Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus
This trial is active, not recruiting.
|Condition||systemic lupus erythematosus|
|Treatments||anti-thymocyte globulin, cyclophosphamide, filgrastim, cd34+ peripheral blood stem cell reinfusion|
|Sponsor||Northwestern Memorial Hospital|
|Start date||April 2001|
|Trial size||10 participants|
|Trial identifier||NCT00017641, 199/14976, NU-95LU1|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
Male or female participants up to 59 years old.
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
|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.|
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