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Ruxolitinib vs Prednisone as First-line Therapy for cGVHD Needing Systemic Therapy
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
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.
Official title: Phase II Randomized Study of Ruxolitinib vs Prednisone as First-Line Therapy for Chronic Graft vs Host Disease Needing Systemic Therapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2024-12-23
Completion Date
2028-12
Last Updated
2026-04-08
Healthy Volunteers
No
Interventions
Ruxolitinib
Ruxolitinib is a Janus kinase inhibitor.
Prednisone
Prednisone is a glucocorticoid.
Locations (5)
Univ of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States