← 返回临床试验

复发/难治性非霍奇金淋巴瘤患者 CAR-T 疗效与毒性的预后模型开发

英文原题:Development of Prognostic Models for Response and Toxicity to CAR-T Cell Therapy in Patients with Relapsed/refractory Non Hodgkin's Lymphoma.

查看英文原题

Development of Prognostic Models for Response and Toxicity to CAR-T Cell Therapy in Patients with Relapsed/refractory Non Hodgkin's Lymphoma.

ClinicalTrials.gov 2024/12/06(首次登记) 注册临床试验(分期未标注) · 尚未开始招募

分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。

⚠ 该试验的登记信息已有 22 个月未更新, 页面上显示的「尚未开始招募」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。

简要介绍

这是一项分期未标注的注册临床试验,评估细胞治疗用于非霍奇金淋巴瘤的安全性、可行性及初步疗效。当前状态:尚未开始招募。计划入组 125 例。试验地点:欧洲 · 博洛尼亚(共 1 个中心)。登记号:NCT06720701。

入组条件决定能不能参加

不限性别 · ≥ 18 Years

纳入标准:

• 年龄≥18岁。
• 复发/难治性非霍奇金淋巴瘤,按临床适应证拟接受 CAR-T 细胞治疗。
• 同意参加本研究。
• 同意处理个人数据。

排除标准:无。
核对登记原文(英文)
Inclusion Criteria:

* Age ≥ 18 years
* Patients with relapsed/refractory non-Hodgkin lymphoma, candidates to receive CAR-T cell therapy according to clinical indication
* Acquisition of informed consent for participation in the study
* Acquisition of consent to the processing of personal data.

Exclusion Criteria:

none

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。

研究终点衡量什么算有效

  • 主要终点建立模型预测复发/难治性非霍奇金淋巴瘤患者 CAR-T 治疗在不同时间点的反应CAR-T 治疗后1、3、6和12个月。
  • 主要终点建立模型预测复发/难治性非霍奇金淋巴瘤患者 CAR-T 治疗相关 CRS 毒性CAR-T 治疗后7天。
  • 主要终点建立模型预测复发/难治性非霍奇金淋巴瘤患者 CAR-T 治疗相关 ICANS 毒性CAR-T 输注后7天。
  • 次要终点估算接受治疗路径的复发/难治性非霍奇金淋巴瘤患者总生存期(OS;意向治疗分析,自单采开始)
  • 次要终点估算接受治疗路径的复发/难治性非霍奇金淋巴瘤患者无进展生存期(PFS;意向治疗分析,自单采开始)
  • 次要终点描述接受 CAR-T 治疗的复发/难治性非霍奇金淋巴瘤患者中 CRS 和 ICANS 以外的治疗相关毒性事件特征,最长至输注后12个月
核对登记原文(英文)

主要终点:Develop predictive models of response to CAR-T cell therapy at different time points in patients with relapsed/refractory non-Hodgkin lymphoma.. · The outcome of objective 1 is the occurrence of one of the following conditions: complete response (CR) or partial response (PR) or stable response (SD) or progression of disease (PD). The outcome will be assessed by performing a PET/CT radiological examination. The response to treatment \[(Overall Response Rate (ORR), or CR + PR\] is defined as negativization of the uptake or Deauville score ≤3. The non-response to treatment/refractoriness \[SD + PD\] is defined as persistence/increase of the uptake, or Deuville Score \>3. · 1,3 ,6 12 months post CAR-T therapy;Develop a predictive model of CRS toxicity to CAR-T cell therapy in patients with relapsed/refractory non-Hodgkin lymphoma · The outcome of this objective is the occurrence of CRS toxicity events. The outcome will be assessed according to CTCAE vers. 5.0 CRS toxicity on treatment is defined as the incidence of CRS events of grade ≥1 and/or the incidence of ICANS of grade ≥1 · 7 days post CAR-T therapy;Develop a predictive model of ICANS toxicity to CAR-T cell therapy in patients with relapsed/refractory non-Hodgkin lymphoma · The outcome of this objective is the occurrence of ICANS toxicity events. The outcome will be assessed according to CTCAE vers. 5.0 ICANS toxicity on treatment is defined as the incidence of ICANS events of grade ≥1. · +7 days post CAR-T infusion
次要终点:To estimate the overall survival (OS) of patients with relapsed/refractory non-Hodgkin lymphoma who have undertaken the therapeutic pathway (i.e. from apheresis, by intention-to-treat);To estimate the progression-free survival (PFS) of patients with relapsed/refractory non-Hodgkin lymphoma who have undertaken the therapeutic pathway (i.e. from apheresis, by intention-to-treat);To describe the characteristics of all therapy-related toxicity events (other than CRS and ICANS) in patients with relapsed/refractory non-Hodgkin lymphoma who received CAR-T cell therapy up to 12 months post-infusion.

研究设计怎么做的

研究类型
观察性研究
入组人数
125 人(预计)

关键日期

开始日期
2024-12
主要完成日期
2026-12-31
全部完成日期
2026-12-31
登记状态核实于
2024-10

联系与责任方公示信息

申办方
IRCCS Azienda Ospedaliero-Universitaria di Bologna
联系电话
+39 0512143680

以上邮箱 / 电话是登记库里的申办方联系方式,通常不直达某家医院。中国中心的联系方式请以医院或登记平台最新公示为准。

登记简述

这是一项单中心、基于组织样本的观察性队列研究,纳入接受 CAR-T 细胞治疗的患者(包括回顾性和前瞻性入组),并开展最长1年的前瞻性随访,以评估研究所需结局。

核对登记原文(英文)

Observational, single-center, tissue-based cohort study involving both retrospective and prospective enrollment of patients undergoing CAR-T cell therapy and up to 1 year of prospective follow-up necessary to detect the outcomes required by the study

登记原文与核验信息

试验登记号
NCT06720701
试验状态
尚未开始招募
试验中心(1 个)
意大利 1
适应症(原文)
Non-Hodgkin Lymphoma