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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number, duration, outcome of all adverse events (AE) within 12 months post last UCART19 infusion.
研究概览
简要总结
To evaluate the long-term safety of patients with advanced lymphoid leukemia who have been previously administered with UCART19.
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 65+ Years, 18-64 Years）
- 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
S68587 - 20 megaCells/ml, S68587 - 15 megaCells/ml, S68587 - 6 megaCells/ml, S68587 - 0.6 megaCells/ml
干预措施: S68587 - 20 megaCells/ml (Drug)
S68587 - 20 megaCells/ml, S68587 - 15 megaCells/ml, S68587 - 6 megaCells/ml, S68587 - 0.6 megaCells/ml
干预措施: S68587 - 15 megaCells/ml (Drug)
S68587 - 20 megaCells/ml, S68587 - 15 megaCells/ml, S68587 - 6 megaCells/ml, S68587 - 0.6 megaCells/ml
干预措施: S68587 - 6 megaCells/ml (Drug)
S68587 - 20 megaCells/ml, S68587 - 15 megaCells/ml, S68587 - 6 megaCells/ml, S68587 - 0.6 megaCells/ml
干预措施: S68587 - 0.6 megaCells/ml (Drug)
结局指标
主要结局
Number, duration, outcome of all adverse events (AE) within 12 months post last UCART19 infusion.
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.
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.
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.
For paediatric patients: assesment of the potential impact on growth curve and puberty.
次要结局
- Proportion of patients who relapse or progress.
- Progression-free survival (PFS), disease specific survival (DSS).
- Duration of remission until the date of progression or death due to any cause, whichever occurs first.
- Overall survival (OS)
- Proportion of patients who underwent allogeneic HSCT if not transplanted within the parent study.
- Time to transplant.
- Measurement of CD19CAR transgene levels by qPCR (and optionally by flow cytometry) in blood, and in bone marrow (if a BM aspirate is collected by the centre as part of the routine care of the patient’s disease).
研究者
Clinical Studies Department
Scientific
Institut De Recherches Internationales Servier IRIS