A Comparison of PTCy-ATG and ATG Strategy in Haploidentical HSCT for Acute Graft-versus-host Disease Prophylaxis
试验速览
- 阶段
- 4 期
- 入组人数
- 260
- 试验地点
- 7
- 主要终点
- CMV DNAemia
研究概览
简要总结
The granulocyte colony-stimulating factor (G-CSF)+antithymocyte globulin (ATG)-based protocols and posttransplantation cyclophosphamide (PTCy) protocols have been widely used for graft-versus-host disease (GVHD) prophylaxis in haploidentical related donor transplantation (haplo-HSCT). Nevertheless, severe acute GVHD remains an obstacle for haplo-HSCT. This study is aim to evaluate the efficacy of a modified protocol that includes PTCY and ATG in recipients of haplo-HSCT.
详细描述
Haploidentical related donor transplantation is now considered an important alternative to allogeneic hematopoietic stem cell transplantation (allo-HSCT). Currently, the strategies for graft-versus-host disease (GVHD) prophylaxis mainly include ex vivo and in vivo T-cell depletion (TCD) in haploidentical HSCT (haplo-HSCT). In vivo TCD modalities have become mainstream including granulocyte colony-stimulating factor (G-CSF)+antithymocyte globulin (ATG)-based protocols and posttransplantation cyclophosphamide (PTCy) protocols. The ATG strategy has been widely used. Nevertheless, severe acute GVHD remains an obstacle for haplo-HSCT. In addition, infections, especially viral infections, remain an important drawback of this strategy. This study is aim to evaluate the efficacy of a modified protocol that includes PTCY and ATG in recipients of haplo-HSCT.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient age of 18-65 years
- •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
PTCy-ATG group
PTCy-ATG group refers to treatment with PTCy-ATG protocol as GVHD prophylaxis at a total dose of 4.5mg/kg ATG, a dose of 50mg/kg/d cyclophosphamide (CTX), a dose of 2.5mg/kg/d Ciclosporin A （CsA）, and a dose of 1.0g/d Mycophenolate Mofetil(MMF).
干预措施: Ciclosporin A (CsA) (Drug)
PTCy-ATG group
PTCy-ATG group refers to treatment with PTCy-ATG protocol as GVHD prophylaxis at a total dose of 4.5mg/kg ATG, a dose of 50mg/kg/d cyclophosphamide (CTX), a dose of 2.5mg/kg/d Ciclosporin A （CsA）, and a dose of 1.0g/d Mycophenolate Mofetil(MMF).
干预措施: ATG (Drug)
PTCy-ATG group
PTCy-ATG group refers to treatment with PTCy-ATG protocol as GVHD prophylaxis at a total dose of 4.5mg/kg ATG, a dose of 50mg/kg/d cyclophosphamide (CTX), a dose of 2.5mg/kg/d Ciclosporin A （CsA）, and a dose of 1.0g/d Mycophenolate Mofetil(MMF).
干预措施: CTX (Drug)
PTCy-ATG group
PTCy-ATG group refers to treatment with PTCy-ATG protocol as GVHD prophylaxis at a total dose of 4.5mg/kg ATG, a dose of 50mg/kg/d cyclophosphamide (CTX), a dose of 2.5mg/kg/d Ciclosporin A （CsA）, and a dose of 1.0g/d Mycophenolate Mofetil(MMF).
干预措施: Mycophenolate Mofetil (Drug)
ATG group
ATG group refers to treatment with ATG protocol as GVHD prophylaxis at a total dose of 7.5mg/kg ATG, a dose of 2.5mg/kg/d Ciclosporin A （CsA）, a dose of 1.0g/d Mycophenolate Mofetil(MMF) and methotrexate (MTX, on days +1, +3 and +6).
干预措施: ATG (Drug)
ATG group
ATG group refers to treatment with ATG protocol as GVHD prophylaxis at a total dose of 7.5mg/kg ATG, a dose of 2.5mg/kg/d Ciclosporin A （CsA）, a dose of 1.0g/d Mycophenolate Mofetil(MMF) and methotrexate (MTX, on days +1, +3 and +6).
干预措施: Mycophenolate Mofetil (Drug)
ATG group
ATG group refers to treatment with ATG protocol as GVHD prophylaxis at a total dose of 7.5mg/kg ATG, a dose of 2.5mg/kg/d Ciclosporin A （CsA）, a dose of 1.0g/d Mycophenolate Mofetil(MMF) and methotrexate (MTX, on days +1, +3 and +6).
干预措施: Ciclosporin A (CsA) (Drug)
ATG group
ATG group refers to treatment with ATG protocol as GVHD prophylaxis at a total dose of 7.5mg/kg ATG, a dose of 2.5mg/kg/d Ciclosporin A （CsA）, a dose of 1.0g/d Mycophenolate Mofetil(MMF) and methotrexate (MTX, on days +1, +3 and +6).
干预措施: methotrexate (MTX) (Drug)
结局指标
主要结局
CMV DNAemia
时间窗: 1 year posttransplantation
CMV DNAemia was defined as positive CMV-DNA in the blood when the copies exceeded 500 copies/ml.
次要结局
- aGVHD(100 days 1 year posttransplantation)
- EBV DNAemia(1 year posttransplantation)
- Leukemia relapse(2 year posttransplantation)
- OS(2 year posttransplantation)
- DFS(2 year posttransplantation)
- cGVHD(2 year posttransplantation)
研究者
Qifa Liu
Professor
Nanfang Hospital, Southern Medical University