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Rationale and design of the 2 by 2 factorial design GnG-trial: a randomized phase-III study to compare two schedules of gemtuzumab ozogamicin as adjunct to intensive induction therapy and to compare double-blinded intensive postremission therapy with or without glasdegib in older patients with newly diagnosed AML

Overall survival remains poor in older patients with acute myeloid leukemia (AML) with less than 10% being alive after 5 years. In recent studies, a significant improvement in event-free, relapse-free and overall survival was shown by adding gemtuzumab ozogamicin (GO), a humanized antibody-drug conj...

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Main Authors: Jaramillo Segura, Sonia (Author) , Krisam, Johannes (Author) , Le Cornet, Lucian (Author) , Kratzmann, Markus (Author) , Baumann, Lukas (Author) , Sauer, Tim (Author) , Crysandt, Martina (Author) , Rank, Andreas (Author) , Behringer, Dirk (Author) , Teichmann, Lino (Author) , Görner, Martin (Author) , Trappe, Ralf-Ulrich (Author) , Röllig, Christoph (Author) , Krause, Stefan (Author) , Hanoun, Maher (Author) , Hopfer, Olaf (Author) , Held, Gerhard (Author) , Buske, Sebastian (Author) , Fransecky, Lars (Author) , Kayser, Sabine (Author) , Schliemann, Christoph (Author) , Schaefer-Eckart, Kerstin (Author) , Al-Fareh, Yousef (Author) , Schubert, Jörg (Author) , Geer, Thomas (Author) , Kaufmann, Martin (Author) , Brecht, Arne (Author) , Niemann, Dirk (Author) , Kieser, Meinhard (Author) , Bornhäuser, Martin (Author) , Platzbecker, Uwe (Author) , Serve, Hubert (Author) , Baldus, Claudia D. (Author) , Müller-Tidow, Carsten (Author) , Schlenk, Richard Friedrich (Author)
Format: Article (Journal)
Language:English
Published: 03 November 2021
In: Trials
Year: 2021, Volume: 22, Pages: 1-13
ISSN:1468-6694
DOI:10.1186/s13063-021-05703-w
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1186/s13063-021-05703-w
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Author Notes:Sonia Jaramillo, Johannes Krisam, Lucian Le Cornet, Markus Kratzmann, Lukas Baumann, Tim Sauer, Martina Crysandt, Andreas Rank, Dirk Behringer, Lino Teichmann, Martin Görner, Ralf-Ulrich Trappe, Christoph Röllig, Stefan Krause, Maher Hanoun, Olaf Hopfer, Gerhard Held, Sebastian Buske, Lars Fransecky, Sabine Kayser, Christoph Schliemann, Kerstin Schaefer-Eckart, Yousef Al-Fareh, Jörg Schubert, Thomas Geer, Martin Kaufmann, Arne Brecht, Dirk Niemann, Meinhard Kieser, Martin Bornhäuser, Uwe Platzbecker, Hubert Serve, Claudia D. Baldus, Carsten Müller-Tidow and Richard F. Schlenk

MARC

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520 |a Overall survival remains poor in older patients with acute myeloid leukemia (AML) with less than 10% being alive after 5 years. In recent studies, a significant improvement in event-free, relapse-free and overall survival was shown by adding gemtuzumab ozogamicin (GO), a humanized antibody-drug conjugate directed against CD33, to intensive induction therapy once or in a sequential dosing schedule. Glasdegib, the small-molecule inhibitor of smoothened (SMO), also showed improved overall survival in patients not eligible for intensive chemotherapy when combined with low-dose cytarabine compared to low-dose cytarabine alone. These findings warrant further investigations in the phase III GnG trial. 
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