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Examining the safety of ziftomenib combinations for patients with relapsed acute myeloid leukemia

Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia

Phase 1 Interventional Kura Oncology, Inc. · NCT06001788

This study is testing if combining ziftomenib with standard treatments can safely help people with relapsed acute myeloid leukemia feel better and improve their chances of recovery.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment171 (estimated)
Ages18 Years and up
SexAll
SponsorKura Oncology, Inc. Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, radiation, gilteritinib
Locations45 sites (Gilbert, Arizona and 44 other locations)
Trial IDNCT06001788 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and tolerability of ziftomenib when combined with standard treatments for patients suffering from relapsed or refractory acute myeloid leukemia (AML). The study will evaluate the antileukemic response of ziftomenib in conjunction with agents such as FLAG-IDA, low-dose cytarabine, and gilteritinib. Participants must have specific genetic mutations associated with AML, and the trial aims to determine the effectiveness of these combinations in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with relapsed/refractory AML who have specific genetic mutations such as NPM1 or KMT2A rearrangements.

Not a fit: Patients with acute promyelocytic leukemia or those with active central nervous system leukemia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with relapsed or refractory AML.

How similar studies have performed: Other studies have shown promise in using targeted therapies for AML, suggesting that this approach may yield beneficial results.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* 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.

Key Exclusion Criteria:

* 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.

Where this trial is running

Gilbert, Arizona and 44 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions AMLAML With Mutated NPM1Hematologic MalignancyKMT2ArNPM1 MutationMLL RearrangementLeukemiaAcute Myeloid Leukemia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.