ATG Used in Allogeneic Hematopoietic Stem Cell Transplantation From HLA-matched Sibling Donor as GVHD Prophylaxis
试验速览
- 阶段
- 4 期
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- the incidence of cGVHD
研究概览
简要总结
The protocols including ciclosporin A （CsA）+methotrexate (MTX) +mycophenolate Mofetil(MMF) have been widely used for graft-versus-host disease (GVHD) prophylaxis in allogeneic hematopoietic stem cell transplantation from HLA-matched sibling donor (MSD). Nevertheless, severe chronic graft-versus-host disease (cGVHD) remains an obstacle for MSD HSCT. A growing body of studies have suggested antithymocyte globulin (ATG) could reduce the incidence of cGVHD. This study is aim to evaluate the efficacy of a protocol that includes CsA, MTX, MMF and ATG in recipients of MSD HSCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient age of 18-65 years
- •MSD 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 group
ATG group refers to treatment with a protocol including low-dose ATG, CsA, short-term MTX and MMF as GVHD prophylaxis.
干预措施: ATG (Drug)
ATG group
ATG group refers to treatment with a protocol including low-dose ATG, CsA, short-term MTX and MMF as GVHD prophylaxis.
干预措施: CsA (Drug)
ATG group
ATG group refers to treatment with a protocol including low-dose ATG, CsA, short-term MTX and MMF as GVHD prophylaxis.
干预措施: MTX (Drug)
ATG group
ATG group refers to treatment with a protocol including low-dose ATG, CsA, short-term MTX and MMF as GVHD prophylaxis.
干预措施: MMF (Drug)
non-ATG group
Non-ATG group refers to treatment with a protocol including CsA, short-term MTX and MMF as GVHD prophylaxis.
干预措施: CsA (Drug)
non-ATG group
Non-ATG group refers to treatment with a protocol including CsA, short-term MTX and MMF as GVHD prophylaxis.
干预措施: MTX (Drug)
non-ATG group
Non-ATG group refers to treatment with a protocol including CsA, short-term MTX and MMF as GVHD prophylaxis.
干预措施: MMF (Drug)
结局指标
主要结局
the incidence of cGVHD
时间窗: 2 year posttransplantation
cGVHD was graded as limited or extensive.
次要结局
- disease-free survival(2 year posttransplantation)
- the incidence of aGVHD(100 days 1 year posttransplantation)
- overall survival(2 year posttransplantation)
研究者
Qifa Liu
Professor
Nanfang Hospital, Southern Medical University