Study of High Dose Cyclophosphamide in Patients With Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria
|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: NCT00004464|
Recruitment Status : Unknown
Verified March 2007 by Office of Rare Diseases (ORD).
Recruitment status was: Active, not recruiting
First Posted : October 19, 1999
Last Update Posted : March 30, 2007
OBJECTIVES: I. Confirm the efficacy demonstrated in a pilot study using high dose cyclophosphamide in patients with severe aplastic anemia.
II. Determine whether the addition of filgrastim (G-CSF) to high dose cyclophosphamide shortens the time to recovery in these patients.
III. Determine whether this regimen is efficacious in treating paroxysmal nocturnal hemoglobinuria.
|Condition or disease||Intervention/treatment||Phase|
|Aplastic Anemia Paroxysmal Hemoglobinuria, Nocturnal||Drug: cyclophosphamide Drug: filgrastim||Not Applicable|
PROTOCOL OUTLINE: Patients receive high dose cyclophosphamide IV on days 1-4. Beginning on day 10, patients receive filgrastim (G-CSF) until the absolute neutrophil count is greater than 1,000/mm3 for 2 consecutive days.
Patients are followed every 3 months for at least 2 years and annually thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||25 participants|
|Study Start Date :||February 1996|
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): NCT00004464
|United States, Maryland|
|Johns Hopkins Oncology Center|
|Baltimore, Maryland, United States, 21231|
|Study Chair:||Robert A. Brodsky||Johns Hopkins University|