NCT00017641

Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (planned)
• Sponsor: Northwestern Memorial Hospital · Academic / Other
• Sex: All
• Age: 0 Years – 59 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	anti-thymocyte globulin
DRUG	cyclophosphamide
DRUG	filgrastim
PROCEDURE	CD34+ Peripheral Blood Stem Cell Reinfusion

Timeline

• Start date: 2001-04-01
• First posted: 2001-06-06
• Last updated: 2005-06-24

Locations

2 sites across 1 country: United States