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OncoMatch/Clinical Trials/NCT06046313

Prolonged Ultra Low-dose Decitabine Plus Venetoclax for Primary Diagnosed Elderly AMLK/MDS

Is NCT06046313 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Decitabine for and VENCLYXTO for acute myeloid leukemia.

Phase 2RecruitingFirst Affiliated Hospital of Zhejiang UniversityNCT06046313Data as of Jun 2026Location: China

Treatment: Decitabine for · VENCLYXTOTo 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.

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Extracted eligibility criteria

Treatments studied

Other

Decitabine forVENCLYXTO

Cancer type

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Performance status

ECOG 0–3(Limited self-care)

Demographics

Ages ≥ 60

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

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.

Frequently asked questions

Is NCT06046313 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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