%0 Journal Article
%A Schlenk, Richard F
%A Paschka, Peter
%A Krzykalla, Julia
%A Weber, Daniela
%A Kapp-Schwoerer, Silke
%A Gaidzik, Verena I
%A Leis, Claudia
%A Fiedler, Walter
%A Kindler, Thomas
%A Schroeder, Thomas
%A Mayer, Karin
%A Lübbert, Michael
%A Wattad, Mohammed
%A Götze, Katharina
%A Horst, Heinz A
%A Koller, Elisabeth
%A Wulf, Gerald
%A Schleicher, Jan
%A Bentz, Martin
%A Greil, Richard
%A Hertenstein, Bernd
%A Krauter, Jürgen
%A Martens, Uwe
%A Nachbaur, David
%A Abu Samra, Maisun
%A Girschikofsky, Michael
%A Basara, Nadezda
%A Benner, Axel
%A Thol, Felicitas
%A Heuser, Michael
%A Ganser, Arnold
%A Döhner, Konstanze
%A Döhner, Hartmut
%T Gemtuzumab Ozogamicin in NPM1-Mutated Acute Myeloid Leukemia: Early Results From the Prospective Randomized AMLSG 09-09 Phase III Study.
%J Journal of clinical oncology
%V 38
%N 6
%@ 1527-7755
%C Alexandria, Va.
%I American Society of Clinical Oncology
%M DKFZ-2020-00805
%P 623 - 632
%D 2020
%X High CD33 expression in acute myeloid leukemia (AML) with mutated NPM1 provides a rationale for the evaluation of gemtuzumab ozogamicin (GO) in this AML entity. We conducted a randomized trial to evaluate GO in combination with intensive induction and consolidation therapy in NPM1-mutated AML.Between May 2010 and September 2017, patients ≥ 18 years old and considered eligible for intensive therapy were randomly assigned up front for induction therapy with idarubicin, cytarabine, etoposide, and all-trans-retinoic acid with or without GO. The early (P = .02) primary end point of event-free survival (EFS) was evaluated 6 months after completion of patient recruitment.Five hundred eighty-eight patients were randomly assigned (standard arm, n = 296; GO arm, n = 292). EFS in the GO arm was not significantly different compared with that in the standard arm (hazard ratio, 0.83; 95
%F PUB:(DE-HGF)16
%9 Journal Article
%$ pmid:31851556
%2 pmc:PMC7030890
%R 10.1200/JCO.19.01406
%U https://inrepo02.dkfz.de/record/154483