This trial is active, not recruiting.

Condition systemic lupus erythematosus
Treatments anti-thymocyte globulin, cyclophosphamide, filgrastim, cd34+ peripheral blood stem cell reinfusion
Phase phase 1
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

Study Design

Primary purpose treatment

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by Office of Rare Diseases (ORD).