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Clinical Trials in China / NCT06046313
Recruiting Phase 2

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

NCT06046313 · tracked via the Priya Life Science China tracker
Sponsor
First Affiliated Hospital of Zhejiang University
Phase
Phase 2
Started
2023-10-19
Last updated
2024-03-05

Condition(s) studied

Acute Myeloid LeukemiaMyelodysplastic Syndromes

Investigational drug(s) / intervention(s)

Decitabine for Injection →VENCLYXTO

Decitabine for Injection: 6mg/m2, ivgtt qd d1-10

VENCLYXTO: 100mg p.o.d1, 200mg p.o.d2, 400mg p.o.d3-21,adjust by blood concentration

Study summary

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.

Eligibility

Sex
ALL
Min age
60 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Patients must be diagnosed with acute myeloid leukemia (non-acute promyelocytic leukemia)/high-risk myelodysplastic syndrome before admission. Diagnostic criteria refer to 2016 WHO classification. 2. Age 60 or older. 3. The scores of physical fitness in the Eastern Tumor Cooperative group (ECOG) ranged from 0 to 3(see Appendix 1). 4. Creatinine clearance ≥30 mL/min(as assessed by the Cockcrod-Gault formula \[Cockcroft et al 1976\] \[13\] or the estimated glomerular filtration rate \[eGFR\] from the Kidney Drink adjustment formula . 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤3× upper limit of normal range (ULN), total bilirubin ≤2×ULN. 6. Echocardiography (ECHO) showed left ventricular ejection fraction (LVEF)≥50% (AHA 2016). 7. Life expectancy \>8 weeks. 8. Sign the informed consent voluntarily, and understand and comply with the requirements of the study. Exclusion Criteria: 1. Age \<60 years old. 2. Treated patients who had received various chemotherapy regiments. 3. 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 (see Appendix 2), or history of myocardial infarction in the 6 months prior to screening. 4. Other serious diseases that may limit participation in the trial (e.g. advanced infections, uncontrolled diabetes). 5. Those who cannot understand and follow the research plan or sign the informed consent.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital, College of Medicine, Zhejiang University Hangzhou Zhejiang Recruiting

More First Affiliated Hospital of Zhejiang University trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06046313 on ClinicalTrials.gov ↗ ← All trials in China