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Can a Two-Drug attack outsmart resistant leukemia?

NCT ID NCT05546580

Disease control Sponsor: Oryzon Genomics S.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This early-stage trial is testing whether adding an experimental drug called iadademstat to the approved leukemia drug gilteritinib can help people with a specific type of acute myeloid leukemia (AML) that has returned or not responded to treatment. The study focuses on patients whose leukemia carries a FLT3 mutation, a genetic change that makes the cancer harder to treat. The main goals are to find a safe dose and to see how well the combination works at shrinking or eliminating the leukemia.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
iadademstat in combination with gilteritinib
What this could lead to
If successful, this combination could offer a new treatment option for people with a hard-to-treat form of AML that has returned or not responded to prior therapy.
What could go wrong
This is an early-phase trial, so the combination may not prove safe or effective. Side effects are possible, and the benefit over gilteritinib alone is not yet established.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Main Inclusion Criteria: * 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. Main Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia refractory Acute myeloid leukemia, in relapse

Contacts and locations

Locations

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Duke University Medical Center

    Durham, North Carolina, 27705, United States

  • Froedtert Hospital & The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital

    New York, New York, 10029, United States

  • Massachusetts General Hospital (MGH)

    Boston, Massachusetts, 02114, United States

  • Miami Cancer Institute

    Miami, Florida, 33176, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Rutgers, The State University

    Piscataway, New Jersey, 08854, United States

  • Sarah Cannon Research Institute, LLC

    Nashville, Tennessee, 37203, United States

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136, United States

  • The John Hopkins University School of Medicine

    Baltimore, Maryland, 21287-0013, United States

  • The University of Arizona Cancer Center - North Campus

    Tucson, Arizona, 85724-5024, United States

  • West Virginia University

    Morgantown, West Virginia, 26506, United States

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