A Pilot Study for Pupillary Assessment to Predict CAR-T Related Neurotoxicity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
研究概览
简要总结
To learn about the relationship between changes in pupil size and reactivity and the start of neurological side effects in patients after receiving CAR-T cell therapy.
详细描述
Primary Objective:
To assess the association between the status of NPi drop from baseline (prior to CAR T-cell infusion) to the lowest NPi post Axi-cel (CD19 CAR-T cell) infusion and the status of immune effector cell-associated neurotoxicity onset within 10 days post CD19 CAR-T cell infusion.
Secondary Objective:
To evaluate the largest absolute difference in NPi between two eyes (∆ NPi) and assess its association with severity of clinical symptoms as measured by Immune Effector Cell Encephalopathy (ICE) and or radiographic / EEG findings
Exploratory Objective:
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
- •To be considered eligible for study participation, patient will satisfy all relevant inclusion criteria and none of the
排除标准
- •Inclusion Criteria:
- •Ages Eligible for Study: 18 Years and above (Adult, Older Adult)
- •Sexes Eligible for Study: All
- •Patient with histologically proven DLBCL, PMBCL or tFL, or follicular Lymphoma receiving axi-cel CAR-T cell therapy in the inpatient setting at MD Anderson Cancer Center
- •Ability to understand and the willingness to sign a written informed consent document.
- •Exclusion Criteria:
- •Patients who have already been administered CAR-T cell therapy.
- •The patient who is unwilling or unable to comply with the requirements of the study including being able to be assessed with pupillometer
- •Patient has a condition which places him at an unacceptable risk as determined by the investigator
结局指标
主要结局
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
时间窗: Through study completion; an average of 1 year.
次要结局
未报告次要终点