Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome

Not Applicable

Completed

• Conditions: Systemic Lupus Erythematosus; Antiphospholipid Antibody Syndrome

• Registration Number: NCT00010400
• Lead Sponsor: Johns Hopkins University

Brief Summary

OBJECTIVES:

I. Determine the induction of durable remission in patients with life-threatening systemic lupus erythematosus or antiphospholipid antibody syndrome treated with cyclophosphamide.

II. Determine the toxicity of this drug in these patients.

Detailed Description

PROTOCOL OUTLINE:

Patients receive cyclophosphamide IV on days 1-4 and filgrastim (G-CSF) beginning on day 10 and continuing until blood counts recover.

Patients are followed monthly for 6 months, and then every 3 months thereafter.

Study Timeline

• Study Start: 1997-04
• Study First Submitted QC: 2001-02-01
• Study First Submitted: 2001-02-02
• Study First Posted: 2001-02-02
• Status Verified: 2004-07
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

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

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States