Retrospective, Observational, Monocentric Study to Assess Efficacy and Safety of the Combination of an Hypomethylating Agent in Combination With Venetoclax for Newly Diagnosed Acute Myeloid Leukemia Patients Not Eligible for Intensive Chemotherapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Complete response (CR) rate
研究概览
简要总结
This is a retrospective, observational, monocentric study to evaluate the efficacy and safety of the combination of an hypomethylating agent with venetoclax newly diagnosed patients with acute myeloid leukemia ineligible for intensive chemotherapy
详细描述
The prognosis of acute myeloid leukemia (AML) patients who are ineligible for intensive chemotherapy is poor (Kantarjian et al). Hypomethylating agents, azacitidine and decitabine, are effective and less toxic regimens, and treatment with these agents has improved the prognosis of these patients (Fenaux et al).
Venetoclax, a Bcl-2 inhibitor, in combination with azacitidine has shown efficacy in AML patients with complete remission rate of 73% and overall survival at 2 years of 40-50% (Di Nardo et al).
On these grounds, the aim of this study is to collect the real-life experience with this combination in previously untreated AML patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years
- •newly diagnosed acute myeloid leukemia not eligible for intensive chemotherapy
排除标准
- •promyelocytic acute myeloid leukemia
- •patients who have already received one or more prior lines of therapy
研究组 & 干预措施
treated patients
hypomethylating agent (azacitidine or decitabine) in combination with venetoclax
干预措施: Venetoclax (Drug)
结局指标
主要结局
Complete response (CR) rate
时间窗: every three months after started treatment up to two years
according to European Leukemia Network (ELN)
次要结局
- Overall response rate (ORR)(every three months after started treatment up to two years)
- Morphologic leukemia-free state (MLFS)(every three months after started treatment up to two years)
- Progression-free-survival(from the start of the treatment until the date of documented progression or date of death from any cause, assessed up to 2 years)
- Overall survival(from the start of the treatment until the date of documented progression or date of death from any cause, assessed up to 2 years)
- adverse events and serious adverse events(through study completion, for an average of 1 year)
研究者
Francesco Zaja
Professor
Ospedale Maggiore Di Trieste