A Retrospective Study on the Relationship Between Donor Leukocyte Telomere Length and Prognosis of Acute Leukemia Patients Treated With Allogeneic Hematopoietic Stem Cell Transplantation

Acute Leukemia Clinical Trial

Official title:

The First Affiliated Hospital, Zhejiang University School of Medicine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06076226
• Other study ID #: Telo-2015-HSCT
• Status: Recruiting
• Start date: January 1, 2015
• Est. completion date: December 1, 2026

Study information

• Verified date: October 2023
• Source: Zhejiang University
• Contact: He Huang, PhD&MD
• Phone: +86 13605714822
• Email: huanghe[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Leukemia
• Leukemia

Intervention

Other:
• No intervention, observation study
No intervention, observation study

Locations

Country	Name	City	State
China	Clinical research ethics committee of the first affiliated hospital, college of medicine, zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	The duration from transplant until death resulted from any cause.	From date of transplantuntil the date of death from any cause, assessed up to 60 months.
Secondary	Relapse-free survival	The time from transplant until death or relapse.	From date of transplant until the date of relapse or death from any cause, assessed up to 60 months.
Secondary	Cumulative incidence of relapse	The time interval between the transplant and the occurrence of relapse.	From date of transplant until the date of relapse, assessed up to 60 months.