肿瘤细胞治疗研究
英文原题：Collection of Biological Samples From Patients Treated With CAR-T Cells for Hematological Malignancies
这是一项分期未标注的注册临床试验，评估 CAR-T 细胞治疗急性淋巴细胞白血病的安全性、可行性及初步疗效。当前状态：招募中。计划入组 300 例。试验地点：欧洲 · 蒙彼利埃（共 1 个中心）。登记号：NCT04290000。
不限性别 · ≥ 18 Years
纳入标准： • 在蒙彼利埃大学医院接受 CAR-T 细胞治疗。 排除标准： • 拒绝签署知情同意书。 • 妊娠。 • 受法律保护或监护的成年人。
Inclusion Criteria: * patient treated by CAR-T cell at the University Hospital of Montpellier Exclusion Criteria: * refusal to sign consent form * pregnant woman * major protected
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：Constitution of biological samples from patient treated with CAR T cells · The aim is only to collect biological samples. This collection will be used later to determine factors influencing efficacy of CAR-T cells treatments.
Blood samples (additional tubes) and marrow (quantity taken in addition from the same aspiration) will be collected in addition to those useful for the follow up of the patients at specific points in his treatment and follow up.
In case of invasion, a skin biopsy will be made, 2 days and 8 days after the beginning of the CAR T Cell Treatment, during the patient's hospitalization and during a consultation visit in case of therapeutic progression or failure. · up to 15 years
次要终点：patient survival
接受 CAR-T 细胞治疗的血液系统恶性肿瘤患者。
针对 CD19 阳性 B 细胞淋巴瘤和急性淋巴细胞白血病的 CAR-T 细胞疗法已产生两种获批药物：Yescarta 和 Kymriah。尽管多项 II 期研究显示疗效显著，复发或难治性疾病患者中仍有约一半对治疗无应答，可能与输注细胞扩增不足、功能受损或持续时间短有关。明确治疗失败原因是优化疗法的第一步。本项目拟在蒙彼利埃大学医院建立接受 CAR-T 治疗的血液系统恶性肿瘤患者队列样本库并收集临床资料，以研究影响 CAR-T 疗效的因素。
Development of CAR-T cell against CD19 B lymphoma and Acute Lymphoblastic Leukemia leaded to 2 authorized medication: Yescarta and Kymriah. Despite impressive outcomes in 3 phase II studies, never met in relapsed or refractory diseases, half of the patients don't respond to this treatment.This can be explained by a low expansion, functional alteration or short persistence of infused cells. Determination of reasons for treatment failure is the first step for optimization of this therapeutics. This project aims to bank blood samples from a cohort of patients treated with CAR-T cell for hematological malignancies in Montpellier University Hospital. Clinical data related to samples will be collected. This samples will be used to determine factors influencing efficacy of CAR-T cells treatments.
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