CMV-specific T Cell Immunity Test Indicated Prophylaxis of Letermovir After Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
- 试验地点
- 5
- 主要终点
- Incidence of late-onset clinical significant CMV (cs-CMV) infection
研究概览
简要总结
To evaluate the efficacy of CMV-specific T cell immunity test in prolonged usage of letermovir for avoiding late-onset csCMVi after all-HSCT.
详细描述
Reactivation of cytomegalovirus (CMV) leads to significant morbidity and mortality following allogeneic hematopoietic stem cell transplantation (allo-HSCT). Letermovir (LTV) has substantially reduced the risk of clinically significant CMV infection (csCMVi) in CMV seropositive recipients of allo-HSCT. LTV discontinuation after day 100 (d100) has been reported to increase the risk of late-onset csCMVi, causing by impaired reconstitution of CMV-specific T immunity. The investigator sought to decrease the probability of CS-CMVi after letermovir withdrawal. Restoration of CMV-specific T cells is imperative for effective control of CMV reactivation following allo-HSCT. Letermovir has been found impending recovery of CMV-specific T immunity. The investigators' retrospective study has proved that lower CMV-specific CD4+ T cells (<2.01 cells/µL) at week 8 increased the risk of late-onset CMV reactivation (50.0%) compared to the higher ones (7.69%, p=0.04) in letermovir prophylaxis. Thus, the guidance of CMV-specific cell immunity is recommended in letermovir prophylaxis.
Therefore, the investigator conduct a multicenter, randomized, controlled study based on retrospective research to further explore and validate the efficacy of CMV-specific T cell immunity test guiding the prolonged usage of letermovir.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first allogeneic hematopoietic stem cell transplantation;
- •18-70 years old;
- •use cytomegalovirus prophylaxis with letemovir after allo-HSCT;
- •CMV Ig G D+/R+;
排除标准
- •Allergy, known hypersensitivity to letermovir tablet or injection components;
- •CMV DNAemia within six months before transplantation or previous CMV disease;
- •Presence of organ failure and inability to tolerate allogeneic hematopoietic stem cell transplantation;
- •Second transplantation;
- •Combination of immunodeficiency diseases;
- •Those judged by the investigator to be unsuitable for participation in this trial.
研究组 & 干预措施
CMI-F
Letemovir prophylaxis stops when CMV-FlowSpot >1.5.
干预措施: Letermovir (Drug)
CMI-N
Letemovir prophylaxis stopos in the first 100 days after allo-HSCT.
干预措施: Letermovir (Drug)
结局指标
主要结局
Incidence of late-onset clinical significant CMV (cs-CMV) infection
时间窗: through study completion, an average of 1 year
Incidence of late-onset clinical significant CMV (cs-CMV) infection
次要结局
- cumulative incidence of cs-CMV infection(through study completion, an average of 1 year)
- overall survival(through study completion, an average of 1 year)
研究者
Hu Xiaoxia
Principal Investigator
Ruijin Hospital