肿瘤细胞治疗研究
英文原题：Quality Of Life and Drug Use in Patients With CAR-T Cells
Quality Of Life and Drug Use in Patients With CAR-T Cells
这是一项分期未标注的注册临床试验，评估细胞治疗用于弥漫大 B 细胞淋巴瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 70 例。试验地点：欧洲 · 皮埃尔贝尼特（共 1 个中心）。登记号：NCT04914091。
不限性别 · ≥ 18 Years
纳入标准： • 年龄>18岁。 • 符合DLBCL适应证下CAR-T细胞治疗条件（不在任何临床试验中），且已安排治疗。 • 在里昂公立医院集团（Hospices Civils de Lyon）血液科接受随访。 • 研究者认为不存在可能干扰研究实施的严重精神障碍。 • 已表示不反对参加本研究。 排除标准： • 居住于机构。 • 受法律保护。
Inclusion Criteria: * Over 18 years old * Eligible for treatment with CAR-T cells (outside any clinical trial) in an indication of DLBCL and for which treatment is scheduled * Follow-up in the Hematology department of the Hospices Civils de Lyon * Without major psychiatric disorder likely to interfere with the conduct of the study, in the opinion of the investigator * Having given his non-opposition to participate in the study. Exclusion Criteria: * In an institution * Under legal protection
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。
主要终点：Change of Mean quality of life score using the EORTC-QLQ C30 questionnaire · Self-administered questionnaire EORTC-QLQ C30 (European Organisation for Research and Treatment of Cancer), developed to assess the quality of life of cancer patients, with 30 items. Score ranges from 0 (the worse) to 100 (the best). · Inclusion (the day before lymphodepletion chemotherapy), Month 3 and Month 6 after the administration of CART-T cells
CAR-T细胞是复发或难治性弥漫性大B细胞淋巴瘤（DLBCL）三线及后续治疗中的重要治疗创新。Kymriah®和Yescarta®是首批获得上市许可并纳入法国医保的CAR-T产品。其临床价值已在非对照I–II期试验中得到证实。 关键注册试验采用非对照设计，且缺乏患者生活质量及药物使用数据；此外CAR-T治疗费用极高（单次治疗约32万欧元），因此有必要开展进一步研究。 这项前瞻性非对照研究旨在真实临床实践中描述接受CAR-T细胞治疗患者的生活质量、实际药物使用情况及患者体验反馈。
CAR-T cells are a major therapeutic innovation in the management of patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) in 3rd line or more. Kymriah® and Yescarta® are the first CAR-T with Marketing Authorization and coverage by the French Health Insurance. Their clinical interest has been demonstrated in non-comparative phase 1-2 trials. The non-comparative design of the pivotal trials, the lack of data on patients' quality of life and drug consumption, as well as the very high cost of CAR-T (about € 320,000 for one treatment) warrant further studies. This prospective non-comparative study aims to describe in real life the quality of life of patients treated with CAR-T cells, real world drug use and patients' experience feedback.
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