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Successful engraftment with fludarabine, cyclophosphamide and thymoglobulin conditioning regimen in unrelated transplantation for severe aplastic anemia: A phase II prospective multi-center study.

Author(s): Kang HJ, Shin HY, Park JE, Chung NG, Cho B, Kim HK, Kim SY, Lee YH, Lim YT, Yoo KH, Sung KW, Koo HH, Im HJ, Seo JJ, Park SK, Ahn HS, The Korean Society of Pediatric Hematology-Oncology

Affiliation(s): Department of Pediatrics, Cancer Research Institute, Seoul National University College of Medicine, Seoul.

Publication date & source: 2010-05-25, Biol Blood Marrow Transplant., [Epub ahead of print]

Anti-thymocyte globulin (ATG) has been used in severe aplastic anemia (SAA) as a part of the conditioning regimen. Among the many kinds of ATG preparations, thymoglobulin had been found to be more effective for preventing graft-versus-host disease (GVHD) and the rejection of organ transplants. After the promising results of our preliminary study, we conducted a phase II prospective multi-center clinical trial using a fludarabine, cyclophosphamide and thymoglobulin conditioning regimen to allow good engraftment in patients who underwent unrelated transplantation for SAA. Twenty-eight patients underwent bone marrow (N=15) or mobilized peripheral blood (N=13) transplantation from HLA matched unrelated donors with cyclophosphamide (50 mg/kg once daily i.v. on days -9, -8, -7 & -6), fludarabine (30 mg/m(2) once daily i.v. on days -5, -4, -3 & -2) and thymoglobulin (2.5 mg/kg once daily i.v. on days -3, -2 & -1). Donor type hematologic recovery was achieved in all patients. The estimated survival rate (SR) was 67.9% and all the events were transplantation related mortality (TRM), which included thrombotic microangiopathy (N=2), pneumonia (N=1), myocardiac infarction (N=1), post-transplantation lymphoprolifarative disease (N=3) and chronic GVHD associated complications (N=2). The SR of patients who received bone marrow (60.0%) was not different from that of patients who received mobilized peripheral blood (76.9%) (P=0.351), but the SR of patients who received more than 15 units of RBC before transplantation (45.5%) was significantly lower than that of the other patients (82.4%) (P=0.048). The fludarabine, cyclophosphamide and thymoglobulin conditioning regimen achieved promising result for successful engraftment, but the TRM was high. This study was registered at www.clinicaltrials.gov (NCT00737685) and now we are performing a new multi-center study (NCT00882323) to decrease the TRM by reducing the dose of cyclophosphamide. Copyright (c) 2010. Published by Elsevier Inc.

Page last updated: 2010-10-05

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