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

ConditionsHematopoietic Stem Cell Transplantation (HSCT)Acute Myeloid Leukemia (AML)Leukemias, Acute MyeloidMyeloid Leukemias, AcuteHemophiliaMyelodysplastic SyndromeMDSLymphomaLeukemiaAplastic AnemiaBleeding DisordersBone Marrow TransplantationMultiple MyelomaMyeloma, MultipleImmune Reconstitution
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorYigeng Cao,MD,PhD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: HSCT Patients and Donors

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yigeng Cao,MD,PhD

Lead sponsor

Affiliated Hospital of Qinghai University

Sponsor institution

Source ClinicalTrials.gov
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