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)

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06191978


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