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

NCT ID NCT07007312

Recruiting now Disease control Sponsor: Kura Oncology, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 4 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.

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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)

Contacts and locations

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Study contacts

Contact

Email: •••••@•••••

Locations

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 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, 735-718, 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
Froedtert & Medical College of Wisconsin
RECRUITING

Milwaukee, Wisconsin, 53226, United States
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, 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 De Burgos
RECRUITING

Burgos, Castille and León, 09006, 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
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, 137-040, 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
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
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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