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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01193283 |
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Date of registration:
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31/08/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cyclophosphamide Plus Cyclosporine in Treatment-Naive Severe Aplastic Anemia
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Scientific title:
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Cyclophosphamide Plus Cyclosporine in Treatment-Naive Severe Aplastic Anemia |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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22 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01193283 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Danielle M Townsley, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Heart, Lung, and Blood Institute (NHLBI) |
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Key inclusion & exclusion criteria
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- INCLUSION CRITERIA:
Severe aplastic anemia characterized by:
Bone marrow cellularity less than 30 percent (excluding lymphocytes)
AND
At least two of the following:
Absolute neutrophil count less than 500/ microL
Platelet count less than 20,000/ microL
Absolute reticulocyte count less than 60,000/ microL
Age greater than or equal to 2 years old
Weight greater than or equal to 12 kg
EXCLUSION CRITERIA:
Diagnosis of Fanconi anemia
Cardiac ejection fraction less than 30 percent (evaluated by ECHO)
Evidence of a clonal hematologic bone marrow disorder on cytogenetics. Patients with the
presence of trisomy 8, loss of Y or del(20q) will not be excluded in the absence of
dysplastic changes in the marrow. Patients with very severe neutropenia (ANC less than 200
/microL) will not be excluded initially if cytogenetics are not available or pending. If
evidence of a clonal disorder is later identified, the patient will go off study.
Prior immunosuppressive therapy with high dose Cy or ATG
Infection not adequately controlled with appropriate therapy
Serologic evidence of HIV infection
Moribund status or concurrent hepatic, renal, cardiac, neurologic, pulmonary, infectious,
or metabolic disease of such severity that it would preclude the patient s ability to
tolerate protocol therapy, or that death within 30 days is likely
Subjects with cancer who are not considered cured, are on active chemotherapeutic treatment
or who take drugs with hematological effects
Current pregnancy or unwillingness to take oral contraceptives or refrain from pregnancy if
of childbearing potential
Not able to understand the investigational nature of the study or to give informed consent.
Age minimum:
2 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Neutropenia
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Aplastic Anemia
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Pancytopenia
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Severe Aplastic Anemia
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Intervention(s)
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Drug: Cyclosporine
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Drug: Cyclophosphamide
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Primary Outcome(s)
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Blood Counts and Adverse Event Profile After 6 Months of Treatment.
[Time Frame: 6 months]
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Secondary ID(s)
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100176
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10-H-0176
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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