NCT00010387

Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (planned)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: I. Determine the response rate and 1-year event-free survival in patients with severe autoimmune hematologic disease treated with high-dose cyclophosphamide.

Detailed description

PROTOCOL OUTLINE: Patients receive high-dose cyclophosphamide IV on days 1-4 and filgrastim (G-CSF) starting on day 10 and continuing until blood counts recover. Patients are followed at 1, 3, 6, and 12 months and then annually thereafter.

Conditions

• Anemia, Hemolytic, Autoimmune
• Felty Syndrome
• Purpura, Thrombocytopenic
• Autoimmune Diseases

Interventions

Type	Name	Description
DRUG	cyclophosphamide
DRUG	filgrastim

Timeline

• Start date: 1999-03-01
• Primary completion: 2007-08-01
• First posted: 2001-02-02
• Last updated: 2008-09-10

Locations

1 site across 1 country: United States