# A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy

> **NCT02752035** · PHASE3 · COMPLETED · sponsor: **Astellas Pharma Global Development, Inc.** · enrollment: 183 (actual)

## Conditions studied

- Acute Myeloid Leukemia (AML)
- Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation

## Interventions

- **DRUG:** gilteritinib
- **DRUG:** azacitidine

## Key facts

- **NCT ID:** NCT02752035
- **Lead sponsor:** Astellas Pharma Global Development, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2016-08-01
- **Primary completion:** 2023-03-10
- **Final completion:** 2024-12-18
- **Target enrollment:** 183 (ACTUAL)
- **Last updated:** 2025-09-12


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02752035

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02752035, "A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT02752035. Licensed CC0.

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