英文原题:Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
这是一项 II/III 期注册临床试验,评估细胞治疗用于肿瘤的安全性、可行性及初步疗效。当前状态:招募中。计划入组 1541 例。试验地点:美国 · 伯明翰、吉尔伯特、凤凰城、斯科茨代尔(共 222 个中心)。登记号:NCT03435796。
不限性别
纳入标准: * 在既往由 Celgene 赞助、Juno Therapeutics、BMS 其他关联公司或 Celgene 联盟合作伙伴赞助的临床试验中接受过至少一次基因修饰(GM)T细胞输注,且已中止治疗,或已按适用情况完成母治疗方案的治疗后随访期。 * 必须在进行任何研究相关的评估/操作之前理解并自愿签署知情同意书/知情赞同书。 排除标准: 不适用 其他方案定义的纳入/排除标准适用
Inclusion Criteria: * Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored, Juno Therapeutics, other affiliates of BMS, or Celgene alliance partner-sponsored trial, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable. * Must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted. Exclusion Criteria: Not Applicable Other protocol-defined inclusion/exclusion criteria apply
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:Incidence of delayed Adverse Events (AEs) · Up to 15 years from last gene-modified (GM) T cell infusion;Persistence of GM T cell drug products · Up to 15 years from last GM T cell infusion;Analysis of vector integration sites · Up to 15 years from last GM T cell infusion;Incidence of replication-competent lentiviruses · Up to 15 years from last GM T cell infusion;Physical growth as assessed by physical examination (pediatric participants only) · Up to 15 years from last GM T cells infusion or until Tanner Stage 5 is reached;Incidence of sexual maturation as assessed by the Tanner staging system (pediatric participants only) · Up to 15 years from last GM T cells infusion or until Tanner Stage 5
次要终点:Lymphocyte count (B-cell)
这是一项前瞻性研究,旨在对所有曾接受基因修饰(GM)T细胞疗法治疗、且参加过既往由Celgene申办或Celgene联盟合作方申办研究的儿童及成年受试者,进行安全性和有效性的长期随访(LTFU)。 既往接受过至少一次GM T细胞输注的受试者,在提前终止或完成既往母方案治疗后,将被邀请入组本LTFU方案。
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Participants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.
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