AzTrials
AzTrials

Acute Myeloid Leukemia (AML)Phase 3NCT07007312

Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML

A Phase 3 study testing Ziftomenib, Venetoclax and Azacitidine (AZA) in people with Acute Myeloid Leukemia (AML), run by Kura Oncology, Inc. at 136 sites in 17 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia (AML)
What is being tested?
Ziftomenib, Venetoclax and Azacitidine (AZA)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,300 participants
Where
136 sitesin 17 countries
Study dates
26 Sep 2025to Nov 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • NONINTENSIVE THERAPY STUDY ONLY (VEN+AZA):
  • Documented NPM1-m.
  • 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):
  • Documented NPM1-m or KMT2A-r (KMT2A-r patients with a partial tandem duplication are not eligible).
  • 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.
  • Ejection fraction of ≥50%.
  • Fit for Intensive Therapy per Investigator opinion.

Who cannot join

  • 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:
  • Basal cell skin cancer or localized squamous cell cancer of the skin
  • Previous malignancy confined and locally resected (or treated with other modalities) with curative intent
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  • 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.

Trial locations and contacts

136 sites in 17 countries. Contact the study team or a site near you to ask about taking part.

Kura Medical Information contact

844-KURAONC (844-587-2662)

medinfo@kuraoncology.com

136 sites in 17 countries

United States44 sites, 44 recruiting

  • University of New Mexico

    Albuquerque, New Mexico, 87131

    Recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Recruiting

  • University of Colorado

    Aurora, Colorado, 80045

    Recruiting

  • Texas Oncology-Austin Midtown

    Austin, Texas, 78705

    Recruiting

  • State University of New York at Buffalo

    Buffalo, New York, 14263

    Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    Recruiting

  • University of North Carolina, Chapel Hill

    Chapel Hill, North Carolina, 27514

    Recruiting

  • University of Virginia School of Medicine

    Charlottesville, Virginia, 22903

    Recruiting

  • University of California, Fresno

    Clovis, California, 93611

    Recruiting

  • Ohio State University

    Columbus, Ohio, 43210

    Recruiting

  • Texas Oncology-Presbyterian Cancer Center

    Dallas, Texas, 75231

    Recruiting

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

    Recruiting

  • Wayne State University School of Medicine

    Detroit, Michigan, 48201

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Recruiting

  • Willamette Valley Cancer Institute

    Eugene, Oregon, 97401

    Recruiting

  • University of Kansas

    Fairway, Kansas, 66205

    Recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

    Recruiting

  • Hartford HealthCare Cancer Institute

    Hartford, Connecticut, 06106

    Recruiting

  • University of Texas

    Houston, Texas, 77030

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52246

    Recruiting

  • University of California, San Diego

    La Jolla, California, 92093

    Recruiting

  • University of Kentucky

    Lexington, Kentucky, 40536

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Recruiting

  • University of California, Los Angeles

    Los Angeles, California, 90095

    Recruiting

  • University of Wisconsin

    Madison, Wisconsin, 53792

    Recruiting

  • Virginia Cancer Specialists

    Manassas, Virginia, 20110

    Recruiting

  • Baptist Clinical Research Institute

    Memphis, Tennessee, 38120

    Recruiting

  • University of Miami

    Miami, Florida, 33136

    Recruiting

  • Froedtert & Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Recruiting

  • Tennessee Oncology

    Nashville, Tennessee, 37203

    Recruiting

  • TriStar Centennial Medical Center

    Nashville, Tennessee, 37203

    Recruiting

  • Rutgers Biomedical and Health Sciences

    New Brunswick, New Jersey, 08903

    Recruiting

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10003

    Recruiting

  • Columbia University

    New York, New York, 10032

    Recruiting

  • Weill Cornell Medical Center

    New York, New York, 10065

    Recruiting

  • University of California, Irvine

    Orange, California, 92868

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • HealthPartners Cancer Center at Regions Hospital (MN)

