OncoMatch/Clinical Trials/NCT05546580
Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)
Is NCT05546580 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including Iadademstat and Gilteritinib Oral Tablet for acute myeloid leukemia, in relapse.
Treatment: Iadademstat · Gilteritinib Oral Tablet — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: FLT3 internal tandem duplication
FLT3 internal tandem duplication (ITD)
Required: FLT3 tyrosine kinase domain D835
FLT3 tyrosine kinase domain (TKD) D835
Required: FLT3 tyrosine kinase domain I836
FLT3 tyrosine kinase domain (TKD) I836
Disease stage
Required: Stage FIRST RELAPSE, SECOND RELAPSE, REFRACTORY
Excluded: Stage RELAPSED AFTER OR REFRACTORY TO MORE THAN 2 LINES OF THERAPY
Patient is in first or second relapse or has refractory disease. AML that has relapsed after or is refractory to more than 2 lines of therapy [excluded].
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: KDM1A/LSD1 inhibitor (iadademstat)
Exception: other KDM1A/LSD1 inhibitors allowed if treatment finalized at least 3 weeks prior to first dose
Prior treatment with iadademstat is not allowed. Treatment with any other agents with KDM1A/LSD1 inhibitory activity is only allowed if treatment finalized at least 3 weeks prior to first dose on study.
Cannot have received: AML therapy
AML that has relapsed after or is refractory to more than 2 lines of therapy. Prior treatment with 3 or more lines of AML therapy.
Cannot have received: investigational product
Exception: allowed if >3 weeks prior to first dose
Treatment with any investigational products within 3 weeks prior to first dose of study treatment.
Lab requirements
Kidney function
normal renal function
Liver function
normal hepatic function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Banner MD Anderson Cancer Center · Gilbert, Arizona
- The University of Arizona Cancer Center - North Campus · Tucson, Arizona
- Sylvester Comprehensive Cancer Center · Miami, Florida
- Miami Cancer Institute · Miami, Florida
- The John Hopkins University School of Medicine · Baltimore, Maryland
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05546580 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior KDM1A/LSD1 inhibitor, AML therapy, investigational product disqualifies patients from enrollment.
Does this trial require FLT3?
Yes, FLT3 internal tandem duplication is a required biomarker for enrollment.
Does this trial require FLT3?
Yes, FLT3 tyrosine kinase domain D835 is a required biomarker for enrollment.
Does this trial require FLT3?
Yes, FLT3 tyrosine kinase domain I836 is a required biomarker for enrollment.
What disease stage is eligible?
Stage FIRST RELAPSE or SECOND RELAPSE or REFRACTORY is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages