Comparisiom of Standard (SD) Therapy and Non-standard (NSD) Therapy in Elderly Acute Myeloid Leukemia (AML)
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
It is known that treatment outcome could be positively associated with treatment intensity. However, tolerance of chemotherapy decreases in the elder, some patients could not tolerate standard (SD) therapy and even died of side effect, and overall survival (OS) might not be prolonged. Whether all elder acute myeloid leukemia (AML) patients could benefit from SD therapy, or some should receive reduced-intensity therapy or even only supporting care remains controvertal. In this multi-center study, we are going to evaluate the benefit of SD and non-SD (NSD) therapy in elder AML patients.
详细描述
It is known that treatment outcome could be positively associated with treatment intensity. However, tolerance of chemotherapy decreases in the elder, some patients could not tolerate standard (SD) therapy and even died of side effect, and overall survival (OS) might not be prolonged. Whether all elder acute myeloid leukemia (AML) patients could benefit from SD therapy, or some should receive reduced-intensity therapy or even only supporting care remains controvertal. SD therapy is definited as the treatment regimen must follow NCCN guildline and chemotherapy intensity could not be reduced. Non-SD (NSD) therapy is definited as patients receiving reduced-intensity therapy or only supporting care. In this multi-center study, we are going to evaluate the benefit of SD and NSD therapy in elder AML patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed AML exclusive of APL; Age from 60 years old to 75 years old.
排除标准
- •Any abnormality in a vital sign (e.g., organ function failure, serious infection ) Patients with any conditions not suitable for the trial (investigators' decision)
结局指标
主要结局
Overall survival
时间窗: 2 years
The time from AML diagnosis to patients death or last folloeing-up.
次要结局
- Relapse-free survival(2 years)
- Relapse incidence(2 years)
- Treatment-related mortality(1 year)
研究者
Qifa Liu
professor
Nanfang Hospital, Southern Medical University