NCT06453460招募中2 期
Prospective Evaluation of Efficacy of CMV-specific T Cell Immunity (CMV-TCIP) Directed Letermovir Prophylaxis After Allogeneic Hematopoietic Cell Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Cumulative incidence of clinically significant cytomegalovirus infection (CS-CMVi) at 52 weeks after transplant
研究概览
简要总结
This is a phase 2, prospective cohort clinical trial evaluating the utilization of CMV T Cell Immunity Panel (CMV-TCIP) assay to guide the duration of primary CMV prophylaxis in CMV-seropositive recipients of allogeneic stem cell transplant or recipients receiving a stem cell graft from a CMV serology positive donor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •≥ 18 years of age on the day of signing informed consent.
- •Karnofsky performance >70%
- •Have documented seropositivity for CMV (either donor or recipient CMV IgG seropositivity) before AHCT.
- •Eligible for AHCT from an HLA-matched related, matched unrelated, mismatched unrelated or haploidentical donor using either bone marrow or peripheral blood stem cells.
- •Have undetectable CMV DNA from a plasma sample collected within 5 days prior to enrollment.
- •Must be within Day-10 thru Day+28 days of planned HSCT at the time of enrollment.
- •Be able to comply with medical recommendations or follow-up.
- •Has adequate organ functions determined by
- •Serum creatinine clearance ≥50 ml/min (calculated with Cockroft-Gault formula).
- •Bilirubin ≤1.5 mg/dl except for Gilbert's disease.
- •ALT or AST ≤200 IU/ml for adults.
- •Conjugated (direct) bilirubin < 2x upper limit of normal.
- •Left ventricular ejection fraction ≥40%.
- •Diffusing capacity for carbon monoxide (DLCO) ≥ 50% predicted corrected for hemoglobin.
排除标准
- •Has a history of CMV end-organ disease or CS-CMVi within 6 months prior to enrollment.
- •Received within 7 days prior to screening or plans to receive during the study any of the following:
- •Ganciclovir
- •Valganciclovir
- •Acyclovir (> 3200 mg PO per day or > 25 mg/kg IV per day)
- •Valacyclovir (> 3000 mg/day)
- •Famciclovir (> 1500 mg/day)
- •Received within 30 days prior to screening or plans to receive during the study any of the following drugs: cidofovir, CMV hyper-immune globulin, any investigational CMV antiviral agent/biologic therapy.
- •Has suspected or known hypersensitivity to active or inactive ingredients of letermovir formulations.
- •Has an uncontrolled infection
- •Requires mechanical ventilation or is hemodynamically unstable
研究组 & 干预措施
AHCT recipients
Experimental
干预措施: CMV T Cell Immunity Panel (CMV-TCIP) (Device)
AHCT recipients
Experimental
干预措施: Letermovir (Drug)
AHCT recipients
Experimental
干预措施: CMV DNA PCR (Diagnostic Test)
结局指标
主要结局
Cumulative incidence of clinically significant cytomegalovirus infection (CS-CMVi) at 52 weeks after transplant
时间窗: 1 year after transplant
Number of patients who develop CS-CMVi within 52 weeks after receiving a transplant
次要结局
- Cumulative incidence of CMV disease at 52 weeks after transplant(1 year after transplant)
- Cumulative incidence of CMV related death at 52 weeks(1 year after transplant)
- Overall Survival at 1 year after transplant(1 year after transplant)
- Positive predictive value of CMV-TCIP assay after transplant in predicting CS-CMVi protection(1 year after transplant)
研究者
Piyanuch Kongtim
Associate Clinical Professor
University of California, Irvine
研究点 (2)
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