Study of Venetoclax and ASTX727 for Relapsed/Refractory AML in Children
This study is for children aged 2 to 18 with acute myeloid leukemia (AML) that has come back or not responded to previous treatments. It is testing a combination of two oral medicines, Venetoclax and ASTX727 (cedazuridine/decitabine). The main goals are to find the safest and most effective dose of these medicines together, understand how they work in the body, and see if they can help treat AML. To join, your child must have at least 5% leukemia cells in their bone marrow or blood. The study will look at side effects and how well the treatment shrinks the leukemia. The current recruitment status is unclear.
- Study design
- This is an open-label study, meaning everyone knows which treatment is being given. It plans to enroll 40 participants to find the recommended dose of the drug combination.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for side effects through study completion, which is an average of 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Amber Gibson, DO · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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What this trial measures
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0Through study completion; an average of 1 year.