Immune Reconstitution to Cytomegalovirus After Allogeneic Hematopoietic Stem Cell Transplantation: Impact of Clinical Factors and Therapy Strategies
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Numbers of immune cells in peripheral blood
研究概览
简要总结
Cytomegalovirus (CMV) remains a significant cause of morbidity and mortality after hematopoietic stem cell transplantation (HSCT). The course and outcome of CMV infection are different clinically, and the mechanism of CMV infection after transplantation has not been clarified. Reconstitution of cellular immunity after HSCT is a critical determinant of the control of CMV infection.
Investigators will dynamically monitor the CMV-specific cellular immune reconstitution after HSCT，and analyze the clinical factors and therapy strategies affecting recovery of CMV-specific immunity during 1 year after HSCT.
详细描述
Cytomegalovirus (CMV) remains a significant cause of morbidity and mortality after hematopoietic stem cell transplantation (HSCT). The course and outcome of CMV infection are different clinically, and the mechanism of CMV infection after transplantation has not been clarified. Reconstitution of cellular immunity after HSCT is a critical determinant of the control of CMV infection.
Investigators will collect peripheral blood at 1 month, 2 month, 3 month, and 6 month after HSCT from the participated patients, and dynamically monitor the CMV-specific T and NK cellular immune reconstitution.
Investigators will also analyze the clinical factors and therapy strategies affecting recovery of CMV-specific immunity during 1 year after HSCT.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be receiving a first allogeneic HSCT.
- •Is male or female, from 14 years to any years of age inclusive.
- •The participant (or legally acceptable representative) agree for cellular immune investigation and has provided documented informed consent/assent for the study.
排除标准
- •Received a previous allogeneic HSCT (Note: Receipt of a previous autologous HSCT is acceptable).
- •Has a history of CMV end-organ disease within 6 months prior to allocation.
- •Has severe organ (hepatic , renal, cardical) insufficiency within 5 days prior to allocation.
- •Any rapidly-progressing disease or immediately life-threatening illness.
研究组 & 干预措施
Letermovir Group
HSCT recipients who received letermovir prophylaxis
干预措施: Letermovir (Drug)
结局指标
主要结局
Numbers of immune cells in peripheral blood
时间窗: 6 months after HSCT
PBMCs from HSCT recipients were collected at 1 month, 2 month, 3 month, and 6 month after HSCT, and tested for NK cells, T cells, CMV-specific T cells and their subsets.
Incidence of clinically significant CMV infection (CSI)
时间窗: 6 months after HSCT
Clinically significant CMV infection (CSI) is defined as the administration of antiviral therapy as preemptive therapy for CMV DNAemia or treatment for CMV disease.
Incidence of refractory CMV infection and CMV disease
时间窗: 6 months after HSCT
Refractory CMV infection is defined as a persistent viral load (CMV viral load at the same level or higher than the peak viral load within 1 week but \<1 log10 increase in CMV DNA titers done in the same laboratory and with the same assay) after at least 2 weeks of appropriately dosed antiviral therapy.
次要结局
- Treatment-ralated mortality(Through study completion, an average of 1 year)
- Overall survival(Through study completion, an average of 1 year)
- Incidence of other viral infection and viral-associated disease(6 months after HSCT)
研究者
Xiao-Jun Huang
Chairman of the department
Peking University People's Hospital