Dose Study of Antithymocyteglobulin in Haploidentical Hematopoietic Stem Cell Transplantation for Acute Graft-versus-host Disease Prophylaxis
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of acute GVHD
研究概览
简要总结
The purpose of this study is to compare the incidences of GVHD in haploidentical hematopoietic stem cell transplant recipients receiving different dose of antithymocyte globulin (ATG) for acute graft-versus-host disease(aGVHD) prophylaxis. The investigators' first objective was to investigate the optimal dose of ATG for aGVHD.
详细描述
Graft-versus-host diseases (GVHD) remains a major cause of morbility and mortality after allogeneic hematopoietic stem cell transplantation (HSCT) with grafts from an HLA-mismatched family donor. Antithymocyteglobulin (ATG) has been widely used to prevent acute GVHD (aGVHD) in haploidentical HSCT. Notwithstanding, immunosuppressive effect of ATG, which may also increase the risk of opportunistic infections, necessitates the use of the lowest possible dose. Till now, the optimal dose of ATG is not known. Here, the investigators compared the outcome of patients receiving haploidentical HSCT treated with two different doses of ATG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Haploidentical hematopoietic stem cell transplant recipient
- •Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
排除标准
- •Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
- •Patients with any conditions not suitable for the trial (investigators' decision)
研究组 & 干预措施
ATG 7.5mg/kg
ATG 7.5mg/kg group refers to treatment with ATG in the total dose of 7.5mg/kg.
干预措施: ATG (Drug)
ATG 10mg/kg
ATG 10mg/kg group refers to treatment with ATG in the total dose of 10mg/kg.
干预措施: ATG (Drug)
结局指标
主要结局
Incidence of acute GVHD
时间窗: 1 years
Acute GVHD was graded according to standard criteria.
次要结局
- Immune reconstitution(3 years)
- Survival(3 years)
研究者
Qifa Liu
Professor
Nanfang Hospital, Southern Medical University