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 (May 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
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 →
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