A Phase 2 Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft Versus Host Disease

Inclusion Criteria:

   - Children and adults with a new diagnosis of chronic GVHD- that requires systemic
   immunosuppressive treatment to a dose of 1mg/kg/day prednisone and who have undergone
   any type of donor hematopoietic cell graft or conditioning regimen.

   - Stable doses of other immunosuppressive medications (e.g. calcineurin inhibitors,
   mycophenolate mofetil) for 2 weeks prior to enrollment. In addition, these other
   immunosuppressive medications should not be dose increased.

   - Men and women of reproductive potential must agree to use an acceptable method of
   birth control during treatment and for six months after completion of treatment.

   - All subjects must provide written informed consent.

Exclusion Criteria:

   - Known life-threatening hypersensitivity to Rituximab or other anti-B cell antibody.

   - Treatment with prednisone (or equivalent) at doses higher than 1 mg/kg/day at the time
   of enrollment. Persistent prednisone treatment of acute GVHD that is less than 1mg/kg
   is allowed.

   - Active, uncontrolled infection- CMV reactivation is excluded (i.e. pneumonitis,
   colitis). Peripheral blood CMV reactivation is allowed as long as it is not associated
   with CMV disease and is responding to therapy.

   - Known Hepatitis B surface Ag positive

   - Active malignant disease relapse.

   - Pregnancy

   - Lactating

   - Inability to comply with the Rituximab treatment regimen.