A Multicenter Randomized Controlled Trial of daGOAT Model-guided Prevention of Severe Acute Graft-versus-host Disease in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 438
研究概览
简要总结
This study aims to evaluate the efficacy of prophylactic ruxolitinib in adult patients at intermediate-to-high risk of severe acute GvHD, as predicted by the daGOAT model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Age > 16 years old.
- •HLA-haploidentical transplant.
- •Able to take oral medications.
- •Patients must provide written informed consent before the start of the study procedures.
排除标准
- •Patients who have undergone tandem transplantation or multiple transplantations.
- •Patients who are allergic to or cannot tolerate ruxolitinib.
- •Patients with mental or other medical conditions that make them unable to comply with the study treatment and monitoring requirements.
- •Patients who are ineligible for the study due to other factors, or who will bear great risk if they participate in the study.
研究组 & 干预措施
Control group
For patients in the control group, they will receive standard prophylaxis without additional GvHD prophylactic agents, including mesenchymal cell infusion, anti-CD25 monoclonal antibodies, and ruxolitinib outside the scope specified in the study protocol.
Intervention group
For patients in the intervention group, the daGOAT model will be used to predict the occurrence of severe acute GvHD from day 17 to day 23 after transplantation. Each subject will be stratified into low-, intermediate-, and high-risk groups, and corresponding preventive interventions were implemented according to their risk levels.
干预措施: Ruxolitinib (Drug)