In-vivo Regulatory T Cell Enhancement With Cyclophosphamide and Sirolimus

Inclusion Criteria

• •Patients must have a documented clinical diagnosis of grade II-IV acute graft-versus- host disease defined as graft versus host disease (GVHD) occurring within the first 100 days of transplantation
• •Patients must be steroid-refractory defines as progression after 3 days of corticosteroid therapy or no response after 5 days of corticosteroid therapy.
• •Progression is defined as up-grading
• •No response is defined as no down-grading
• •Progression after 3 days requires patients to have received at least 2 mg/mg/day for a total of 6 mg/kg of methylprednisolone or its equivalent.
• •No response after 5 days requires patient to have received at least 2 mg/kg/d for a total of 10 mg/kg of methylprednisolone or its equivalent.
• •Patients with exacerbation of GVHD during steroid taper will require re-treatment with 2mg/kg/d of corticosteroids and will need to meet the criteria
• •Age 18-70
• •Patients must have received an allogeneic hematopoietic stem cell transplant within 100 days of study enrollment.
• •Serum creatinine \< 2 mg/dL