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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06397027
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