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

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Brief Summary

The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 1

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Key Inclusion Criteria:

  • Has been diagnosed with relapsed/refractory AML.
  • Has a documented NPM1 mutation or KMT2A rearrangement.
  • Has a documented FLT3 mutation (cohort A-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.

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Study Stats
Protocol No.
24-5067
Category
Leukemia
Contact
Bruck Habtemariam
Location
  • UCLA Westwood
For Providers
NCT No.
NCT06001788
For detailed technical eligibility, visit ClinicalTrials.gov.