Chimeric Antigen Receptor (CAR) Cell Therapy Related Cardiovascular Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Detected abnormalities - Composite
研究概览
简要总结
This will be a cohort study of all patients receiving Cluster of Differentiation 19 (CD19)-specific CAR T cell therapy for relapsed/refractory B cell haematological malignancies. Patients will receive cardiac assessment and have serum cardiac biomarkers, ECG, transthoracic echocardiogram and cardiac magnetic resonance imaging performed at baseline prior to CAR T cell therapy, 7 days post CAR T cell infusion, and 3 months post CAR T cell infusion. Abnormalities in these cardiac investigations will be used to demonstrate cardiac injury and identify which patients are most at risk of developing cardiac injury related to CAR T cell therapy.
详细描述
CD19-specific chimeric antigen receptor (CAR) T cells are a novel therapy for relapsing or refractory blood cancers, which have delivered a significant improvement in the rates of complete and partial remission. However, they are associated with toxicities, with some of early evidence suggestive of cardiovascular involvement. Despite this, the full extent of cardiovascular toxicity is poorly understood.
This research study seeks to understand the cardiac safety of CAR T cells in patients who receive this therapy as part of standard care for relapsed/refractory B-cell blood cancer. They will be assessed for cardiovascular risk factors via history, blood biomarkers, and cardiac imaging tests. These parameters will be repeated at 7 days following administration of the CAR T cells or if there are signs of cardiovascular deterioration, and again at 3 months follow up.
The aim is to predict the cohort most at risk of cardiovascular toxicity, and demonstrate evidence of cardiac injury on the cardiac imaging scans.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with capacity, (aged 16 and older)
- •Undergoing CAR T cells for treatment for relapsing or refractory haematological malignancies
排除标准
- •Patients under 16 years
结局指标
主要结局
Detected abnormalities - Composite
时间窗: 3 months
The primary outcome is a composite of detected abnormalities on biomarkers, transthoracic echocardiogram (TTE), or Cardiac magnetic resonance (CMR) following CAR T cell infusion.
次要结局
- Detected abnormalities - Individual(3 months)
研究者
Derek Yellon
Professor
University College London Hospitals