Anti Cytokine Combination Therapy With Daclizumab and Infliximab for Treatment of Steroid Refractory Acute GVHD

Inclusion criteria

• Diagnosis of steroid refractory aGVHD defined as no response to methylprednisolone at 2 mg/kg for 1 week or disease progression after 72 hours of methylprednisolone at this dose. Potential subject will have had no decrease in any GVHD organ staging as follows:

• Skin rash, if present, does not decrease by one stage. This is based on the percent of the body involved with rash, plus presence of bullae and desquamation.
• Gut GVHD, if present, does not decrease by one stage. This is based on volume of diarrhea, pain, and ileus.
• Upper gastrointestinal GVHD, if present, does not resolve.
• Liver GVHD, if present, does not decrease by one stage. This is based on total bilirubin level.
• Prior allogeneic hematopoietic stem cell transplantation using bone marrow, peripheral blood or umbilical cord cells. Recipients of standard as well as nonmyeloablative transplants are eligible.
• No previous immune suppressive therapy given for treatment of acute GVHD except for corticosteroids.
• Absolute neutrophil count greater than 0.5x106/L.
• Estimated creatinine clearance greater than 30 mL/minute.
• Written informed consent

Exclusion criteria

• Patient receiving either infliximab or daclizumab within seven days of study.
• Patient with uncontrolled infections will be excluded.
• Patients receiving other investigational agents for GVHD prophylaxis or treatment.
• Patients with congestive heart failure.
• Patients with history of intolerance/ hypersensitivity to daclizumab or infliximab.
• Age less than 18 years.
• Patients who are pregnant or at risk of pregnancy and unwilling to use acceptable birth control methods.
• Patients with an allergy to murine products.