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Ziftomenib for Untreated AML with NPM1-m or KMT2A-r Mutations

This study is testing an investigational drug called ziftomenib for people with newly diagnosed acute myeloid leukemia (AML) who have specific genetic changes (NPM1-m or KMT2A-r). Ziftomenib works by targeting a specific pathway in cancer cells. The study has two parts: one for older patients or those with other health issues, where ziftomenib or a placebo (inactive substance) is added to standard treatments venetoclax and azacitidine. The second part is for patients who can receive more intensive treatment, where ziftomenib or a placebo is added to standard chemotherapy (daunorubicin and cytarabine). Researchers will measure how long patients live and if their cancer goes into remission to see if ziftomenib is helpful. You must be at least 18 years old and have a diagnosis of AML to participate.

Study design
This is a Phase 3, randomized, double-blind, placebo-controlled study with a planned enrollment of 1300 participants. It compares ziftomenib plus standard treatments to standard treatments plus a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 36 months after the last patient joins the study to assess outcomes like survival and remission.

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NCT07007312

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Kura Oncology, Inc.
~1,300 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:ZiftomenibPlaceboVenetoclaxAzacitidine (AZA)DaunorubicinCytarabine (Ara-C)

At a glance

Recruiting sites
113 of 115 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Nonintensive Therapy Study: (Primary Endpoint for all countries): Overall survival (OS)
Measured over Defined as the time from randomization to date of death from any cause, assessed up to 36 months after last patient inclusion
+3 more outcomes measured

Conditions

Acute Myeloid Leukemia (AML)

Explore related trials

Acute Myeloid LeukemiaKMT2A GeneNPM1 Gene

Where it's being run

115 sites across 75 states
California5
New York4
Texas4
Île-de-France Region4
Tennessee3
Auvergne-Rhône-Alpes3
National Capital Region3
Gyeongsangnam-do3

Who to contact

Kura Medical Information
[email protected]
844-KURAONC (844-587-2662)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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):
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):

Exclusion

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:
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.

What this trial measures

  • Nonintensive Therapy Study: (Primary Endpoint for all countries): Overall survival (OS)Defined as the time from randomization to date of death from any cause, assessed up to 36 months after last patient inclusion

    OS

  • Nonintensive Therapy Study: (Dual Primary Endpoint for US & US reference countries only): Complete remission (CR)Assessed up to 36 months after last patient inclusion

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

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

    EFS

  • 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 patientsAssessed up to 36 months after last patient inclusion

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