The Feasibility of a Bridging Treatment With Low-dose Azacitidine (AZA) in Combination With Short Term CAG Derived Regimen Prior to Allogeneic Stem Cell Transplantation (Allo-HSCT) in Patients With Advanced Myelodysplastic Syndromes (MDS)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean Time to Engraftment
研究概览
简要总结
This single arm, prospective study on the feasibility of a bridging treatment with low-dose azacitidine (AZA) in combination with short term CAG derived regimen prior to allogeneic stem cell transplantation (allo-HSCT) in patients with advanced myelodysplastic syndromes (MDS) .
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
- — 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New Diagnosed advanced myelodysplastic syndrome (MDS) for whom an allogeneic hematopoietic stem cell transplant is planned
- •Recipient of an allogeneic hematopoietic stem cell transplantation
- •Age < 65 years
- •ECOG performance status ≤2
- •Written informed consent
- •No psychological, familial, social, or geographic reason that would compromise clinical follow up
排除标准
- •Relapsed or refractory advanced MDS
- •Severe pshyciatric or organic disorder, supposed to be independent from advanced MDS, that would contraindicate treatment
- •Known allergic or hypersensitivity to azacitidine, aclarubicin or cytarabine or to any of the test compounds, materials
- •Concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the subject at unacceptable risk
- •A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications
研究组 & 干预措施
AZA with CAG derived regimen
Azacitidine 50mg/m²/day, D1-D5 (IV) Aclarubicin 5mg/m²/day, D1-D4 (IV) Cytarabine 10mg/m²/12h, D1-D6 (IV) G-CSF 5-10ug/kg/day, D1-D7 (SC)
干预措施: Azacitidine (Drug)
AZA with CAG derived regimen
Azacitidine 50mg/m²/day, D1-D5 (IV) Aclarubicin 5mg/m²/day, D1-D4 (IV) Cytarabine 10mg/m²/12h, D1-D6 (IV) G-CSF 5-10ug/kg/day, D1-D7 (SC)
干预措施: CAG Protocol (Drug)
结局指标
主要结局
Mean Time to Engraftment
时间窗: Baseline to engraftment, assessed minimally 28 days post transplant
次要结局
- Cumulative Incidence of Graft-versus Host Disease(Up to 2 years)
- Incidence of systemic infections(Up to 2 years)
- Overall survival(Up to 2 years)
研究者
Ting YANG
Principal Investigator
Fujian Medical University