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.
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.
Study Type
OBSERVATIONAL
Enrollment
100
Allogeneic umbilical cord blood transplantation as a standard treatment for underlying hematological diseases.
the First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
RECRUITINGReconstitution level of γδ T cells
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.
Time frame: 1 year
Overall Survival (OS)
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.
Time frame: 1-5 year
Leukemia-free Survival (LFS)
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.
Time frame: 1-5 year
GRFS (Graft-versus-Host Disease-free, Relapse-free Survival)
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.
Time frame: 1-2 year
Cumulative Incidence of Relapse
The cumulative incidence of disease relapse will be calculated, considering death without relapse as a competing risk.
Time frame: 1-5 year
Incidence of Acute Graft-versus-Host Disease (aGVHD) or Chronic Graft-versus-Host Disease (cGVHD)
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.
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Time frame: 100 days, 1-2 year