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

The First Affiliated Hospital, Zhejiang University School of Medicine

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06076226
Enrollment
2500
Registered
2023-10-10
Start date
2015-01-01
Completion date
2026-12-01
Last updated
2023-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Leukemia

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.

Interventions

OTHERNo intervention, observation study

No intervention, observation study

Sponsors

Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 90 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Overall survivalFrom 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

MeasureTime frameDescription
Relapse-free survivalFrom date of transplant until the date of relapse or death from any cause, assessed up to 60 months.The time from transplant until death or relapse.
Cumulative incidence of relapseFrom date of transplant until the date of relapse, assessed up to 60 months.The time interval between the transplant and the occurrence of relapse.

Countries

China

Contacts

Primary ContactHe Huang, PhD&MD
huanghe@zju.edu.cn+86 13605714822

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026