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New hope for AML patients: targeted drug ziftomenib enters final testing phase

NCT ID NCT07007312

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 21, 2026 · Updated 6 times

Summary

This large Phase 3 trial is testing whether adding the experimental drug ziftomenib to standard chemotherapy helps people with untreated acute myeloid leukemia (AML) who have specific genetic mutations. About 1,300 participants will be randomly assigned to receive either ziftomenib or a placebo alongside their regular treatment. The study is double-blind, meaning neither patients nor doctors know who gets the real drug.

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 lead to a new targeted treatment option for people with certain genetic types of AML, potentially improving survival and remission rates.
What could go wrong
This is a large Phase 3 trial, but the drug is still investigational. It may not prove more effective than standard therapy, and side effects from combining drugs are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,300 people

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

Started

Sep 2025

Expected to finish

Nov 2031

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: The following criteria apply to both the Nonintensive Therapy Study and the Intensive Therapy Study unless otherwise noted: * Age ≥18 years at time of signing the informed consent form. * Diagnosis of AML per the 2022 WHO Classification of Hematolymphoid Tumors (5th Edition). * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Adequate liver and kidney function according to protocol requirements. * A female of childbearing potential must agree to use adequate contraception from the time of screening through 180 days following the last dose of study intervention. A male with a female partner of childbearing potential must agree to use abstinence or adequate contraception from the time of screening through 90 days following the last dose of study intervention. * NONINTENSIVE THERAPY STUDY ONLY (VEN+AZA): 1. Documented NPM1-m. 2. Patients considered ineligible for Intensive Therapy defined by the following: * i. Age ≥75, OR * ii. Age \<75 with an ECOG performance status of 2 or cardiac, renal, or hepatic impairment per protocol criteria. * INTENSIVE THERAPY STUDY ONLY (7+3): 1. Documented NPM1-m or KMT2A-r (KMT2A-r patients with a partial tandem duplication are not eligible). 2. Documented FLT3 wild-type or ITD ratio \<0.05 OR ineligible to receive FLT3-targeted therapy (medically ineligible or mutation in which FLT3 inhibition is not SOC). Lack of access to an FLT3 inhibitor is not considered "ineligible" for FLT3-targeted therapy. 3. Ejection fraction of ≥50%. 4. Fit for Intensive Therapy per Investigator opinion. Key Exclusion Criteria: * Prior therapy for AML (except hydroxyurea or leukapheresis for WBC control). * Diagnosis of acute promyelocytic leukemia (APL), blast phase chronic myeloid leukemia, or isolated myeloid sarcoma. * Known history of BCR-ABL mutation. * History of other active concurrent malignancies prior to study entry except: 1. Basal cell skin cancer or localized squamous cell cancer of the skin 2. Previous malignancy confined and locally resected (or treated with other modalities) with curative intent 3. Prostate or breast cancer receiving adjuvant hormonal therapy. * Active central nervous system (CNS) involvement by AML. * Clinical signs/symptoms of leukostasis or white blood cells (WBC) \>25×10\^9/L prior to start of ziftomenib/placebo. Note: Hydroxyurea and/or leukapheresis are permitted to meet this criterion. * Known uncontrolled HIV infection or known active hepatitis B virus, hepatitis C virus infection, or other uncontrolled infection. * Uncontrolled intercurrent illness including but not limited to, cardiac illness as defined in the protocol. * Women who are pregnant or lactating.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia acute myeloid leukemia with mutated NPM1 acute myeloid leukemia, MLL gene rearrangement hematopoietic and lymphoid system neoplasm leukemia

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 study's own enquiry address

