Gemtuzumab ozogamicin plus midostaurin in combination with standard '7 + 3' induction therapy in newly diagnosed AML: Results from the SAL-MODULE phase I study

Research output: Contribution to journal › Research article › Contributed › peer-review

Contributors

  • Christoph Röllig - , Department of Internal Medicine I, University Hospital Carl Gustav Carus Dresden (Author)
  • Christoph Schliemann - , University Hospital Münster (Author)
  • Leo Ruhnke - , Department of Internal Medicine I, University Hospital Carl Gustav Carus Dresden (Author)
  • Lars Fransecky - , University Hospital Schleswig-Holstein Campus Kiel (Author)
  • Björn-Niklas Heydrich - , University Hospital Schleswig-Holstein Campus Kiel (Author)
  • Maher Hanoun - , University Hospital Essen (Author)
  • Richard Noppeney - , University Hospital Essen (Author)
  • Kerstin Schäfer-Eckart - , Paracelsus Medical University Nuremberg (Author)
  • Knut Wendelin - , Paracelsus Medical University Nuremberg (Author)
  • Jan-Henrik Mikesch - , University Hospital Münster (Author)
  • Jan Moritz Middeke - , Department of Internal Medicine I, University Hospital Carl Gustav Carus Dresden (Author)
  • Manja Reimann - , University Hospital Carl Gustav Carus Dresden, Department of internal Medicine I (Author)
  • Frank Fiebig - , Department of Internal Medicine I, University Hospital Carl Gustav Carus Dresden (Author)
  • Sven Zukunft - , Department of Internal Medicine I, University Hospital Carl Gustav Carus Dresden (Author)
  • Martin Wermke - , Department of Internal Medicine I, University Hospital Carl Gustav Carus Dresden (Author)
  • Hubert Serve - , University Hospital Frankfurt (Author)
  • Uwe Platzbecker - , University Hospital Leipzig (Author)
  • Carsten Müller-Tidow - , University Hospital Heidelberg (Author)
  • Claudia D Baldus - , University Hospital Schleswig-Holstein Campus Kiel (Author)
  • Martin Bornhäuser - , Department of Internal Medicine I, National Center for Tumor Diseases Dresden, University Hospital Carl Gustav Carus Dresden (Author)

Abstract

We conducted a phase I trial in newly diagnosed acute myeloid leukaemia (AML) to investigate the combination of two novel targeted agents, gemtuzumab ozogamicin (GO) and midostaurin, with intensive chemotherapy in FLT3-mutated AML and CBF leukaemia. Three dose levels of midostaurin and one to three sequential doses of 3 mg/m2 GO in combination with '7 + 3' induction were evaluated. Based on safety findings in 12 patients, our results show that 3 mg/m2 GO on Days 1 + 4 and 100 mg midostaurin on Days 8-21 can be safely combined with IC in newly diagnosed AML.

Details

Original languageEnglish
Pages (from-to)2254-2258
Number of pages5
JournalBritish journal of haematology
Volume204
Issue number6
Publication statusPublished - Jun 2024
Peer-reviewedYes

External IDs

Scopus 85190409025

Keywords

Keywords

  • Adult, Aged, Aminoglycosides/administration & dosage, Antibodies, Monoclonal, Humanized/administration & dosage, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Female, Gemtuzumab/administration & dosage, Humans, Induction Chemotherapy, Leukemia, Myeloid, Acute/drug therapy, Male, Middle Aged, Staurosporine/analogs & derivatives, fms-Like Tyrosine Kinase 3/genetics