肿瘤细胞治疗研究
英文原题：Study of CAR-T Therapy in Older Patients
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、B 细胞淋巴瘤、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 154 例。试验地点：美国 · 纽约（共 1 个中心）。登记号：NCT04300998。
不限性别 · ≥ 60 Years
纳入标准：所有队列年龄≥60岁；所有队列均为病理确诊的复发/难治性淋巴系统恶性肿瘤或浆细胞疾病患者，且将接受商业化CAR-T产品；仅队列1和4要求能说并理解英语；仅队列4要求在CAR-T治疗前由老年科医生进行综合老年评估时MoCA评分<30分中的26分（即低于26分）。排除标准：所有队列既往接受过商业化或研究性CAR-T治疗；仅队列1排除当前诊断为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；仅队列1排除病历或患者报告的神经系统疾病、神经退行性疾病，或伴意识丧失>60分钟的创伤性脑损伤史；仅队列1排除目前持续物质滥用和/或既往物质滥用史；仅队列4排除中枢神经系统疾病史。
Inclusion Criteria: * are ≥60 years old (all cohorts) * have pathologically confirmed, relapsed refractory lymphoid malignancy or plasma cell disorder receiving a commercial CAR T-cell product (all cohorts) * able to speak and understand English (cohort 1 and 4 only) * have a MoCA score of less than 26 out of 30 during the GA visit by a geriatrician prior to CAR T-cell treatment (cohort 4 only) Exclusion Criteria: * Any prior commercial or investigational CAR T therapy (all cohorts) * Current diagnosis of major Axis I psychiatric disorder (DSM-IV), major depression, bipolar disorder, or schizophrenia, as per medical records or patient report (cohort 1 only) * History of a neurological disorder, neurodegenerative disease, or traumatic brain injury with loss of consciousness (\>60 minutes), as per medical records or patient report (cohort 1 only) * Current ongoing substance abuse and/or history of substance abuse, as per medical records or patient report (cohort 1 only) * History of CNS disease (cohort 4 only)
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：Number of participants who complete all required assessment visits prior to disease progression or death · Participants who complete all assessment visits prior to disease progression or death will be considered as a success for a feasibility endpoint. · 1 year
前瞻性观察队列：18名年龄≥60岁、接受CAR-T治疗复发/难治性高级别B细胞淋巴瘤的老年患者，将在CAR-T治疗前后接受连续的综合老年评估、神经认知测试和生活质量评估。标准随访期为1年。
前瞻性观察队列：80名年龄≥60岁、接受CAR-T治疗复发/难治性淋巴瘤及其他淋巴系统恶性肿瘤的老年患者，将在CAR-T治疗前后接受综合老年评估、衰老生物标志物分析和生活质量评估。标准随访期为1年。
前瞻性观察队列：40名年龄≥60岁、接受CAR-T治疗复发/难治性浆细胞疾病的老年患者。原登记源未提供进一步描述。
前瞻性观察队列，纳入CAR-T治疗前存在认知障碍的16名年龄≥60岁的淋巴瘤患者。
本研究旨在了解老年患者对CAR-T细胞治疗的反应，以及治疗对其生活质量的影响。这是一项生活质量研究，参与研究不涉及额外治疗，参与者仅接受其疾病的标准治疗。
This study is being done to find out how older patients respond to CAR-T cell therapy and how the treatment affects their quality of life. This is a quality of life study and participating in the study does not involve receiving any treatment, other than the standard treatment for participants' disease.
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