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 (Sep 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
Cannot have received: anti-cancer therapy
Exception: hydroxyurea allowed during first 2 cycles only
Concomitant other anti-cancer therapy and/or participation in any other investigational clinical trials except for hydroxyurea. Concurrent hydroxyurea use should be limited to the first 2 cycles of therapy only.
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/AST ≤3 x ULN (≤5 x ULN if suspected leukemic liver involvement)
Total serum bilirubin ≤1.5 x ULN for age, unless the increased value is likely attributed to disease involvement. 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 anti-cancer 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