NCT07007312Phase 3Recruiting

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

Study sponsor: Kura Oncology, Inc. · KURA

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2031-11Estimated

Enrollment · participants1300Estimated

Source updated2026-08-20Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2025-10-22 · 1 field changed

Recruitment status changed

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~~Not yet recruiting~~

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Recruiting

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Study details

Conditions studied

Acute Myeloid Leukemia (AML)

Treatments or interventions studied

ZiftomenibDrugAlso known as KO-539
PlaceboDrug
VenetoclaxDrugAlso known as Venclexta, Venclyxto
Azacitidine (AZA)DrugAlso known as Vidaza, Azadine
DaunorubicinDrugAlso known as Cerubidine, daunomycin
Cytarabine (Ara-C)DrugAlso known as cytosine arabinoside (ara-C), Cytosar-U, Tarabine PFS

Primary outcomes · main study measures

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measure: Nonintensive Therapy Study: (Primary Endpoint for all countries): Overall survival (OS); description: OS; timeFrame: Defined as the time from randomization to date of death from any cause, assessed up to 36 months after last patient inclusion; measure: Nonintensive Therapy Study: (Dual Primary Endpoint for US & US reference countries only): Complete remission (CR); description: CR rate per European Leukemia Network (ELN) 2022 criteria per Investigator assessment; timeFrame: Assessed up to 36 months after last patient inclusion; measure: Intensive Therapy Study: (Primary Endpoint for all countries): Event-free survival (EFS); description: EFS; timeFrame: 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; measure: 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; description: CR rate per ELN 2022 criteria per Investigator assessment with central BM MRD negativity; timeFrame: Assessed up to 36 months after last patient inclusion

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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