Haematologica (Aug 2024)
Hematopoietic cell transplantation for older acute myeloid leukemia patients in first complete remission: results of a randomized phase III study
- 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
Affiliations
- Dietger Niederwieser
- University Leipzig, Germany; Aichi Medical University School of Medicine, Nagakute, Japan; KaunoKlinikos University of Health Sciences, Kaunas, Lithuania
- Dirk Hasenclever
- Institute for Medical Informatics, Statistics and Epidemiology (IMISE) ) in cooperation with the Clinical trial Centre (ZKS), University of Leipzig, Germany,04107 Leipzig
- Wolfgang Berdel
- Universitätsklinikum, 48149 Münster
- Bart J. Biemond
- Amsterdam University Medical Centers, University of Amsterdam, Amsterdam
- Haifa Al-Ali
- University Hospital, Halle
- Yves Chalandon
- Geneva University Hospitals and Faculty of Medicine, University of Geneva, Geneva, Switzerland; Swiss Group for Clinical Cancer Research (SAKK), Bern
- Michel van Gelder
- Maastricht University Medical Center, 6202 AZ Maastricht
- Christian Junghanß
- Universitätsklinikum Rostock, 18057 Rostock
- Gösta Gahrton
- Dep. of Medicine, Karolinska Institute, Huddinge 141 86 Stockholm Sweden
- Mathias Hänel
- Klinikum Chemnitz gGmbH, Flemmingstraße 2, 09116 Chemnitz
- Rüdiger Hehlmann
- Medizinische Fakultät Mannheim, Universität Heidelberg, and European Leukemia Net Foundation, Weinheim, Germany Hehlmann
- Thomas Heinicke
- Department of Hematology and Oncology, Otto-von-Guericke University, Magdeburg
- Andreas Hochhaus
- Universitätsklinikum Jena, Jena
- Simona Iacobelli
- Università di Roma "Tor Vergata", Dipartimento di Biologia – 00133 Roma
- Rien van Marwijk Kooy
- Isala Clinic Zwolle, Dokter van Heesweg 2, 8025 AB Zwolle
- Nicolaus Kröger
- University Medical Center Hamburg/Germany
- Jeroen Janssen
- Amsterdam University Medical Centers, University of Amsterdam, Amsterdam
- Madlen Jentzsch
- University of Leipzig
- Frank Breywisch
- Department of Hematology, Oncology and Palliative Care, Ernst Von Bergmann Hospital, Potsdam
- Mohamad Mohty
- Sorbonne University, Hospital Saint Antoine Department of Hematology, INSERM UMRs938, Paris, France mohamad
- Stavroula Masouridi-Levrat
- Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland; Geneva University Hospitals and Faculty of Medicine, University of Geneva, Geneva
- Gert Ossenkoppele
- VU University Medical Center, 1081 HV Amsterdam, Netherlands
- Jacob Passweg
- Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland; Klinik für Hämatologie, Universitätsspital Basel, Petersgraben 4, CH-4031 Basel
- Wolfram Pönisch
- University Leipzig
- Johannes Schetelig
- University Hospital, TU Dresden
- Christoph Schliemann
- University Hospital Münster, Department of Medicine A, 48149 Münster
- Sebastian Schwind
- University of Leipzig
- Matthias Stelljes
- University Hospital Münster, Department of Medicine A, 48149 Münster,
- Leo F. Verdonck
- Isala Clinic Zwolle, Dokter van Heesweg 2, 8025 AB Zwolle, Netherlands
- Vladan Vucinic
- University of Leipzig
- Bob Löwenberg
- Erasmus University Medical Center Rotterdam and Erasmus MC Cancer Institute, 3015 GD Rotterdam
- Jan Cornelissen
- Erasmus University Medical Center Rotterdam and Erasmus MC Cancer Institute, 3015 GD Rotterdam
- DOI
- https://doi.org/10.3324/haematol.2024.285879
- Journal volume & issue
-
Vol. 999,
no. 1
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/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
