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

NCT06076226 | Recruiting

• 1 other identifier: Telo-2015-HSCT
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Leukemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Relapse-free survival

  From date of transplant until the date of relapse or death from any cause, assessed up to 60 months.

• Cumulative incidence of relapse

  From date of transplant until the date of relapse, assessed up to 60 months.

Study Arms (2)

Donors aged 40 years or older

Other: No intervention, observation study

Donors aged < 40

Other: No intervention, observation study

Interventions

No intervention, observation study OTHER

No intervention, observation study

Donors aged 40 years or older; Donors aged < 40

Eligibility Criteria

• Age: 5 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study aims to investigate the influence of donor blood telomere length on recipients' clinical outcomes post-allogeneic hematopoietic stem cell transplant.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

Clinical research ethics committee of the first affiliated hospital, college of medicine, zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Central Study Contacts

He Huang, PhD&MD

CONTACT

+86 13605714822; huanghe@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The President of the First Affiliated Hospital, Zhejiang University School of Medicine

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 10, 2023
• Study Start: January 1, 2015
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)