Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease
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|ClinicalTrials.gov Identifier: NCT00010387|
Recruitment Status : Completed
First Posted : February 2, 2001
Last Update Posted : September 10, 2008
I. Determine the response rate and 1-year event-free survival in patients with severe autoimmune hematologic disease treated with high-dose cyclophosphamide.
|Condition or disease||Intervention/treatment||Phase|
|Anemia, Hemolytic, Autoimmune Felty Syndrome Purpura, Thrombocytopenic Autoimmune Diseases||Drug: cyclophosphamide Drug: filgrastim||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Study Start Date :||March 1999|
|Primary Completion Date :||August 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00010387
|United States, Maryland|
|Johns Hopkins Oncology Center|
|Baltimore, Maryland, United States, 21231|
|Study Chair:||Robert A. Brodsky||Johns Hopkins University|