloid (AML)

## Interventions

- **DRUG:** gilteritinib
- **DRUG:** LoDAC (Low Dose Cytarabine)
- **DRUG:** Azacitidine
- **DRUG:** MEC (Mitoxantrone, Etoposide, Cytarabine)
- **DRUG:** FLAG-IDA (Granulocyte-Colony Stimulating Factor (G-CSF), Fludarabine, Cytarabine, Idarubicin)

## Key facts

- **NCT ID:** NCT02421939
- **Lead sponsor:** Astellas Pharma Global Development, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2015-10-20
- **Primary completion:** 2018-09-17
- **Final completion:** 2025-02-25
- **Target enrollment:** 371 (ACTUAL)
- **Last updated:** 2025-12-04


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02421939

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02421939, "A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation". Retrieved via AI Analytics 2026-08-18 from https://api.ai-analytics.org/clinical/NCT02421939. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*