Hematopoietic cell transplantation for older acute myeloid leukemia patients in first complete remission: results of a randomized phase III study

Autor: Dietger Niederwieser, Dirk Hasenclever, Wolfgang Berdel, Bart J. Biemond, Haifa Al-Ali, Yves Chalandon, Michel van Gelder, Christian Junghanß, Gösta Gahrton, Mathias Hänel, Rüdiger Hehlmann, Thomas Heinicke, Andreas Hochhaus, Simona Iacobelli, Rien van Marwijk Kooy, Nicolaus Kröger, Jeroen Janssen, Madlen Jentzsch, Frank Breywisch, Mohamad Mohty, Stavroula Masouridi-Levrat, Gert Ossenkoppele, Jacob Passweg, Wolfram Pönisch, Johannes Schetelig, Christoph Schliemann, Sebastian Schwind, Matthias Stelljes, Leo F. Verdonck, Vladan Vucinic, Bob Löwenberg, Jan Cornelissen
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Haematologica, Vol 999, Iss 1 (2024)
Druh dokumentu: article
ISSN: 0390-6078
1592-8721
DOI: 10.3324/haematol.2024.285879
Popis: Given the selection of elderly patients with AML in first complete remission (CR1) the advantage of consolidation with allogeneic hematopoietic cell transplantation (HCT) over chemotherapy is still unclear. Newly diagnosed AML patients in CR1 aged 60-75 years were registered and a donor search initiated. After one consolidation cycle, patients with a matched donor were randomized to HCT with fludarabine/lowdose total body irradiation and cyclosporine/mycophenolate mofetil immunosuppression or conventional non-HCT. Primary outcome was restricted mean leukemia-free survival (RM-LFS) up to five years. Between 2010 and 2017, 245 patients (median age 67 years) were registered at CR1. After one consolidation, 26.9% of patients failed inclusion criteria. Of the 179 (73%) patients still on study, 75.4% had an HLA identical donor. Ten ineligible patients were excluded, and 125 randomized to HCT (n=83) or non-HCT (n=42). The primary outcome RM-LFS up to 5 years was 24.5 months (95%CI:18.9-30.1) in the HCT and 15.6 months (95%CI:10.4-20.8) in the non-HCT arm (p=0.022) due to a decrease in cumulative relapse incidence from 91.1 (95%CI:80.7-100.0) after non-HCT to 37.8 (95%CI:27.2-48.4)% after HCT (p
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