Moxibustion for Steroid-Refractory Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

Exclusion Criteria11

• Participants meeting any of the following criteria will be excluded:
• Prior treatment with ≥1 systemic therapy for aGVHD other than corticosteroids. Diagnosis of GVHD overlap syndrome according to NIH criteria. History of splenectomy after transplantation. Evidence of relapse of the underlying disease or receipt of anti-relapse therapy after transplantation.
• Unresolved toxicities or complications from prior transplantation (excluding GVHD).
• Prior moxibustion therapy after transplantation. Uncontrolled active infection. Known human immunodeficiency virus (HIV) infection. Active hepatitis B or C infection requiring treatment, or risk of HBV reactivation.
• Receipt of other investigational therapy within 21 days prior to enrollment (or within 5 half-lives, whichever is longer).
• Renal dysfunction: serum creatinine ≥ 2.0 mg/dL or creatinine clearance < 40 mL/min.
• Hepatic dysfunction unrelated to GVHD, including cholestatic disease or unresolved hepatic veno-occlusive disease.
• Severe cardiovascular disease, including unstable angina, myocardial infarction within 6 months, NYHA class III-IV heart failure, or circulatory failure requiring vasoactive support.
• Severe respiratory disease requiring mechanical ventilation or ≥50% oxygen support.
• Use of high-dose corticosteroids (≥1 mg/kg/day methylprednisolone or equivalent) for non-GVHD indications within 7 days prior to enrollment.
• Pregnant or breastfeeding women. Severe skin damage or known allergy/intolerance to study-related procedures. Any other condition that, in the investigator's judgment, would interfere with study participation.