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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: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00004323
Date of registration: 18/10/1999
Prospective Registration: No
Primary sponsor: National Center for Research Resources (NCRR)
Public title: Phase II Study of Bone Marrow Transplantation Using Related Donors in Patients With Aplastic Anemia
Scientific title:
Date of first enrolment: February 1995
Target sample size: 10
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00004323
Study type:  Interventional
Study design:  Endpoint Classification: Efficacy Study, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Mary Carol Territo
Address: 
Telephone:
Email:
Affiliation:  University of California, Los Angeles
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Aplastic Anemia
Intervention(s)
Drug: anti-thymocyte globulin
Drug: cyclophosphamide
Drug: cyclosporine
Drug: mesna
Drug: methotrexate
Drug: methylprednisolone
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
199/11863
UCLA-94020602
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
University of California, Los Angeles
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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