Reconstruction Kinetics of γδ T Cells After Unrelated Cord Blood Transplantation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAnhui Provincial Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Procedure/Surgery

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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Immune reconstitution after umbilical cord blood transplant1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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