Pilot Study of Cyclophosphamide in Patients With Life-Threatening Systemic Lupus Erythematosus or Antiphospholipid Antibody Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00010400|
Recruitment Status : Completed
First Posted : February 2, 2001
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment|
|Systemic Lupus Erythematosus Antiphospholipid Antibody Syndrome||Drug: Cyclophosphamide Drug: filgrastim|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Study Start Date :||April 1997|
U.S. FDA Resources
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): NCT00010400
|United States, Maryland|
|Johns Hopkins University School of Medicine|
|Baltimore, Maryland, United States, 21205|
|Johns Hopkins Oncology Center|
|Baltimore, Maryland, United States, 21231|
|Study Chair:||Robert A. Brodsky||Johns Hopkins University|