CARs for CNS-Leukemia Relapse: A Retrospective International Study
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
CAR T cells targeting CD19 have been approved for patients with relapsed or refractory ALL, failing two or more prior protocols. Several institutional-based studies with other CAR T cells targeting CD19 have demonstrated outstanding response rates in patients with refractory disease, and the ability of CAR T cells to clear CNS leukemia. Nevertheless, these cases are sparse and have never been reported collectively.
Here, we aim to retrospectively assess toxicity and long term outcome of patients treated with CAR T cells for CNS relapse of ALL.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior diagnosis of B-cell acute lymphoblastic leukemia involving the central nervous system
- •Treatment with CAR T cells (either on a clinical trial or commercial use) due to this indication
排除标准
- 未提供
结局指标
主要结局
Overall survival
时间窗: 6 months
Duration between CAR T-cell infusion and death or last follow-up, according to Kaplan-Meier analysis
次要结局
- Incidence of CAR-related CRS or ICANS per ASCTC guidelines(2 months)
- Leukemia-free survival(6 months)
- CNS-leukemia free survival(6 months)
研究者
Elad Jacoby, MD
Head, Pediatric Cancer Immunotherapy
Sheba Medical Center
