Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
← catalyst calendarNCT06001788 · readout ≤ 12 d
Sponsored by Kura Oncology, Inc. (industry) · KURA — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
171estimated
Sites
45
Countries
Italy, Spain, United States
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 | 2024-02-22 | actual | When the study began enrolling |
| Primary completion | Aug 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Aug 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2023-08-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-14 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- AML
- AML With Mutated NPM1
- Hematologic Malignancy
- KMT2Ar
- NPM1 Mutation
- MLL Rearrangement
- Leukemia
- Acute Myeloid Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Acute Leukemia
- Neoplasms by Histologic Type
Interventions
- Drug: Ziftomenib — also filed as KO-539
- Drug: Fludarabine
- Drug: Idarubicin
- Drug: Cytarabine
- Drug: Gilteritinib — also filed as Xospata
- Biological: Granulocyte colony-stimulating factor
Primary outcomes
what the primary-completion date above is the date OFRate of dose limiting toxicities (DLTs) per dose level
measured During the first 28 days of ziftomenib in combination with SOC treatment (1 cycle)
Descriptive statistics of adverse events
measured First dose of ziftomenib up to and including 28 days after last dose of ziftomenib, or if the patient is lost to follow-up, whichever comes first
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