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 (see section 9.0) 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, 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 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)
- A clinical presentation resembling de novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment
- Patients who are pregnant
- Patients requiring mechanical ventilation or cardiac pressor support
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Conditions:
- Graft vs Host Disease