Observational Retrospective and Prospective Multicentric Study on CAR-T Cell for the Treatment of Pediatric and Adult B-cell Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 107
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供