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NCT Number: NCT06076226

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

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.

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Key information

Conditions

Age range

5 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Hangzhou, Zhejiang, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention, observation study

Other

No intervention, observation study

Primary outcomes

  1. Overall survival

    Time frame: 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 outcomes

  1. Relapse-free survival

    Time frame: 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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

He Huang, PhD&MD

CONTACT

[email protected]

+86 13605714822

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

The First Affiliated Hospital, Zhejiang University School of Medicine

Important dates

Study start
2015
Primary completion
2025
Study completion
2026
First posted
Oct 10, 2023
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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