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

Sponsor
Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06076226
Collaborator
(none)
2,500
1
143
17.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention, observation study

Study Design

Study Type:
Observational
Anticipated Enrollment :
2500 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The First Affiliated Hospital, Zhejiang University School of Medicine
Actual Study Start Date :
Jan 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Donors aged 40 years or older

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

Donors aged < 40

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

Outcome Measures

Primary Outcome Measures

  1. Overall survival [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 Outcome Measures

  1. Relapse-free survival [From 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.

  2. Cumulative incidence of relapse [From date of transplant until the date of relapse, assessed up to 60 months.]

    The time interval between the transplant and the occurrence of relapse.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 90 Years
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
He Huang, The President of the First Affiliated Hospital, Zhejiang University School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT06076226
Other Study ID Numbers:
  • Telo-2015-HSCT
First Posted:
Oct 10, 2023
Last Update Posted:
Oct 10, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 10, 2023