NCT06279338尚未招募不适用
A Clinical Study of Azacitidine Combined With BUCY2 Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome With Moderate High IPSS-M Score
Wuhan Union Hospital, China0 个研究点目标入组 40 人开始时间: 2024年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Progression-free survival (PFS) at 18 months post-transplant, month
研究概览
简要总结
Figure out the Efficacy and Safety of Azacitidine Combined with BUCY2 Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome with Moderate High IPSS-M Score
详细描述
This study is a prospective, single-center, single-arm clinical study, which plans to enroll 40 patients with high-risk myelodysplastic syndrome (MDS) to be given azacitidine (AZA) combined with busulfan and cyclophosphamide (BUCY2) conditioning regimen to evaluate 18-month progression-free survival (PFS), aiming to evaluate the efficacy and safety of azacitidine plus BUCY2 pretreatment regimen.
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
- •Patients fully understand this study, voluntarily participate and sign the informed consent form
- •Age equal or more than 18 years old
- •Patients with moderate high-risk MDS with an IPSS-M score which is higher than 0
- •Patients planning to undergo allogeneic hematopoietic stem cell transplantation, HCT-CI ≤ 3 or KPS ≥ 80%
排除标准
- •Patients who refuse to participate in this clinical study
- •Patients with central nervous system involvement
- •Patients with HIV seropositive
- •Patients with other serious medical conditions with a life expectancy of less than six months
- •Patients with severe psychiatric or psychological disorders
研究组 & 干预措施
Azacitidine
Experimental
Combining azacitidine with classic BUCY2 regimen as conditioning regimen
干预措施: Azacitidine Injection (Drug)
结局指标
主要结局
Progression-free survival (PFS) at 18 months post-transplant, month
时间窗: 18 months post-transplantation
PFS is measured from the date of allo-HSCT to the date of relapse or death from any cause or the last follow-up for surviving patients.
次要结局
- Overall survival (OS) at 18 months post-transplant, month(18 months post-transplantation)
研究者
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