RecruitingPhase 1NCT06397027

A Phase I Study Investigating the Combination of the Ziftomenib, Venetoclax and Azacitidine in Pediatric Relapsed and Refractory Acute Leukemias


Sponsor

M.D. Anderson Cancer Center

Enrollment

22 participants

Start Date

Dec 27, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To find the highest safe dose of ziftomenib that can be combined with venetoclax and azacitidine in pediatric participants with acute leukemia that has certain types of genetic mutations (changes).


Eligibility

Min Age: 2 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests a three-drug combination — ziftomenib (a menin inhibitor), venetoclax (a BCL-2 inhibitor), and azacitidine (a chemotherapy drug) — in patients with acute myeloid leukemia (AML) that has specific genetic mutations or has come back after treatment. **You may be eligible if...** - You have been diagnosed with AML - Your leukemia has a specific genetic mutation (such as NPM1 mutation or KMT2A rearrangement), OR your AML has returned or not responded to prior treatment - You are at least 18 years old with adequate liver and kidney function - You have not received prior menin inhibitor therapy **You may NOT be eligible if...** - You have leukemia that has spread to the brain or spinal fluid - You have serious heart problems (QT prolongation) or active severe infections - You are pregnant or breastfeeding - You are unable to swallow oral medications 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

Given by IV

DRUGVenetoclax

Given by PO

DRUGAzacitidine

Given by PO


Locations(1)

MD Anderson Cancer Center

Houston, Texas, United States

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NCT06397027


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