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

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NCT07007312 · readout ≤ 1,929 d

Sponsored by Kura Oncology, Inc. (industry) · KURA — their whole pipeline →.

Phase

Phase 3

Status

Recruiting

Study type

Interventional

Design

Randomized · Quadruple · Treatment

Enrollment

1,300estimated

Sites

106

Countries

Australia, Belgium, Canada +13

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2025-09-26

actual

When the study began enrolling

Primary completion

Nov 2031

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

Nov 2031

estimated

The whole study's end, after follow-up

First posted

2025-06-05

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-07-27

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Acute Myeloid Leukemia (AML)

Interventions

Drug: Ziftomenib — also filed as KO-539
Drug: Placebo
Drug: Venetoclax — also filed as Venclexta, Venclyxto
Drug: Azacitidine (AZA) — also filed as Vidaza, Azadine
Drug: Daunorubicin — also filed as Cerubidine, daunomycin
Drug: Cytarabine (Ara-C) — also filed as cytosine arabinoside (ara-C), Cytosar-U, Tarabine PFS

Primary outcomes

what the primary-completion date above is the date OF

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

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

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

measured Assessed up to 36 months after last patient inclusion

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

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

measured Assessed up to 36 months after last patient inclusion

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