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儿童肿瘤科临床试验参与者基因治疗相关迟发不良事件的随访评估

英文原题:Follow-Up Evaluation for Gene-Therapy-Related Delayed Adverse Events After Participation in Pediatric Oncology Branch Clinical Trials

ClinicalTrials.gov 2014/12/12(首次登记) 注册临床试验(分期未标注) · 邀请入组

简要介绍

这是一项分期未标注的注册临床试验,评估抗 CD19 细胞治疗用于恶性肿瘤、血液系统恶性肿瘤、实体瘤的安全性、可行性及初步疗效。当前状态:邀请入组。计划入组 500 例。试验地点:美国 · 贝塞斯达(共 1 个中心)。登记号:NCT02315599。

入组条件决定能不能参加

不限性别 · ≥ 1 Year 且 ≤ 99 Years

纳入标准:

• 经确认符合儿童肿瘤科(POB)基因工程细胞治疗临床试验条件、正在参加或曾参加该试验,并已接受或计划接受基因工程细胞治疗。
• 本方案所述监测和检测仅针对在美国国立卫生研究院(NIH)接受的基因工程细胞治疗。若细胞在其他机构给药,则不进行复制型逆转录病毒/慢病毒(RCR/RCL)监测和细胞持续性监测。
核对登记原文(英文)
* INCLUSION CRITERIA:
* Participants must be identified eligible for, participating in, or have participated in a POB genetically engineered cellular therapy clinical trial and have received/or be scheduled to receive a genetically engineered cellular therapy.
* All monitoring and testing described in this protocol will pertain ONLY to genetically engineered cellular therapy received at the National Institutes of Health (NIH). RCR/RCL monitoring and persistence will NOT be followed for cells administered at another institution.

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

  • 主要终点基因治疗后的长期安全性评估第1年每3个月一次,随后每年一次,最长15年。
核对登记原文(英文)

主要终点:Conduct long term safety evaluations after gene therapy · PCR results (for RCR/RCL, gene transduced cells) · Every 3 months X 1 year then annually X 15 years

研究设计怎么做的

研究类型
观察性研究
入组人数
500 人(预计)
  • 队列1

    筛查中、正在参加或曾参加 POB 基因治疗临床试验,且已接受或计划接受基因工程细胞治疗的患者。

核对分组登记原文(英文)
  • 1 · Patients screening for, participating in, or have participated in a POB gene therapy clinical trial and have received/or be scheduled to receive a genetically engineered cellular therapy.

关键日期

开始日期
2014-12-23
主要完成日期
2035-04-01
全部完成日期
2050-08-01
登记状态核实于
2026-05-01

联系与责任方

申办方
National Cancer Institute (NCI)

登记简述

背景:基因治疗通过改变人体细胞内的基因来治疗疾病,受到严格监管。接受该疗法者可能在数月甚至数年后出现问题,但其长期副作用尚不清楚,因此研究者拟对既往接受治疗者开展最长15年的研究随访。 目的:随时间评估基因工程细胞治疗的迟发不良反应,研究对象为曾参加美国国家癌症研究所儿童肿瘤科(POB)基因治疗试验者。 资格:目前或既往参加美国国家癌症研究所 POB 基因治疗研究者。 研究流程:基因改造细胞输注前采血;输注作为另一项研究的一部分进行。之后1年内至少每3个月到诊所或由当地医生随访一次,询问健康状况并采血;之后5年每年到诊所或由当地医生体检和采血;再后10年每年收集健康信息。参加者须向研究团队更新联系方式,研究人员也可能致电询问健康状况。若接受基因治疗时未满18岁,且在随访期间年满18岁,则须重新签署知情同意书。

核对登记原文(英文)

Background: \- Gene therapy involves changing the genes inside the body s cells to stop disease. It is very closely regulated. People who have had this therapy may have problems months or even years later. Researchers do not know the long-term side effects, so they want to study people who have had the therapy. They want the study to continue over the next 15 years. Objective: \- To study over time the negative side effects from genetically engineered cellular therapy. This will be studied in people who have been in Pediatric Oncology Branch (POB) gene therapy trials. Eligibility: \- People who are currently or were previously in a research study with gene therapy in the National Cancer Institute POB. Design: * Participants blood will be tested right before they get the genetically changed cells. They will get the cells as part of another study. * For the next year, they will come back to the clinic or see their doctor at home at least every 3 months. They will answer questions about their health and blood will be drawn. * For the next 5 years, they will go to the clinic or see their own doctor once a year. They will have physical exam and blood will be drawn. * For 10 years after that, they will be asked every year for health information. * Participants will keep their contact information up to date with researchers. They may be phoned for more health information. * If the participant was under 18 years old when given the gene therapy and turns 18 during this follow-up, they will be asked to sign a new consent form when they turn 18.

登记原文与核验信息

试验登记号
NCT02315599
试验状态
邀请入组
试验中心
National Institutes of Health Clinical Center · 贝塞斯达 · 美国
适应症(原文)
Pediatric Cancers; Hematologic Malignancies; Solid Tumors
干预方式(原文)
anti-CD19 CAR