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RecruitingPhase 2NCT06046313

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

A Multi-center Prospective Single Arm Clinical Study of Prolonged Ultra Low-dose Decitabine Combined With Venetoclax (Bcl-2 Inhibitor) as First Line Treatment for Elderly Acute Myeloid Leukemia and High-risk Myelodysplastic Syndromes

Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

120 participants

Start Date

Oct 19, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid LeukemiaMyelodysplastic Syndromes

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

Min Age: 60 Years

Inclusion Criteria9

  • 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 Criteria5

  • 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.

Interventions

DRUGDecitabine for Injection

6mg/m2, ivgtt qd d1-10

DRUGVENCLYXTO

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

Locations(1)

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

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NCT06046313

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