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

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • Dietger Niederwieser - , Aichi Medical University, Lithuanian University of Health Sciences (Author)
  • Dirk Hasenclever - , Leipzig University (Author)
  • Wolfgang E. Berdel - , University of Münster (Author)
  • Bart J. Biemond - , Amsterdam University Medical Centers (UMC) (Author)
  • Haifa Al-Ali - , Martin Luther University Hospital (Author)
  • Yves Chalandon - , Swiss Group for Clinical Cancer Research (Author)
  • Michel van Gelder - , Maastricht University Medical Centre (UMC+) (Author)
  • Christian Junghanß - , University of Rostock (Author)
  • Gösta Gahrton - , Karolinska Institutet (Author)
  • Mathias Hänel - , Klinikum Chemnitz gGmbH (Author)
  • Rüdiger Hehlmann - , Heidelberg University  (Author)
  • Thomas Heinicke - , Otto von Guericke University Magdeburg (Author)
  • Andreas Hochhaus - , Friedrich Schiller University Jena (Author)
  • Simona Iacobelli - , University of Rome Tor Vergata (Author)
  • Rien van Marwijk Kooy - , Isala Hospital Zwolle (Author)
  • Nicolaus Kröger - , University of Hamburg (Author)
  • Jeroen Janssen - , Amsterdam University Medical Centers (UMC) (Author)
  • Madlen Jentzsch - , Leipzig University (Author)
  • Frank Breywisch - , Klinikum Ernst von Bergmann gGmbH (Author)
  • Mohamad Mohty - , Sorbonne Université (Author)
  • Stavroula Masouridi-Levrat - , Swiss Group for Clinical Cancer Research, Geneva University Hospitals (Author)
  • Gert Ossenkoppele - , Vrije Universiteit Amsterdam (VU) (Author)
  • Jacob Passweg - , Swiss Group for Clinical Cancer Research, University of Basel (Author)
  • Wolfram Pönisch - , Leipzig University (Author)
  • Johannes Schetelig - , Department of Internal Medicine I (Author)
  • Christoph Schliemann - , University Hospital Münster (Author)
  • Sebastian Schwind - , Leipzig University (Author)
  • Matthias Stelljes - , University Hospital Münster (Author)
  • Leo F. Verdonck - , Isala Clinics (Author)
  • Vladan Vucinic - , Leipzig University (Author)
  • Bob Löwenberg - , Erasmus University Rotterdam (Author)
  • Jan Cornelissen - , Erasmus University Rotterdam (Author)

Abstract

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/low-dose total body irradiation and cyclosporine/mycophenolate mofetil immunosuppression or conventional non-HCT. Primary outcome was restricted mean leukemia-free survival (RM-LFS) up to 5 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% confidence interval [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<0.0001). The secondary endpoints RM-OS up to 5 years was 27.8 months (95% CI:22.3-33.2) in the HCT as compared to 28.6 months (95% CI: 22.2-35.0) in the non-HCT arm; non-relapse mortality at 5 years was 33.4% (95% CI: 23.0-43.9) with HCT and 0% without. In older patients with AML in CR1 5-year RM-LFS is better with HCT than with non-HCT consolidation treatment. The long-term RM-LFS benefit did not translate into a better RM-OS during the study period.

Details

Original languageEnglish
Pages (from-to)68-77
Number of pages10
JournalHaematologica
Volume110
Issue number1
Publication statusPublished - Jan 2025
Peer-reviewedYes

External IDs

PubMed 39113672

Keywords

ASJC Scopus subject areas