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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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TRANSPLANTATION

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, Joachim Kienast, for the Cooperative German Transplant Study Group

From the 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; Clinic for Bone Marrow Transplantation and Hematology/Oncology, Idar-Oberstein, Germany; Department of Medical Informatics and Biomathematics, University of Muenster, Muenster, Germany.

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 2 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 received a transplant in complete remission (CR) and 35 had untreated or refractory disease (non-CR). Median patient age was 51 years (range, 20-66 years). Sustained engraftment was attained in all evaluable patients. With a median follow-up of 25.9 months (range, 3.7-61.2 months) in surviving patients, probabilities of overall survival for patients who received a transplant 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 nonrelapse 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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