Metoprolol for the Treatment of Cytokine Release Syndrome in Patients Treated With Chimeric Antigen Receptor T Cells
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety and tolerability of metoprolol in patients treated by CAR T infusions.
研究概览
简要总结
The aim of this prospective study is to evaluate the feasibility and efficacy of metoprolol, a beta-1 adrenergic receptor blocker, in the treatment of cytokine release syndrome (CRS) caused by chimeric antigen receptor T (CAR T) cell infusions, its effects on the serum levels of Interleukin-6 (IL-6) and other cytokines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with lymphoma, leukemia or other malignant diseases who were enrolled for CAR T cell therapy.
排除标准
- •Patients with contraindications indicated in metoprolol instruction, including:
- •Significant bradycardia (heart rate < 45/min)
- •Cardiogenic shock
- •Severe or acute heart failure
- •Poor peripheral circulation perfusion
- •Grade II or III atrioventricular block
- •Sick sinus syndrome
- •Severe peripheral vascular disease
研究组 & 干预措施
Conditional therapy mode group
Metoprolol (12.5-25 mg per dose, every 12 hours) was initially given from the day of CRS diagnosis confirmation post CAR T cell infusions till CRS remission in patients without bulky tumor burden. For all metoprolol-treated patients, the use of antibodies (infliximab, etanercept and tocilizumab) and/or other agents were not completely limited under the consideration of clinical requirement for sufficient control of continuously progressed CRS.
干预措施: Metoprolol (Drug)
Conditional therapy mode group
Metoprolol (12.5-25 mg per dose, every 12 hours) was initially given from the day of CRS diagnosis confirmation post CAR T cell infusions till CRS remission in patients without bulky tumor burden. For all metoprolol-treated patients, the use of antibodies (infliximab, etanercept and tocilizumab) and/or other agents were not completely limited under the consideration of clinical requirement for sufficient control of continuously progressed CRS.
干预措施: metoprolol, infliximab, etanercept, tocilizumab and/or other agents (Drug)
Prophylactic therapy mode group
Metoprolol (12.5-25 mg per dose, every 12 hours) was given starting from the day before CAR T infusion till CRS remission in patients with bulky disease. For all metoprolol-treated patients, the use of antibodies (infliximab, etanercept and tocilizumab) and/or other agents were not completely limited under the consideration of clinical requirement for sufficient control of continuously progressed CRS.
干预措施: Metoprolol (Drug)
Prophylactic therapy mode group
Metoprolol (12.5-25 mg per dose, every 12 hours) was given starting from the day before CAR T infusion till CRS remission in patients with bulky disease. For all metoprolol-treated patients, the use of antibodies (infliximab, etanercept and tocilizumab) and/or other agents were not completely limited under the consideration of clinical requirement for sufficient control of continuously progressed CRS.
干预措施: metoprolol, infliximab, etanercept, tocilizumab and/or other agents (Drug)
结局指标
主要结局
Safety and tolerability of metoprolol in patients treated by CAR T infusions.
时间窗: 2-4 weeks
Reduction of blood pressure in mmHg
次要结局
- Efficacy of metoprolol for CRS control(2-4 weeks)
- Efficacy of metoprolol for CRS precaution(2-4 weeks)
研究者
Han weidong
Principal Investigator
Chinese PLA General Hospital