Measurable residual disease-guided treatment with azacitidine to prevent haematological relapse in patients with myelodysplastic syndrome and acute myeloid leukaemia (RELAZA2): an open-label, multicentre, phase 2 trial

Background - Monitoring of measurable residual disease (MRD) in patients with advanced myelodysplastic syndromes (MDS) or acute myeloid leukaemia (AML) who achieve a morphological complete remission can predict haematological relapse. In this prospective study, we aimed to determine whether MRD-guid...

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Hauptverfasser: Platzbecker, Uwe (VerfasserIn) , Krämer, Alwin (VerfasserIn) , Bochtler, Tilmann (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 12 November 2018
In: The lancet. Oncology
Year: 2018, Jahrgang: 19, Heft: 12, Pages: 1668-1679
ISSN:1474-5488
DOI:10.1016/S1470-2045(18)30580-1
Online-Zugang:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/S1470-2045(18)30580-1
Verlag, lizenzpflichtig, Volltext: http://www.sciencedirect.com/science/article/pii/S1470204518305801
Volltext
Verfasserangaben:Uwe Platzbecker, Jan Moritz Middeke, Katja Sockel, Regina Herbst, Dominik Wolf, Claudia D Baldus, Uta Oelschlägel, Anke Mütherig, Lars Fransecky, Richard Noppeney, Gesine Bug, Katharina S Götze, Alwin Krämer, Tilmann Bochtler, Matthias Stelljes, Christoph Groth, Antje Schubert, Marika Mende, Friedrich Stölzel, Christine Borkmann, Anne Sophie Kubasch, Malte von Bonin, Hubert Serve, Mathias Hänel, Ulrich Dührsen, Johannes Schetelig, Christoph Röllig, Michael Kramer, Gerhard Ehninger, Martin Bornhäuser, Christian Thiede
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Zusammenfassung:Background - Monitoring of measurable residual disease (MRD) in patients with advanced myelodysplastic syndromes (MDS) or acute myeloid leukaemia (AML) who achieve a morphological complete remission can predict haematological relapse. In this prospective study, we aimed to determine whether MRD-guided pre-emptive treatment with azacitidine could prevent relapse in these patients. - Methods - The relapse prevention with azacitidine (RELAZA2) study is an open-label, multicentre, phase 2 trial done at nine university health centres in Germany. Patients aged 18 years or older with advanced MDS or AML, who had achieved a complete remission after conventional chemotherapy or allogeneic haemopoietic stem-cell transplantation, were prospectively screened for MRD during 24 months from baseline by either quantitative PCR for mutant NPM1, leukaemia-specific fusion genes (DEK-NUP214, RUNX1-RUNX1T1, CBFb-MYH11), or analysis of donor-chimaerism in flow cytometry-sorted CD34-positive cells in patients who received allogeneic haemopoietic stem-cell transplantation.
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Beschreibung:Online Resource
ISSN:1474-5488
DOI:10.1016/S1470-2045(18)30580-1