Study of High Dose Cyclophosphamide in Patients With Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria
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|ClinicalTrials.gov Identifier: NCT00004464|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : January 18, 2019
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||Phase 2|
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)|
|Actual Enrollment :||69 participants|
|Official Title:||High Dose Cyclophosphamide for the Treatment of Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria|
|Study Start Date :||February 1996|
|Actual Primary Completion Date :||March 1, 2007|
|Actual Study Completion Date :||November 11, 2008|
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|