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

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Donors aged 40 years or older

No intervention, observation study

Intervention Type OTHER

No intervention, observation study

Donors aged < 40

No intervention, observation study

Intervention Type OTHER

No intervention, observation study

Interventions

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No intervention, observation study

No intervention, observation study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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He Huang

The President of the First Affiliated Hospital, Zhejiang University School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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He Huang, PhD&MD

Role: CONTACT

+86 13605714822

Facility Contacts

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He Huang

Role: primary

0571-87233772

Other Identifiers

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Telo-2015-HSCT

Identifier Type: -

Identifier Source: org_study_id

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