RECRUITING
Phase 3
ClinicalTrials.gov
Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML
Sponsor: Kura Oncology, Inc. • ClinicalTrials.gov ID: NCT07007312
Registry updated: 2026-10-13
Ad
Recruiting for Similar Conditions?
Sponsors are looking for patients like you. See if you qualify for compensated research studies.
Check Eligibility →Description
Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with eligible genetic alterations. Ziftomenib is a type of therapy known to target the menin pathway in cancer cells. This protocol has 2 separate studies that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) AML treatments in patients with certain genetic mutations who have not received any treatment for their AML. In the first study, the Nonintensive Therapy Study, older patients or those with serious medical problems will receive the SOC therapies venetoclax (ven) and azacitidine (aza), plus either ziftomenib or a placebo. In the second study, the Intensive Therapy Study, medically fit patients will receive (a) the SOC therapies cytarabine and daunorubicin, plus either ziftomenib or a placebo during a first treatment phase called induction, (b) cytarabine plus either ziftomenib or a placebo during a second treatment phase called consolidation, and (c) ziftomenib or a placebo during a third treatment phase called maintenance. The physician will determine which study is the appropriate treatment for the patient, but neither the patient nor their physician will know whether the patient has been assigned to receive ziftomenib or a placebo. This design is called "double-blinded".
Interventions
-
Ziftomenib
(Drug)
Oral administration
-
Placebo
(Drug)
Oral administration
-
Venetoclax
(Drug)
Oral administration
-
Azacitidine (AZA)
(Drug)
Intravenous or subcutaneous administration
-
Daunorubicin
(Drug)
Intravenous administration
-
Cytarabine (Ara-C)
(Drug)
Intravenous administration
Eligibility criteria
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.
Conditions
Acute Myeloid Leukemia (AML)
Locations
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
- University of California, Fresno — Clovis, California, United States
- University of California, San Diego — La Jolla, California, United States
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- University of California, Los Angeles — Los Angeles, California, United States
- University of California, Irvine — Orange, California, United States
- University of Colorado — Aurora, Colorado, United States
- Colorado Blood Cancer Institute — Denver, Colorado, United States
- Hartford HealthCare Cancer Institute — Hartford, Connecticut, United States
- Yale University School of Medicine — New Haven, Connecticut, United States
- University of Miami — Miami, Florida, United States
- Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
- University of Iowa — Iowa City, Iowa, United States
- University of Kansas — Fairway, Kansas, United States
- University of Kentucky — Lexington, Kentucky, United States
- University of Massachusetts — Worcester, Massachusetts, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Wayne State University School of Medicine — Detroit, Michigan, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- HealthPartners Cancer Center at Regions Hospital (MN) — Saint Paul, Minnesota, United States
- Rutgers Biomedical and Health Sciences — New Brunswick, New Jersey, United States
- University of New Mexico — Albuquerque, New Mexico, United States
- State University of New York at Buffalo — Buffalo, New York, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- Columbia University — New York, New York, United States
- Weill Cornell Medical Center — New York, New York, United States
- University of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Ohio State University — Columbus, Ohio, United States
- Willamette Valley Cancer Institute — Eugene, Oregon, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Baptist Clinical Research Institute — Memphis, Tennessee, United States
