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 (May 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
Cancer type
Acute Myeloid Leukemia
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 →
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