Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT for Elderly Patients With Higher-risk Myelodysplastic Syndromes
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The goal of this phase 1/2 trial is to test the safety and efficacy of Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT in treating patients with higher-risk MDS.
详细描述
The investigators will evaluate 2 year overall survival(OS) after transplantation in patients with higher-risk MDS. Progression free survival (PFS), incidence of acute GVHD, non-relapse mortality (NRM), graft-versus-host disease (GVHD)-free relapse-free survival(GRFS), and incidence of chronic GVHD at 1 and 2 years after transplantation 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
- 70 Years 至 —（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 higher risk MDS according to the standard criteria of the World Health Organization (WHO).
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.
研究组 & 干预措施
Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT
Patients were treated by Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT
干预措施: Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT (Drug)
结局指标
主要结局
Overall Survival
时间窗: 3 year
OS was defined as time from diagnosis to death from any cause or the last follow-up
次要结局
- Progression Free Survival (PFS)(3 year)
- Incidence of acute GVHD and chronic GVHD(3 year)
- Non-relapse mortality (NRM)(3 year)
- Graft-versus-host disease (GVHD)-free relapse-free survival(GRFS)(3 year)
研究者
Liren Qian
Vice Director
Navy General Hospital, Beijing