Treatment Response and Biomarker-Guided Steroid Taper for Children with GVHD

Inclusion Criteria

• Newly diagnosed GVHD that meets criteria for Minnesota standard risk except isolated skin rash < 25% body surface area without other manifestations
• Ann Arbor 1 GVHD by biomarkers
• GVHD not previously treated systemically (topical therapies and non-absorbed steroids are allowed)
• Any donor type, human leukocyte antigen (HLA)-match, conditioning regimen is acceptable
• Age 0-21 years at the time of screening
• Signed and dated written informed consent obtained from patient or legal representative and assent from pediatric patients capable of providing assent

Exclusion Criteria

• Patients treated for GVHD with > 0.5 mg/kg/day prednisone for any duration or any steroid treatment for GVHD for more than 1 day prior to screening * Patients on ≤ 0.5 mg/kg/day prednisone for ≤ 1 day for new onset GVHD can be eligible
• Patients receiving corticosteroids > 0.1 mg/kg prednisone (or other steroid equivalent) for any indication within 7 days before the onset of acute GVHD except for adrenal insufficiency, premedication for transfusions/IV medications, or intermittent use for symptom control such as nausea/vomiting
• Relapsed, progressing, or persistent malignancy or other condition (e.g., known declining donor chimerism) requiring withdrawal of systemic immune suppression or donor leukocyte infusion (DLI)
• Patients with uncontrolled infection (i.e., progressive symptoms related to infection despite treatment, persistently positive microbiological cultures despite treatment, viral reactivations unresponsive to treatment, or any other evidence of severe infection)
• Patients requiring mechanical ventilation or cardiac pressor support
• A clinical presentation resembling first occurrence chronic GVHD or overlap syndrome developing before or present at the time of enrollment
• Patients who are pregnant