Systemic Lupus Erythematosus Clinical Trial
Official title:
A Pilot Study of High-Dose Immunosuppression Followed by Infusion of CD34-Selected Autologous or Syngeneic Peripheral Blood Stem Cells for Treatment of Refractory Autoimmune Disorders
OBJECTIVES: I. Determine the safety and long term complications of total body irradiation in
combination with cyclophosphamide, anti-thymocyte globulin, and autologous CD34-selected
peripheral blood stem cell (PBSC) transplantation in children with refractory autoimmune
disorders.
II. Determine the efficacy of this treatment regimen in these patients. III. Determine the
reconstitution of immunity after autologous CD34-selected PBSC transplantation in these
patients.
IV. Determine engraftment of autologous CD34-selected PBSC in these patients.
PROTOCOL OUTLINE: This is a multicenter study. Patients receive filgrastim (G-CSF)
subcutaneously daily until peripheral blood stem cell (PBSC) collection is completed. CD34+
cells are separated from the rest of the PBSCs.
Patients undergo total body irradiation twice daily on days -5 and -4. Patients receive
anti-thymocyte globulin IV on days -5, -3, -1, 1, 3, and 5 and cyclophosphamide IV on days
-3 and -2. CD34-selected PBSCs are reinfused on day 0. Patients receive G-CSF IV daily
beginning on day 0 and continuing until blood counts recover.
Patients are followed annually for 5 years and then every 5 years thereafter.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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