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临床试验/NCT04158011
NCT04158011Unknown不适用

CARs for CNS-Leukemia Relapse: A Retrospective International Study

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年11月6日最近更新:
适应症

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

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

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Elad Jacoby, MD

Head, Pediatric Cancer Immunotherapy

Sheba Medical Center

研究点 (1)

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