Efficacy and Safety of Selinexor Combined With Azacitidine as Maintenance Therapy in High-Risk Myeloid Neoplasms Patients Post-Transplantation: A Single-Center, Single-Arm, Explorato
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 2-year recurrence free survival rate (RFS)
研究概览
简要总结
Efficacy and Safety of Selinexor Combined with Azacitidine as Maintenance Therapy in High-Risk Myeloid Neoplasms Patients Post-Transplantation: A Single-Center, Single-Arm, Exploratory Study
详细描述
Treatment period: From the time of transplantation, after screening by inclusion and exclusion criteria, patients who meet the criteria are enrolled and given maintenance therapy with Selinexor in combination with azacitidine (Selinexor: 40 mg/weekly, administered on D1; azacitidine: 50 mg/m2*5d; every 28 days for a cycle of treatment, for at least one year of medication, or until progression of the disease, or until the development of intolerable toxicity, whichever comes first)
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
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
patients with high-risk myeloid neoplasms after transplantation
maintenance therapy with Selinexor combined with Azacitidine
干预措施: Selinexor (Drug)
结局指标
主要结局
2-year recurrence free survival rate (RFS)
时间窗: 2 years
the rate at which a patient has been on the drug for at least 1 year without morphological relapse or death of the subject from the transplantation date (whichever comes first)
次要结局
- 2-year non-relapse mortality rate (NRM)(2 years)
- 2-year survival rate (OS)(2 years)
- Median overall survival (OS)(2 years)
- Cumulative incidence of acute graft-versus-host disease (GVHD)(2 years)