Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug cocktail takes aim at Hard-to-Treat leukemia

NCT ID NCT06001788

Disease control Sponsor: Kura Oncology, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This early-stage trial is testing a new drug called ziftomenib combined with standard chemotherapy or another targeted drug for people with relapsed or treatment-resistant acute myeloid leukemia (AML) that has specific genetic changes. The main goal is to see if these combinations are safe and tolerable. About 171 participants will receive different treatment combinations to find the best dose and check for side effects.

What this could mean

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

Active substance
ziftomenib (a targeted drug) combined with chemotherapy (FLAG-IDA, low-dose cytarabine) or gilteritinib
What this could lead to
If successful, this could point toward a new combination treatment option for people with hard-to-treat AML who have specific genetic mutations.
What could go wrong
This is an early Phase 1 trial with only 171 participants, focused on safety. It is too soon to know if the combinations will work better than existing treatments, and side effects are unknown.
Why investors are watching

Kura Oncology is testing ziftomenib in combination with standard AML treatments in a Phase 1 trial for patients with relapsed or refractory disease. For a small company, this readout matters because it could show whether the drug works safely alongside existing therapies, which would broaden its potential use beyond a single-agent setting.

If it works: A positive safety and response signal could support further development of ziftomenib combinations, potentially expanding its market reach and strengthening the company's pipeline. This might also attract partnership interest from larger drugmakers.

If it fails: Phase 1 trials often fail to show adequate safety or efficacy, and a poor result could delay or halt the program. Since Kura is small, a setback in this trial could weigh heavily on its prospects without other late-stage assets to fall back on.

AI-written from the trial record. Speculative, and not investment advice.

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 171 people

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

Started

Feb 2024

Expected to finish

Aug 2027

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.

Key Inclusion Criteria: * Has been diagnosed with relapsed/refractory AML. * Has a documented NPM1 mutation or KMT2A rearrangement. * Has a documented FLT3 mutation (cA-3 only). * Has an Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2. * Has adequate hepatic and renal function as defined per protocol. * Has an ejection fraction above a protocol defined limit. * Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure. * Has agreed to use contraception as defined per protocol. Key Exclusion Criteria: * Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia. * Has clinically active central nervous system leukemia. * Has an active and uncontrolled infection. * Has a mean corrected QT interval (QTcF) \> 480ms. * Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease. * Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy \<14 days or within 5 drug half-lives prior to the first dose of study intervention. * Has had major surgery within 4 weeks prior to the first dose of study intervention. * Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria. * Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD * Participant is pregnant or lactating.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute leukemia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

acute leukemia acute myeloid leukemia acute myeloid leukemia with mutated NPM1 acute myeloid leukemia, MLL gene rearrangement early-onset generalized dystonia hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm leukemia myeloid leukemia neoplasm Neoplasms by Histologic Type

As listed by the trial registrant

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

Acute leukemia Acute myeloid leukemia AML AML with mutated NPM1 Hematologic malignancy KMT2AR Leukemia Leukemia, myeloid Leukemia, myeloid, acute MLL rearrangement Neoplasms by histologic type NPM1 mutation

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    43 sites in 3 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Atrium Health Levine Cancer Center

    RECRUITING

    Charlotte, North Carolina, 60201, United States

  • Banner MD Anderson Cancer Center

    RECRUITING

    Gilbert, Arizona, 85234, United States

    Contact Email: •••••@•••••

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Colorado Blood Cancer Institute

    RECRUITING

    Denver, Colorado, 80218, United States

  • Emory Healthcare - The Emory Clinic

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Roma, 00168, Italy

  • Froedtert & Medical College Clinics

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Georgia Cancer Center at Augusta University

    RECRUITING

    Augusta, Georgia, 30912, United States

  • Henry Ford Cancer Institute

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitari y Politecnic La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario Central de Asturias

    RECRUITING

    Oviedo, 33011, Spain

  • Hospital Universitario Virgen del Rocío

    RECRUITING

    Seville, 41013, Spain

  • IRCCS Azienda Ospedaliero-Universitaria do Bologna - Policlinico di Sant'Orsola

    RECRUITING

    Bologna, 40138, Italy

  • John Theurer Cancer Center at Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Lehigh Valley Topper Cancer Institute

    WITHDRAWN

    Allentown, Pennsylvania, 18103, United States

  • Loyola University Medical Center

    RECRUITING

    Maywood, Illinois, 60153, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10021, United States

  • Northwell Health, LLC PRIME

    RECRUITING

    Lake Success, New York, 11042, United States

  • OU Health Stephenson Cancer Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Ospedale Santa Maria delle Croci

    RECRUITING

    Ravenna, 48121, Italy

  • Prisma Health

    RECRUITING

    Greenville, South Carolina, 29615, United States

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

    Contact Email: •••••@•••••

  • Roswell Park Comprehensive Cancer Center

    RECRUITING

    Buffalo, New York, 14263, United States

  • Simmons Cancer Institute

    WITHDRAWN

    Springfield, Illinois, 62702, United States

  • Smilow Cancer Hospital at Yale New Haven

    RECRUITING

    New Haven, Connecticut, 06511, United States

  • Stony Brook Cancer Center

    RECRUITING

    Stony Brook, New York, 11794, United States

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    RECRUITING

    Dallas, Texas, 75246, United States

  • The University of Kansas Cancer Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • UC Irvine Health Chao Family Comprehensive Cancer Center

    RECRUITING

    Orange, California, 92868, United States

    Contact Email: •••••@•••••

  • UCLA Health - Bowyer Oncology Center

    RECRUITING

    Los Angeles, California, 90095, United States

  • UH Seidman Cancer Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • USC Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90089, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94115, United States

  • University of Iowa Hospitals & Clinics

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • University of Vermont

    RECRUITING

    Burlington, Vermont, 05401, United States

  • University of Virginia Comprehensive Cancer Center

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98109, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medical College-NY Presbyterian Hospital

    RECRUITING

    New York, New York, 10065, United States

  • Wilmot Cancer Institute, University of Rochester

    RECRUITING

    Rochester, New York, 14642, United States

    Contact Email: •••••@•••••

More trials for these conditions

Other studies related to the condition(s) this trial covers.