Open Label Single Arm Pilot Trial of Letermovir for Cytomegalovirus Prophylaxis After Axicabtagene Ciloleucel Therapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Safety and Adverse Events (AEs)
研究概览
简要总结
The goal of this clinical research study is to learn if a drug called Letermovir can help to prevent CMV reactivation.
详细描述
Primary Objective:
Estimate the probabilities at days d = +28 and +98 following CAR T cell infusion, among patients alive at the day of evaluation, of CMV reactivation in CMV seropositive patients receiving letermovir for CMV prophylaxis after standard of care (SOC) axicabtagene ciloleucel (AXI-CEL) therapy, using the cutoff CMV DNA qPCR > c for c = 400 and 1000 IU/mL to define CMV reactivation, for a total of four (d, c) combinations.
Secondary Objectives:
Estimate overall survival probabilities at days+28, +98, and +364 following CAR T cell infusion of CMV seropositive patients receiving letermovir for CMV prophylaxis after SOC AXI-CEL therapy.
Describe the tolerability of letermovir during the period of CMV prophylaxis after SOC AXI-CEL therapy in CMV seropositive patients at high risk for CMV reactivation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years of age.
- •Have an ECOG performance status of 0 or
- •The participant must be scheduled for SOC AXI-CEL.
- •The participant must be seropositive for CMV (defined as having anti-CMV IgG antibodies)
- •Creatinine clearance > 10 mL/min
- •Child Pugh class A or B if liver disease is present.
- •Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately.
- •Participant must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
排除标准
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection not responding to treatment, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Female participants who are pregnant or breastfeeding.
- •Unwilling or unable to follow protocol requirements.
- •Planned to receive any other anti-CMV therapy such as high dose acyclovir (500 mg/m2/dose intravenously every 8 hours or 800 mg orally 4 times a day) or high dose valacyclovir (2 grams three to four times daily or 2 grams three times daily) for the prophylaxis of CMV reactivation. Acyclovir or valacyclovir at lower doses for the prevention of HSV and VZV are allowed.
- •Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug.
- •Evidence for CMV infection defined as any positive CMV DNA qPCR test within 1 week prior to starting letermovir.
- •Child Pugh class C liver disease.
研究组 & 干预措施
Open label Single arm: Letermovir
Participants will be identified/recruited/screened from the Lymphoma and Stem Cell Transplantation and Cellular Therapy services at MD Anderson Cancer Center.
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