NCT07782684

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
50mo left

Started Oct 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Oct 2025Oct 2030

Study Start

First participant enrolled

October 9, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2030

Last Updated

August 24, 2026

Status Verified

October 1, 2025

Enrollment Period

1.1 years

First QC Date

August 20, 2026

Last Update Submit

August 20, 2026

Conditions

Keywords

Umbilical Cord Blood TransplantationImmune reconstitutionγδ T

Outcome Measures

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.

    1 year

Secondary Outcomes (5)

  • Overall Survival (OS)

    1-5 year

  • Leukemia-free Survival (LFS)

    1-5 year

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

    1-2 year

  • Cumulative Incidence of Relapse

    1-5 year

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

    100 days, 1-2 year

Study Arms (1)

Immune reconstitution after umbilical cord blood transplant

This is the single cohort of the study, comprising all patients who received an allogeneic umbilical cord blood transplant. The kinetics of γδ T cell and other immune cells reconstitution will be analyzed for the entire cohort.

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

Interventions

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

Immune reconstitution after umbilical cord blood transplant

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study 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).

You may qualify if:

  • : Patients undergo their first unrelated cord blood transplantation (UCBT) at our institution.
  • : Diagnosis of a hematologic malignancy or disorder eligible for UCBT (e.g., acute leukemia, myelodysplastic syndrome, severe aplastic anemia)
  • : Willing and able to provide written informed consent.
  • : No restrictions on gender, age, or race.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hefei, Anhui, 230000, China

RECRUITING

MeSH Terms

Conditions

Hematologic DiseasesDisease

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xiao yu Zhu, ph.D

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao yu Zhu, ph.D

CONTACT

Xing chi Chen

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2026

First Posted

August 24, 2026

Study Start

October 9, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

October 1, 2030

Last Updated

August 24, 2026

Record last verified: 2025-10

Locations