TY  - JOUR
AU  - Schlenk, Richard F
AU  - Paschka, Peter
AU  - Krzykalla, Julia
AU  - Weber, Daniela
AU  - Kapp-Schwoerer, Silke
AU  - Gaidzik, Verena I
AU  - Leis, Claudia
AU  - Fiedler, Walter
AU  - Kindler, Thomas
AU  - Schroeder, Thomas
AU  - Mayer, Karin
AU  - Lübbert, Michael
AU  - Wattad, Mohammed
AU  - Götze, Katharina
AU  - Horst, Heinz A
AU  - Koller, Elisabeth
AU  - Wulf, Gerald
AU  - Schleicher, Jan
AU  - Bentz, Martin
AU  - Greil, Richard
AU  - Hertenstein, Bernd
AU  - Krauter, Jürgen
AU  - Martens, Uwe
AU  - Nachbaur, David
AU  - Abu Samra, Maisun
AU  - Girschikofsky, Michael
AU  - Basara, Nadezda
AU  - Benner, Axel
AU  - Thol, Felicitas
AU  - Heuser, Michael
AU  - Ganser, Arnold
AU  - Döhner, Konstanze
AU  - Döhner, Hartmut
TI  - Gemtuzumab Ozogamicin in NPM1-Mutated Acute Myeloid Leukemia: Early Results From the Prospective Randomized AMLSG 09-09 Phase III Study.
JO  - Journal of clinical oncology
VL  - 38
IS  - 6
SN  - 1527-7755
CY  - Alexandria, Va.
PB  - American Society of Clinical Oncology
M1  - DKFZ-2020-00805
SP  - 623 - 632
PY  - 2020
AB  - 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
LB  - PUB:(DE-HGF)16
C6  - pmid:31851556
C2  - pmc:PMC7030890
DO  - DOI:10.1200/JCO.19.01406
UR  - https://inrepo02.dkfz.de/record/154483
ER  -