Acute Myeloid Leukemia (AML), Aplastic Anemia, Bleeding Disorders, Bone Marrow Transplantation, Hematopoietic Stem Cell Transplantation (HSCT), Hemophilia, Immune Reconstitution, Leukemia, Leukemias, Acute Myeloid, Lymphoma, MDS, Multiple Myeloma, Myelodysplastic Syndrome, Myeloid Leukemias, Acute, Myeloma, Multiple
Conditions
Keywords
High-altitude Bone marrow transplantation Allogeneic HSCT Autologous HSCT Immune reconstitution Graft-versus-host disease Relapse Survival Quality of life
Brief 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. 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.
Interventions
None listed
Sponsors
Yigeng Cao,MD,PhD
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patients diagnosed with hematologic diseases who are admitted to the HSCT center of Qinghai University Affiliated Hospital on or after September 1, 2023. 2. Planned or actual hematopoietic stem cell transplantation (HSCT). 3. Provision of signed informed consent.
Exclusion criteria
1. Inability to provide long-term follow-up data due to severe comorbidities or logistical reasons. 2. Substance abuse compromising adherence. 3. Any condition judged by investigators to jeopardize safety or compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to neutrophil engraftment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | From the date of HSCT until death from any cause, assessed up to 12 months | OS is defined as time from HSCT to death from any cause. Patients alive at last follow-up will be censored. |
| Disease-free survival | From the date of HSCT until relapse/progression or death from any cause, whichever occurs first, assessed up to 12 months | DFS is defined as survival without relapse or progression. Patients alive without relapse at last follow-up will be censored. |
| Incidence of acute GVHD | From the date of HSCT until day +100, assessed up to 100 days | 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). |
| Immune reconstitution | From the date of HSCT until 12 months post-transplant, assessed at prespecified time points (e.g., day +30, +180,) | Serial assessment of immune reconstitution, including lymphocyte subsets, immunoglobulin recovery, and functional immune assays. |
| Incidence of chronic GVHD | From the date of HSCT until 12 months post-transplant, assessed up to 12 months | Proportion of patients developing chronic GVHD, diagnosed and graded according to NIH 2014 consensus criteria. Death and relapse treated as competing risks. |
| Cumulative incidence of relapse | From the date of HSCT until relapse/progression, assessed up to 12 months | Cumulative incidence of relapse/progression, with non-relapse mortality treated as a competing risk. |
Countries
China
Contacts
Primary ContactYigeng CAO, MD,PhD
Backup ContactHui Geng
Outcome results
None listed