    Saint Paul, Minnesota, 55101

    Recruiting

  • Texas Oncology - San Antonio Medical Center

    San Antonio, Texas, 78240

    Recruiting

  • Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

    Recruiting

  • WVU Medicine Wheeling Hospital

    Wheeling, West Virginia, 26003

    Recruiting

  • University of Massachusetts

    Worcester, Massachusetts, 01605

    Recruiting

Other trials in United States

France17 sites, 17 recruiting

  • Centre Hospitalier de Béziers

    Béziers, Occitanie, 35400

    Recruiting

  • Hôpital Avicenne

    Bobigny, Île-de-France Region, 93009

    Recruiting

  • Centre Hospitalier Universitaire Estaing - Clermont-Ferrand

    Clermont-Ferrand, Auvergne-Rhône-Alpes, 63003

    Recruiting

  • Hôpital Universitaire Henri Mondor

    Créteil, Val-de-Marne, 94010

    Recruiting

  • Centre Hospitalier de Versailles

    Le Chesnay, Île-de-France Region, 78150

    Recruiting

  • Centre Hospitalier de Roubaix

    Lille, Nord, 59000

    Recruiting

  • Centre Hospitalier Universitaire de Marseille - Hôpital de la Conception

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

    Recruiting

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

    Mulhouse, Grand Est, 68100

    Recruiting

  • Centre Hospitalier Universitaire de Nantes

    Nantes, Loire-Atlantique, 44000

    Recruiting

  • Hôpital Saint Louis

    Paris, Île-de-France Region, 75010

    Recruiting

  • Hôpital Pitié-Salpêtrière

    Paris, Île-de-France Region, 75013

    Recruiting

  • Centre Hospitalier Universitaire de Bordeaux

    Pessac, New Aquitaine, 33604

    Recruiting

  • Hôpital Lyon Sud

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495

    Recruiting

  • Centre Henri Becquerel

    Rouen, Normandy, 76038

    Recruiting

  • Centre Hospitalier Universitaire de Saint Etienne

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

    Recruiting

  • Centre Hospitalier Régional et Universitaire de Nancy Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, Grand Est, 54510

    Recruiting

  • Institut Gustave Roussy

    Villejuif, Val-De-Marne, 94805

    Recruiting

Other trials in France

Spain11 sites, 11 recruiting

  • Hospital General Universitario de Albacete

    Albacete, Castille-La Mancha, 02006

    Recruiting

  • Hospital Universitario De Burgos

    Burgos, Castille and León, 09006

    Recruiting

  • Hospital Universitario Infanta Leonor

    Madrid, Madrid, 28031

    Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, Madrid, 28040

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041

    Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

    Recruiting

  • Hospital Clinico Universitario de Salamanxa

    Salamanca, Castille and León, 37007

    Recruiting

  • University Hospital Virgen Del Rocio S.L.

