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Iadademstat and Gilteritinib for Relapsed/Refractory AML with FLT3 Mutation

This study is testing a new combination treatment for acute myeloid leukemia (AML) that has come back (relapsed) or hasn't responded to previous treatments (refractory), specifically in patients with a certain gene change called a FLT3 mutation. You may be able to join if you have AML with this mutation and are 18 or older. The study combines iadademstat with gilteritinib, a drug already approved for this type of AML. Researchers will look at side effects and how well the combination works over 18 months. The goal is to find a safe and effective dose of iadademstat when given with gilteritinib.

Study design
This is an open-label, single-arm study, meaning all participants receive the same treatment and everyone knows what treatment is being given. It plans to enroll 50 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events, laboratory abnormalities, and vital sign changes for up to 18 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05546580

Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Oryzon Genomics S.A.
~50 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:IadademstatGilteritinib Oral Tablet

At a glance

Recruiting sites
0 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Events (AE)
Measured over Up to 18 months
+10 more outcomes measured

Conditions

Acute Myeloid Leukemia, in Relapse
Acute Myeloid Leukemia Refractory

Explore related trials

Acute Myeloid LeukemiaReceptor-Type Tyrosine-Protein Kinase FLT3

Where it's being run

13 sites across 11 states
Arizona2
Florida2
Maryland1
Massachusetts1
New Jersey1
New York1
North Carolina1
Oregon1

Study leadership

  • Mónica Reale-Vidal, MD · STUDY_CHAIR · Oryzon Genomics

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of primary AML or AML with myelodysplasia-related changes (AML-MRC)
Patient is in first or second relapse or has refractory disease. Patients must have had histologic verification of AML at the original diagnosis.
Patient must be positive for the following FLT3 mutations in bone marrow or PB: FLT3 internal tandem duplication (ITD), FLT3 tyrosine kinase domain (TKD) D835 or I836 or FLT3-ITD and specified FLT3-TKD.
ECOG performance status 0-2
Life expectancy of at least 3 months in the opinion of the investigator.
Normal hepatic and renal function.
Patient is able to swallow oral medications.
Female patients are postmenopausal, documented as surgically sterile, use two methods of contraception or practice true abstinence and have a negative urine pregnancy test at screening.
Male patients even if surgically sterilized agree to practice true abstinence or use highly effective barrier contraception.

Exclusion

Diagnosis of acute promyelocytic leukemia.
Known BCR-ABL-positive leukemia.
AML secondary to prior chemotherapy for other neoplasms (except for MDS).
AML that has relapsed after or is refractory to more than 2 lines of therapy.
Clinically active central nervous system leukemia or prior history of NCI CTCAE Grade ≥ 3 drug-related CNS toxicity.
Major surgery or radiation therapy within 4 weeks prior to the first study 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. Previous treatment with FLT3 inhibitors is allowed in the following cases: midostaurin and sorafenib are allowed when used in first-line therapy regimen as part of induction, consolidation and/or maintenance: quizartinib and gilteritinib are allowed when used in first-line therapy regimen, as part of induction, consolidation and/or maintenance, ONLY if patients were not refractory to the drugs or if responding, relapse did not occur while on these drugs.
Patients not eligible to receive gilteritinib per label.
Prior treatment with 3 or more lines of AML therapy.
Treatment with any investigational products within 3 weeks prior to first dose of study treatment.
Uncontrolled hypertension or poorly controlled diabetes.
Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
Pregnant or lactating women.

What this trial measures

  • Adverse Events (AE)Up to 18 months

    Number of participants with Adverse Events (AE) after treatment with iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R AML.

  • Laboratory value abnormalities and/or adverse events (AE)Up to 18 months

    Number of participants with laboratory value abnormalities and/or Adverse Events (AE) after treatment with iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R AML.

  • Vital sign abnormalities and/or adverse events (AEs)Up to 18 months

    Number of participants with vital signs abnormalities and/or Adverse Events (AE) after treatment with iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R AML.

  • Routine 12-lead electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)Up to 18 months

    Number of participants with Routine 12-lead electrocardiogram (ECG )abnormalities and/or Adverse Events (AE) after treatment with iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R AML.

  • Recommend Phase 2 dose (RP2D)Up to 18 months

    Determine the recommended Phase 2 dose (RP2D) of iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R

  • iadademstat tmaxUp to 26 days

    Measurement of the time it takes for iadademstat to reach the maximum concentration (Cmax) in blood.

  • Iadademstat CmaxUp to 26 days

    Measurement of the highest concentration of iadademstat in the blood after a dose is given.

  • iadademstat CminUp to 26 days

    Measurement of the lowest concentration of iadademstat in the blood, after a dose is given.

  • iadademstat AUCUp to 26 days

    Measurement of how much iadadmestat reaches a person's bloodstream in a given period of time after a dose is given.

  • iadademstat Target Engagement (TE)Up to 26 days

    Percent of drug covalently bound to LSD1 molecule

  • OR rateUp to 18 months

    Proportion of patients achieving complete remission (CR), CR with incomplete hematologic recovery (CRi), and partial remission (PR).