|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT00004464 |
|
Date of registration:
|
18/10/1999 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Study of High Dose Cyclophosphamide in Patients With Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria
|
|
Scientific title:
|
High Dose Cyclophosphamide for the Treatment of Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria |
|
Date of first enrolment:
|
February 1996 |
|
Target sample size:
|
69 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00004464 |
|
Study type:
|
Interventional |
|
Study design:
|
Primary purpose: Treatment.
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Robert A. Brodsky |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Johns Hopkins University |
| | |
|
Key inclusion & exclusion criteria
|
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Acquired severe aplastic anemia or paroxysmal nocturnal hemoglobinuria
- Not a candidate for allogeneic bone marrow transplantation
- Must meet one of the following criteria:
- Severe aplastic anemia
- Less than 25% bone marrow cellularity and depression in two of three blood
counts (reticulocytes less than 40,000/mm3
- platelet count less than 20,000/mm3 and granulocytes less than 500/mm3)
- Life-threatening paroxysmal nocturnal hemoglobinuria
- Absolute neutrophil count less than 500/mm3
- platelet transfusion dependent
- thrombotic disease
- No Fanconi anemia
- No abnormal cytogenetics
--Patient Characteristics--
- Renal: Creatinine no greater than 2.0 mg/dL
- Cardiovascular: Cardiac ejection fraction at least 45%
- Other: Not preterminal or moribund Not pregnant
Age minimum:
N/A
Age maximum:
70 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Paroxysmal Hemoglobinuria, Nocturnal
|
|
Aplastic Anemia
|
|
Intervention(s)
|
|
Drug: cyclophosphamide
|
|
Drug: filgrastim
|
|
Secondary ID(s)
|
|
199/13895
|
|
96-01-17-02
|
|
JHOC-96011702
|
|
J9611
|
|
JHOC-9611
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|