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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

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 Summary:

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.

Sponsor: Johns Hopkins University

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Office of Rare Diseases (ORD)

Dates:
Date Received: February 2, 2001
Date Started: April 1997
Date Completion:
Last Updated: June 23, 2005
Last Verified: July 2004