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Blood, 1 November 2005, Vol. 106, No. 9, pp. 3314-3321.
Prepublished online as a Blood First Edition Paper on July 14, 2005; DOI 10.1182/blood-2005-04-1377.
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Submitted April 4, 2005
Accepted June 30, 2005
Conditioning with 8 Gy total body irradiation and fludarabine for allogeneic hematopoietic stem cell transplantation in acute myeloid leukemia
Matthias Stelljes, Martin Bornhauser, Matthias Kroger, Joerg Beyer, Maria C Sauerland, Achim Heinecke, Bjorna Berning, Christian Scheffold, Gerda Silling, Thomas Buchner, Andreas Neubauer, Axel A Fauser, Gerhard Ehninger, Wolfgang E Berdel, and Joachim Kienast*
Department of Medicine / Hematology and Oncology, University of Muenster, Muenster, Germany
Department of Hematology/Oncology, University of Dresden, Dresden, Germany
Department of Medicine, Hematology/Oncology, University of Marburg, Marburg, Germany
Department of Medical Informatics and Biomathematics, University of Muenster, Muenster, Germany
Clinic for BMT and Hematology/Oncology, Idar-Oberstein, Germany
* Corresponding author; email: kienast{at}uni-muenster.de.
Seventy-one patients with acute myeloid leukemia (AML), most of them (63/71) considered ineligible for conventional allogeneic hematopoietic stem cell transplantation (HSCT), were enrolled into a phase II study on reduced intensity myeloablative conditioning with fractionated 8 Gy total body irradiation (TBI) and fludarabine (120 mg/m2). Patients received mobilized peripheral blood stem cells (n=68) or bone marrow (n=3) from siblings (n=39) or unrelated donors (n=32). Thirty-six patients were transplanted in complete remission (CR) and 35 with untreated or refractory disease (non-CR). Median patient age was 51 years (range, 20-66). Sustained engraftment was attained in all evaluable patients. With a median follow-up of 25.9 months (range, 3.7-61.2) in surviving patients, probabilities of overall survival for patients transplanted in CR and non-CR were 81% and 21% at 2 years, respectively. Relapse-free survival rates were 78% and 16%. The cumulative incidence of non-relapse mortality (NRM) in CR patients was 8% at 2 years and beyond, but amounted to 37% at 2 years in non-CR patients. Outcome data in this poor risk population indicate that allogeneic HSCT from related or unrelated donors with 8 Gy TBI/fludarabine conditioning is feasible with low NRM and preserved antileukemic activity in AML patients in first or later CR.

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