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

  2. The places running it

    115 sites in 16 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

  • ASST Spedali Civili di Brescia

    RECRUITING

    Brescia, Lombardy, 25123, Italy

  • ASUGI Ospedale Maggiore di Trieste

    RECRUITING

    Trieste, Friuli Venezia Giulia, 76038, Italy

  • Algemeen Ziekenhuis Delta VZW

    RECRUITING

    Roeselare, West-Vlaanderen, 8800, Belgium

  • Algemeen Ziekenhuis Sint-Jan Brugge

    RECRUITING

    Bruges, West-Vlaanderen, 8800, Belgium

  • Anam Hospital Korea University

    RECRUITING

    Seoul, Seoul-T'Ukpyolsi, 02841, South Korea

  • Attikon University General Hospital of Athens

    RECRUITING

    Chaïdári, Attica, 12462, Greece

  • Azienda Ospedaliero-Universitaria

    RECRUITING

    Perugia, Umbria, 42270, Italy

  • Azienda Sanitaria Territoriale di Ascoli Piceno

    RECRUITING

    Ascoli Piceno, The Marches, 63100, Italy

  • Baguio General Hospital and Medical Center

    RECRUITING

    Baguio City, Benguet, 02600, Philippines

  • Banner MD Anderson Cancer Center

    RECRUITING

    Gilbert, Arizona, 85234, United States

  • Baptist Clinical Research Institute

    RECRUITING

    Memphis, Tennessee, 38120, United States

  • Box Hill Hospital

    RECRUITING

    Heidelberg, Victoria, 3128, Australia

  • Calvary Mater Newcastle

    RECRUITING

    Waratah, New South Wales, 02298, Australia

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Centre Henri Becquerel

    RECRUITING

    Rouen, Normandy, 76038, France

  • Centre Hospitalier Régional Verviers East Belgium

    RECRUITING

    Verviers, Walloonia, 4800, Belgium

  • Centre Hospitalier Régional et Universitaire de Nancy Hôpitaux de Brabois

    RECRUITING

    Vandœuvre-lès-Nancy, Grand Est, 54510, France

  • Centre Hospitalier Universitaire Estaing - Clermont-Ferrand

    RECRUITING

    Clermont-Ferrand, Auvergne-Rhône-Alpes, 63003, France

  • Centre Hospitalier Universitaire de Bordeaux

    RECRUITING

    Pessac, New Aquitaine, 33604, France

  • Centre Hospitalier Universitaire de Marseille - Hôpital de la Conception

    RECRUITING

    Marseille, Provence-Alpes-Côte d'Azur Region, 13385, France

  • Centre Hospitalier Universitaire de Nantes

    RECRUITING

    Nantes, Loire-Atlantique, 44000, France

  • Centre Hospitalier Universitaire de Saint Etienne

    RECRUITING

    Saint-Priest-en-Jarez, Auvergne-Rhône-Alpes, 42270, France

  • Centre Hospitalier de Béziers

    RECRUITING

    Béziers, Occitanie, 35400, France

  • Centre Hospitalier de Roubaix

    RECRUITING

    Lille, Nord, 59000, France

  • Centre Hospitalier de Versailles

    RECRUITING

    Le Chesnay, Île-de-France Region, 78150, France

  • Chang Bing Show Chwan Memorial Hospital

    RECRUITING

    Lugang, Central Taiwan, 505, Taiwan

  • Chonnam National University Hwasun Hospital

    RECRUITING

    Hwasun, Jeollanam-do, 58128, South Korea

  • Chungnam National University Daejeon Hospital

    RECRUITING

    Daejeon, Daejeon Gwang'Yeogsi, 35015, South Korea

  • Colorado Blood Cancer Institute

    RECRUITING

    Denver, Colorado, 80218, United States

  • Columbia University

    RECRUITING

    New York, New York, 10032, United States

  • Daegu Catholic University Hospital

    RECRUITING

    Daegu, Gyeongsangbuk-do, 42472, South Korea

  • Dong-A University Hospital

    RECRUITING

    Pusan, Gyeongsangnam-do, 49201, South Korea

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Fakultni Nemocnice Ostrava

    RECRUITING

    Ostrava-Poruba, Moravian-Silesian, 70852, Czechia

  • Fakultní Nemocnice Královské Vinohrady

    RECRUITING

    Prague, Prague, 10034, Czechia

  • Fiona Stanley Hospital

    RECRUITING

    Murdoch, Western Australia, 6150, Australia

  • Froedtert & Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Gachon University Gil Medical Center

    RECRUITING

    Namdong, Incheon Gwang'Yeogsi, 21565, South Korea

  • General Hospital of Thessaloniki G. Papanikolaou

    RECRUITING

    Exochi, Central Macedonia, 57010, Greece

  • Groupe Hospitalier de la Region de Mulhouse et Sud Alsace Hôpital Emile Muller

    RECRUITING

    Mulhouse, Grand Est, 68100, France

  • Hartford HealthCare Cancer Institute

    RECRUITING

    Hartford, Connecticut, 06106, United States

  • Helios Klinikum Bad Saarow

    RECRUITING

    Bad Saarow, Brandenburg, 15526, Germany

  • Hospital Clinico Universitario Lozano Blesa

    RECRUITING

    Zaragoza, Aragon, 50009, Spain

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, València, 46010, Spain

  • Hospital General Universitario de Albacete

    RECRUITING

    Albacete, Castille-La Mancha, 02006, Spain

  • Hospital Santa Maria delle Croci

    RECRUITING

    Ravenna, Emilia-Romagna, 48121, Italy

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Madrid, 28041, Spain

  • Hospital Universitario Central de Asturias

    RECRUITING

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario De Burgos

    RECRUITING

    Burgos, Castille and León, 09006, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    RECRUITING

    Madrid, Madrid, 28040, Spain

  • Hospital Universitario Infanta Leonor

    RECRUITING

    Madrid, Madrid, 28031, Spain

  • Hospital Universitario Y Politecnico La Fe

    RECRUITING

    Valencia, València, 46026, Spain

  • Hospital de Braga, Centro Clínico Académico de Braga

    RECRUITING

    Braga, 1099-023, Portugal

  • Hôpital Avicenne

    RECRUITING

    Bobigny, Île-de-France Region, 93009, France

  • Hôpital Lyon Sud

    RECRUITING

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France

  • Hôpital Pitié-Salpêtrière

    RECRUITING

    Paris, Île-de-France Region, 75013, France

  • Hôpital Saint Louis

    RECRUITING

    Paris, Île-de-France Region, 75010, France

  • Hôpital Universitaire Henri Mondor

    RECRUITING

    Créteil, Val-de-Marne, 94010, France

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10003, United States

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, Val-De-Marne, 94805, France

