Phase II Study of Bone Marrow Transplantation Using Related Donors in Patients With Aplastic Anemia
NCT ID: NCT00004323
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
1995-02-28
Brief Summary
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II. Evaluate the efficacy of related, HLA-nonidentical bone marrow transplantation following CTX and total-body irradiation/total-lymphoid irradiation in patients with aplastic anemia.
Detailed Description
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Patients with HLA-nonidentical (5/6 or 4/6) donors and those with a systemic reaction to ATG receive the same dosage of myeloablative chemotherapy and rescue. In addition, these patients are treated with total-body irradiation, total-lymphoid irradiation, and methotrexate.
All patients received MePRDL and cyclosporine for graft-versus-host prophylaxis.
Conditions
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Study Design
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TREATMENT
Interventions
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anti-thymocyte globulin
cyclophosphamide
cyclosporine
mesna
methotrexate
methylprednisolone
Eligibility Criteria
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Inclusion 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
0 Years
55 Years
ALL
No
Sponsors
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University of California, Los Angeles
OTHER
National Center for Research Resources (NCRR)
NIH
Principal Investigators
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Mary Carol Territo
Role: STUDY_CHAIR
University of California, Los Angeles
Locations
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Center for Health Sciences
Los Angeles, California, United States
Countries
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Other Identifiers
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UCLA-94020602
Identifier Type: -
Identifier Source: secondary_id
199/11863
Identifier Type: -
Identifier Source: org_study_id