肿瘤细胞治疗研究
英文原题：Immunotherapy in Lymphoma
⚠ 该试验的登记信息已有 20 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 CAR-T 细胞治疗 B 细胞淋巴瘤、弥漫大 B 细胞淋巴瘤、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 72 例。试验地点：韩国 · 首尔（共 2 个中心）。登记号：NCT06796517。
不限性别 · ≥ 19 Years 且 ≤ 74 Years
纳入标准： • 年龄19至74岁。 • 2015年1月以后确诊以下任一疾病：弥漫性大 B 细胞淋巴瘤、原发性纵隔大 B 细胞淋巴瘤、高级别 B 细胞淋巴瘤或伯基特淋巴瘤。 • 接受过免疫化疗治疗复发/难治性淋巴瘤。 排除标准： • 疾病进展为急性白血病。 • 治疗期间发生实体瘤。 • 活动性感染，如急性肺炎、病毒感染、活动性乙肝或活动性肺结核等。
Inclusion Criteria: * Adults aged 19 to 74 years. * Diagnosed with any of the following after January 2015: diffuse large B cell lymphoma, primary mediastinal large B cell lymphoma, high grade B cell lymphoma, or Burkitt lymphoma * Patients who have received immunochemotherapy as treatment for relapsed/refractory lymphoma Exclusion Criteria: * Patients who have progressed to acute leukemia * Patients who developed solid tumor during treatment * Patients with active infectious status (acute pneumonia, viral infection, active hepatitis B state, or active pulmonary tuberculosis etc.)
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：Overall survival · Survival status is assessed through periodic follow-ups and medical records. Patients lost of follow-up are censored at their last known date of contact. The endpoint is either the date of death documented in medical records or the date of the last known follow-up for patients still alive. · From the start of treatment or the date of study enrollment until death from any cause, assessed up to 100 months.
次要终点：Progression-free survival
接受 CAR-T 细胞疗法、双特异性抗体或抗体药物偶联物的复发/难治性高级别 B 细胞淋巴瘤患者。
接受蛋白酶体抑制剂、免疫调节药物或单克隆抗体治疗的复发/难治性高级别 B 细胞淋巴瘤患者。
这项观察性研究比较复发/难治性高级别 B 细胞淋巴瘤患者接受新型免疫化疗与传统免疫化疗的疗效。主要问题是：包括 CAR-T、双特异性抗体和抗体药物偶联物在内的新型免疫化疗，是否比蛋白酶体抑制剂、免疫调节药物和单克隆抗体等传统免疫化疗带来更好的生存结局。研究者将比较两类治疗患者的生存结局，并使用实验室检查结果和电子病历评估生存及治疗相关安全性。
The goal of this observational study is to compare the efficacy of advanced immunochemotherapy and classical immunochemotherapy in relapsed/refractory high grade B cell lymophoma patients. The main question it aims to answer is: Does advanced immunochemotherapy, including CAR-T therapy, bispecific antibody, and antibody-drug conjugate offer superior survival outcomes than when treated with classical immunochemotherapy, such as proteasome inhibitors, immune modulatory drugs, and monoclonal antibodies? Researchers will compare patients receiving advanced immunochemotherapy with those receiving classical immunochemotherapy to determine if advanced therapies result in better survival outcomes. Laboratory findings and electronic medical records (EMR) from participants will be used to assess survival outcomes and treatment-related safety profiles.
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