CHG Regimen Combined With Venetoclax and Azacytidine in Newly Diagnosed Acute Myeloid Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The goal of this phase 2 trial is to test the safety and efficacy of CHG Combined With Venetoclax in treating patients with newly diagnosed AML.
详细描述
The investigators will evaluate response rate of CHG regimen Combined With Venetoclax in newly diagnosed acute myeloid leukemia. After induction therapy, patients will be given standardized treatment according to risk stratification according to NCCN guidelines. Progression free survival (PFS), Overall survival (OS), and Toxicity will be counted.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient should, in the investigator's opinion, be able to meet all clinical trial requirements.
- •The patient is willing and able to adhere to the study visit schedule and other protocol requirements.
- •The patient should be diagnosed with AML according to the standard criteria of the World Health Organisation (WHO).
- •The patient should not have received any prior treatment for AML.
排除标准
- •Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
- •Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
- •Pregnant or lactating women.
研究组 & 干预措施
CHG Combined With Venetoclax and Azacytidine
Patients were treated by CHG Combined With Venetoclax and Azacytidine
干预措施: CHG Combined With Venetoclax and Azacytidine (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 1 year
ORR was defined as the proportion of patients who achieved CR or PR as their best response
次要结局
- Overall Survival (OS)(through study completion, an average of 3 years)
- Progression Free Survival (PFS)(2 years)
研究者
Liren Qian
Vice Director
Navy General Hospital, Beijing