The Use of Cytomegalovirus Cell Mediated Immunity to Optimize the Duration of Letermovir Prophylaxis in Hematopoietic Cell Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Safety and Adverse Events (AEs).
研究概览
简要总结
The goal of this laboratory research study is to learn if interrupting a patient's letermovir dosing based on their immune system response can help HSC transplant patients avoid post-treatment CMV infections better than taking letermovir every day without interruption.
详细描述
Primary Objective
•To compare the proportion of CS-CMVi in allo-HCT recipients who had interrupted letermovir prophylaxis based on CMV CMI or extended duration of letermovir prophylaxis up to 200 days post transplantation.
Secondary Objectives
- To compare the proportion of CS-CMVi in HCT recipients who had interrupted letermovir prophylaxis based on CMV CMI or extended duration of letermovir prophylaxis at 365 days post transplantation.
- To compare the overall use of letermovir in HCT recipients in both arms.
- To compare CMV CMI in HCT recipients in both arms.
- To compare all-cause mortality and nonrelapse mortality between the 2 arms at day +200 and day +365.
- Healthcare expenditures for letermovir use and TCIP for both arms from day +100 to day +200.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Allogeneic HCT recipients with positive CMV serostatus
- •On letermovir prophylaxis at day 90 post transplant (+/- 7 days)
- •At high risk for CMV reactivation after day +100:
- •Prior or active graft versus host disease requiring systemic steroids
- •Mismatch stem cell donor (includes haploidentical, mismatch unrelated donor (MMUD), match related donor with at least one mismatch at one of the three specified HLA gene loci (HLA-A, HLA-B, or HLA-DR) and cord donor recipients)
- •Received T cell depletion or anti thymoglobulin during conditioning
- •CMV reactivation prior to day 100 post transplant
- •On steroids at any dose within 2 weeks of enrollment
排除标准
- •Patients under the age of 18
- •Patients are discharged from our institution and unwilling to come back for follow up
- •Patients are actively undergoing treatment for CS-CMVi at time of screening. Prior CS-CMVi is not an exclusion from study.
- •Patients are allergic or intolerant to letermovir or have history of letermovir resistant CMV infection.
- •Not able to procure letermovir for extended prophylaxis beyond day +100.
研究组 & 干预措施
Interrupted letermovir prophylaxis
Participants assigned to the investigational group, you will also receive letermovir at first, but depending on the result of the study blood tests, your dose may be paused as long as your immune system shows an immune response against CMV.
干预措施: Letermovir (Drug)
Interrupted letermovir prophylaxis
Participants assigned to the investigational group, you will also receive letermovir at first, but depending on the result of the study blood tests, your dose may be paused as long as your immune system shows an immune response against CMV.
干预措施: Hematopoietic Cell Transplant (Procedure)
Standard letermovir prophylaxis
Participants assigned to the standard care group, you will receive treatment with letermovir every day to prevent CMV infection.
干预措施: Hematopoietic Cell Transplant (Procedure)
Standard letermovir prophylaxis
Participants assigned to the standard care group, you will receive treatment with letermovir every day to prevent CMV infection.
干预措施: Letermovir (Drug)
结局指标
主要结局
Safety and Adverse Events (AEs).
时间窗: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点