Ruxolitinib vs Prednisone as First-line Therapy for cGVHD Needing Systemic Therapy
Phase II Randomized Study of Ruxolitinib vs Prednisone as First-Line Therapy for Chronic Graft vs Host Disease Needing Systemic Therapy
H. Lee Moffitt Cancer Center and Research Institute
120 participants
Dec 23, 2024
INTERVENTIONAL
Conditions
Summary
Allogeneic transplant is potentially curative for hematological malignancies but its use is limited by the development of GVHD. Ruxolitinib now has FDA approval for treatment of chronic GVHD that has failed 1-2 prior lines of therapy based on a prior large, randomized phase III study. Given this evidence of safety and efficacy in the early refractory setting (after prednisone failure), Ruxolitinib represents an ideal agent to test in the primary therapy setting. Here investigators propose a phase 2 randomized study to compare Ruxolitinib to prednisone as a first-line therapy in the treatment of chronic GVHD.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Ruxolitinib is a Janus kinase inhibitor.
Prednisone is a glucocorticoid.
Locations(5)
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NCT06660355