PhI Ziftomenib Comb Tx of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia

UCI Specialty Area: Cancer

Principal Investigator: Kiran Naqvi

Official Title: Phase I Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-Rearranged or NPM1-Mutant Relapsed/Refractory Acute Myeloid Leukemia

A Study On:

Myeloid and Monocytic Leukemia

Study Description

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.

Eligibility

-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

-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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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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