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观察接受 CAR-T 治疗的淋巴瘤患者的认知和脑部变化

英文原题:Looking at Cognitive and Brain Changes in People With Lymphoma Receiving CAR-T Therapy

查看英文原题

Looking at Cognitive and Brain Changes in People With Lymphoma Receiving CAR-T Therapy

ClinicalTrials.gov 2019/09/27(首次登记) 注册临床试验(分期未标注) · 招募中

分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。

简要介绍

这是一项分期未标注的注册临床试验,评估细胞治疗用于淋巴瘤的安全性、可行性及初步疗效。当前状态:招募中。计划入组 120 例。试验地点:美国 · 纽约(共 1 个中心)。登记号:NCT04107285。

入组条件决定能不能参加

不限性别 · ≥ 18 Years

纳入标准:年龄≥18岁;计划接受商业化CD19特异性CAR-T 治疗淋巴瘤(axicabtagene ciloleucel、tisagenlecleucel、lisocabtagene maraleucel或brexucabtagene autoleucel);器官功能足以接受CAR-T 治疗,包括ECOG体能状态0-2分,并符合对应产品说明书中对心、肺、血液、肝、肾功能的要求;入组时无中枢神经系统疾病证据;经同意人员判断,英语流利且能够充分交流以完成研究评估并提供知情同意。若患者表示英语不是其主要语言,则须回答美国人口普查英语熟练度问题“How well do you speak English”,并回答“very well”。排除标准:入组时或研究期间经医生、病历或脑MRI判定存在CNS癌症体征和/或症状(如转移、软脑膜病);当前诊断为DSM-IV主要I轴精神障碍、重度抑郁症、双相障碍或精神分裂症;神经退行性疾病史,或伴意识丧失>60分钟的创伤性脑损伤史;癫痫史;目前持续物质滥用和/或物质滥用史;视力或听力损害导致无法完成评估;按放射科常规筛查指南存在MRI检查禁忌证(如铁磁性材料或植入物、起搏器或除颤器、支架、幽闭恐惧症)。
核对登记原文(英文)
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

以上为辅助阅读译文。是否适合入组须由主治医生判断,最终以登记平台与研究者确认为准。

研究终点衡量什么算有效

  • 主要终点神经认知功能变化1年。
  • 主要终点功能连接变化1年。
核对登记原文(英文)

主要终点:changes in neurocognitive functions · 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). · 1 year;changes in functional connectivity · MRIs · 1 year

研究设计怎么做的

研究类型
观察性研究
入组人数
120 人(预计)
  • CAR-T 治疗前后神经认知评估
核对分组登记原文(英文)
  • Neurocognitive evaluation prior to and following CART

关键日期

开始日期
2019-09-25
主要完成日期
2026-09
全部完成日期
2026-09
登记状态核实于
2025-10

联系与责任方公示信息

申办方
Memorial Sloan Kettering Cancer Center
联系邮箱
santomab@mskcc.org
联系电话
646-888-2092

以上邮箱 / 电话是登记库里的申办方联系方式(号码归属待核实),通常不直达某家医院。中国中心的联系方式请以医院或登记平台最新公示为准。

登记简述

本研究旨在了解接受CAR-T 治疗的淋巴瘤患者认知能力(如记忆和注意力)以及脑部结构和功能可能发生的变化。

核对登记原文(英文)

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.

登记原文与核验信息

试验登记号
NCT04107285
试验状态
招募中
试验中心(1 个)
美国 1
适应症(原文)
Lymphoma Receiving CAR-T Therapy
干预方式(原文)
neurocognitive evaluations; brain MRIs; Blood samples