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Recruiting NCT06046313

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

Phase II Interventional Acute Myeloid Leukemia Myelodysplastic Syndromes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Decitabine for Injection, VENCLYXTO.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 opportunity to receive allogeneic hematopoietic stem cell transplantation, resulting in poor prognosis and short survival.

In recent years, with the advent of molecular targeted drugs Bcl-2 inhibitors, the treatment of elderly AML/ high-risk MDS has achieved breakthrough progress. In particular, the combination of demethylated drugs (decitabine/azacidacidin) and Bcl-2 inhibitors of chemotherapy-free regimen has been recommended by NCCN as the first-line treatment for elderly and frail patients.

However, how to achieve the optimal combination of decitabine and Bcl-2 inhibitors is an urgent problem to be solved.

Our previous pilot trial showed that prolonged low-dose decitabine combined with venetoclax (Bcl-2 inhibitor) resulted in higher complete remission rate, longer disease-free survival, and lower treatment-related risks.

The purpose of this study was to expand the multi-center sample to explore the efficacy and safety of prolonged low-dose decitabine plus venetoclax regimen in primary diagnosed elderly or frail AML/ high-risk MDS.

Interventions

  • Drug Decitabine for Injection
    6mg/m2, ivgtt qd d1-10
  • Drug VENCLYXTO
    100mg p.o.d1, 200mg p.o.d2, 400mg p.o.d3-21,adjust by blood concentration

Primary outcome measures

  • Complete response rate(CR+CRi) [Time frame: at Week 8]
Secondary outcome measures (3)
  • MRD [Time frame: at Week 8]
  • EFS [Time frame: up to 2 years after induction therpy]
  • OS [Time frame: up to 2 years after induction therpy]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou

Identifiers

NCT: NCT06046313 · IIT202300032C

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