    Seville, Andalusia, 41013

    Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, València, 46010

    Recruiting

  • Hospital Universitario Y Politecnico La Fe

    Valencia, València, 46026

    Recruiting

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, Aragon, 50009

    Recruiting

Other trials in Spain

Italy10 sites, 10 recruiting

  • Azienda Ospedaliera Universitaria SS Antonio e Biagio e Cesare Arrigo

    Alessandria, Piedmont, 15121

    Recruiting

  • Azienda Sanitaria Territoriale di Ascoli Piceno

    Ascoli Piceno, The Marches, 63100

    Recruiting

  • ASST Papa Giovanni XXIII

    Bergamo, Lombardy, 94805

    Recruiting

  • L'IRCCS Azienda Ospedaliero - Universitaria di Bologna

    Bologna, Emilia-Romagna, 40138

    Recruiting

  • ASST Spedali Civili di Brescia

    Brescia, Lombardy, 25123

    Recruiting

  • Azienda Ospedaliero - Universitaria DI Modena

    Modena, Emilia-Romagna, 41124

    Recruiting

  • Azienda Ospedaliero-Universitaria

    Perugia, Umbria, 42270

    Recruiting

  • Hospital Santa Maria delle Croci

    Ravenna, Emilia-Romagna, 48121

    Recruiting

  • ASUGI Ospedale Maggiore di Trieste

    Trieste, Friuli Venezia Giulia, 76038

    Recruiting

  • Ematologia Ospedale San Bortolo

    Vicenza, Veneto, 36100

    Recruiting

Other trials in Italy

South Korea10 sites, 10 recruiting

  • Pusan National University Hospital

    Busan-si, Gyeongsangnam-do, 49241

    Recruiting

  • Daegu Catholic University Hospital

    Daegu, Gyeongsangbuk-do, 42472

    Recruiting

  • Chungnam National University Daejeon Hospital

    Daejeon, Daejeon Gwang'Yeogsi, 35015

    Recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128

    Recruiting

  • Gachon University Gil Medical Center

    Namdong, Incheon Gwang'Yeogsi, 21565

    Recruiting

  • Dong-A University Hospital

    Pusan, Gyeongsangnam-do, 49201

    Recruiting

  • Anam Hospital Korea University

    Seoul, Seoul-T'Ukpyolsi, 02841

    Recruiting

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

    Seoul, Seoul-T'Ukpyolsi, 06591

    Recruiting

  • Samsung Medical Center

    Seoul, Seoul-T'Ukpyolsi, 35015

    Recruiting

  • Ulsan University Hospital

    Ulsan, Gyeongsangnam-do, 44033

    Recruiting

Other trials in South Korea

Australia6 sites, 6 recruiting

  • Austin Health

    Heidelberg, Victoria, 3084

    Recruiting

  • Box Hill Hospital

    Heidelberg, Victoria, 3128

    Recruiting

  • Gachon University Gil Medical Center

    Kurralta Park, South Australia, 5037

    Recruiting

  • Northern Health Epping

    Melbourne, Victoria, 3004

    Recruiting

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

    Recruiting

  • Calvary Mater Newcastle

    Waratah, New South Wales, 02298

    Recruiting

Other trials in Australia

Philippines6 sites, 6 recruiting

  • Baguio General Hospital and Medical Center

    Baguio City, Benguet, 02600

    Recruiting

  • Perpetual Succour Hospital

    Cebu City, Central Visayas, 6000

    Recruiting

  • Philippine General Hospital

    Ermita, National Capital Region, 1000

    Recruiting

  • University of Santo Tomas

    Manila, National Capital Region, 1015

    Recruiting

  • The Medical City

    Pasig, National Capital Region, 1605

    Recruiting

  • St. Luke's Medical Center - Quezon City

    Quezon City, National Capital Region, 1112

    Recruiting

Other trials in Philippines

Belgium5 sites, 5 recruiting

  • Algemeen Ziekenhuis Sint-Jan Brugge

    Bruges, West-Vlaanderen, 8800

    Recruiting

  • Universitair Ziekenhuis Gent

    Ghent, Oost-Vlaanderen, 9000

    Recruiting

  • Universitair Ziekenhuis Brussel

    Jette, Brussels Capital, 1090

    Recruiting

  • Algemeen Ziekenhuis Delta VZW

    Roeselare, West-Vlaanderen, 8800

    Recruiting

  • Centre Hospitalier Régional Verviers East Belgium

    Verviers, Walloonia, 4800

    Recruiting

Other trials in Belgium

Greece5 sites, 5 recruiting

  • University General Hospital of Alexandroupoli

    Alexandroupoli, East Macedonia and Thrace, 68100

    Recruiting

  • Laiko General Hospital of Athens

    Athens, Attica, 11527

    Recruiting

  • Attikon University General Hospital of Athens

    Chaïdári, Attica, 12462

    Recruiting

  • General Hospital of Thessaloniki G. Papanikolaou

