Actively Recruiting
Prolonged Ultra Low-dose Decitabine Plus Venetoclax for Primary Diagnosed Elderly AMLK/MDS
Led by First Affiliated Hospital of Zhejiang University · Updated on 2024-03-05
120
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prolonged Ultra Low-dose Decitabine Plus Venetoclax for Primary Diagnosed Elderly AMLK/MDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with acute myeloid leukemia (non-acute promyelocytic leukemia) or high-risk myelodysplastic syndrome according to 2016 WHO classification
- Age 60 years or older
- Physical fitness score (ECOG) between 0 and 3
- Creatinine clearance of at least 30 mL/min
- Liver enzymes (AST and ALT) no more than 3 times the upper normal limit, total bilirubin no more than 2 times the upper normal limit
- Left ventricular ejection fraction of 50% or higher
- Life expectancy greater than 8 weeks
- Able to voluntarily sign informed consent and comply with study requirements
You will not qualify if you...
- Younger than 60 years old
- Previously treated with chemotherapy
- Active serious heart disease such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, severe heart disease (NYHA grade 3 or 4), or myocardial infarction within 6 months
- Other serious illnesses that prevent participation, such as advanced infections or uncontrolled diabetes
- Unable to understand or follow the study plan or unable to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
W
Weiyan Zheng, MD
CONTACT
X
Xuepin Luo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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