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
Public ClinicalTrials.gov record NCT02752035. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Multicenter, Open-label, Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia With FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy
Study identification
- NCT ID
- NCT02752035
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Industry
- Enrollment
- 183 participants
Conditions and interventions
Conditions
Interventions
- azacitidine Drug
- gilteritinib Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2016
- Primary completion
- Mar 9, 2023
- Completion
- Dec 17, 2024
- Last update posted
- Sep 11, 2025
2016 – 2024
United States locations
- U.S. sites
- 12
- U.S. states
- 7
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA David Geffen School of Medicine | Los Angeles | California | 90095 | — |
| University of California, Irvine Medical Center | Orange | California | 92868 | — |
| Robert H. Lurie Comprehensive Cancer Center | Chicago | Illinois | 60611-5975 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| St. Louis University Cancer Center - Hematology/Oncology | St Louis | Missouri | 63110 | — |
| Hackensack University Medical Center - John Theurer Cancer Center | Hackensack | New Jersey | 07601 | — |
| Hematology-Oncology Associates of Northern NJ | Morristown | New Jersey | 07962 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | — |
| Weill Cornell Medical College-New York Presbyterian Hospital | New York | New York | 10021 | — |
| GHS Cancer Institute | Greenville | South Carolina | 26615 | — |
| LDS Hospital | Salt Lake City | Utah | 84143 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 99 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02752035, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 11, 2025 · Synced May 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02752035 live on ClinicalTrials.gov.