Using the Composite Immune Risk Score to Assess and Modulate the Patient's Immune Reconstitution After Allogeneic Hematopoietic Stem Cell Transplantation, a Prospective, Multicenter, Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 456
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
To assess the effectiveness of interventions including health monitoring and regular return follow-up reminders for patients with a high Composite Immune Risk Score.
详细描述
This study aims to prospectively evaluate the effectiveness of the Composite Immune Risk Score in real-world clinical setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) Patients must be ≥ 16 years of age;
- •2) Patients receiving haploidentical allo-HSCT;
- •3) Patients have to sign an informed consent form before the start of the research procedure.
排除标准
- •1) Tandem transplantation or multiple transplantations;
- •2) Mental or other medical conditions that make the patients unable to comply with the research treatment and monitoring requirements;
- •3) Patients who are ineligible for the study due to other factors, or will bear great risk if participating in the study.
研究组 & 干预措施
Intervention group
Remind patients to test their immune status among 120-180 days post-transplantation. Physicians assessed the risk level of patients in the intervention group based on their immune status on days 91-180 using the CIRS.
干预措施: Health monitoring and regular return follow-up reminders (Behavioral)
Control group
Only remind patients to test their immune status among 120-180 days post-transplantation.
结局指标
主要结局
Survival
时间窗: 1.5 years after transplantation
Overall survival during 1.5 years after transplantation
次要结局
- Non-relapse mortality rate(1.5 years after transplantation)
- Incidence of infections(1.5 years after transplantation)
- Immune cell count(1.5 years after transplantation)