NCT06554197招募中不适用
Evaluation of Cytomegalovirus and Epstein-Barr Virus Specific Immune Reformulation in Prophylaxis for Cytomegalovirus in Haploid Hematopoietic Stem Cell Transplantation
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- CMV-CMI
研究概览
简要总结
The purpose of this prospective, open-label, Single Arm, single-center study is to evaluate the cytomegalovirus and Epstein-Barr virus specific immune reestablishment for patients with hemopathy undergoingin prophylaxis for cytomegalovirus in haploid hematopoietic stem cell transplantation(haplo-HSCT) .
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 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients were diagnosed with hemopathy.
- •All patients should have the indication of Haploidentical hematopoietic stem cell transplant and receive the prophylaxis for cytomegalovirus.
- •All patients should sign an informed consent document indicating that they understand the purpose of and procedures required for the study and be willing to participate in the study.
排除标准
- •Patients with any conditions not suitable for the trial (investigators' decision).
结局指标
主要结局
CMV-CMI
时间窗: 6 months after transplantation
CMV specific immune reconstitution from pre-HSCT to 180 days after HSCT
EBV-CMI
时间窗: 6 months after transplantation
EBV specific immune reconstitution from pre-HSCT to 180 days after HSCT
次要结局
- Non-relapse mortality (NRM)(1 years after transplantation)
- Overall survival (OS)(1 years after transplantation)
- Cumulative incidence of CMV reactivation(1 years after transplantation)
- Cumulative incidences of EBV reactivation(1 years after transplantation)
- GVHD-free and relapse-free survival (GRFS)(1 years after transplantation)
- Cumulative incidences of aGVHD(100 days after transplantation)
- Relapse-related mortality (RRM)(1 years after transplantation)
研究者
研究点 (1)
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