Kinectics of Donor-specific Anti-HLA Antibody After HLA-incompatible Allogeneic Haematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 314
- 试验地点
- 1
- 主要终点
- Positive rates of post-transplantation donor-specific anti-HLA antibody (DSA).
研究概览
简要总结
Donor specific anti-HLA antibody (DSA) is closely related not only to primary graft rejection (GR) after HLA-incompatible transplantation, but also to the occurrence of primary PGF. Desensitisation therapy can reduce the level of DSA in patients and decrease the incidence of PGF after transplantation. However, most studies at home and abroad have focused on DSA levels in recipients before transplantation, risk factors and their effects on prognosis. Very few studies have focused on the rate of DSA positivity and its risk factors after transplantation. Therefore, this project aims to clarify the rate of DSA positivity after HLA-incompatible Allo-HSCT and reveal the influencing factors of post-transplantation DSA positivity with the help of a prospective, registry-based clinical cohort of HLA-incompatible transplant recipients, in order to provide a basis for the prevention and treatment of DSA-induced graft rejection or PGF.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis haematological disorders undergoing HLA-incompatible allogeneic haematopoietic stem cell transplantation Between 15 and 60 years-old Must sign the informed consent
排除标准
- •Withdraw of the signed informed consent for any reason Lack of ability to provide consent due to psychiatric or physical illness
结局指标
主要结局
Positive rates of post-transplantation donor-specific anti-HLA antibody (DSA).
时间窗: through study completion, an average of 2 years
HLA-A, -B, -C, -DRB1, -DQB1, and -DPB1 alleles were determined according to the literatures published by our group \[Huo MR, et al. Bone Marrow Transplant. 2018;53(5):600-608\].
次要结局
- Acute graft-versus-host disease (aGVHD)(2 years)
- Chronic graft-versus-host disease (cGVHD)(2 years)
- Platelet engraftment(2 years)
- Primary graft failure(2 years)
- Non-relaspe mortality (NRM)(2 years)
- Cumulative incidence of relapse(2 years)
- Overall survival (OS)(2 years)
- Neutrophil engraftment(2 years)
- Secondary graft-failurefunction(2 years)
- Disease-free survival (LFS)(2 years)
研究者
Chang Yingjun
Professor and Chief Physician
Peking University