Letermovir Prophylaxis for CMV in Patients With Graft-versus-host Disease After Allogeneic Hematopoietic Cell Transplantation: a Proof of Concept Multicenter Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 42
- 主要终点
- Incidence of CMV infection
研究概览
简要总结
Explore the tolerability and efficacy of letermovir in the prevention of CMV reactivation in patients with acute and chronic graft-versus-host disease (GVHD) beyond day 100.
详细描述
42 patients meeting the inclusion criteria will receive letermovir 480 mg per day. Patients receiving concomitant cyclosporine will receive 240 mg of letermovir. Letermovir will be given during 14 weeks or until prednisone dose is reduced below 0.2 mg / kg / day, whichever comes earlier.
All the patients will continue herpesvirus prophylaxis with acyclovir or valacyclovir.
Patients will be evaluated biweekly until letermovir discontinuation. A PCR CMV test will be performed biweekly. Patients in whom clinically significant CMV infection (defined as CMV disease or CMV viremia leading to preemptive treatment) develop, will discontinue the trial regimen and begin anti-CMV therapy according to local practice. The threshold for preemptive treatment for CMV viremia will be >1000 copies/ ml.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients
- •After allogeneic transplantation
- •Seropositive for CMV
- •Who already received letermovir prophylaxis until day 100 without CMV reactivation
- •Beyond day 100 after transplantation at enrollment
- •With acute or chronic GVHD
- •Daily prednisone dose ≥ 0.5 mg/kg (or equivalent dose of another glucocorticoid) at enrollment.
- •Negative polymerase chain reaction (PCR) for CMV at enrollment
- •Provided informed consent
排除标准
- •Seronegative for CMV
- •Positive PCR for CMV at enrollment
- •Patient has previously had CMV reactivation under letermovir.
研究组 & 干预措施
Letermovir
Patients meeting the inclusion criteria will receive letermovir 480 mg per day. Patients receiving concomitant cyclosporine will receive 240 mg of letermovir. Letermovir will be given during 14 weeks or until prednisone dose is reduced below 0.2 mg / kg / day, whichever comes earlier.
干预措施: Letermovir (Drug)
结局指标
主要结局
Incidence of CMV infection
时间窗: 14 weeks
The proportion of patients with clinically significant CMV infection through week 14 after enrollment or until prednisone dose is reduced below 0.2 mg / kg / day, whichever comes earlier.
次要结局
未报告次要终点