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Trial Title:
A Retrospective Study on the Relationship Between Donor Leukocyte Telomere Length and Prognosis of Acute Leukemia Patients Treated With Allogeneic Hematopoietic Stem Cell Transplantation
NCT ID:
NCT06076226
Condition:
Acute Leukemia
Conditions: Official terms:
Leukemia
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
No intervention, observation study
Description:
No intervention, observation study
Arm group label:
Donors aged 40 years or older
Arm group label:
Donors aged < 40
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.
Criteria for eligibility:
Study pop:
This study aims to investigate the influence of donor blood telomere length on
recipients' clinical outcomes post-allogeneic hematopoietic stem cell transplant.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
5 Years
Maximum age:
90 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Clinical research ethics committee of the first affiliated hospital, college of medicine, zhejiang University
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
He Huang
Phone:
0571-87233772
Email:
hehuang@zju.edu.cn
Start date:
January 1, 2015
Completion date:
December 1, 2026
Lead sponsor:
Agency:
Zhejiang University
Agency class:
Other
Source:
Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06076226
