Retrospective Analysis of the Use of CAR-T Cell Therapy in Patients With Hematological Malignancies in Spain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The prognosis of relapsed or refractory lymphoblastic leukaemia (ALL) and diffuse large B-cell lymphoma (DLBCL) is poor with conventional treatment with complete response rates around 25-30% with a median progression-free survival (PFS) of around 2 months and 7 months, respectively, despite the use of allogeneic and autologous haematopoietic stem cell transplantation. The recent introduction of CAR-T (Chimeric Antigen Receptor T-cells) therapy as a therapeutic option has been a breakthrough in the management of these entities.
详细描述
Information on baseline patient characteristics, haematological disease, comorbidities and CAR-T therapy procedure (lymphodepletion schedule, infused product) will be collected. Early post-infusion toxicity and recurrence data will be collected. The grading of adverse effects will follow the EBMT and ASTCT guidelines. Finally, data will be collected to analyse survival and, in case of death, cause of death).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients >18 y/o
- •Patients receiving CAR-T cell therapy in Spain, since 2018.
排除标准
- •Patients receiving CART therapy as part of a clinical trial.
结局指标
主要结局
Progression free survival
时间窗: 24 month
Patients who relapse or progress at 24 month after CART infussion.
次要结局
- Overall survival(6 month,12 month and 24 month)
- Progression free survival(6 month,12 month and 24 month)
- High relevance toxicity rates(During the firs month)