A Study of Longitudinal Neurocognitive and Neuroimaging Evaluations for Adult Patients With Lymphoma Receiving CD19 CAR T Cell Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- changes in neurocognitive functions
研究概览
简要总结
The purpose of this study is to learn about possible changes in cognitive (mental) abilities, such as memory skills and concentration, and in brain anatomy (structure) and function, in people with lymphoma receiving CAR-T therapy.
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
- •Patients must be 18 years of age or older
- •Planned treatment with commercial CD19-specific CAR T cells (axicabtagene ciloleucel, tisagenlecleucel, lisocabtagene maraleucel, or brexacabtagene autoleucel) for lymphoma.
- •Patients must have adequate end organ function for CAR T cell therapy
- •Eastern Cooperative Group (ECOG) performance status of 0 to 2
- •Meet cardiac, pulmonary, hematologic, hepatic, and renal requirements for CART therapy as described in corresponding product package insert
- •No evidence of central nervous system disease at study entry
- •Fluent and able to communicate well enough in English to complete the study assessments and provide informed consent, in the judgment of the consenting professional. o Patients who report that English is not their primary language will be asked the US Census English proficiency question: "How well do you speak English," and the answer "very well" will be required
排除标准
- •Signs and/or symptoms of central nervous system cancer (e.g., metastases, leptomeningeal disease) as determined by their physician, medical records, or by a brain MRI, either at the time of enrollment or during the study period.
- •Current diagnosis of major Axis I psychiatric disorder (DSM-IV), major depression, bipolar disorder, or schizophrenia, as per medical records or patient report
- •History of neurodegenerative disease, or traumatic brain injury with loss of consciousness (>60 minutes), as per medical records or patient report
- •A history of epilepsy as per medical records or patient report
- •Current ongoing substance abuse and/or history of substance abuse, as per medical records or patient report
- •Evidence of visual or auditory impairment that would preclude completion of the assessments, as per medical records or patient report
- •Contraindications to MRI examinations as per standard screening guidelines used in the Department of Radiology (i.e., ferromagnetic material or implants, pacemakers or defibrillators, stents, claustrophobia)
结局指标
主要结局
changes in neurocognitive functions
时间窗: 1 year
correlations of neurocognitive scores with the FACIT-FS (fatigue) scale score The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Version 4 (FACITFS V-4 56, is a 13-item questionnaire designed to assess symptoms and concerns specific to the QOL of patients with fatigue \[66\]. The questionnaire asks respondents to indicate the extent to which each item applied to them over "the past 7 days" using a 5-point Likert-type response format ranging from "0 - Not at all" to "4 - Very much". The 13 items produce the Fatigue Subscale (FS) score (range 0 - 52).
changes in functional connectivity
时间窗: 1 year
MRIs
次要结局
未报告次要终点