OncoMatch/Clinical Trials/NCT06191978
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)
Is NCT06191978 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including ASTX727 and Venetoclax for acute myeloid leukemia.
Treatment: ASTX727 · Venetoclax — To find a recommended dose of ASTX727 (cedazuridine/decitabine) in combination with venetoclax for pediatric patients with relapsed AML.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Acute Myeloid Leukemia
Demographics
Prior therapy
Must have received: chemotherapy
Relapsed/refractory AML
Cannot have received: chemotherapy, radiotherapy, investigational therapy
Exception: intravenous cytarabine, steroids or hydroxyurea for blast reduction or palliation (no washout necessary for these agents)
Prior chemotherapy/radiotherapy/investigational therapy within 2 weeks before the start of study drugs with the following exception: To reduce the circulating blast count or palliation: intravenous cytarabine, steroids or hydroxyurea. No washout necessary for these agents.
Lab requirements
Kidney function
Creatinine clearance (Schwartz-Formula) or radioisotope GFR ≥ 60ml/min/1.73 m2 or a serum creatinine based on age/sex
Liver function
Total serum bilirubin ≤1.5 x ULN for age (≤5 x ULN for Gilbert's syndrome); ALT and/or AST ≤3 x ULN (≤5 x ULN in case of suspected leukemic liver involvement)
Total serum bilirubin ≤1.5 x ULN for age. Participants with known Gilbert's syndrome may have a total bilirubin up to ≤5 x ULN for age. Creatinine clearance (Schwartz-Formula) or radioisotope GFR ≥ 60ml/min/1.73 m2 or a serum creatinine based on age/sex as follows: Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤3 x ULN; ≤5 x ULN in case of suspected leukemic liver involvement.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06191978 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, radiotherapy, investigational therapy disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 18 years or younger and at least 2 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages