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NCT Number: NCT07782684

Reconstruction Kinetics of γδ T Cells After Unrelated Cord Blood Transplantation

The primary objective is to investigate the correlation between specific patterns of γδ T cell reconstitution after umbilical cord blood transplantation and key clinical outcomes.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

the First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, 230000, China

Location status: Recruiting

Location contact

星驰 陈

CONTACT

[email protected]

+8613803774813

About this study

This study is a prospective, observational clinical investigation. Allogeneic umbilical cord blood transplantation is a critical treatment for hematological malignancies and other disorders. However, the reconstitution of the immune system post-transplantation, particularly the dynamics of non-conventional γδ T cells compared to αβ T cells, and their impact on clinical outcomes remain poorly understood.

This study aims to systematically characterize the reconstitution kinetics of γδ T cells and their subsets in patients following allogeneic UCBT. We will sequentially collect peripheral blood samples from patients post-transplant and dynamically monitor the quantity, proportion, and changes in major functional subsets of γδ T cells using flow cytometry.

The primary objective is to investigate the correlation between specific patterns of γδ T cell reconstitution and key clinical outcomes. These outcomes include the incidence and severity of graft-versus-host disease, disease relapse rate, transplant-related mortality, and overall patient survival. We anticipate that this study will identify novel biomarkers for assessing immune reconstitution status after UCBT and provide a rationale for future immunotherapeutic strategies aimed at modulating γδ T cells to improve patient prognosis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1: Patients undergo their first unrelated cord blood transplantation (UCBT) at our institution.

2: Diagnosis of a hematologic malignancy or disorder eligible for UCBT (e.g., acute leukemia, myelodysplastic syndrome, severe aplastic anemia)

3: Willing and able to provide written informed consent.

4: No restrictions on gender, age, or race.

Exclusion criteria

  • Participation in an interventional clinical trial investigating prophylactic donor-derived cell infusion (e.g., DLI, MSC) during the study period.

Treatment and study plan

Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders

Procedure

Allogeneic umbilical cord blood transplantation as a standard treatment for underlying hematological diseases.

Primary outcomes

  1. Reconstitution level of γδ T cells

    Time frame: 1 year

    The reconstitution level of γδ T cells in peripheral blood will be measured by flow cytometry at 1, 2, 3, 6, 9, and 12 months after umbilical cord blood transplantation. The outcome is measured as the absolute cell count per microliter of blood and/or the percentage of γδ T cells within total lymphocytes.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: 1-5 year

    Overall survival is defined as the time from the date of umbilical cord blood transplantation to the date of death from any cause. Patients who are still alive at the time of analysis will be censored at the last known date of contact.

  2. Leukemia-free Survival (LFS)

    Time frame: 1-5 year

    Leukemia-free survival is defined as the time from transplantation to the first event of either relapse or death from any cause. Patients who are alive and relapse-free at the time of analysis will be censored at the last follow-up date.

  3. GRFS (Graft-versus-Host Disease-free, Relapse-free Survival)

    Time frame: 1-2 year

    GRFS is defined as the time from transplantation to the first event of grade III-IV acute GVHD, chronic GVHD requiring systemic treatment, relapse, or death from any cause.

  4. Cumulative Incidence of Relapse

    Time frame: 1-5 year

    The cumulative incidence of disease relapse will be calculated, considering death without relapse as a competing risk.

  5. Incidence of Acute Graft-versus-Host Disease (aGVHD) or Chronic Graft-versus-Host Disease (cGVHD)

    Time frame: 100 days, 1-2 year

    The incidence and severity of grades II-IV and III-IV acute GVHD will be assessed and graded according to the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria or the classic Glucksberg criteria. The incidence and severity of chronic GVHD will be assessed and graded according to the National Institutes of Health (NIH) consensus criteria.

Study contacts

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

Xiao yu Zhu, ph.D

CONTACT

[email protected]

15255456091

Xing chi Chen

CONTACT

[email protected]

13803774813

Sponsors and collaborators

Lead sponsor

Anhui Provincial Hospital

Other Gov

Registry information

Official study title

Reconstruction Kinetics of γδ T Cells and Their Clinical Impact After Unrelated Cord Blood Transplantation

Important dates

Study start
2025
Primary completion
2026
Study completion
2030
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

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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