RecruitingPhase 1NCT06191978
A Phase Ia/Ib Open-label, Multiple Dose, Study to Determine the Recommended Dose, Evaluate PKs, PDs, Safety, and Activity of Venetoclax in Combination With Oral Decitabine/Cedazuridine (ASTX727) in Pediatric Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML)
Sponsor
M.D. Anderson Cancer Center
Enrollment
40 participants
Start Date
Mar 7, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
To find a recommended dose of ASTX727 (cedazuridine/decitabine) in combination with venetoclax for pediatric patients with relapsed AML.
Eligibility
Min Age: 2 YearsMax Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This study is testing a combination of venetoclax (a targeted cancer drug) with oral decitabine/cedazuridine (chemotherapy pills) in children and teenagers with acute myeloid leukemia (AML) that has come back or did not respond to prior treatment.
**Your child may be eligible if...**
- They are between 2 and 18 years old
- They have been diagnosed with AML that has relapsed or is refractory to prior treatment
- At least 5% of their bone marrow or blood cells are leukemia cells
- They are able to swallow pills
- Their kidney, liver, and overall health function meet study requirements
**Your child may NOT be eligible if...**
- They have the APL subtype of AML
- They have AML spread to the brain or spinal fluid
- They have severe organ impairment
- They are pregnant (if applicable)
Talk to your doctor to see if this trial is right for your child.
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
DRUGASTX727
Given by PO
DRUGVenetoclax
Given by PO
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06191978
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