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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06448013
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