A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia
Public ClinicalTrials.gov record NCT05520567. 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 1/2, Multicenter, Open-Label, Randomized Dose Ranging and Expansion Study of the Combination of Gilteritinib, Venetoclax and Azacitidine in Patients With Newly Diagnosed FLT3 Mutated Acute Myeloid Leukemia (AML) Not Eligible for Intensive Induction Chemotherapy
Study identification
- NCT ID
- NCT05520567
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Industry
- Enrollment
- 70 participants
Conditions and interventions
Interventions
- Azacitidine Drug
- Gilteritinib Drug
- Venetoclax 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
- Jan 30, 2023
- Primary completion
- Jul 30, 2028
- Completion
- Jul 30, 2028
- Last update posted
- Mar 3, 2026
2023 – 2028
United States locations
- U.S. sites
- 20
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Nat'l Medical Center | Duarte | California | 91010 | — |
| Univ. of California - Irvine | Irvine | California | 92697 | — |
| UCLA Medical Center | Los Angeles | California | 90095 | — |
| Sarah Cannon Research Institute | Denver | Colorado | 80218 | — |
| Memorial Cancer Institute | Pembroke Pines | Florida | 33028 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Robert H. Lurie Comprehensive Cancer Center | Chicago | Illinois | 61612 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Weill Cornell Medical College | New York | New York | 10065 | — |
| Motefiore-Einstein Center for Cancer Care | The Bronx | New York | 10461 | — |
| Novant Health | Winston-Salem | North Carolina | 27103 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| University of Pennsylvania-Abramson CCC-Dept. of Hem Onc | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| The University of Texas MD | Houston | Texas | 77030 | — |
| The Medical College of Wisconsin- Froedtert Hospital | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05520567, 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 Mar 3, 2026 · Synced May 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05520567 live on ClinicalTrials.gov.