About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1: Patients undergo their first unrelated cord blood transplantation (UCBT) at our institution.
Disqualifiers
Participation in an interventional clinical trial investigating prophylactic donor-derived cell infusion (e.g., DLI, MSC) during the study period.
Trial population
The study population will consist of patients undergoing their first allogeneic unrelated donor umbilical cord blood transplantation as standard treatment for their underlying hematological diseases (both malignant and non-malignant) in the Department of Hematology at the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital).
Trial design
Cohort
Prospective
Treatments tested in this trial
Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders
Procedure/SurgeryAllogeneic umbilical cord blood transplantation as a standard treatment for underlying hematological diseases.
Treatment groups
Trial outcomes
Primary outcomes
Reconstitution 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.
Secondary outcomes
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.
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.
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.
Cumulative Incidence of Relapse
The cumulative incidence of disease relapse will be calculated, considering death without relapse as a competing risk.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.