Hematologic Disease and Disorders
Conditions
Keywords
Umbilical Cord Blood Transplantation, Immune reconstitution, γδ T
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREUmbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders
Allogeneic umbilical cord blood transplantation as a standard treatment for underlying hematological diseases.
Sponsors
Anhui Provincial Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reconstitution level of γδ T cells | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 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. |
| Leukemia-free Survival (LFS) | 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. |
| GRFS (Graft-versus-Host Disease-free, Relapse-free Survival) | 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. |
| Cumulative Incidence of Relapse | 1-5 year | The cumulative incidence of disease relapse will be calculated, considering death without relapse as a competing risk. |
| Incidence of Acute Graft-versus-Host Disease (aGVHD) or Chronic Graft-versus-Host Disease (cGVHD) | 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. |
Countries
China
Contacts
CONTACTXiao yu Zhu, ph.D
CONTACTXing chi Chen
PRINCIPAL_INVESTIGATORXiao yu Zhu, ph.D
The First Affiliated Hospital of University of Science and Technology of China
Outcome results
None listed