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

Phase 2

Completed

• Conditions: Anemia, Hemolytic, Autoimmune; Felty Syndrome; Purpura, Thrombocytopenic; Autoimmune Diseases

• Registration Number: NCT00010387
• Lead Sponsor: Johns Hopkins University

Brief 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.

Study Timeline

• Study Start: 1999-03
• Study First Submitted QC: 2001-02-01
• Study First Submitted: 2001-02-02
• Study First Posted: 2001-02-02
• Primary Completion: 2007-08
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-08
• Last Update Posted: 2008-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Johns Hopkins Oncology Center; 🇺🇸 Baltimore, Maryland, United States