Cardiovascular Effects of Chimeric Antigen Receptor T-Cell (CART Cell) Therapy: An Observational Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Incidence of Left Ventricular (LV) Dysfunction
研究概览
简要总结
This is an observational study aiming to prospectively define the rate of occurrence, natural history and progression of cardiac dysfunction in adults, and to identify the patients at high risk of developing cardiovascular events. The study enrolls patients prior to infusion with CART cell therapy and follows them with serial echocardiography, cardiac biomarkers, clinical data, and quality of life questionnaire.
详细描述
Patients have echo, blood draw, and QoL survey prior to CART infusion, then 2 days, 1 week, 1 month and 6 months following CART infusion. If patients experiences CRS, study team acquires echo within 72 hours of onset. As part of an optional substudy, patients wear an event monitor for 10 days, starting day of CART infusion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •At least 18 years of age
- •Diagnosed with CD19+ malignancy undergoing treatment with CART cells
排除标准
- •Unable to provide informed consent
结局指标
主要结局
Incidence of Left Ventricular (LV) Dysfunction
时间窗: 6 months
LV dysfunction, defined as a decrease in LV ejection fraction of at least 10% to less than or equal to 53%
次要结局
- Incidence of Cardiovascular Events(6 months)