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临床试验/NCT07101913
NCT07101913进行中(未招募)不适用

Incidence and Risk Factors of Acute Kidney Injury (AKI) After Anti-CD19 CAR-T Cells Treatments in B-cell Lymphoma and Long Term Evolution.

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年4月1日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
300
试验地点
1
主要终点
Incidence of AKI after CAR-T cell therapy in B-cell lymphoma. In percentage, according to the 2012 KDIGO.

研究概览

简要总结

The investigators want to describe the incidence of AKI after CAR-T cells therapy in B-cell lymphoma. With the aim of highlight risk factors in AKI occurrence. Then, look at outcomes in the subgroup with chronic kidney disease at baseline. Finally, the investigators will examine long term evolution of kidney function.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients followed in haematology center in "Hospices civils de Lyon"
  • For a B-cell lymphoma
  • Treated by anti-CD19 CAR-T cells

排除标准

  • Less than 18 years old
  • Patients with legal protection measure
  • CAR-T cells therapy for another disease : leukemia, autoimmune disease...

研究组 & 干预措施

CAR-T cells treatment

All patients followed in haematology center in "Hospices civils de Lyon" for a B-cell lymphoma and treated by anti-CD19 CAR-T cells.

干预措施: Incidence of acute kidney injury (Biological)

CAR-T cells treatment

All patients followed in haematology center in "Hospices civils de Lyon" for a B-cell lymphoma and treated by anti-CD19 CAR-T cells.

干预措施: Describe risk factors in AKI occurrence. (Other)

CAR-T cells treatment

All patients followed in haematology center in "Hospices civils de Lyon" for a B-cell lymphoma and treated by anti-CD19 CAR-T cells.

干预措施: Focus on patient with chronic kidney disease at baseline (Other)

CAR-T cells treatment

All patients followed in haematology center in "Hospices civils de Lyon" for a B-cell lymphoma and treated by anti-CD19 CAR-T cells.

干预措施: Long term evolution after treatment by CAR-T cells (Other)

结局指标

主要结局

Incidence of AKI after CAR-T cell therapy in B-cell lymphoma. In percentage, according to the 2012 KDIGO.

时间窗: AKI from the day of the injection of CAR-T cells, until 28 days after the injection.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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