Hematopoietic Stem Cell Transplantation (HSCT)HALO-SCTNCT07205523
High-Altitude Hematology Observation-Stem Cell Transplantation (HALO-SCT)
An observational study of Hematopoietic Stem Cell Transplantation (HSCT) and Acute Myeloid Leukemia (AML), run by Yigeng Cao,MD,PhD at 1 site in China.
Trial summary
The High-Altitude Hematology Observation-Stem Cell Transplantation (HALO-SCT) study is the first prospective real-world cohort of hematologic diseases and transplantation in the Qinghai-Tibet Plateau. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation (HSCT), Acute Myeloid Leukemia (AML), Leukemias, Acute Myeloid
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 Dec 2100
- How long will I take part?
- 100 Years
- 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: Patients with hematologic diseases undergoing hematopoietic stem cell transplantation (HSCT) and their donors at the Affiliated Hospital of Qinghai University, located in the Qinghai-Tibet Plateau. The registry systematically captures demographic, clinical, and outcome data under real-world conditions in a high-altitude environment.
Who may be able to join
- Patients diagnosed with hematologic diseases who are admitted to the HSCT center of Qinghai University Affiliated Hospital on or after September 1, 2023.
- Planned or actual hematopoietic stem cell transplantation (HSCT).
- Provision of signed informed consent.
Who cannot join
- Inability to provide long-term follow-up data due to severe comorbidities or logistical reasons.
- Substance abuse compromising adherence.
- Any condition judged by investigators to jeopardize safety or compliance.
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
Affiliated Hospital of Qinghai University
Xining, Qinghai, 810001
Yigeng CAO, MD,PhD, +8618622477066, caoyigeng@ihcams.ac.cn
Hui Geng, gh0227@sina.com
About this study
Official title: High-Altitude Hematology Observation-Stem Cell Transplantation (HALO-SCT): A Prospective Real-World Cohort Study in the Qinghai-Tibet Plateau
The High-Altitude Hematology Observation-Stem Cell Transplantation (HALO-SCT) study is the first prospective real-world cohort of hematologic diseases and transplantation in the Qinghai-Tibet Plateau. Patients undergoing hematopoietic stem cell transplantation (HSCT) at Qinghai University Affiliated Hospital, together with their donors, are systematically enrolled. The registry collects demographic, diagnostic, treatment, prognosis, and medical expense information, as well as biospecimens for future analyses. Historical data are incorporated, and prospective data collection is ongoing with long-term follow-up planned. The registry is designed as a sustainable research infrastructure to provide comprehensive data on disease incidence, treatment patterns, outcomes, and resource utilization in a high-altitude setting.
Read the detailed description
HALO-SCT is a prospective observational patient registry established at Qinghai University Affiliated Hospital, the first HSCT center in the Qinghai-Tibet Plateau. The registry aims to systematically capture patient and donor characteristics, transplant-related procedures, treatment outcomes, and long-term follow-up data in a high-altitude environment. Biospecimens, including peripheral blood and bone marrow samples, are collected at baseline and follow-up time points for future multi-omics studies. All clinical decisions follow routine practice; no experimental interventions are mandated by the protocol. The registry is intended as a long-term infrastructure project, with continuous data collection and integration into national and international collaborative research efforts.
- Conditions
- Hematopoietic Stem Cell Transplantation (HSCT), Acute Myeloid Leukemia (AML), Leukemias, Acute Myeloid, Myeloid Leukemias, Acute, Hemophilia, Myelodysplastic Syndrome
- Keywords
- High-altitude Bone marrow transplantation Allogeneic HSCT Autologous HSCT Immune reconstitution Graft-versus-host disease Relapse Survival Quality of life
- Medical subject headings
- Leukemia, Myeloid, Acute, Hemophilia A, Myelodysplastic Syndromes, Lymphoma, Leukemia, Anemia, Aplastic, Hemostatic Disorders, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HSCT Patients and Donors | Patients undergoing hematopoietic stem cell transplantation (HSCT) at Qinghai University Affiliated Hospital, and their related or unrelated stem cell donors. Participants are prospectively followed for clinical outcomes and biospecimen collection under real-world conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to neutrophil engraftment
Defined as the first of 3 consecutive days with absolute neutrophil count (ANC) ≥ 0.5 × 10⁹/L without primary graft failure. Patients who die without engraftment before day +60 will be censored.