  • L'IRCCS Azienda Ospedaliero - Universitaria di Bologna

    RECRUITING

    Bologna, Emilia-Romagna, 40138, Italy

  • Laiko General Hospital of Athens

    RECRUITING

    Athens, Attica, 11527, Greece

  • Moffitt Cancer Center & Research Institute

    RECRUITING

    Tampa, Florida, 33612, United States

  • National Taiwan University Hospital

    RECRUITING

    Taipei, Northern Taiwan, 10002, Taiwan

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Pusan National University Hospital

    RECRUITING

    Busan-si, Gyeongsangnam-do, 49241, South Korea

  • Royal Victoria Hospital

    RECRUITING

    Montreal, Quebec, H4A3J1, Canada

  • Rutgers Biomedical and Health Sciences

    RECRUITING

    New Brunswick, New Jersey, 08903, United States

  • Samsung Medical Center

    RECRUITING

    Seoul, Seoul-T'Ukpyolsi, 35015, South Korea

  • St. Bartholomew's Hospital

    NOT_YET_RECRUITING

    London, England, EC1A 7BE, United Kingdom

  • St. George's, University of London

    NOT_YET_RECRUITING

    London, England, SW17 0QT, United Kingdom

  • St. Luke's Medical Center - Quezon City

    RECRUITING

    Quezon City, National Capital Region, 1112, Philippines

  • State University of New York at Buffalo

    RECRUITING

    Buffalo, New York, 14263, United States

  • Szpital Wojewodzki w Opolu

    RECRUITING

    Opole, Opole Voivodeship, 45-061, Poland

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, Central Taiwan, 407, Taiwan

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, Northern Taiwan, 613, Taiwan

  • Tennessee Oncology

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Texas Oncology - San Antonio Medical Center

    RECRUITING

    San Antonio, Texas, 78240, United States

  • Texas Oncology-Austin Midtown

    RECRUITING

    Austin, Texas, 78705, United States

  • Texas Oncology-Presbyterian Cancer Center

    RECRUITING

    Dallas, Texas, 75231, United States

  • The Catholic University of Korea Seoul St. Mary's Hospital

    RECRUITING

    Seoul, Seoul-T'Ukpyolsi, 06591, South Korea

  • The Medical City

    RECRUITING

    Pasig, National Capital Region, 1605, Philippines

  • TriStar Centennial Medical Center

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Ulsan University Hospital

    RECRUITING

    Ulsan, Gyeongsangnam-do, 44033, South Korea

  • Universitair Ziekenhuis Brussel

    RECRUITING

    Jette, Brussels Capital, 1090, Belgium

  • Universitair Ziekenhuis Gent

    RECRUITING

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • University General Hospital of Alexandroupoli

    RECRUITING

    Alexandroupoli, East Macedonia and Thrace, 68100, Greece

  • University General Hospital of Ioannina

    RECRUITING

    Ioannina, Epirus, 45500, Greece

  • University Hospital Virgen Del Rocio S.L.

    RECRUITING

    Seville, Andalusia, 41013, Spain

  • University of California, Fresno

    RECRUITING

    Clovis, California, 93611, United States

  • University of California, Irvine

    RECRUITING

    Orange, California, 92868, United States

  • University of California, Los Angeles

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of California, San Diego

    RECRUITING

    La Jolla, California, 92093, United States

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52246, United States

  • University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Massachusetts

    RECRUITING

    Worcester, Massachusetts, 01605, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of New Mexico

    RECRUITING

    Albuquerque, New Mexico, 87131, United States

  • University of North Carolina, Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Santo Tomas

    RECRUITING

    Manila, National Capital Region, 1015, Philippines

  • University of Texas

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Vermont Medical Center

    RECRUITING

    Burlington, Vermont, 05401, United States

  • University of Virginia School of Medicine

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Universitätsklinikum Aachen

    RECRUITING

    Aachen, North Rhine-Westphalia, 52074, Germany

  • Virginia Cancer Specialists

    RECRUITING

    Manassas, Virginia, 20110, United States

  • WVU Medicine Wheeling Hospital

    RECRUITING

    Wheeling, West Virginia, 26003, United States

  • Wayne State University School of Medicine

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Weill Cornell Medical Center

    RECRUITING

    New York, New York, 10065, United States

  • Willamette Valley Cancer Institute

    RECRUITING

    Eugene, Oregon, 97401, United States

  • Yale University School of Medicine

    RECRUITING

    New Haven, Connecticut, 06510, United States

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