    Exochi, Central Macedonia, 57010

    Recruiting

  • University General Hospital of Ioannina

    Ioannina, Epirus, 45500

    Recruiting

Other trials in Greece

Taiwan4 sites, 4 recruiting

  • Chang Bing Show Chwan Memorial Hospital

    Lugang, Central Taiwan, 505

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, Central Taiwan, 407

    Recruiting

  • National Taiwan University Hospital

    Taipei, Northern Taiwan, 10002

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, Northern Taiwan, 613

    Recruiting

Other trials in Taiwan

United Kingdom4 sites, 4 recruiting

  • St. Bartholomew's Hospital

    London, England, EC1A 7BE

    Not yet recruiting

  • St. Bartholomew's Hospital

    London, England, EC1A 7BE

    Recruiting

  • St. George's, University of London

    London, England, SW17 0QT

    Not yet recruiting

  • St. George's, University of London

    London, England, SW17 0QT

    Recruiting

Other trials in United Kingdom

Canada3 sites, 3 recruiting

  • Royal Victoria Hospital

    Montreal, Quebec, H4A3J1

    Recruiting

  • Centre hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec, QC H2x 3E4

    Recruiting

  • Gordon and Leslie Diamond Health Cancer Centre-Leukemia/BMT Program of BC

    Vancouver, British Columbia, V5Z1M9

    Recruiting

Other trials in Canada

Hungary3 sites, 3 recruiting

  • DPC-Hospital

    Budapest, Budapest, 1097

    Recruiting

  • Győr-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház

    Győr, Gyor-Moson-Sopron County, 9024

    Recruiting

  • Kaposi Mor County Hospital

    Kaposvár, Somogy County, 7400

    Recruiting

Other trials in Hungary

Czechia2 sites, 2 recruiting

  • Fakultni Nemocnice Ostrava

    Ostrava-Poruba, Moravian-Silesian, 70852

    Recruiting

  • Fakultní Nemocnice Královské Vinohrady

    Prague, Prague, 10034

    Recruiting

Other trials in Czechia

Germany2 sites, 2 recruiting

  • Universitätsklinikum Aachen

    Aachen, North Rhine-Westphalia, 52074

    Recruiting

  • Helios Klinikum Bad Saarow

    Bad Saarow, Brandenburg, 15526

    Recruiting

Other trials in Germany

Poland2 sites, 2 recruiting

  • University Clinical Hospital Gdansk

    Gdansk, Pomeranian Voivodeship, 80-214

    Recruiting

  • Szpital Wojewodzki w Opolu

    Opole, Opole Voivodeship, 45-061

    Recruiting

Other trials in Poland

Portugal2 sites, 2 recruiting

  • Hospital de Braga, Centro Clínico Académico de Braga

    Braga, 1099-023

    Recruiting

  • Instituto Português de Oncologia de Lisboa Francisco Gentil - EPE

    Lisbon, Lisbon District, 4200-072

    Recruiting

Other trials in Portugal

About this study

Official title: Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination With Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients With Untreated NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia

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".

Read the detailed description

This protocol encompasses two phase 3, randomized, double-blind, placebo-controlled clinical studies to assess the efficacy, safety, and tolerability of ziftomenib in combination with: (a) the standard of care (SOC) nonintensive regimen (venetoclax [ven]+azacitidine [aza]) in untreated adults with nucleophosmin 1 mutated (NPM1-m) acute myeloid leukemia (AML); or (b) the SOC intensive regimen (cytarabine+daunorubicin induction, referred to here as 7+3, and cytarabine consolidation) in untreated adults with NPM1-m or lysine[K]-specific methyltransferase 2A rearranged (KMT2A-r) AML, as well as a maintenance phase.

Nonintensive Therapy Study (Ven+Aza)

Eligible NPM1-m patients will be enrolled and randomized to receive:

  • Arm A: Ziftomenib in combination with ven+aza or
  • Arm B: Placebo in combination with ven+aza.

Patients will be randomized to treatment arms in a double-blind manner.

Intensive Therapy Study (Cytarabine+Daunorubicin)

Eligible NPM1-m or KMT2A-r patients will be enrolled and randomized to 1 of the following treatment arms:

  • Arm A: Ziftomenib+7+3 (induction), ziftomenib+cytarabine (consolidation), ziftomenib (maintenance) or
  • Arm B: Ziftomenib+7+3 (induction), ziftomenib+cytarabine (consolidation), placebo (maintenance) or
  • Arm C: Placebo+7+3 (induction), placebo+cytarabine (consolidation), placebo (maintenance).