- Tennessee Oncology — Nashville, Tennessee, United States
- TriStar Centennial Medical Center — Nashville, Tennessee, United States
- Texas Oncology-Austin Midtown — Austin, Texas, United States
- Texas Oncology-Presbyterian Cancer Center — Dallas, Texas, United States
- University of Texas — Houston, Texas, United States
- Texas Oncology - San Antonio Medical Center — San Antonio, Texas, United States
- University of Vermont Medical Center — Burlington, Vermont, United States
- University of Virginia School of Medicine — Charlottesville, Virginia, United States
- Virginia Cancer Specialists — Manassas, Virginia, United States
- WVU Medicine Wheeling Hospital — Wheeling, West Virginia, United States
- University of Wisconsin — Madison, Wisconsin, United States
- Froedtert & Medical College of Wisconsin — Milwaukee, Wisconsin, United States
- Calvary Mater Newcastle — Waratah, New South Wales, Australia
- Gachon University Gil Medical Center — Kurralta Park, South Australia, Australia
- Austin Health — Heidelberg, Victoria, Australia
- Box Hill Hospital — Heidelberg, Victoria, Australia
- Northern Health Epping — Melbourne, Victoria, Australia
- Fiona Stanley Hospital — Murdoch, Western Australia, Australia
- Universitair Ziekenhuis Brussel — Jette, Brussels Capital, Belgium
- Universitair Ziekenhuis Gent — Ghent, Oost-Vlaanderen, Belgium
- Centre Hospitalier Régional Verviers East Belgium — Verviers, Walloonia, Belgium
- Algemeen Ziekenhuis Sint-Jan Brugge — Bruges, West-Vlaanderen, Belgium
- Algemeen Ziekenhuis Delta VZW — Roeselare, West-Vlaanderen, Belgium
- Gordon and Leslie Diamond Health Cancer Centre-Leukemia/BMT Program of BC — Vancouver, British Columbia, Canada
- Royal Victoria Hospital — Montreal, Quebec, Canada
- Centre hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec, Canada
- Fakultni Nemocnice Ostrava — Ostrava-Poruba, Moravian-Silesian, Czechia
- Fakultní Nemocnice Královské Vinohrady — Prague, Prague, Czechia
- Centre Hospitalier Universitaire Estaing - Clermont-Ferrand — Clermont-Ferrand, Auvergne-Rhône-Alpes, France
- Hôpital Lyon Sud — Pierre-Bénite, Auvergne-Rhône-Alpes, France
- Centre Hospitalier Universitaire de Saint Etienne — Saint-Priest-en-Jarez, Auvergne-Rhône-Alpes, France
- Groupe Hospitalier de la Region de Mulhouse et Sud Alsace Hôpital Emile Muller — Mulhouse, Grand Est, France
- Centre Hospitalier Régional et Universitaire de Nancy Hôpitaux de Brabois — Vandœuvre-lès-Nancy, Grand Est, France
- Centre Hospitalier Universitaire de Nantes — Nantes, Loire-Atlantique, France
- Centre Hospitalier Universitaire de Bordeaux — Pessac, New Aquitaine, France
- Centre Hospitalier de Roubaix — Lille, Nord, France
- Centre Henri Becquerel — Rouen, Normandy, France
- Centre Hospitalier de Béziers — Béziers, Occitanie, France
- Centre Hospitalier Universitaire de Marseille - Hôpital de la Conception — Marseille, Provence-Alpes-Côte d'Azur Region, France
- Hôpital Universitaire Henri Mondor — Créteil, Val-de-Marne, France
- Institut Gustave Roussy — Villejuif, Val-De-Marne, France
- Hôpital Avicenne — Bobigny, Île-de-France Region, France
- Centre Hospitalier de Versailles — Le Chesnay, Île-de-France Region, France
- Hôpital Saint Louis — Paris, Île-de-France Region, France
- Hôpital Pitié-Salpêtrière — Paris, Île-de-France Region, France
- Helios Klinikum Bad Saarow — Bad Saarow, Brandenburg, Germany
- Universitätsklinikum Aachen — Aachen, North Rhine-Westphalia, Germany
- Laiko General Hospital of Athens — Athens, Attica, Greece
- Attikon University General Hospital of Athens — Chaïdári, Attica, Greece
- General Hospital of Thessaloniki G. Papanikolaou — Exochi, Central Macedonia, Greece
- University General Hospital of Alexandroupoli — Alexandroupoli, East Macedonia and Thrace, Greece
- University General Hospital of Ioannina — Ioannina, Epirus, Greece
- DPC-Hospital — Budapest, Budapest, Hungary
- Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház — Győr, Gyor-Moson-Sopron County, Hungary
