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接受 CAR-T 治疗的复发/难治性血液肿瘤儿童和青年神经毒性后的认知影响

英文原题:Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed/Refractory Hematologic Malignancies Who Receive CAR T-cell Therapy

查看英文原题

Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed/Refractory Hematologic Malignancies Who Receive CAR T-cell Therapy

ClinicalTrials.gov 2022/02/14(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

这是一项观察性研究,观察细胞治疗用于淋巴瘤、白血病的真实世界诊疗与结局。当前状态:招募中。计划入组 60 例。试验地点:美国 · 洛杉矶、贝塞斯达、西雅图(共 3 个中心)。登记号:NCT05237986。

入组条件决定能不能参加

不限性别 · ≥ 5 Years · 接受健康志愿者

疾病患者纳入标准:确诊复发/难治性白血病或淋巴瘤,并计划在入组中心接受CAR-T 治疗;若参加CAR-T 治疗方案,须允许为本研究目的共享数据;年龄5–35岁;有符合条件且愿意完成受试者评估的照护者/知情人;受试者(未满18岁者,或必要时≥18岁者)须有合格照护者协助设置远程评估环境;能够说和理解英语或西班牙语;可使用带摄像头和网络的电脑或平板;参与者或父母/监护人能够理解并愿意签署书面同意。

照护者(知情人)纳入标准:能够说和阅读英语或西班牙语;是上述疾病患者的照护者;年龄≥18岁;能够使用电脑或平板;愿意协助儿童患者(<18岁,或必要时>18岁者)设置远程评估环境;能够理解并愿意签署书面同意。

排除标准:疾病患者存在既往普遍性智力障碍(如唐氏综合征)。
核对登记原文(英文)
* INCLUSION CRITERIA:
* Participants with disease

  * Participants are diagnosed with relapsed/refractory leukemias or lymphomas, and are scheduled to receive CAR T-cell treatment in one of the enrolling sites
  * For participants enrolled on a CAR T-cell treatment protocol, data sharing for the purposes of this study must be allowed.
  * Age \>= 5 and \<=35 years old
  * Participant must have an eligible caregiver (informant) who is willing to complete assessments about the participant of this study
  * Participants (\<18 years, or \>=18 years if needed) must have an eligible caregiver to assist with setting up an appropriate test environment for the remote evaluations
  * Participant must be able to speak and understand English or Spanish
  * Participants must have access to a computer or tablet with a camera and an internet connection
  * Participant or parent/guardian must be able to understand and willing to sign a written consent document
* Caregivers (informants)

  * Participants must be able to speak and read in English or Spanish
  * Participants who are caregivers for participants with disease addressed above
  * Age \>= 18 years old
  * Participants must have access to a computer or tablet
  * Participants (of children \<18 years, or \>18 years if needed) must be willing to help set up an appropriate test environment for the remote evaluations
  * Participant is able to understand and willing to sign a written consent document

EXCLUSION CRITERIA:

-Participants with disease who have a pre-existing global intellectual disability (e.g., Down Syndrome)

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

  • 主要终点评估复发/难治性白血病或淋巴瘤儿童及青年CAR-T 治疗后12个月工作记忆的变化CAR-T 治疗后12个月。
  • 次要终点评估复发/难治性白血病或淋巴瘤儿童及青年CAR-T 治疗后12个月其他神经认知领域的变化
核对登记原文(英文)

主要终点:To evaluate changes in working memory in children and young adults with relapsed/refractory leukemia or lymphoma at 12 months post CAR T-cell therapy · The changes in working memory (as measured by Cogstate One-Back reaction time standardized score) from baseline to 12-month post-infusion will be determined for each participant and the paired difference will be tested for a change from zero using a paired t-test. If the paired difference is not consistent with a normal distribution, then a Wilcoxon signed rank test may be used instead. · 12 months post CAR T-cell therapy
次要终点:To evaluate changes in additional neurocognitive domains in children and young adults with relapsed/refractory leukemia or lymphoma at 12 months post CAR T-cell therapy

研究设计怎么做的

研究类型
观察性研究
入组人数
60 人(预计)
  • 队列1

    计划接受CAR-T 细胞治疗的复发/难治性白血病或淋巴瘤患者。

  • 队列2

    照护者(知情人)。

核对分组登记原文(英文)
  • Cohort 1 · Participants with relapsed/refractory leukemias or lymphomas, scheduled to receive CAR T-cell therapy.
  • Cohort 2 · Caregivers (informants)

关键日期

开始日期
2025-06-23
主要完成日期
2028-09-01
全部完成日期
2028-12-01
登记状态核实于
2026-08-11

联系与责任方公示信息

申办方
National Cancer Institute (NCI)
联系电话
(240) 760-6970

以上邮箱 / 电话是登记库里的申办方联系方式,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

CAR-T 细胞治疗是血液癌症的一种新疗法,治疗时会对患者T细胞进行基因改造,使其杀伤癌细胞。本研究关注治疗相关问题是否及如何影响脑功能和思维能力,评估CAR-T 治疗对儿童和成人思考、信息处理及记忆能力的影响。研究收集病史及病历资料;参与者在家或NIH完成电脑及纸笔测试,评估思维、阅读、学习、记忆、推理和注意力,测试少于1小时;参与者及家长/成年观察者填写背景信息表和神经系统症状清单,并回答相关症状、健康状况和需求问卷。部分测试和问卷会在不同时间点重复,参与最长3年。

核对登记原文(英文)

Background: CAR T-cell therapy is a promising new treatment for blood cancers. During treatment, a person s T-cells are genetically changed to kill cancer cells. Researchers want to learn more about the effects of potential problems that may be associated with this treatment. We are specifically interested in learning if and how this treatment may affect the brain or your thinking skills. Objective: To learn if CAR T-cell therapy can affect how children and adults think, process, and remember things. Eligibility: People aged 5-35 who have blood cancer that has not responded to treatment, or the blood cancer has come back after treatment, and who will receive CAR T-cell therapy. Caregivers are also needed. All participants must be able to speak and read in English or Spanish. Design: Participants will be screened with a medical history. Information from participants medical records will be collected. Participants will take tests at home or at NIH to see how well they think, read, learn, remember, reason, and pay attention. The tests will be both computerized and paper/pencil. They will take less than 1 hour to complete. Participants and a parent/adult observer will complete a 5-minute Background Information Form and a checklist of nervous system symptoms. If participants are 5 years or older, they will participate in activities to test their ability to do different thinking tasks, like answer questions, complete puzzle patterns, and remember things. Participants and their caregivers will complete questions to see if they are having specific symptoms related to receiving CAR T-cells. The questions will assess their well-being and needs. The questions will take less than 1 hour to complete. Some tests and questions will be repeated at different time points in the study. Participation will last for up to 3 years.

登记原文与核验信息

试验登记号
NCT05237986
试验状态
招募中
试验中心(3 个)
美国 3
适应症(原文)
Lymphoma; Leukemia