Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)
Public ClinicalTrials.gov record NCT05546580. 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
An Escalation/Expansion, Open Label, Multicenter Study of Iadademstat and Gilteritinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+): The FRIDA Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Iadademstat is being studied as a treatment for subjects with Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) with FMS-like tyrosine kinase mutation (FLT3 mut+). During the trial, iadademstat will be given in combination with gilteritinib, a drug that is already approved to treat patients with FLT3-mutated R/R AML.
Study identification
- NCT ID
- NCT05546580
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 50 participants
Conditions and interventions
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
- Nov 14, 2022 (Actual)
- Primary completion
- Jan 30, 2026 (Actual)
- Completion
- Dec 5, 2026 (Estimated)
- Last update posted
- Aug 24, 2026
2022 – 2026
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | — |
| The University of Arizona Cancer Center - North Campus | Tucson | Arizona | 85724-5024 | — |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| Miami Cancer Institute | Miami | Florida | 33176 | — |
| The John Hopkins University School of Medicine | Baltimore | Maryland | 21287-0013 | — |
| Massachusetts General Hospital (MGH) | Boston | Massachusetts | 02114 | — |
| Rutgers, The State University | Piscataway | New Jersey | 08854 | — |
| Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital | New York | New York | 10029 | — |
| Duke University Medical Center | Durham | North Carolina | 27705 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Sarah Cannon Research Institute, LLC | Nashville | Tennessee | 37203 | — |
| West Virginia University | Morgantown | West Virginia | 26506 | — |
| Froedtert Hospital & The Medical College of Wisconsin | 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 NCT05546580, 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 Aug 24, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05546580 live on ClinicalTrials.gov.