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CAR-T 治疗非霍奇金淋巴瘤患者治疗后首月疲劳与特定副作用的相关性研究

英文原题:Study of the Association Between Fatigue Experienced by Patients and the Specific Side Effects of CART Cells, During the First Month After Administration for Non-Hodgkin's Lymphoma

查看英文原题

Study of the Association Between Fatigue Experienced by Patients and the Specific Side Effects of CART Cells, During the First Month After Administration for Non-Hodgkin's Lymphoma

ClinicalTrials.gov 2025/03/21(首次登记) 注册临床试验(分期未标注) · 尚未开始招募

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。

⚠ 该试验的登记信息已有 19 个月未更新, 页面上显示的「尚未开始招募」可能已经失效。联系研究中心之前,建议先到 ClinicalTrials.gov 核对登记原文的最新状态与联系方式。

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:尚未开始招募。计划入组 100 例。登记号:NCT06890091。

入组条件决定能不能参加

不限性别 · ≥ 18 Years

纳入标准:成人(年龄>18岁);因非霍奇金淋巴瘤住院接受CAR-T 细胞治疗;能够理解和阅读法语。

排除标准:受法律保护的患者;反对参加研究。
核对登记原文(英文)
Inclusion Criteria:

* Adult (age\> 18year old)
* Person hospitalised for treatment with CAR-T Cells for non-Hodgkin's lymphoma.
* Person able to understand and read the French language.

Exclusion Criteria:

* Patient under legal protection
* Opposition to research

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

  • 主要终点疲劳评分第30天。
  • 次要终点疲劳评分
  • 次要终点疲劳评分
  • 次要终点疲劳评分
  • 次要终点疲劳评分
  • 次要终点身体疲劳分量表评分
  • 次要终点身体疲劳分量表评分
  • 次要终点身体疲劳分量表评分
  • 次要终点身体疲劳分量表评分
核对登记原文(英文)

主要终点:Fatigue score · European Organization for Research and Treatment of Cancer Fatigue Scale. This is a 12 items questionnaire ranging from 0 to 100. Higher scores indicate more severe fatigue. 30 days after CAR-T cell injection · At day 30
次要终点:Fatigue score;Fatigue score;Fatigue score;Fatigue score;Physical Fatigue subscore;Physical Fatigue subscore;Physical Fatigue subscore;Physical Fatigue subscore

研究设计怎么做的

研究类型
观察性研究
入组人数
100 人(预计)
  • 接受CAR-T 治疗的非霍奇金淋巴瘤成人患者
核对分组登记原文(英文)
  • Adults receiving CAR-T Cell treatment for non-Hodgkin's lymphoma

关键日期

开始日期
2025-04-01
主要完成日期
2026-05-01
全部完成日期
2026-05-01
登记状态核实于
2025-03

联系与责任方公示信息

申办方
Assistance Publique - Hôpitaux de Paris
联系电话
+33142494585

以上邮箱 / 电话是登记库里的申办方联系方式(国际号码,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

2023年法国癌症新发病例估计为433,136例,其中血液系统肿瘤占12%,约三分之二为淋巴系统肿瘤,尤其是淋巴瘤。2018年起,CAR-T 等免疫治疗改变了部分非霍奇金淋巴瘤的治疗选择,但可能造成短期或长期不良反应。CAR-T 住院治疗期间的急性副作用包括细胞因子释放综合征(CRS)和免疫效应细胞相关神经毒性综合征(ICANS),此外还可出现治疗相关血细胞减少。患者在治疗后首月常感到疲劳,医护人员可能低估其程度。研究拟使用EORTC QLQ-FA12多维量表评估躯体、情绪和认知疲劳,并以症状管理理论为框架,探究接受CAR-T 治疗的非霍奇金淋巴瘤患者首月的治疗副作用与疲劳状态之间是否相关。

核对登记原文(英文)

The incidence of cancer in 2023 is estimated at 433136 cases, according to INCa. Haemopathies account for 12% of these new cases of cancer cases of cancer, and around two-thirds are lymphoid haemopathies, in particular lymphomas. There are many treatments available for lymphoma. However, the arrival in France in 2018 of immunotherapy treatments such as CAR-T Cells have changed the paradigm of treatment options for certain non-Hodgkin's lymphomas. In these treatments can have both short-term and long-term adverse effects and long-term adverse effects. During hospitalisation for the administration of CAR-T Cells, acute side effects include CRS and ICANS. There is also another complication very specific to this treatment that has been observed in patients: cytopenias. This is despite the fact that one of the symptoms frequently mentioned and felt by patients during the first month after month after treatment is fatigue. Despite numerous studies on the prevalence of fatigue, healthcare professionals often underestimate this symptom. Nurses, and in particular the advanced practice nurse have a crucial role to play in assessing fatigue. The EORTC scale QLQ-FA12 is a multidimensional scale which assesses the physical emotional and cognitive dimensions of fatigue. The theory of symptom management, which was developed in 1994 by the California College of Nursing in San Francisco, is a relevant framework for understanding fatigue in patients. This theory places the patient's experience at the centre of care. This holistic approach provides a detailed framework for understanding this symptom. "According to the theoretical model, measuring the symptom is an important step and characterising it is an essential element in better targeting the actions to be taken". Although CAR-T Cell therapy is innovative and allows long-term remissions, it is important to evaluate and understand how patients live with this treatment. To our knowledge, few studies have been carried out on quality of life, particularly regarding fatigue, following the first month of CAR-T Cell administration. The research question we will address in this study is: "Is there an association between the side effects of CAR-T Cell treatment and the state of fatigue in patients receiving this treatment for non-Hodgkin's lymphoma during the first month?"

登记原文与核验信息

试验登记号
NCT06890091
试验状态
尚未开始招募
适应症(原文)
Fatigue Symptom; Lymphoma Non-Hodgkin; Chimeric Antigen Receptor T-cell Therapy; Adverse Events
干预方式(原文)
Fatigue assessment