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Clinical Trials/NCT06076226
NCT06076226RecruitingNot Applicable

The First Affiliated Hospital, Zhejiang University School of Medicine

Zhejiang University1 site in 1 country2,500 target enrollmentStarted: January 1, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
2,500
Locations
1
Primary Endpoint
Overall survival

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
5 Years to 90 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Overall survival

Time Frame: 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.

Secondary Outcomes

  • 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.)

Investigators

Sponsor
Zhejiang University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

He Huang

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

Zhejiang University

Study Sites (1)

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