Pediatric GVHD Low Risk Steroid Taper Trial
Study Phase: Phase 2
Recruitment Status: Recruiting
Start Date: May 01, 2023
End Date: March 01, 2025
Inclusion Criteria:
- Newly diagnosed GVHD that meets criteria for Minnesota standard risk except GVHD that is limited to skin rash <50% body surface area (grade I GVHD) OR isolated upper gastrointestinal tract involvement
- Ann Arbor 1 GVHD by biomarkers
- GVHD not previously treated systemically (topical therapies and non-absorbed steroids are allowed)
- Any donor type, HLA-match, conditioning regimen is acceptable
- Age 0-21 years at the time of screening
- Performance score (Lansky/Karnofsky) ≥70%
- 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 prednisone or any steroid treatment for GVHD for more than 3 days prior to enrollment
- 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
- 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)
- Severe organ dysfunction including requirement for dialysis, mechanical ventilation, or oxygen supplementation exceeding 40% FiO2 within 7 days of enrollment
- Significant liver disease evidenced by direct bilirubin >2 mg/dl or ALT or AST >5 times the upper limit of normal
- Creatinine clearance or estimated glomerular filtration rate <30 ml/min as calculated by institutional practice
- A clinical presentation resembling de novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment
- Patients who are pregnant
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Conditions:
- Graft vs Host Disease