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          Institute: MPI für molekulare Biomedizin     Collection: Yearbook 2013     Display Documents

ID: 648368.0, MPI für molekulare Biomedizin / Yearbook 2013
Fludarabine-based conditioning for marrow transplantation from unrelated donors in severe aplastic anemia: early results of a cyclophosphamide dose deescalation study show life-threatening adverse events at predefined cyclophosphamide dose levels
Authors:Tolar, J.; Deeg, H. J.; Arai, S.; Horwitz, M.; Antin, J. H.; McCarty, J. M.; Adams, R. H.; Ewell, M.; Leifer, E. S.; Gersten, I. D.; Carter, S. L.; Horowitz, M. M.; Nakamura, R.; Pulsipher, M. A.; Difronzo, N. L.; Confer, D. L.; Eapen, M.; Anderlini, P.
Date of Publication (YYYY-MM-DD):2012-07
Title of Journal:Biol Blood Marrow Transplant
Issue / Number:7
Start Page:1007
End Page:1011
Review Status:Internal review
Audience:Not Specified
Abstract / Description:Excessive adverse events were encountered in a Phase I/II study of cyclophosphamide (CY) dose deescalation in a fludarabine-based conditioning regimen for bone marrow transplantation from unrelated donors in patients with severe aplastic anemia. All patients received fixed doses of antithymocyte globulin, fludarabine, and low-dose total body irradiation. The starting CY dose was 150 mg/kg, with deescalation to 100 mg/kg, 50 mg/kg, or 0 mg/kg. CY dose level 0 mg/kg was closed due to graft failure in 3 of 3 patients. CY dose level 150 mg/kg was closed due to excessive organ toxicity (n = 6) or viral pneumonia (n = 1), resulting in the death of 7 of 14 patients. CY dose levels 50 and 100 mg/kg remain open. Thus, CY at doses of 150 mg/kg in combination with total body irradiation (2 Gy), fludarabine (120 mg/m(2)), and antithymocyte globulin was associated with excessive organ toxicity.
External Publication Status:published
Document Type:Article
Communicated by:keuker
Affiliations:MPI für molekulare Biomedizin
External Affiliations:%G eng
Identifiers:ISSN:1523-6536 (Electronic) 1083-8791 (Linking) %R 10.1... [ID No:1]
URL:http://www.ncbi.nlm.nih.gov/pubmed/22546497 [ID No:2]
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