OncoMatch/Clinical Trials/NCT06046313
Prolonged Ultra Low-dose Decitabine Plus Venetoclax for Primary Diagnosed Elderly AMLK/MDS
Is NCT06046313 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Decitabine for and VENCLYXTO for acute myeloid leukemia.
Treatment: Decitabine for · VENCLYXTO — To explore the efficacy and safety of prolonged low-dose decitabine (10 days of 6mg/m2) plus venetoclax (3 weeks/cycle) regimen in primary diagnosed elderly or frail AML/ high-risk MDS.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Cannot have received: chemotherapy
Treated patients who had received various chemotherapy regiments.
Lab requirements
Kidney function
Creatinine clearance ≥30 mL/min (Cockcroft-Gault or eGFR)
Liver function
AST and ALT ≤3× ULN, total bilirubin ≤2× ULN
Cardiac function
LVEF ≥50% (ECHO); exclusion of uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease (NYHA), or history of myocardial infarction in the 6 months prior to screening
Creatinine clearance ≥30 mL/min (Cockcroft-Gault or eGFR). AST and ALT ≤3× ULN, total bilirubin ≤2× ULN. Echocardiography (ECHO) showed LVEF ≥50% (AHA 2016). Present clinically significant active cardiovascular disease, such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional scale, or history of myocardial infarction in the 6 months prior to screening.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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