肿瘤细胞治疗研究
英文原题：Geriatric Assessment Guided Interventions to Accelerate Functional Recovery After CAR-T Therapy for Patients 60 Years and Older With B-cell Non-Hodgkin Lymphoma or Multiple Myeloma, GOCART Study
这是一项 II 期注册临床试验，评估细胞治疗用于非霍奇金淋巴瘤、多发性骨髓瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 164 例。试验地点：美国 · 杜阿尔特、尔湾、温斯顿-塞勒姆、哥伦布（共 4 个中心）。登记号：NCT06052826。
不限性别 · ≥ 60 Years
纳入标准： * 能够提供知情同意 * 患者的主治医生必须同意患者参加本研究。医生可以选择对其照护的所有符合条件的 CAR-T 患者给予一揽子同意 * 能够阅读英文或西班牙文。若调查问卷有相应语言版本且该语言不妨碍完成研究程序，经研究中心主要研究者（PI）同意后可接受其他语言 * 年龄：入组时 >= 60 岁 * 已计划接受美国食品药品监督管理局（FDA）批准的 CAR-T 治疗多发性骨髓瘤或 B 细胞非霍奇金淋巴瘤 * 愿意并能够完成研究要求 * 预期患者能够在淋巴细胞清除前至少参加一次三模式优化访视 排除标准： * 既往接受过 CAR-T 治疗 * 任何经研究者判断，因临床研究程序的安全性顾虑而不适合患者参加本临床研究的情况 * 经研究者判断，可能无法遵守所有研究程序（包括与可行性/后勤相关的依从性问题）的潜在受试者
Inclusion Criteria: * Ability to provide informed consent * Patient's physician must agree for patient participation. A physician may elect to provide blanket agreement for participation of any eligible CAR-T patient under their care * Ability to read English, or Spanish. Other languages will be acceptable with site principal investigator (PI) agreement if surveys are available and language does not preclude completing study procedures * Age: \>= 60 years at the time of enrollment * Scheduled to receive an Food and Drug Administration (FDA)-approved CAR-T for treatment of multiple myeloma or B-cell non- Hodgkin lymphoma * Willing and able to complete study requirements * Patients expect to be able to participate at least once before lymphodepletion with trimodality optimization visits Exclusion Criteria: * Prior CAR-T therapy * Any condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
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：Changes in Short Physical Performance Battery (SPPB) · T-test will be used to compare SPPB changes score between two arms at 30 days after CAR-T infusion. · From baseline to day 30 after chimeric antigen receptor T-cell (CAR-T) infusion
次要终点：Successful in coordinating initial optimization；Frailty progression；Cognitive impairment；Weight loss；CAR-T associated neurotoxicity
患者在淋巴细胞清除化疗前接受老年综合评估（GA），并根据评估结果向主治医生传达建议。患者在淋巴细胞清除前接受物理治疗和谵妄预防教育，在CAR-T治疗前至少一次，住院期间每周至少2次，出院后至第30天每两周至少一次。此外，患者在淋巴细胞清除前、CAR-T治疗前以及至第30天每周至少一次接受注册营养师的个性化营养指导。
患者在研究全程接受老年综合评估（GA）并接受标准治疗。
本临床试验比较在60岁及以上B细胞非霍奇金淋巴瘤（NHL）或多发性骨髓瘤（MM）患者中，老年综合评估（GA）指导的干预措施与标准治疗（SOC）相比，加速嵌合抗原受体T细胞（CAR-T）治疗后功能恢复的有效性。大量确诊癌症的患者年龄超过60岁，但大多数癌症治疗方法是针对较年轻患者开发的。因此，由于可能出现的副作用，老年患者可能较少被提供更强的治疗，如CAR-T疗法。老年综合评估是一种多维健康评估工具，结合患者自述和客观指标，涵盖身体功能、心理过程（认知）和营养。治疗前评估可识别老年患者的薄弱环节，并可指导物理治疗、认知变化和营养方面的干预措施，以减少CAR-T治疗的副作用并改善NHL或MM老年患者的照护。
This clinical trial compares the effectiveness of geriatric assessment (GA) guided interventions to accelerate functional recovery after chimeric antigen receptor T-cell (CAR-T) therapy compared to standard of care (SOC) in patients 60 years and older with B-cell non-Hodgkin lymphoma (NHL) or multiple myeloma (MM). A large number of patients diagnosed with cancer are over the age of 60, yet most cancer treatments are developed for younger patients. Therefore, older patients may be less likely to be offered stronger treatments, such as CAR-T therapy, due to possible side effects. Geriatric assessment is a multi-dimensional health assessment tool combining patient reported and objective measures covering physical function, mental processes (cognitive), and nutrition. Pre-treatment assessments may identify weaknesses in older adults and may guide interventions for physical therapy, cognitive changes and nutrition to decrease CAR-T therapy side effects and improve care in older adults with NHL or MM.
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