Back to search results

Ziftomenib Combinations for Relapsed/Refractory AML

This study is looking at the safety and how well different combinations of ziftomenib work for patients with acute myeloid leukemia (AML) that has come back or not responded to previous treatment. You might be eligible if you have AML with specific genetic changes (NPM1 mutation or KMT2A rearrangement, and possibly a FLT3 mutation). Researchers are testing ziftomenib with standard treatments like fludarabine, idarubicin, cytarabine, and gilteritinib. The main goal is to see what side effects occur and how well patients tolerate these combinations. The study plans to enroll 171 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 171 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Adverse events will be monitored from the first dose of ziftomenib up to 28 days after the last dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06001788

Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Recruiting
PHASE1Ages 18+InterventionalTreatment
Kura Oncology, Inc.
~171 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:ZiftomenibFludarabineIdarubicinCytarabineGilteritinibGranulocyte colony-stimulating factor

At a glance

Recruiting sites
43 of 45 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of dose limiting toxicities (DLTs) per dose level
Measured over During the first 28 days of ziftomenib in combination with SOC treatment (1 cycle)
+1 more outcome measured

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

Explore related trials

Acute Myeloid LeukemiaKMT2A GeneNPM1 GeneReceptor-Type Tyrosine-Protein Kinase FLT3

Where it's being run

45 sites across 27 states
New York6
California4
Spain4
Illinois3
Italy3
Georgia2
Michigan2
Texas2

Who to contact

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

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Has been diagnosed with relapsed/refractory AML.
Has a documented NPM1 mutation or KMT2A rearrangement.
Has a documented FLT3 mutation (cA-3 only).
Has an Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.
Has adequate hepatic and renal function as defined per protocol.
Has an ejection fraction above a protocol defined limit.
Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.
Has agreed to use contraception as defined per protocol.

Exclusion

Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia.
Has clinically active central nervous system leukemia.
Has an active and uncontrolled infection.
Has a mean corrected QT interval (QTcF) \> 480ms.
Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.
Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy \<14 days or within 5 drug half-lives prior to the first dose of study intervention.
Has had major surgery within 4 weeks prior to the first dose of study intervention.
Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria.
Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD
Participant is pregnant or lactating.

What this trial measures

  • Rate of dose limiting toxicities (DLTs) per dose levelDuring the first 28 days of ziftomenib in combination with SOC treatment (1 cycle)

    Assessed by the NCI-CTCAE v5.0

  • Descriptive statistics of adverse eventsFirst 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

    Assessed by the NCI-CTCAE v5.0