Phase II Study of Tocilizumab for Patients With Glucocorticoid-refractory Acute GVHD After Allogeneic Hematopoetic Stem Cell Transplant (HSCT)

Inclusion Criteria: * Men or women ≥ 18 and ≤ 80 years of age * Karnofsky Performance Status Scale ≥ 50% * Glucocorticosteroid refractory acute GVHD Grade 2-4 by the Glucksberg functional classification. * Patients who had experienced aGVHD grade 2-4 and responded to glucocorticosteroids in the past then had a flare of aGVHD requiring increasing immune suppression to 1 mg/kg of prednisone or equivalent are eligible for this study if they are refractory to steroids and provided that they did not receive a second line therapy for aGVHD in the past. * Glucocorticosteroid refractory GVHD is defined as the following: * No response to corticosteroid therapy at ≥ 1.0 mg/kg methylprednisolone or equivalent after the onset of acute GVHD for a minimum of 3 and a maximum of 7 days OR * Progression of at least 1 overall grade within 3 days of glucocorticosteroid use OR * Incomplete response by 14 days of glucocorticosteroid use * Ability to comply with planned procedures * Ability to understand the information provided and to provide written evidence of informed consent * Willingness of females of childbearing potential to use adequate contraception. * Post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3 months prior to screening Exclusion Criteria: * Subjects with only grade 1 acute GVHD * Concurrent medical condition or disease that may interfere with clinical trial participation * Relapsed or persistent malignancy. * Receiving other drugs …