Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease
I. Determine the response rate and 1-year event-free survival in patients with severe autoimmune hematologic disease treated with high-dose cyclophosphamide.
|Anemia, Hemolytic, Autoimmune Felty Syndrome Purpura, Thrombocytopenic Autoimmune Diseases||Drug: cyclophosphamide Drug: filgrastim||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Study Start Date:||March 1999|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00010387
|United States, Maryland|
|Johns Hopkins Oncology Center|
|Baltimore, Maryland, United States, 21231|
|Study Chair:||Robert A. Brodsky||Johns Hopkins University|