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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Complete response rate(CR+CRi)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
treatment group
Acute Myeloid Leukemia Myelodysplastic Syndrome
干预措施: Decitabine for Injection (Drug)
treatment group
Acute Myeloid Leukemia Myelodysplastic Syndrome
干预措施: VENCLYXTO (Drug)
结局指标
主要结局
Complete response rate(CR+CRi)
时间窗: at Week 8
Assessment of CR(CR=CR+CRi) at Week 8
次要结局
- MRD(at Week 8)
- EFS(up to 2 years after induction therpy)
- OS(up to 2 years after induction therpy)
研究者
Weiyan Zheng
Clinical Professor
First Affiliated Hospital of Zhejiang University