Measured: From the date of HSCT until neutrophil engraftment or death, assessed up to 60 days
Secondary outcomes (6)
Incidence of acute GVHD
Proportion of patients developing grade I-IV acute GVHD, excluding events occurring after donor lymphocyte infusion (DLI). Diagnosis and grading based on consensus criteria (e.g., MAGIC).
Measured: From the date of HSCT until day +100, assessed up to 100 days
Overall survival
OS is defined as time from HSCT to death from any cause. Patients alive at last follow-up will be censored.
Measured: From the date of HSCT until death from any cause, assessed up to 12 months
Disease-free survival
DFS is defined as survival without relapse or progression. Patients alive without relapse at last follow-up will be censored.
Measured: From the date of HSCT until relapse/progression or death from any cause, whichever occurs first, assessed up to 12 months
Cumulative incidence of relapse
Cumulative incidence of relapse/progression, with non-relapse mortality treated as a competing risk.
Measured: From the date of HSCT until relapse/progression, assessed up to 12 months
Immune reconstitution
Serial assessment of immune reconstitution, including lymphocyte subsets, immunoglobulin recovery, and functional immune assays.
Measured: From the date of HSCT until 12 months post-transplant, assessed at prespecified time points (e.g., day +30, +180,)
Incidence of chronic GVHD
Proportion of patients developing chronic GVHD, diagnosed and graded according to NIH 2014 consensus criteria. Death and relapse treated as competing risks.
Measured: From the date of HSCT until 12 months post-transplant, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Sep 2023
- Primary completion31 Dec 2060 (estimated)
- Study completion31 Dec 2100 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell Transplantation (HSCT)Studies of the same condition, open and under way.
- 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
- 1,000 participants (estimated)
- Target duration
- 100 Years
Sponsor and investigators
- Lead sponsor
- Yigeng Cao,MD,PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yigeng Cao,MD,PhD, Affiliated Hospital of Qinghai University
- Investigators
- Hui Geng, Principal investigator, Affiliated Hospital of Qinghai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205523
- Sponsor's protocol ID
- HALO-SCT-2023
- Acronym
- HALO-SCT
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the registry collects sensitive clinical and genetic information from transplant patients and donors in a high-altitude region. Data sharing may compromise patient privacy and is not permitted under current institutional and ethical committee policies. Only aggregated results will be reported publicly.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Altitude Hematology Observation-Stem Cell Transplantation (HALO-SCT): A Prospective Real-World Cohort Study in the Qinghai-Tibet Plateau
- ClinicalTrials.gov ID
- NCT07205523
- Acronym / sponsor ID
- HALO-SCT / HALO-SCT-2023
- Conditions
- Hematopoietic Stem Cell Transplantation (HSCT), Acute Myeloid Leukemia (AML), Leukemias, Acute Myeloid, Myeloid Leukemias, Acute, Hemophilia, Myelodysplastic Syndrome
- Keywords
- High-altitude Bone marrow transplantation Allogeneic HSCT Autologous HSCT Immune reconstitution Graft-versus-host disease Relapse Survival Quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Yigeng Cao,MD,PhDUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2060 (estimated)
- Study completion
- 31 Dec 2100 (estimated)
- First posted
- 3 Oct 2025 (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 High-Altitude Hematology Observation-Stem Cell Transplantation (HALO-SCT) study is the first prospective real-world cohort of hematologic diseases and transplantation in the Qinghai-Tibet Plateau. Patients undergoing hematopoietic stem cell transplantation (HSCT) at Qinghai University Affiliated Hospital, together with their donors, are systematically enrolled. The registry collects demographic, diagnostic, treatment, prognosis, and medical expense information, as well as biospecimens for future analyses. Historical data are incorporated, and prospective data collection is ongoing with long-term follow-up planned. The registry is designed as a sustainable research infrastructure to provide comprehensive data on disease incidence, treatment patterns, outcomes, and resource utilization in a high-altitude setting.
