Actively Recruiting

Phase 2
Age: 60Years +
All Genders
NCT06046313

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

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China, 310003

Actively Recruiting

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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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