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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
anti-thymocyte globulin, cyclophosphamide, cyclosporine, filgrastim, methylprednisolone, prednisone, Autologous Peripheral Blood Stem Cell Transplantation
Fairview University Medical Center
Active, not recruiting
Office of Rare Diseases (ORD)
Published on BioPortfolio: 2014-08-27T03:57:31-0400
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Phase I Pilot Study of Total-Body Irradiation, Anti-Thymocyte Globulin and Cyclophosphamide Followed By Syngeneic or Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Sclerosis
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A water-soluble ester of METHYLPREDNISOLONE used for cardiac, allergic, and hypoxic emergencies.
A PREDNISOLONE derivative with similar anti-inflammatory action.
A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.
Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.
Immunizing agent containing IMMUNOGLOBULIN G anti-Rho(D) used for preventing Rh immunization in Rh-negative individuals exposed to Rh-positive red blood cells.
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