An observational study in Hematologic Disease and Disorders, sponsored by Anhui Provincial Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Anhui Provincial Hospital · Observational
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.
609 studies on the registry are indexed under Hematologic Diseases; 108 are open to participants now.
This study's planned enrollment of 100 is below the median of 250 across 127 observational studies indexed under Hematologic Diseases.
Browse Hematologic Diseases studies →Anhui Provincial Hospital is the lead sponsor of 135 studies on the registry; 101 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1: Patients undergo their first unrelated cord blood transplantation (UCBT) at our institution.
2: Diagnosis of a hematologic or disorder eligible for UCBT (e.g., acute leukemia, myelodysplastic syndrome, severe aplastic anemia)
3: Willing and able to provide written .
4: No restrictions on gender, age, or race.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Allogeneic umbilical cord blood transplantation as a standard treatment for underlying hematological diseases.
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
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.
Time frame: 100 days, 1-2 year
Started Oct 2025 (actual). Primary completion is estimated for Nov 2026, 12 months after the start.
Of 47 non-industry observational studies under Hematologic Diseases, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 190. This study's planned 12 months is below that.
Counting every sponsor, half of 64 studies reached it within 51 months; a quarter within 16 and three quarters within 78.
How these figures are worked out, and which studies are left out of them.
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