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临床试验/NCT06076226
NCT06076226招募中不适用

The First Affiliated Hospital, Zhejiang University School of Medicine

Zhejiang University1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,500
试验地点
1
主要终点
Overall survival

研究概览

简要总结

This post hoc analysis included patients with acute leukemia who underwent allo-HSCT at the First Affiliated Hospital of Zhejiang University School of Medicine and Ruijin Hospital Shanghai Jiaotong University School of Medicine. Patients and their donors were assessed for eligibility to join this study. The inclusion criteria were: (1) age ≥ 5 years; (2) diagnosis of acute leukemia including acute myeloid leukemia, acute lymphocytic leukemia, and mixed phenotype acute leukemia; (3) patients attained complete remission (CR) and achieved full engraftment with 100% donor chimerism following allo-HSCT; (4) telomere testing was conducted on peripheral leukocytes of donors before granulocyte colony-stimulating factor (G-CSF) mobilization, and the results were obtained. Written informed consent was obtained from all included patients and their donors, and the study was conducted in compliance with the Declaration of Helsinki. Ethical approval was approved by the ethics review committee of the First Affiliated Hospital of Zhejiang University School of Medicine.

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
5 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 5 years
  • First allo-HSCT from matched related, unrelated, or haploidentical donors
  • Achievement of complete remission after allo-HSCT
  • Donor blood sample collection before granulocyte colony-stimulating factor mobilization
  • Exclusion Criteria
  • Non-acute leukemia diagnoses, including acute myeloid leukemia, acute lymphocytic leukemia, and mixed phenotype acute leukemia
  • Failure to achieve engraftment with full donor chimerism after allo-HSCT
  • Inability to extract DNA for telomere length analysis.

排除标准

  • 未提供

结局指标

主要结局

Overall survival

时间窗: From date of transplantuntil the date of death from any cause, assessed up to 60 months.

The duration from transplant until death resulted from any cause.

次要结局

  • Relapse-free survival(From date of transplant until the date of relapse or death from any cause, assessed up to 60 months.)
  • Cumulative incidence of relapse(From date of transplant until the date of relapse, assessed up to 60 months.)

研究者

发起方
Zhejiang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

He Huang

The President of the First Affiliated Hospital, Zhejiang University School of Medicine

Zhejiang University

研究点 (1)

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