RecruitingPhase 1NCT06769490

Dose Escalation and Expansion of Ziftomenib in Combination With Quizartinib in Acute Myeloid Leukemia

Phase 1 Dose Escalation and Expansion of Ziftomenib in Combination With Quizartinib in Acute Myeloid Leukemia


Sponsor

M.D. Anderson Cancer Center

Enrollment

44 participants

Start Date

Jul 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this all-oral combination is to deliver safe and effective therapy for the largest portion of AML subtypes (NPM1mt, KMT2Ar, NUP98r \~ 40-45%).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — ziftomenib and quizartinib — in people with acute myeloid leukemia (AML), a cancer of the blood and bone marrow, whose cancer has come back or stopped responding to previous treatment. The study is testing different doses to find the safest and most effective combination. **You may be eligible if...** - You are 18 or older with AML or a related blood cancer that has relapsed or stopped responding to treatment - Your cancer has a specific genetic change (NPM1, KMT2A, or NUP98 mutation) - Your heart is pumping well enough (ejection fraction above 40%) - Your liver and kidneys are functioning adequately - You can swallow pills **You may NOT be eligible if...** - You have previously been treated with a menin inhibitor drug - You have active hepatitis B, hepatitis C, or HIV - You are pregnant or breastfeeding - You had a heart attack, severe heart failure, or stroke in the past 6 months - You have active, uncontrolled leukemia in your brain or spinal fluid - You have severe graft-versus-host disease (from a prior bone marrow transplant) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZiftomenib

Participants will receive treatment in tablet form

DRUGQuizartinib

Participants will receive treatment in tablet form


Locations(1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

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NCT06769490


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