- Kaposi Mor County Hospital — Kaposvár, Somogy County, Hungary
- L'IRCCS Azienda Ospedaliero - Universitaria di Bologna — Bologna, Emilia-Romagna, Italy
- Azienda Ospedaliero - Universitaria DI Modena — Modena, Emilia-Romagna, Italy
- Hospital Santa Maria delle Croci — Ravenna, Emilia-Romagna, Italy
- ASUGI Ospedale Maggiore di Trieste — Trieste, Friuli Venezia Giulia, Italy
- ASST Papa Giovanni XXIII — Bergamo, Lombardy, Italy
- ASST Spedali Civili di Brescia — Brescia, Lombardy, Italy
- Azienda Ospedaliera Universitaria SS Antonio e Biagio e Cesare Arrigo — Alessandria, Piedmont, Italy
- Azienda Sanitaria Territoriale di Ascoli Piceno — Ascoli Piceno, The Marches, Italy
- Azienda Ospedaliero-Universitaria — Perugia, Umbria, Italy
- Ematologia Ospedale San Bortolo — Vicenza, Veneto, Italy
- Baguio General Hospital and Medical Center — Baguio City, Benguet, Philippines
- Perpetual Succour Hospital — Cebu City, Central Visayas, Philippines
- Philippine General Hospital — Ermita, National Capital Region, Philippines
- University of Santo Tomas — Manila, National Capital Region, Philippines
- The Medical City — Pasig, National Capital Region, Philippines
- St. Luke's Medical Center - Quezon City — Quezon City, National Capital Region, Philippines
- Szpital Wojewodzki w Opolu — Opole, Opole Voivodeship, Poland
- University Clinical Hospital Gdansk — Gdansk, Pomeranian Voivodeship, Poland
- Instituto Português de Oncologia de Lisboa Francisco Gentil - EPE — Lisbon, Lisbon District, Portugal
- Hospital de Braga, Centro Clínico Académico de Braga — Braga, Portugal
- Chungnam National University Daejeon Hospital — Daejeon, Daejeon Gwang'Yeogsi, South Korea
- Daegu Catholic University Hospital — Daegu, Gyeongsangbuk-do, South Korea
- Pusan National University Hospital — Busan-si, Gyeongsangnam-do, South Korea
- Dong-A University Hospital — Pusan, Gyeongsangnam-do, South Korea
- Ulsan University Hospital — Ulsan, Gyeongsangnam-do, South Korea
- Gachon University Gil Medical Center — Namdong, Incheon Gwang'Yeogsi, South Korea
- Chonnam National University Hwasun Hospital — Hwasun, Jeollanam-do, South Korea
- Anam Hospital Korea University — Seoul, Seoul-T'Ukpyolsi, South Korea
- The Catholic University of Korea Seoul St. Mary's Hospital — Seoul, Seoul-T'Ukpyolsi, South Korea
- Samsung Medical Center — Seoul, Seoul-T'Ukpyolsi, South Korea
- University Hospital Virgen Del Rocio S.L. — Seville, Andalusia, Spain
- Hospital Clinico Universitario Lozano Blesa — Zaragoza, Aragon, Spain
- Hospital Universitario De Burgos — Burgos, Castille and León, Spain
- Hospital Clinico Universitario de Salamanxa — Salamanca, Castille and León, Spain
- Hospital General Universitario de Albacete — Albacete, Castille-La Mancha, Spain
- Hospital Universitario Infanta Leonor — Madrid, Madrid, Spain
- Hospital Universitario Fundación Jiménez Díaz — Madrid, Madrid, Spain
- Hospital Universitario 12 de Octubre — Madrid, Madrid, Spain
- Hospital Universitario Central de Asturias — Oviedo, Principality of Asturias, Spain
- Hospital Clinico Universitario de Valencia — Valencia, València, Spain
- Hospital Universitario Y Politecnico La Fe — Valencia, València, Spain
- Chang Bing Show Chwan Memorial Hospital — Lugang, Central Taiwan, Taiwan
- Taichung Veterans General Hospital — Taichung, Central Taiwan, Taiwan
- National Taiwan University Hospital — Taipei, Northern Taiwan, Taiwan
- Taipei Veterans General Hospital — Taipei, Northern Taiwan, Taiwan
- St. Bartholomew's Hospital — London, England, United Kingdom
- St. Bartholomew's Hospital — London, England, United Kingdom
- St. George's, University of London — London, England, United Kingdom
- St. George's, University of London — London, England, United Kingdom
Sponsored
Partner with Nurenyx
Showcase your study to thousands of motivated patients matching your criteria.
Learn MoreOfficial Source
Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
View Official Record