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@ARTICLE{Dhner:307552,
      author       = {H. Döhner and D. Späth and M. Saadati$^*$ and W. Fiedler
                      and K. S. Götze and E. Koller and J. Westermann and W.
                      Vogel and M. Heuser and M. Lübbert and H.-J. Tischler and
                      U. Germing and L. L. Teichmann and L. Fransecky and A.
                      Wölfler and D. Nachbaur and B. Hertenstein and R. Schroers
                      and U. M. Martens and S. von Harsdorf and M. P. Radsak and
                      G. Aschauer and S. Weißhaar and A. Corbacioglu and A.
                      Schrade and V. I. Gaidzik and F. R. Thol and P. Paschka and
                      L. Bullinger and A. Benner$^*$ and K. Döhner and A. Ganser},
      title        = {{P}hase 3 study of intensive chemotherapy with or without
                      dasatinib in core-binding factor acute myeloid leukemia.},
      journal      = {Blood},
      volume       = {nn},
      issn         = {0006-4971},
      address      = {Washington, DC},
      publisher    = {American Society of Hematology},
      reportid     = {DKFZ-2026-00049},
      pages        = {nn},
      year         = {2026},
      note         = {epub},
      abstract     = {Core-binding factor acute myeloid leukemia (CBF-AML) is
                      associated with KIT mutations and deregulated expression of
                      KIT.We report results from the randomized, open-label, phase
                      3 trial of intensive chemotherapy with or without the
                      multi-kinase inhibitor dasatinib in adult patients with
                      CBF-AML.Patients received '3+7' induction therapy, followed
                      by 4 cycles of high-dose cytarabine; in the investigational
                      arm, patients received dasatinib 100 mg QD on days 8-21 in
                      induction, and on days 6-28 in consolidation cycles,
                      followed by 12-month single-agent dasatinib 100 mg QD.
                      Primary endpoint was event-free survival (EFS). Secondary
                      endpoints included overall survival, relapse-free survival,
                      and cumulative incidence of relapse.202 patients were
                      randomly assigned to the standard arm (n=102) and to the
                      dasatinib arm (n=100). Median age was 49 years (range, 18,
                      77); 94 patients had t(8;21), 108 had inv(16)/t(16;16); 58
                      $(28.7\%)$ patients had a KIT co-mutation. There was no
                      statistically significant difference in EFS (HR 0.92,
                      $95\%-CI$ 0.63, 1.33; p=0.66) or secondary endpoints between
                      treatment arms. There was also no significant difference in
                      EFS in subgroup analyses according to age, CBF-AML type, and
                      KIT mutation status. The incidence of serious adverse events
                      was higher in the investigational arm $(64\%)$ than in the
                      standard arm $(36\%).In$ patients with CBF-AML, the addition
                      of dasatinib to intensive chemotherapy failed to improve
                      survival outcomes. The addition of dasatinib was associated
                      with an increase in toxicity. This trial was registered at
                      www.gov as NCT02013648.},
      cin          = {C060},
      ddc          = {610},
      cid          = {I:(DE-He78)C060-20160331},
      pnm          = {313 - Krebsrisikofaktoren und Prävention (POF4-313)},
      pid          = {G:(DE-HGF)POF4-313},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:41490515},
      doi          = {10.1182/blood.2025030722},
      url          = {https://inrepo02.dkfz.de/record/307552},
}