Donor Neutrophil Subsets to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Association between donor neutrophil subsets and acute graft-vs.-host disease (aGVHD) outcomes.
研究概览
简要总结
This is a prospective study to explore the association between donor neutrophil subsets and acute graft-vs.-host disease outcomes. Approximately 260 subjects (including 130 donors and 130 corresponding recipients) will be recruited.
详细描述
This study was a single-center, observational, prospective cohort study. The study lasted for 3 months, from 2023.12 to 2024.3, the clinical enrollment was completed, and from 2024.3 to 2024.6, the follow-up was completed. It is planned to enroll 260 subjects, divided into 130 donors and 130 patients.
No randomization or any protocol-driven treatment will be performed or provided to subjects during the course of the study. Treatment decisions and selection of treatment options are left to the discretion of the treating physician, if clinically appropriate.
All recipients will be followed for aGVHD evaluation, relapse, cGVHD, leukemia relapse, disease-free survival (DFS), non-relapse mortality (NRM). aGVHD and cGVHD were graded according to published guidelines. All recipients will be monitored every month until the study is completed.
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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign the informed consent form;
- •Age 16-65 years old
- •Donors whose HLA-matched or HLA-mismatched to the corresponding recipients
- •Voluntarily sign the informed consent form
- •Age 16-65 years old
- •Willing to undergo HLA-matched or HLA-mismatched allo-HSCT
排除标准
- •Have a history of other tumors
- •With poor compliance or mental disorders
- •Infected with HIV and HCV
- •With uncontrolled HBV infection
- •With other autoimmune diseases
- •Those who are judged by the researcher to be unsuitable to participate in this study
- •Have a history of other tumors
- •With poor compliance or mental disorders
- •Infected with HIV and HCV
- •With uncontrolled HBV infection
- •With other autoimmune diseases
- •Those who are judged by the researcher to be unsuitable to participate in this study
结局指标
主要结局
Association between donor neutrophil subsets and acute graft-vs.-host disease (aGVHD) outcomes.
时间窗: 100days
次要结局
- Association between donor neutrophil subsets and leukemia relapse(6 months)
- Association between donor neutrophil subsets and non-relapse mortality (NRM)(6 months)
- Association between donor neutrophil subsets and disease-free survival (DFS)(6 months)
- Association between donor neutrophil subsets and chronic GVHD (cGVHD)(6 months)