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

About

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.