RecruitingPhase 1NCT06448013

A Phase I Study Investigating the Combination of the Menin Inhibitor Ziftomenib With Venetoclax and Gemtuzumab in Pediatric Patients With Acute Myeloid Leukemia


Sponsor

M.D. Anderson Cancer Center

Enrollment

22 participants

Start Date

Mar 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To find the recommended dose of ziftomenib in combination with gemtuzumab ozogamicin and venetoclax that can be given to pediatric participants who have relapsed or refractory AML or MPAL.


Eligibility

Min Age: 3 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This Phase I study tests a three-drug combination — ziftomenib (a menin inhibitor), venetoclax, and gemtuzumab ozogamicin — in children and young adults with a type of blood cancer called acute myeloid leukemia (AML) that has returned or is not responding to standard treatments. **You may be eligible if...** - You are between 3 and 21 years old - You have relapsed or refractory AML (or a mixed-lineage leukemia with myeloid features) - Your leukemia has a specific genetic mutation (such as KMT2A rearrangement, NUP98, NPM1, or other HOX pathway mutations) - Your white blood cell count is below 25,000/µL at enrollment **You may NOT be eligible if...** - You have had a prior bone marrow transplant within a certain timeframe - Your overall health condition is too poor to tolerate the treatment 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

DRUGVenetoclax

Given by PO

DRUGGemtuzumab

Given by IV

DRUGZiftomenib

Given by PO


Locations(1)

MD Anderson Cancer Center

Houston, Texas, United States

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NCT06448013


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