NCT02735083进行中（未招募）1 期
Long-term Follow-up Study of Patients Who Have Previously Been Exposed to UCART19 (Allogeneic Engineered T-cells Expressing a Lentiviral-based Anti-CD19 Chimeric Antigen Receptor)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 16
- 主要终点
- Long-term safety of UCART19 with or without alemtuzumab
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety and efficacy of UCART19 administration to patients with advanced lymphoid leukemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •No exclusion criteria for this study
研究组 & 干预措施
UCART19 follow-up
Experimental
干预措施: UCART19 follow-up (Biological)
结局指标
主要结局
Long-term safety of UCART19 with or without alemtuzumab
时间窗: Up to 15 Year
* 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
次要结局
- Proportion of patients who underwent allogeneic HSCT (Hematopoietic Stem Cell Transplantation) for patients treated with UCART19(Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15)
- Proportion of patients with detectable UCART19 levels in blood(Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing (If no more UCART19 detectable at the Month 12 visit), then every 6 months up to Year 3, then yearly up to Year 15 or the first evidence of no more detectable UCART19 (if earlier))
- Assessment of long-term anti tumor activity of UCART19(Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing then every 6 months up to Year 3, then yearly up to Year 15)
- Time to transplant for patients treated with UCART19(Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15)
- Assessment of overall survival(Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15)
- Proportion of patients with detectable UCART19 levels in bone marrow(Month 3, Month 6, Month 12 during Year 1 following last UCART19 dosing, then every 6 months up to Year 3, then yearly up to Year 15)
研究者
研究点 (16)
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