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临床试验/NCT06208137
NCT06208137招募中不适用

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.

Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 456 人开始时间: 2024年2月29日最近更新:
适应症

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

入选标准

  • Patients must be ≥ 16 years of age;
  • Patients receiving haploidentical allo-HSCT;
  • Patients have to sign an informed consent form before the start of the research procedure.

排除标准

  • Tandem transplantation or multiple transplantations;
  • Mental or other medical conditions that make the patients unable to comply with the research treatment and monitoring requirements;
  • Patients who are ineligible for the study due to other factors, or will bear great risk if participating in the study.

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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