Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus
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|ClinicalTrials.gov Identifier: NCT00017641|
Recruitment Status : Unknown
Verified November 2003 by Office of Rare Diseases (ORD).
Recruitment status was: Active, not recruiting
First Posted : June 6, 2001
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Drug: anti-thymocyte globulin Drug: cyclophosphamide Drug: filgrastim Procedure: CD34+ Peripheral Blood Stem Cell Reinfusion||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Study Start Date :||April 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00017641
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics|
|Madison, Wisconsin, United States, 53792-0001|
|Study Chair:||Ann Traynor||Northwestern Memorial Hospital|