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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00004323 |
Date of registration:
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18/10/1999 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Phase II Study of Bone Marrow Transplantation Using Related Donors in Patients With Aplastic Anemia
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Scientific title:
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Date of first enrolment:
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February 1995 |
Target sample size:
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10 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00004323 |
Study type:
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Interventional |
Study design:
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Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
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Phase:
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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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Mary Carol Territo |
Address:
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Telephone:
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Email:
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Affiliation:
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University of California, Los Angeles |
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Key inclusion & exclusion criteria
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PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Severe aplastic anemia with 2 of the following criteria:
Polymorphonuclear neutrophils no more than 0.5 x 10 to the ninth/L Platelets no more than
20 x 10 to the ninth/L Reticulocytes no more than 30 x 10 to the ninth/L Hypocellular bone
marrow Related donor aged 6 weeks or more, matching at least 4 of 6 HLA A, B, and DRI
loci, as follows: HLA-identical family member for patients aged less than 40 years
HLA-nonidentical family member for patients aged less than 55 years failing antithymocyte
globulin or other immunosuppressive therapy The following eligible for transplantation as
initial therapy: Patients aged less than 40 years with HLA-matched donor Patients aged
40-45 years with HLA-identical donor No neoplastic or preneoplastic evolution --Patient
Characteristics-- Age: Under 40 (55 if ATG failure) Hepatic: No severe liver dysfunction
Renal: No severe renal dysfunction Cardiovascular: No severe cardiac dysfunction Other: No
other organ dysfunction that would compromise survival after transplant No HIV infection
Age minimum:
N/A
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Aplastic Anemia
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Intervention(s)
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Drug: cyclosporine
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Drug: methylprednisolone
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Drug: cyclophosphamide
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Drug: anti-thymocyte globulin
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Drug: methotrexate
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Drug: mesna
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Secondary ID(s)
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UCLA-94020602
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199/11863
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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