Systemic Lupus Erythematosus Clinical Trial
OBJECTIVES:
I. Determine the safety of immune ablation with high-dose cyclophosphamide and
anti-thymocyte globulin followed by peripheral blood stem cell support in patients with
systemic lupus erythematosus.
PROTOCOL OUTLINE: Patients receive cyclophosphamide IV over 1 hour for 2 doses. Patients
receive filgrastim (G-CSF) subcutaneously (SC) beginning 24 hours after completion of
cyclophosphamide and continuing until leukapheresis is complete. Leukapheresis continues
daily until target number of cells is harvested. CD 34+ cells are isolated from peripheral
blood stem cells (PBSC) in vitro.
Patients then receive cyclophosphamide IV over 1 hour on days -5 to -2, anti-thymocyte
globulin IV over 10 hours on days -4 to -2, and G-CSF SC beginning on day 0 and continuing
until blood counts recover. Patients undergo reinfusion of CD34+ PBSC on day 0.
Patients are followed weekly for 90 days, monthly for 1 year, and at 2 years.
;
Primary Purpose: Treatment
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