肿瘤细胞治疗研究
英文原题：A Study to Evaluate the Long-term Safety of Patients With Advanced Lymphoid Leukemia Who Have Been Previously Administered With UCART19
A Study to Evaluate the Long-term Safety of Patients With Advanced Lymphoid Leukemia Who Have Been Previously Administered With UCART19
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 18 个月未更新， 页面上显示的「进行中（不再招募）」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。
这是一项 I 期注册临床试验，评估细胞治疗用于白血病的安全性、可行性及初步疗效。当前状态：进行中（不再招募）。计划入组 28 例。试验地点：美国 · 洛杉矶、丹佛、坦帕、查尔斯敦（共 16 个中心）。登记号：NCT02735083。
不限性别
纳入标准： • 在任何研究特定程序开始前，已由患者、父母或法定代表人签署书面知情同意。 • 已接受UCART19给药并完成或提前退出UCART19申办方研究或研究者发起研究，或通过特殊准入计划（同情用药）接受UCART19。 • 有生育可能的女性患者及其伴侣有生育可能的男性患者，在末次UCART19给药后12个月内须持续使用有效避孕方法，伴侣亦须采取有效避孕。 排除标准： • 本研究无排除标准。
Inclusion Criteria: * Written informed consent obtained prior any study-specific procedure (patient or parent(s) or legal representative) * Patient dosed with UCART19 who completed or discontinued early from a sponsored or from any investigator-initiated study that tested UCART19, or patients who were administered UCART19 under a special access scheme (compassionate use); * Female patients of childbearing potential and male patients with partners of childbearing potential must continue to use an effective method of birth control as well as their partners for a 12-month duration after the last UCART19 administration. Exclusion Criteria: \- No exclusion criteria for this study
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：Long-term safety of UCART19 with or without alemtuzumab · * Number, duration, outcome of all adverse events (AE) within 12 months post last UCART19 infusion
* Number, duration, outcome of adverse events of special interest (AESI) up to the end of the study
* Proportion of patients with adverse events leading to death up to the end of the study
* For paediatric patients: assesment of the potential impact on growth curve and puberty · Up to 15 Year
次要终点：Assessment of long-term anti tumor activity of UCART19；Proportion of patients who underwent allogeneic HSCT (Hematopoietic Stem Cell Transplantation) for patients treated with UCART19；Time to transplant for patients treated with UCART19；Assessment of overall survival；Proportion of patients with detectable UCART19 levels in blood；Proportion of patients with detectable UCART19 levels in bone marrow
本研究旨在评估UCART19用于晚期淋巴细胞白血病患者的长期安全性和疗效。
The purpose of this study is to evaluate the long-term safety and efficacy of UCART19 administration to patients with advanced lymphoid leukemia.
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