CAR-T Treatment in Pediatric and Adult Acute Lymphoblastic Leukemia
Observational Retrospective and Prospective Multicentric Study on CAR-T Cell for the Treatment of Pediatric and Adult B-cell Acute Lymphoblastic Leukemia
The goal of this observational study is to evaluate the efficacy of the treatment with approved CAR-T cells in Italy in pediatric and adult patients with acute B-cell lymphoblastic leukemia. The main question it aims to answer is:
which is the overall response rate in pediatric and adult patients with acute B-cell lymphoblastic leukemia treated with approved CAR-T cells?
Data will be extracted from patients medical records.
研究概览
地位
详细说明
This is a nationwide, prospective and retrospective, prospective, multicenter observational study that will enroll all B-ALL patients treated in Italy with commercially approved anti-CD19 CAR T cell therapy. The planned enrolment period is 24 months, followed by an additional 12-month follow-up period.
Only clinical and laboratory data produced at participating centers, as per normal clinical practice, will be collected.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Enrico Crea
- 电话号码：+390670390514
- 邮箱：e.crea@gimema.it
研究联系人备份
- 姓名：Paola Fazi
- 电话号码：+39 0670390528
- 邮箱：p.fazi@gimema.it
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Diagnosis of ALL R/R CD19+
- Patients are pediatric (all patients up to the age of 18) adult (all comers older than 18)
- Prescribed treatment with Tisagenlecleucel or Brexucabtagene autoleucel as per approved AIFA criteria, or obecabtagene autoleucel - as well as other products - when available
- Provided consent (or did not opposed) for collection and use of patient data per local regulations
Exclusion Criteria:
None
-
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
Patients with acute lymphoblastic leukemia treated with CAR-T cells
Pediatric and adult patients with B-cell acute lymhoblastic leukemia treated with approved CAR-T cells in Italy
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall response
大体时间：12 months
|
Rate of patients that obatain a response
|
12 months
|
合作者和调查者
调查人员
- 首席研究员：Federico Lussana、Ospedale Papa Giovanni XXIII, Bergamo
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- ALL3226
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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