Chronic Graft-versus-Host Disease Treatment (BMT CTN 0801)

Exclusion Criteria

• •Patients with late persistent acute GVHD or recurrent acute GVHD only.
• •Inability to begin prednisone therapy at a dose of greater than 0.5 mg/kg/day.
• •Receiving sirolimus for treatment of chronic GVHD (sirolimus for prophylaxis or treatment of acute GVHD is acceptable).
• •Already receiving sirolimus (for prophylaxis or treatment of acute GVHD) with prednisone at ≥ 0.25 mg/kg/day (or equivalent) ± additional agents.
• •Receiving therapy for chronic GVHD for more than 16 weeks.
• •Invasive fungal or viral infection not responding to appropriate antifungal or antiviral therapies.
• •Inadequate renal function defined as measured creatinine clearance less than 50 mL/min/1.73 m\^2 based on the Cockcroft-Gault formula (adults) or Schwartz formula (age less than or equal to 12 years). Adults: estimated creatinine clearance rate (eCCr) (mL/min/) = (140 - age) x mass (kg) x (0.85 if female)/72 x serum creatinine (mg/dL; Creatinine clearance (mL/min/1.73m\^2) = eCCr x 1.73/Body Surface Area (BSA) (m\^2); Children: eCCr (mL/min/1.73 m\^2) = k x height (cm) / serum creatinine (mg/dL) k = 0.33 (pre-term), 0.45 (full term to 1 year old), 0.55 (age 1-12 years).
• •Inability to tolerate oral medications.
• •Absolute neutrophil count less than 1500 per microliter.
• •Requirement for platelet transfusions.
• •Pregnancy (positive serum β-HCG) or breastfeeding.
• •Receiving any treatment for persistent, progressive or recurrent malignancy.
• •Progressive or recurrent malignancy defined other than by quantitative molecular assays.
• •Known hypersensitivity to sirolimus.