Letermovir (LMV) Prophylaxis in CMV-seronegative Allogeneic Stem Cell Transplant Recipients With CMV Seropositive Donors: an Exploratory Study From Spanish GETH/TC Centers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- CMV DNAemia requiring preemptive treatment or CMV disease
研究概览
简要总结
This is an observational cohort study. Two cohort will be enrolled:
LMV cohort: All patients included in in this study will receive LMV according to standard of care.
Historical cohort: an historical cohort will be included to compare the results of both groups (LMV vs historical cohort).
详细描述
All patients will receive treatment wtith LMV according to standard of care.
Eligible patients will be enrolled in the study under the supervision of the investigator or designated sub-investigators. If possible, patients will receive treatment on an outpatient basis except for the hospitalization requirement established in the protocol.
Patients will receive oral or intravenous LMV (if available) at a dose of 480 mg/day. For patients receiving concomitant treatment with cyclosporine, the dose of LMV will be 240 mg/day. According to the standard of care, LMV will be administered daily until week 14 post-transplant for up to 8 weeks (~day 100) starting on day +1.
Patients could be discontinued earlier if, disease progression, patient withdrawal, loss to follow-up, end of study, or death.
After completion of the treatment period, an end-of-treatment visit will occur within 30 days of receipt of the last dose of study drug.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Age ≥18 years
- •First allogenic HCT
- •Pre-HCT patient CMV negative IgG serology with CMV IgG positive donor serostatus
- •Able to provide written consent and complete the informed consent
- •Absence of CMV DNAemia requiring antiviral therapy within 5 days before initiation of LMV. Low levels CMVDNAemia before the inception of letermovir are allowed
- •Exclusion Criteria
- •Active pre-emptive therapy for csCMV-I.
- •Patients who have received LMV prophylaxis prior to enrollment
- •Patients enrolled in a CMV pre-emptive therapy clinical trial
- •Glomerular filtration rate (GFR) </=30 mL/min/1.73m^2 (equivalent to creatinine clearance </=10 mL/min)
- •Severe hepatic function grade 3-4 CTAE at the time of study entry.
- •Suspected or known hypersensitivity to active or inactive ingredients of LMV formulations
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to letermovir.
- •Pregnancy or breastfeeding
- •Plans to conceive or father children within the projected duration of the trial
- •History of current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or would place the subject at undue risk as judged by the investigator, such that it is not in the best interest of the subject to participate in this study
排除标准
- 未提供
结局指标
主要结局
CMV DNAemia requiring preemptive treatment or CMV disease
时间窗: Week 14 post-SCT
To determinate the incidence of csCMV infection through week 14 post-SCT.
次要结局
- Incidence of CMV DNAemia requiring PET within 100-180 days after HCT(From day 100 to day 180 after HCT)
- Neutrophile (>0,5x10e9/L) and platelets engraftment (>20 x10e9/L) by day +40 post-SCT.(Day +40 post-SCT)
- Death by any cause and death not related with disease relapse or progression(Week 14 post-SCT)
- Death by any cause non related to relapse(Week 24 post-SCT)
- Duration of any CMV-antiviral treatment by day 180 post-SCT(day 180 post-SCT)
- Time to onset of all-cause failure of prophylaxis against CMV infection during the 8 weeks of study-drug administration period (day +100 post-transplant)(Up to 8 weeks of study-drug administration period (day +100 post-transplant))
- Incidence of non-CMV infections within 180 days after HCT and its onset and severity(180 days post-SCT)
- Neutrophile (>0,5x10e9/L) and platelets engraftment (>20 x10e9/L) by day +100 post-SCT.(Day +100 post-SCT)
- Incidence of blips, clinical and analytic characteristics.(180 days post-SCT)
- Incidence of untreated CMV DNAemia(180 days post-SCT)
- Incidence of relapse within 180 days after HCT and its onset and severity(180 days post-SCT)
- Adverse events according to the CTCAE, physical examination and regular laboratory tests(180 days post-SCT)
- Incidence of aGVHD within 120 days after HCT and its onset and severity(120 days post-SCT)