Status:
RECRUITING
Prolonged Ultra Low-dose Decitabine Plus Venetoclax for Primary Diagnosed Elderly AMLK/MDS
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief 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.
Detailed Description
Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) are hematological malignancies. Some patients are over 65 years old, have poor response to traditional chemotherapy, and rarely have the...
Eligibility Criteria
Inclusion
- 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.
- Age 60 or older.
- The scores of physical fitness in the Eastern Tumor Cooperative group (ECOG) ranged from 0 to 3(see Appendix 1).
- 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 .
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤3× upper limit of normal range (ULN), total bilirubin ≤2×ULN.
- Echocardiography (ECHO) showed left ventricular ejection fraction (LVEF)≥50% (AHA 2016).
- Life expectancy \>8 weeks.
- Sign the informed consent voluntarily, and understand and comply with the requirements of the study.
Exclusion
- Age \<60 years old.
- Treated patients who had received various chemotherapy regiments.
- 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.
- Other serious diseases that may limit participation in the trial (e.g. advanced infections, uncontrolled diabetes).
- Those who cannot understand and follow the research plan or sign the informed consent.
Key Trial Info
Start Date :
October 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 19 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06046313
Start Date
October 19 2023
End Date
October 19 2026
Last Update
March 5 2024
Active Locations (1)
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1
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003