Ruxolitinib for Bronchiolitis Obliterans Syndrome (BOS) After Allogeneic Hematopoietic Cell Transplantation (HCT)

Exclusion Criteria

• •Recurrent malignancy or disease progression requiring anticancer therapy.
• •Currently receiving or have previously received ruxolitinib for chronic GVHD therapy.
• •Known history of allergy to ruxolitinib or its excipients.
• •Pregnant females or nursing mothers.
• •Hepatic dysfunction: transaminases (ALT, AST) \> 5X ULN and/or total bilirubin \> 3X ULN.
• •Hematologic dysfunction: absolute neutrophil count \<1000/μL, platelet cout \<50K, and/or Hgb \< 8 g/dL.
• •Renal dysfunction: calculated creatinine clearance \< 40 mL/min (Cockcroft-Gault formula)
• •Receipt of any non-FDA approved study medication within the last 4 weeks (This does not apply to use of FDA-approved drugs for an off-label indication).
• •Presence of an active uncontrolled infection. An active uncontrolled infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without signs or symptoms will not be interpreted as an active uncontrolled infection.
• •Known human immunodeficiency virus infection.
• •Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Subjects with previous positive serology results must have negative polymerase chain reaction results. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment.
• •Severe organ dysfunction unrelated to underlying GVHD, including: Cholestatic disorders or unresolved veno-occlusive disease of the liver (defined as persistent bilirubin abnormalities not attributable to GVHD and ongoing organ dysfunction).
• •Clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, circulatory collapse requiring vasopressor or inotropic support, or arrhythmia that requires therapy.
• •Clinically active asthma (variable and recurring symptoms of airflow obstruction and bronchial hyper-responsiveness), chronic obstructive pulmonary disease, interstitial lung disease, or cryptogenic organizing pneumonia or other causes of restrictive lung disease such as neuromuscular weakness or diaphragmatic paralysis.
• •Any condition that, in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements.
• •Uncontrolled substance abuse or psychiatric disorder.
• •Deemed (by the local PI or the PFT lab) unable to reliably perform pulmonary function tests.
• •Active smoker of cigarettes or marijuana.