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Clinical Trial 19119
Cancer Type: Malignant Hematology
Interventions:Jakafi (Ruxolitinib); Methylprednisolone; Ruxolitinib; prednisone
Study Type: Treatment
Phase of Study: Phase II
A Single-Cohort, Phase 2 Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease
The purpose of the Study is to find out if taking ruxolitinib in combination with corticosteroids is safe and effective in participants with Grades II to IV steroid-refractory acute graft-versus-host disease (GVHD).
Primary Objective: Assess the efficacy of ruxolitinib in combination with corticosteroids in subjects with Grade II to IV steroid-refractory acute graft-versus-host disease (GVHD). Secondary Objectives: Assess additional response and longer-term efficacy outcomes in the study population. Assess the incidence and severity of adverse events (AEs) and serious adverse events (SAEs). Evaluate the pharmacokinetics of ruxolitinib when administered in combination with corticosteroids.