Patients will be randomized to treatment arms in a double-blind manner.

Being tested
Ziftomenib, Placebo, Venetoclax, Azacitidine (AZA), Daunorubicin
Keywords
AML, Hematological malignancy, KMT2A, NPM1, Menin, Acute Leukemia, Leukemia, Acute Myeloid Leukemia, Newly diagnosed AML, Newly diagnosed KMT2A-r AML, Newly diagnosed NPM1m AML, Untreated AML, Untreated NPM1m AML, Untreated KMT2A-r AML, MLL
Medical subject headings
Leukemia, Myeloid, Acute, Hematologic Neoplasms, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZiftomenibDrug

    Also called KO-539

    Oral administration

  • PlaceboDrug

    Oral administration

  • VenetoclaxDrug

    Also called Venclexta, Venclyxto

    Oral administration

  • Azacitidine (AZA)Drug

    Also called Vidaza, Azadine

    Intravenous or subcutaneous administration

  • DaunorubicinDrug

    Also called Cerubidine, daunomycin

    Intravenous administration

  • Cytarabine (Ara-C)Drug

    Also called cytosine arabinoside (ara-C), Cytosar-U, Tarabine PFS

    Intravenous administration

Study groups in NCT07007312
Study groupRoleWhat they receive
Nonintensive Therapy Study, Arm AExperimentalZiftomenib in combination with venetoclax+azacitidine
Receives: Drug: Ziftomenib; Drug: Venetoclax; Drug: Azacitidine (AZA)
Nonintensive Therapy Study, Arm BPlacebo comparatorPlacebo in combination with venetoclax+azacitidine
Receives: Drug: Placebo; Drug: Venetoclax; Drug: Azacitidine (AZA)
Intensive Therapy Study, Arm AExperimentalZiftomenib+cytarabine+daunorubicin (induction), ziftomenib+cytarabine (consolidation), ziftomenib (maintenance)
Receives: Drug: Ziftomenib; Drug: Daunorubicin; Drug: Cytarabine (Ara-C)
Intensive Therapy Study, Arm BExperimentalZiftomenib+cytarabine+daunorubicin (induction), ziftomenib+cytarabine (consolidation), placebo (maintenance)
Receives: Drug: Ziftomenib; Drug: Placebo; Drug: Daunorubicin; Drug: Cytarabine (Ara-C)
Intensive Therapy Study, Arm CPlacebo comparatorPlacebo+cytarabine+daunorubicin (induction), placebo+cytarabine (consolidation), placebo (maintenance)
Receives: Drug: Placebo; Drug: Daunorubicin; Drug: Cytarabine (Ara-C)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nonintensive Therapy Study: (Primary Endpoint for all countries): Overall survival (OS)

    OS

    Measured: Defined as the time from randomization to date of death from any cause, assessed up to 36 months after last patient inclusion

  2. Nonintensive Therapy Study: (Dual Primary Endpoint for US & US reference countries only): Complete remission (CR)

    CR rate per European Leukemia Network (ELN) 2022 criteria per Investigator assessment

    Measured: Assessed up to 36 months after last patient inclusion

  3. Intensive Therapy Study: (Primary Endpoint for all countries): Event-free survival (EFS)

    EFS

    Measured: Defined as the time from randomization to treatment failure, hematologic relapse following CR, or death from any cause, whichever comes first, assessed up to 36 months after last patient inclusion

  4. Intensive Therapy Study: (Dual Primary Endpoint for US & US reference countries only): Complete remission (CR) with bone marrow (BM) measurable residual disease (MRD) negativity in NPM1-m patients

    CR rate per ELN 2022 criteria per Investigator assessment with central BM MRD negativity

    Measured: Assessed up to 36 months after last patient inclusion

Secondary outcomes (13)

