MAGIC Ruxolitinib for aGVHD

Exclusion Criteria

• •Systemic treatment with ruxolitinib or any other JAK inhibitor within 7 days of study entry
• •Prior use of ruxolitinib to treat GVHD at any time
• •Relapsed, progressing or persistent malignancy requiring withdrawal of systemic immunosuppression
• •Relapse prior to development of GVHD unless subsequently in remission for at least 3 months
• •GVHD that developed after DLI for relapse is not allowed without study PI or medical monitor approval
• •Uncontrolled infection (i.e., progressive symptoms related to infection despite treatment or persistently positive microbiological cultures despite treatment or any other evidence of severe sepsis)
• •Severe organ dysfunction within 3 days of enrollment including requirement for dialysis, mechanical ventilation, continuous BiPAP, or continuous high flow oxygen by nasal cannula, or total bilirubin ≥ 3x upper limit of normal not due to GVHD.
• •A clinical presentation resembling de novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment (except for mild oral or ocular GVHD)
• •Corticosteroids \>10 mg/day methylprednisolone (or other methylprednisolone equivalent, MPE) for any indication within 5 days before the onset of acute GVHD except for adrenal insufficiency or premedication for transfusions/IV meds
• •Participation in clinical trials using experimental agents not approved by the FDA for any indication within 14 days of enrollment or five half-lives, whichever is longer provided any prior adverse events have improved to ≤grade 1
• •Patients who are pregnant or nursing
• •History of allergic reaction to ruxolitinib or any JAK inhibitor