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New hope for japanese AML patients: experimental drug ziftomenib enters trial

NCT ID NCT07623616

Disease control Sponsor: Kyowa Kirin Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an experimental drug called ziftomenib in 6 Japanese adults with a specific type of acute myeloid leukemia (AML) that has returned or not responded to treatment. The drug is taken as a pill once daily. The goal is to see if it can help control the disease and how safe it is.

What this could mean

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

Active substance
ziftomenib
What this could lead to
If successful, this could point toward a new treatment option for Japanese patients with a specific type of AML that has come back or not responded to other therapies.
What could go wrong
This is a very small, early-phase study with only 6 participants, so results may not apply broadly. The drug may not work or could cause side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 6 people

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

Started

Apr 2026

Expected to finish

Dec 2028

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.

Inclusion Criteria: * Voluntary written informed consent and willingness to comply with all study procedures * Age ≥ 18 years * Confirmed diagnosis of acute myeloid leukemia (AML) * Patients with R/R AML with NPM1-m * No available standard of care expected to provide clinical benefit, ineligible for or declined standard therapy. * ECOG performance status 0-2. * White blood cell count ≤ 30,000/mm³ at screening (hydroxyurea permitted for cytoreduction). * Adequate organ function according to protocol requirements. * Women of childbearing potential must be willing to use a highly effective method of contraception throughout the study and for at least 187 days after the last dose of study treatment. * Males with female partners of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 97 days after the last dose of study treatment. Exclusion Criteria: * Diagnosis of acute promyelocytic leukemia. * Donor lymphocyte infusion \< 30 days prior to study entry. * Clinically active central nervous system (CNS) leukemia. * Prior hematopoietic stem cell transplantation (HSCT) without adequate hematologic recovery. * Active Grade ≥ 2 acute graft-versus-host disease or moderate/severe chronic graft-versus-host disease. * Prior treatment with a menin inhibitor. * Receipt of chemotherapy, immunotherapy, radiotherapy, or investigational therapy within 14 days or 5 half-lives prior to first dose. * Unresolved toxicities from prior therapy \> Grade 1. * Requirement for strong CYP3A4 inducers. * Active or uncontrolled infection, including hepatitis B, hepatitis C, or HIV. * Conditions predisposing to serious or life-threatening infection or significant immunodeficiency. * Cardiovascular disease or QTcF \> 480 ms. * Interstitial lung disease. * Major surgery within 4 weeks prior to first dose. * Women who are pregnant or lactating * Any medical, psychiatric, or social condition that may interfere with study participation or safety, or that makes the patient unsuitable in the investigator's judgment.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia acute myeloid leukemia with mutated NPM1

As listed by the trial registrant

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

Acute myeloid leukemia (AML)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chiba Aoba Municipal Hospital

    RECRUITING

    Chiba, Japan

  • Dokkyo Medical University Hospital

    RECRUITING

    Tochigi, Japan

  • Gifu Municipal Hospital

    RECRUITING

    Gifu, Japan

  • Hyogo Medical University Hospital

    NOT_YET_RECRUITING

    Hyōgo, Japan

  • Imamura General Hospital

    RECRUITING

    Kagoshima, Japan

  • Jichi Medical University Hospital

    RECRUITING

    Tochigi, Japan

  • Jichi Medical University Saitama Medical Center

    NOT_YET_RECRUITING

    Saitama, Japan

  • Kanagawa Cancer Center

    RECRUITING

    Kanagawa, Japan

  • Kansai Medical University Hospital

    RECRUITING

    Osaka, Japan

  • Keio University Hospital

    NOT_YET_RECRUITING

    Tokyo, Japan

  • Kurashiki Central Hospital

    RECRUITING

    Okayama, Japan

  • Kyoto University Hospital

    NOT_YET_RECRUITING

    Kyoto, Japan

  • Matsumoto National Hospital

    RECRUITING

    Nagano, Japan

  • Mito Medical Center

    RECRUITING

    Ibaraki, Japan

  • Nagasaki University Hospital

    RECRUITING

    Nagasaki, Japan

  • Nippon Medical School Hospital

    NOT_YET_RECRUITING

    Tokyo, Japan

  • Okayama University Hospital

    RECRUITING

    Okayama, Japan

  • Osaka Metropolitan University Hospital

    RECRUITING

    Osaka, Japan

  • Tohoku University Hospital

    RECRUITING

    Miyagi, Japan

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    RECRUITING

    Tokyo, Japan

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