Detailed description
HALO-SCT is a prospective observational patient registry established at Qinghai University Affiliated Hospital, the first HSCT center in the Qinghai-Tibet Plateau. The registry aims to systematically capture patient and donor characteristics, transplant-related procedures, treatment outcomes, and long-term follow-up data in a high-altitude environment. Biospecimens, including peripheral blood and bone marrow samples, are collected at baseline and follow-up time points for future multi-omics studies. All clinical decisions follow routine practice; no experimental interventions are mandated by the protocol. The registry is intended as a long-term infrastructure project, with continuous data collection and integration into national and international collaborative research efforts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 100 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HSCT Patients and Donors | – | –Patients undergoing hematopoietic stem cell transplantation (HSCT) at Qinghai University Affiliated Hospital, and their related or unrelated stem cell donors. Participants are prospectively followed for clinical outcomes and biospecimen collection under real-world conditions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with hematologic diseases undergoing hematopoietic stem cell transplantation (HSCT) and their donors at the Affiliated Hospital of Qinghai University, located in the Qinghai-Tibet Plateau. The registry systematically captures demographic, clinical, and outcome data under real-world conditions in a high-altitude environment.
Key inclusion criteria (3 listed)
- Patients diagnosed with hematologic diseases who are admitted to the HSCT center of Qinghai University Affiliated Hospital on or after September 1, 2023.
- Planned or actual hematopoietic stem cell transplantation (HSCT).
- Provision of signed informed consent.
Key exclusion criteria (3 listed)
- Inability to provide long-term follow-up data due to severe comorbidities or logistical reasons.
- Substance abuse compromising adherence.
- Any condition judged by investigators to jeopardize safety or compliance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to neutrophil engraftment
Time frame: From the date of HSCT until neutrophil engraftment or death, assessed up to 60 days
Defined as the first of 3 consecutive days with absolute neutrophil count (ANC) ≥ 0.5 × 10⁹/L without primary graft failure. Patients who die without engraftment before day +60 will be censored.
6 secondary outcomes
Incidence of acute GVHD
Time frame: From the date of HSCT until day +100, assessed up to 100 days
Overall survival
Time frame: From the date of HSCT until death from any cause, assessed up to 12 months
Disease-free survival
Time frame: From the date of HSCT until relapse/progression or death from any cause, whichever occurs first, assessed up to 12 months
Cumulative incidence of relapse
Time frame: From the date of HSCT until relapse/progression, assessed up to 12 months
Immune reconstitution
Time frame: From the date of HSCT until 12 months post-transplant, assessed at prespecified time points (e.g., day +30, +180,)
Incidence of chronic GVHD
Time frame: From the date of HSCT until 12 months post-transplant, assessed up to 12 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 3 Oct 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the registry collects sensitive clinical and genetic information from transplant patients and donors in a high-altitude region. Data sharing may compromise patient privacy and is not permitted under current institutional and ethical committee policies. Only aggregated results will be reported publicly.
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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.
Hui Geng principal investigator
Affiliated Hospital of Qinghai University
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 Hematopoietic Stem Cell Transplantation (HSCT) and Acute Myeloid Leukemia (AML), run by Yigeng Cao,MD,PhD 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 3 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 3 Oct 2025. 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 Yigeng CAO, MD,PhD (+8618622477066, caoyigeng@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to neutrophil engraftment (time frame: From the date of HSCT until neutrophil engraftment or death, assessed up to 60 days). 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 3 Oct 2025.