Clinical Research Directory

Inclusion Criteria: * Age ≥ 18 * Ability to swallow capsules * Have undergone allo-HCT from any donor source * Upper GI aGVHD stage 1 and/or lower GI aGVHD stage 1-4. aGVHD affecting other organs (e.g. skin, liver) are allowed * Steroid-refractory, steroid-dependent or intolerant, defined as: * Progressive (i.e., increase in stage of the lower GI tract) after 3 days of treatment with corticosteroids (≥1 mg/kg/day prednisone or IV equivalent), or * Failure to improve (i.e., decrease in stage in the GI tract) after 5 days of corticosteroid treatment (≥1 mg/kg/day prednisone or IV equivalent), or * Incomplete response after \>28 days of corticosteroids, or * Corticosteroid dependent (inability to taper prednisone \<1 mg/kg/day or recurrence of aGVHD activity or flare during steroid taper), or * Corticosteroid intolerance (unacceptable toxicity due to the use of corticosteroids). * Absolute neutrophil count (ANC) ≥0.5 x10\^9/L and platelets \>20,000/mm3. Use of growth factor supplementation and platelet transfusional support is allowed * Ability to start ruxolitinib therapy for aGVHD Exclusion Criteria: Has received more than one systemic treatment for aGVHD other than corticosteroids +/- CNI or sirolimus prophylaxis or treatment * Active GI bleeding requiring intervention or transfusional support * Toxic megacolon * Active uncontrolled infection requiring systemic antibiotic treatment including persistent bacteremia (controlled infection receiving definitive therapy for 48 hours prior to enrollment are eligible). * Treatment with broad spectrum antibiotic with anaerobic coverage for 48 hours prior to enrollment * Elevated total bilirubin not caused by GVHD or Gilbert's disease of \>5 x upper limit of normal (ULN) * Use of investigational agent within 14 days pre-treatment * Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months * Uncontrolled psychiatric illness * Patients with an active secondary malignancy or prior malignancy requiring systemic therapy within the past 3 years. Exceptions include adequately treated localized non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma), as well as localized prostate cancer considered low risk and stable under treatment or surveillance * Female patient who is pregnant or breastfeeding * Known allergy or sensitivity to ruxolitinib and/or MARCO live biotherapeutic