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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06076226
Other study ID # Telo-2015-HSCT
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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