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NCT Number: NCT07205523

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

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.

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Key information

Conditions

Hematopoietic Stem Cell Transplantation (HSCT) Acute Myeloid Leukemia (AML) Anemia Anemia, Aplastic Aplastic Anemia Bleeding Disorders Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Blood Protein Disorders Bone Marrow Diseases Bone Marrow Failure Disorders Bone Marrow Transplantation Cardiovascular Diseases Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia Hemophilia A Hemorrhagic Disorders Hemostatic Disorders Immune Reconstitution Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemias, Acute Myeloid Lymphatic Diseases Lymphoma Lymphoproliferative Disorders MDS Multiple Myeloma Myelodysplastic Syndrome Myelodysplastic Syndromes Myeloid Leukemias, Acute Myeloma, Multiple Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Incidence of acute GVHD

    Time frame: 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).

  2. Overall survival

    Time frame: 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.

  3. 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

    DFS is defined as survival without relapse or progression. Patients alive without relapse at last follow-up will be censored.

  4. Cumulative incidence of relapse

    Time frame: 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.

  5. Immune reconstitution

    Time frame: 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.

  6. Incidence of chronic GVHD

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Geng

CONTACT

[email protected]

+8618729989935

Yigeng CAO, MD,PhD

CONTACT

[email protected]

+8618622477066

Sponsors and collaborators

Lead sponsor

Yigeng Cao,MD,PhD

Other

Registry information

Official study title

High-Altitude Hematology Observation-Stem Cell Transplantation (HALO-SCT): A Prospective Real-World Cohort Study in the Qinghai-Tibet Plateau

Acronym: HALO-SCT

Important dates

Study start
2023
Primary completion
2060
Study completion
2100
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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