High-Altitude Hematology Observation-Stem Cell Transplantation (HALO-SCT)

Recruiting

• Conditions: Hematopoietic Stem Cell Transplantation (HSCT); Acute Myeloid Leukemia (AML); Leukemias, Acute Myeloid; Myeloid Leukemias, Acute; Hemophilia; Myelodysplastic Syndrome; MDS; Lymphoma; Leukemia; Aplastic Anemia

• Registration Number: NCT07205523
• Lead Sponsor: Yigeng Cao,MD,PhD

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.

Study Timeline

• Study Start: 2023-09-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-12
• Study First Submitted QC: 2025-09-25
• Last Update Submitted: 2025-09-25
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Primary Completion: 2060-12-31
• Study Completion: 2100-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.
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.
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.

Trial Locations

Locations (1)

Affiliated Hospital of Qinghai University; 🇨🇳 Xining, Qinghai, China