Acute LeukemiaNCT06076226
A Retrospective Study on the Relationship Between Donor Leukocyte Telomere Length and Prognosis of Acute Leukemia Patients Treated With Allogeneic Hematopoietic Stem Cell Transplantation
An observational study of Acute Leukemia, run by Zhejiang University at 1 site in China.
Trial summary
This post hoc analysis included patients with acute leukemia who underwent allo-HSCT at the First Affiliated Hospital of Zhejiang University School of Medicine and Ruijin Hospital Shanghai Jiaotong University School of Medicine. Patients and their donors were assessed for eligibility to join this study. Read more about this study
- Who is it for?
- Ages 5 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Leukemia
- How many people
- 2,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 1 Dec 2026
- 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 5 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This study aims to investigate the influence of donor blood telomere length on recipients' clinical outcomes post-allogeneic hematopoietic stem cell transplant.
Who may be able to join
- Age ≥ 5 years
- First allo-HSCT from matched related, unrelated, or haploidentical donors
- Achievement of complete remission after allo-HSCT
- Donor blood sample collection before granulocyte colony-stimulating factor mobilization
Who cannot join
- Non-acute leukemia diagnoses, including acute myeloid leukemia, acute lymphocytic leukemia, and mixed phenotype acute leukemia
- Failure to achieve engraftment with full donor chimerism after allo-HSCT
- Inability to extract DNA for telomere length analysis.
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
Clinical research ethics committee of the first affiliated hospital, college of medicine, zhejiang University
Hangzhou, Zhejiang
He Huang, 0571-87233772, hehuang@zju.edu.cn
About this study
Official title: The First Affiliated Hospital, Zhejiang University School of Medicine
This post hoc analysis included patients with acute leukemia who underwent allo-HSCT at the First Affiliated Hospital of Zhejiang University School of Medicine and Ruijin Hospital Shanghai Jiaotong University School of Medicine. Patients and their donors were assessed for eligibility to join this study. The inclusion criteria were: (1) age ≥ 5 years; (2) diagnosis of acute leukemia including acute myeloid leukemia, acute lymphocytic leukemia, and mixed phenotype acute leukemia; (3) patients attained complete remission (CR) and achieved full engraftment with 100% donor chimerism following allo-HSCT; (4) telomere testing was conducted on peripheral leukocytes of donors before granulocyte colony-stimulating factor (G-CSF) mobilization, and the results were obtained. Written informed consent was obtained from all included patients and their donors, and the study was conducted in compliance with the Declaration of Helsinki. Ethical approval was approved by the ethics review committee of the First Affiliated Hospital of Zhejiang University School of Medicine.
- Conditions
- Acute Leukemia
- Being tested
- No intervention, observation study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, observation studyOther
No intervention, observation study
| Study group | Role | What they receive |
|---|---|---|
| Donors aged 40 years or older | Not described Receives: Other: No intervention, observation study | |
| Donors aged < 40 | Not described Receives: Other: No intervention, observation study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The duration from transplant until death resulted from any cause.
Measured: From date of transplantuntil the date of death from any cause, assessed up to 60 months.
Secondary outcomes (2)
Relapse-free survival
The time from transplant until death or relapse.
Measured: From date of transplant until the date of relapse or death from any cause, assessed up to 60 months.
Cumulative incidence of relapse
The time interval between the transplant and the occurrence of relapse.
Measured: From date of transplant until the date of relapse, assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Jan 2015
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Huang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076226
- Sponsor's protocol ID
- Telo-2015-HSCT
- Status last verified
- Oct 2023
- First submitted
- 27 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Affiliated Hospital, Zhejiang University School of Medicine
- ClinicalTrials.gov ID
- NCT06076226
- Acronym / sponsor ID
- Telo-2015-HSCT
- Conditions
- Acute Leukemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 10 Oct 2023 (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.
This post hoc analysis included patients with acute leukemia who underwent allo-HSCT at the First Affiliated Hospital of Zhejiang University School of Medicine and Ruijin Hospital Shanghai Jiaotong University School of Medicine. Patients and their donors were assessed for eligibility to join this study. The inclusion criteria were: (1) age ≥ 5 years; (2) diagnosis of acute leukemia including acute myeloid leukemia, acute lymphocytic leukemia, and mixed phenotype acute leukemia; (3) patients attained complete remission (CR) and achieved full engraftment with 100% donor chimerism following allo-HSCT; (4) telomere testing was conducted on peripheral leukocytes of donors before granulocyte colony-stimulating factor (G-CSF) mobilization, and the results were obtained. Written informed consent was obtained from all included patients and their donors, and the study was conducted in compliance with the Declaration of Helsinki. Ethical approval was approved by the ethics review committee of the First Affiliated Hospital of Zhejiang University School of Medicine.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donors aged 40 years or older | – | Other: No intervention, observation study |
| Donors aged < 40 | – | Other: No intervention, observation study |
Who may qualify
- Ages
- 5 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study aims to investigate the influence of donor blood telomere length on recipients' clinical outcomes post-allogeneic hematopoietic stem cell transplant.
Key inclusion criteria (4 listed)
- Age ≥ 5 years
- First allo-HSCT from matched related, unrelated, or haploidentical donors
- Achievement of complete remission after allo-HSCT
- Donor blood sample collection before granulocyte colony-stimulating factor mobilization
Key exclusion criteria (3 listed)
- Non-acute leukemia diagnoses, including acute myeloid leukemia, acute lymphocytic leukemia, and mixed phenotype acute leukemia
- Failure to achieve engraftment with full donor chimerism after allo-HSCT
- Inability to extract DNA for telomere length analysis.
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 |
|---|---|---|
| No intervention, observation studyNo intervention, observation study | Other | Donors aged 40 years or older, Donors aged < 40 |
Primary outcome
Overall survival
Time frame: From date of transplantuntil the date of death from any cause, assessed up to 60 months.
The duration from transplant until death resulted from any cause.
2 secondary outcomes
Relapse-free survival
Time frame: From date of transplant until the date of relapse or death from any cause, assessed up to 60 months.
Cumulative incidence of relapse
Time frame: From date of transplant until the date of relapse, assessed up to 60 months.
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 10 Oct 2023.
- Individual participant dataSharing planned: No
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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.
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 Acute Leukemia, run by Zhejiang University 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 3 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 10 Oct 2023. 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 He Huang, PhD&MD (+86 13605714822, huanghe@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From date of transplantuntil the date of death from any cause, assessed up to 60 months.). 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 10 Oct 2023.