决定异体 CAR T 细胞排斥与扩增的细胞和分子机制
Cellular and molecular mechanisms determining allogeneic CAR T cell rejection and expansion.
英文原题:Italian Observational Study on CAR-T Therapy for Lymphoma
Italian Observational Study on CAR-T Therapy for Lymphoma
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⚠ 该试验的登记信息已有 30 个月未更新, 页面上显示的「招募中」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。
这是一项分期未标注的注册临床试验,评估细胞治疗用于 B 细胞淋巴瘤、大 B 细胞淋巴瘤、套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 5300 例。试验地点:欧洲 · 米兰(共 1 个中心)。登记号:NCT06339255。
不限性别 · ≥ 18 Years
纳入标准: • 确诊弥漫性大 B 细胞淋巴瘤(DLBCL)、原发性纵隔大 B 细胞淋巴瘤(PMBCL)、套细胞淋巴瘤(MCL)或滤泡性淋巴瘤(FL),且符合在意大利接受已上市 CAR-T 产品治疗的条件。 排除标准:不适用。
Inclusion Criteria: * Patients with diagnosis of DLCBL, PMBCL, MCL and FL eligible for CAR-T treatment with commercialy available products in Italy. Exclusion Criteria: * Not applicable
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:Feasibility of the CAR-T cells treatment in lymphomas in the italian real life practice · Evaluate the feasibility of CAR T-cell treatment in the real-life setting, with particular regard to eligible patients versus those subjected to leukapheresis versus those finally treated. The percentage of patients infused will be estimated as the number of patients infused divided by the total number of those declared eligible; the corresponding exact confidence intervals at 95% will also be estimated. · 10 years enrollment, minimum 1 year follow-up;Efficacy of the CAR-T cells treatment in lymphomas in the italian real life practice · Evaluate the survival outcome of PMBCL, DLBCL, MCL and FL patients treated with CAR T-cells versus those potentially eligible, but excluded from cellular therapy for other causes (either related to the patient or to the manufacturing) · 10 years enrollment, minimum 1 year follow-up
次要终点:Evaluation of Outcome: Overall Response rate (ORR), according to Lugano criteria.;Evaluation of Outcome: Overall survival (OS), according to Lugano criteria.;Evaluation of Outcome: Progression free survival (PFS);Evaluation of Outcome: duration of response (DoR);Evaluation of Outcome: Overall Response rate (ORR);Evaluation of Outcome: Overall survival (OS);Evaluation of Outcome: non-relapse mortality (NRM);Evaluation of safety (CRS, neurotoxicity, infections, cytopenias, B cell aplasia, second malignancies) with particular attention to the safety in the new indications
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本观察性研究在真实临床环境中监测CAR-T 细胞治疗的可行性、疗效、毒性和生物标志物。参加者将同意收集临床数据,并可选择参加生物学研究,以评估毒性和治疗反应相关生物标志物(临床特征、细胞因子谱、细胞组成及 CAR-T 产品类型、淋巴瘤基因组学)。研究还将在常规临床实践中通过 PET 和 CT 按 Lugano 标准评估疾病反应。
The goal of this observational study on chimeric antigen receptor T-cell therapy is to monitor the feasibility, efficacy, toxicity and biomarkers in a real life setting. Partecipants will be asked to agree to their clinical data collection and to partecipate to the optional biological study that aims to evaluate biomarkers of toxicity and response (clinical characteristics, cytokine profile, cellcomposition and type of the CAR-T cell product, lymphoma genomics). The study will evaluate even the disease response according to lugano criteria by PET and CT in routine clinical activity.
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