NCT05416554撤回不适用
Long-term Cognitive, Neuropsychiatric and Functional Outcomes in Adults Who Have Received Chimeric Antigen-Receptor T-Cell (CAR-T) Therapy for Aggressive Lymphoma at Stanford - A Pilot Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of patients who complete telehealth neuropsychological testing in the post-CAR-T adult
研究概览
简要总结
This study aims to assess the feasibility of performing neuropsychological testing to measure the cognitive performance of individuals following Axicabtagene ciloleucel CAR-T therapy at Stanford.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •>/= 18 years-old
- •Treated with Axicabtagene ciloleucel CAR-T therapy at Stanford Or
- •Treated with standard commercial Axicabtagene ciloleucel CAR-T therapy elsewhere and followed primarily by SHC Blood and Bone Marrow transplant providers
- •>/= 6 months from the date of CAR-T infusion
- •Fluent in English
- •Able to attend and participate in in-person testing (Arm I)
- •Able to participate in remote video testing with adequate workspace, computer and internet capabilities for a reliable telehealth video connection (Arm II)
排除标准
- •Concurrent enrollment in a CAR-T therapeutics research study
- •Unable to be present for the scheduled testing
- •Unable to participate in testing due to severe cognitive or physical limitation
- •Actively receiving chemotherapy
- •Progressive cancer
研究组 & 干预措施
Neuropsychological testing
Other
Participants will take neuropsychological testing in-person or via telehealth video
干预措施: Neuropsychological testing (Behavioral)
结局指标
主要结局
Number of patients who complete telehealth neuropsychological testing in the post-CAR-T adult
时间窗: 6 months
Number of patients who complete neuropsychological testing in the post-CAR-T adult population
时间窗: 6 months
次要结局
- Trails A and B (Oral Trails)(Baseline)
- Wechsler Test of Adult Reading WTAR Neuropsychological testing(Baseline)
- Patient Health Questionnaire PHQ9(Baseline)
- Hopkins Verbal Learning Test HVLT(Baseline)
- Controlled Oral Work Association Test COWAT(Baseline)
- Digit Span(Baseline)
- Clock Drawing Test(Baseline)
- Short form of Quality of Life SF-36(Baseline)
- General Anxiety Disorder Assessment GAD-7(Baseline)
研究者
研究点 (2)
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