  1. Nonintensive Therapy Study: (EU & EU reference countries only): Complete remission (CR)

    CR rate per ELN 2022 criteria per Investigator assessment

    Measured: Up to 36 months after last patient inclusion

  2. Nonintensive Therapy Study: Bone marrow (BM) measurable residual disease (MRD) negativity

    Central BM MRD negativity rate

    Measured: Up to 36 months after last patient inclusion

  3. Nonintensive Therapy Study: Complete remission (CR) + complete remission with partial hematologic recovery (CRh)

    CR + CRh rate per ELN 2022 criteria per Investigator assessment

    Measured: Up to 36 months after last patient inclusion

  4. Nonintensive Therapy Study: Descriptive statistics of Adverse Events (AEs)

    Assessed by NCI-CTCAE v5.0

    Measured: From start of treatment to 28 days from last dose of ziftomenib or placebo

  5. Nonintensive Therapy Study: Area under the concentration-time curve (AUC) of ziftomenib and venetoclax

    To characterize the AUC of ziftomenib and venetoclax

    Measured: During treatment for up to 36 months after last patient inclusion

  6. Nonintensive Therapy Study: Trough concentration (Ctrough) of ziftomenib and venetoclax

    To characterize the Ctrough of ziftomenib and venetoclax

    Measured: During treatment for up to 36 months after last patient inclusion

  7. Nonintensive Therapy Study: Health-related patient-reported outcomes (PRO) assessments

    Health-related quality of life (HRQoL) was evaluated by EORTC QLQ-C30 global health status/quality of life composite scale in all randomized participants. The QLQ-C30 is a cancer-specific, self-administered questionnaire that contains 30 questions, covering global, functional, and symptom scales. Scores range from 0 to 100. Higher scores on global and functional scales indicated better quality of life (QoL), while higher scores on the symptom scales indicated declining QoL.

    Measured: Up to 36 months after last patient inclusion

  8. Intensive Therapy Study: (EU & EU reference countries only): Complete remission (CR) with bone marrow (BM) measurable residual disease (MRD) negativity in NPM1-m patients

    CR rate per ELN 2022 criteria per Investigator assessment with central BM MRD negativity

    Measured: Up to 36 months after last patient inclusion

  9. Intensive Therapy Study: Overall survival (OS)

    OS

    Measured: Defined as the time from randomization to date of death from any cause, up to 36 months after last patient inclusion

  10. Intensive Therapy Study: Descriptive statistics of Adverse Events (AEs)

    Assessed by NCI-CTCAE v5.0

    Measured: From start of treatment to 28 days from last dose of ziftomenib or placebo

  11. Intensive Therapy Study: Health-related patient-reported outcomes (PRO) assessments

    Health-related quality of life (HRQoL) was evaluated by EORTC QLQ-C30 global health status/quality of life composite scale in all randomized participants. The QLQ-C30 is a cancer-specific, self-administered questionnaire that contains 30 questions, covering global, functional, and symptom scales. Scores range from 0 to 100. Higher scores on global and functional scales indicated better quality of life (QoL), while higher scores on the symptom scales indicated declining QoL.

    Measured: Up to 36 months after last patient inclusion

  12. Intensive Therapy Study: Area under the concentration-time curve (AUC) of ziftomenib

    To characterize the AUC of ziftomenib

    Measured: During treatment for up to 36 months after last patient inclusion

  13. Intensive Therapy Study: Trough concentration (Ctrough) of ziftomenib

    To characterize the Ctrough of ziftomenib

    Measured: During treatment for up to 36 months after last patient inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2025
  2. Study start26 Sep 2025
  3. Primary completionNov 2031 (estimated)
  4. Study completionNov 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07007312
Sponsor's protocol ID
KO-MEN-017
Other IDs
2025-521314-25-00, 2025
Status last verified
Aug 2026
First submitted
16 May 2025
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ziftomenib, Venetoclax and Azacitidine (AZA) in people with Acute Myeloid Leukemia (AML), run by Kura Oncology, Inc. at 136 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 136 sites in United States, France, Spain, Italy, South Korea and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kura Medical Information (844-KURAONC (844-587-2662), medinfo@kuraoncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nonintensive Therapy Study: (Primary Endpoint for all countries): Overall survival (OS) (time frame: Defined as the time from randomization to date of death from any cause, assessed up to 36 months after last patient inclusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07007312.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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