TY - JOUR
T1 - Hematopoietic cell transplantation for older acute myeloid leukemia patients in first complete remission
T2 - results of a randomized phase III study
AU - Niederwieser, Dietger
AU - Hasenclever, Dirk
AU - Berdel, Wolfgang E.
AU - Biemond, Bart J
AU - Al-Ali, Haifa
AU - Chalandon, Yves
AU - Van Gelder, Michel
AU - Junghanß, Christian
AU - Gahrton, Gösta
AU - Hänel, Mathias
AU - Hehlmann, Rüdiger
AU - Heinicke, Thomas
AU - Hochhaus, Andreas
AU - Iacobelli, Simona
AU - Kooy, Rien van Marwijk
AU - Kröger, Nicolaus
AU - Janssen, Jeroen
AU - Jentzsch, Madlen
AU - Breywisch, Frank
AU - Mohty, Mohamad
AU - Masouridi-Levrat, Stavroula
AU - Ossenkoppele, Gert
AU - Passweg, Jacob
AU - Pönisch, Wolfram
AU - Schetelig, Johannes
AU - Schliemann, Christoph
AU - Schwind, Sebastian
AU - Stelljes, Matthias
AU - Verdonck, Leo F
AU - Vucinic, Vladan
AU - Löwenberg, Bob
AU - Cornelissen, Jan
PY - 2024/8/8
Y1 - 2024/8/8
N2 - 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.
AB - 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.
U2 - 10.3324/haematol.2024.285879
DO - 10.3324/haematol.2024.285879
M3 - Article
SN - 0390-6078
JO - Haematologica-the Hematology Journal
JF - Haematologica-the Hematology Journal
ER -