NCT04300998招募中不适用
Observational Study of Commercial Chimeric Antigen Receptor T-cell (CAR T) Therapy in Older Patients With Hematologic Malignancies and With an Embedded Pilot Study of Longitudinal Geriatric and Neurocognitive Evaluation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Number of participants who complete all required assessment visits prior to disease progression or death
研究概览
简要总结
This study is being done to find out how older patients respond to CAR-T cell therapy and how the treatment affects their quality of life. This is a quality of life study and participating in the study does not involve receiving any treatment, other than the standard treatment for participants' disease.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are ≥60 years old (all cohorts)
- •have pathologically confirmed, relapsed refractory lymphoid malignancy or plasma cell disorder receiving a commercial CAR T-cell product (all cohorts)
- •able to speak and understand English (cohort 1 and 4 only)
- •have a MoCA score of less than 26 out of 30 during the GA visit by a geriatrician prior to CAR T-cell treatment (cohort 4 only)
排除标准
- •Any prior commercial or investigational CAR T therapy (all cohorts)
- •Current diagnosis of major Axis I psychiatric disorder (DSM-IV), major depression, bipolar disorder, or schizophrenia, as per medical records or patient report (cohort 1 only)
- •History of a neurological disorder, neurodegenerative disease, or traumatic brain injury with loss of consciousness (>60 minutes), as per medical records or patient report (cohort 1 only)
- •Current ongoing substance abuse and/or history of substance abuse, as per medical records or patient report (cohort 1 only)
- •History of CNS disease (cohort 4 only)
结局指标
主要结局
Number of participants who complete all required assessment visits prior to disease progression or death
时间窗: 1 year
Participants who complete all assessment visits prior to disease progression or death will be considered as a success for a feasibility endpoint.
次要结局
未报告次要终点
研究者
研究点 (1)
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