Ruxolitinib vs Prednisone as First-line Therapy for cGVHD Needing Systemic Therapy

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 institutional upper limit of normal (ULN) unless attributable to GVH
• •d. AST(SGOT)/ALT(SGPT) ≤5 × institutional ULN unless attributable to GVH e. creatinine clearance ≥30 ml/min
• •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study drug administration.
• •Ability to understand and the willingness to sign a written informed consent document.