Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring arthritis & connective tissue diseases, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus
Eligibility 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
Sites / Locations
- Northwestern Memorial Hospital
- University of Wisconsin Hospital and Clinics