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
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years. * Karnofsky performance status ≥60%. * Patients with a diagnosis of chronic GVHD per NIH diagnostic criteria5 who are in need for first systemic therapy as per treating physician's discretion, Overlap chronic GVHD will be allowed. * No new immune suppressive therapy added within preceding 2 weeks prior to study enrolment. * Able to take oral medications. * Participants must have adequate organ and marrow function as defined below: 1. absolute neutrophil count ≥1,000/mcL 2. platelets ≥30,000/mcL 3. Hemoglobin ≥ 7 g/dL 4. Bilirubin ≤ 3 times instit…
Interventions
- DrugRuxolitinib
Ruxolitinib is a Janus kinase inhibitor.
- DrugPrednisone
Prednisone is a glucocorticoid.
Locations (5)
- Univ of Miami - Sylvester Comprehensive Cancer CenterMiami, Florida
- Moffitt Cancer CenterTampa, Florida
- University of Kansas Cancer CenterKansas City, Kansas
- University of Virginia Comprehensive Cancer CenterCharlottesville, Virginia
- Virginia Commonwealth UniversityRichmond, Virginia