Systemic Lupus Erythematosus
Conditions
Keywords
arthritis & connective tissue diseases, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus
Brief summary
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.
Detailed description
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.
Interventions
DRUGanti-thymocyte globulin
DRUGcyclophosphamide
DRUGfilgrastim
PROCEDURECD34+ Peripheral Blood Stem Cell Reinfusion
Sponsors
Northwestern Memorial Hospital
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
0 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of systemic lupus erythematosus with 1 of the following malignant features: * Nephritis (WHO class III or IV) * Failed NIH short-course cyclophosphamide therapy * Vasculitis/immune complex deposition causing end organ signs or symptoms (e.g., cerebritis, transverse myelitis, pulmonary hemorrhage, cardiac failure, or renal failure) * Hematologic cytopenias that are immune mediated and uncontrolled by conservative measures with any of the following: Transfusion-dependent anemia with untransfused hemoglobin less than 8 g/dL Platelet count less than 40,000/mm3 (without transfusions) Granulocyte count less than 1,000/mm3 Catastrophic anti-phospholipid syndrome --Patient Characteristics-- Cardiovascular: * LVEF at least 35% * No lupus-induced myocarditis * No history of unstable angina Pulmonary: * FEV1/FVC at least 50% predicted * DLCO at least 50% predicted Other: * HIV negative * No prior or concurrent malignancy except localized basal cell or squamous cell skin cancer * No uncontrolled diabetes mellitus * No medical illness that would preclude study * No psychiatric illness or mental deficiency that would preclude study * No known hypersensitivity to E. coli-derived proteins * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception
Countries
United States
Outcome results
None listed