An observational study in Hematopoietic Stem Cell Transplantation (HSCT), Acute Myeloid Leukemia (AML) and Leukemias, Acute Myeloid, sponsored by Yigeng Cao,MD,PhD. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by Yigeng Cao,MD,PhD · Observational
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.
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.
3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 114 across 395 observational studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →This is the only study on the registry with Yigeng Cao,MD,PhD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
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.
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.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
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.
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.
Time frame: From the date of HSCT until neutrophil engraftment or death, assessed up to 60 days
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).
Time frame: 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.
Time frame: 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.
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
Cumulative incidence of relapse/progression, with non-relapse mortality treated as a competing risk.
Time frame: 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.
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
Proportion of patients developing chronic GVHD, diagnosed and graded according to NIH 2014 consensus criteria. Death and relapse treated as competing risks.
Time frame: From the date of HSCT until 12 months post-transplant, assessed up to 12 months
Plan to share: 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.
No publications or documents are linked to this record.
Started Sep 2023 (actual). Primary completion is estimated for Dec 2060, 447 months after the start.
Of 128 non-industry observational studies under Leukemia, Myeloid, Acute, half reached primary completion within 66 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 234. This study's planned 447 months is above that.
Counting every sponsor, half of 160 studies reached it within 54 months; a quarter within 36 and three quarters within 154.
How these figures are worked out, and which studies are left out of them.
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