Rheumatoid Arthritis Clinical Trial
OBJECTIVES: I. Determine whether there is prompt engraftment after autologous peripheral
blood stem cell transplantation using filgrastim (G-CSF) mobilization in patients with life
threatening autoimmune diseases.
II. Determine the kinetics of T- and B-cell immune reconstitution after a combination of
timed plasmapheresis, high dose cyclophosphamide and total lymphoid irradiation, and
posttransplant immunosuppression with cyclosporine in these patients.
III. Determine whether this treatment regimen beneficially influences the clinical course of
these patients.
PROTOCOL OUTLINE: Patients receive filgrastim (G-CSF) SC daily until peripheral blood stem
cells (PBSC) are collected. On the fifth day of G-CSF therapy, PBSC are collected. Patients
undergo plasmapheresis on days -9 to -7. Patients receive cyclophosphamide IV on days -6 to
-3 and total lymphoid irradiation on day -1. PBSC are reinfused on day 0. Following PBSC
reinfusion, patients receive prophylaxis with oral prednisone or methylprednisolone IV on
days -1 to 28, antithymocyte globulin IV on days 1-3, and cyclosporine every 12 hours on
days 1-60.
Patients with autoimmune thrombocytopenia purpura, autoimmune hemolytic anemia, or pure red
cell aplasia are followed on days 7, 14, 21, 28, 60, and 100, 6 months, and 1, 2, and 5
years. Patients with rheumatoid arthritis, juvenile rheumatoid arthritis, or systemic lupus
erythematosus are followed on days 14, 28, 60, and 100, and then every 6 months. Patients
with vasculitis are monitored for abnormal clinical and laboratory parameters characteristic
of the individual type of vasculitis.
;
Primary Purpose: Treatment
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