Hematologic Disease and DisordersNCT07782684
Reconstruction Kinetics of γδ T Cells After Unrelated Cord Blood Transplantation
An observational study of Hematologic Disease and Disorders, run by Anhui Provincial Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematologic Disease and Disorders
- What is being tested?
- Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2025to 1 Oct 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- Participation in an interventional clinical trial investigating prophylactic donor-derived cell infusion (e.g., DLI, MSC) during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230000
星驰 陈, +8613803774813, drchen76@mail.ustc.edu.cn
About this study
Official title: Reconstruction Kinetics of γδ T Cells and Their Clinical Impact After Unrelated Cord Blood Transplantation
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.
Read the 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.
- Conditions
- Hematologic Disease and Disorders
- Being tested
- Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders
- Keywords
- Umbilical Cord Blood Transplantation, Immune reconstitution, γδ T
- Medical subject headings
- Hematologic Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic DisordersProcedure or surgery
Allogeneic umbilical cord blood transplantation as a standard treatment for underlying hematological diseases.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 1-2 year
Cumulative Incidence of Relapse
The cumulative incidence of disease relapse will be calculated, considering death without relapse as a competing risk.
Measured: 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.
Measured: 100 days, 1-2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start9 Oct 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic Disease and DisordersStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Xiao yu Zhu, ph.D, Principal investigator, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782684
- Sponsor's protocol ID
- CBγδT001
- Status last verified
- Oct 2025
- First submitted
- 20 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction Kinetics of γδ T Cells and Their Clinical Impact After Unrelated Cord Blood Transplantation
- ClinicalTrials.gov ID
- NCT07782684
- Acronym / sponsor ID
- CBγδT001
- Conditions
- Hematologic Disease and Disorders
- Keywords
- Umbilical Cord Blood Transplantation, Immune reconstitution, γδ T
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immune reconstitution after umbilical cord blood transplant | – | Procedure: Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic DisordersThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Participation in an interventional clinical trial investigating prophylactic donor-derived cell infusion (e.g., DLI, MSC) during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic DisordersAllogeneic umbilical cord blood transplantation as a standard treatment for underlying hematological diseases. | Procedure or surgery | Immune reconstitution after umbilical cord blood transplant |
Primary outcome
Reconstitution level of γδ T cells
Time frame: 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.
5 secondary outcomes
Overall Survival (OS)
Time frame: 1-5 year
Leukemia-free Survival (LFS)
Time frame: 1-5 year
GRFS (Graft-versus-Host Disease-free, Relapse-free Survival)
Time frame: 1-2 year
Cumulative Incidence of Relapse
Time frame: 1-5 year
Incidence of Acute Graft-versus-Host Disease (aGVHD) or Chronic Graft-versus-Host Disease (cGVHD)
Time frame: 100 days, 1-2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiao yu Zhu, ph.D principal investigator
The First Affiliated Hospital of University of Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Disease and Disorders, run by Anhui Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiao yu Zhu, ph.D (15255456091, xiaoyuz@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reconstitution level of γδ T cells (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.