Home > Publications database > Gemtuzumab Ozogamicin in NPM1-Mutated Acute Myeloid Leukemia: Early Results From the Prospective Randomized AMLSG 09-09 Phase III Study. > print |
001 | 154483 | ||
005 | 20240229123103.0 | ||
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037 | _ | _ | |a DKFZ-2020-00805 |
041 | _ | _ | |a eng |
082 | _ | _ | |a 610 |
100 | 1 | _ | |a Schlenk, Richard F |b 0 |
245 | _ | _ | |a Gemtuzumab Ozogamicin in NPM1-Mutated Acute Myeloid Leukemia: Early Results From the Prospective Randomized AMLSG 09-09 Phase III Study. |
260 | _ | _ | |a Alexandria, Va. |c 2020 |b American Society of Clinical Oncology |
336 | 7 | _ | |a article |2 DRIVER |
336 | 7 | _ | |a Output Types/Journal article |2 DataCite |
336 | 7 | _ | |a Journal Article |b journal |m journal |0 PUB:(DE-HGF)16 |s 1586874753_14355 |2 PUB:(DE-HGF) |
336 | 7 | _ | |a ARTICLE |2 BibTeX |
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336 | 7 | _ | |a Journal Article |0 0 |2 EndNote |
520 | _ | _ | |a 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% CI, 0.65 to 1.04; P = .10). The early death rate during induction therapy was 10.3% in the GO arm and 5.7% in the standard arm (P = .05). Causes of death in both arms were mainly infections. The cumulative incidence of relapse (CIR) in patients achieving a complete remission (CR) or CR with incomplete hematologic recovery (CRi) was significantly reduced in the GO arm compared with the standard arm (P = .005), with no difference in the cumulative incidence of death (P = .80). Subgroup analysis revealed a significant beneficial effect of GO in female, younger (≤ 70 years), and FLT3 internal tandem duplication-negative patients with respect to EFS and CIR.The trial did not meet its early primary end point of EFS, mainly as a result of a higher early death rate in the GO arm. However, in patients achieving CR/CRi after induction therapy, significantly fewer relapses occurred in the GO compared with the standard arm. |
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700 | 1 | _ | |a Paschka, Peter |b 1 |
700 | 1 | _ | |a Krzykalla, Julia |0 P:(DE-He78)5a7a75d1b29b770f98f1bb2062fc3df9 |b 2 |u dkfz |
700 | 1 | _ | |a Weber, Daniela |b 3 |
700 | 1 | _ | |a Kapp-Schwoerer, Silke |b 4 |
700 | 1 | _ | |a Gaidzik, Verena I |b 5 |
700 | 1 | _ | |a Leis, Claudia |b 6 |
700 | 1 | _ | |a Fiedler, Walter |b 7 |
700 | 1 | _ | |a Kindler, Thomas |b 8 |
700 | 1 | _ | |a Schroeder, Thomas |b 9 |
700 | 1 | _ | |a Mayer, Karin |b 10 |
700 | 1 | _ | |a Lübbert, Michael |b 11 |
700 | 1 | _ | |a Wattad, Mohammed |b 12 |
700 | 1 | _ | |a Götze, Katharina |b 13 |
700 | 1 | _ | |a Horst, Heinz A |b 14 |
700 | 1 | _ | |a Koller, Elisabeth |b 15 |
700 | 1 | _ | |a Wulf, Gerald |b 16 |
700 | 1 | _ | |a Schleicher, Jan |b 17 |
700 | 1 | _ | |a Bentz, Martin |b 18 |
700 | 1 | _ | |a Greil, Richard |b 19 |
700 | 1 | _ | |a Hertenstein, Bernd |b 20 |
700 | 1 | _ | |a Krauter, Jürgen |b 21 |
700 | 1 | _ | |a Martens, Uwe |b 22 |
700 | 1 | _ | |a Nachbaur, David |b 23 |
700 | 1 | _ | |a Abu Samra, Maisun |b 24 |
700 | 1 | _ | |a Girschikofsky, Michael |b 25 |
700 | 1 | _ | |a Basara, Nadezda |b 26 |
700 | 1 | _ | |a Benner, Axel |b 27 |
700 | 1 | _ | |a Thol, Felicitas |b 28 |
700 | 1 | _ | |a Heuser, Michael |b 29 |
700 | 1 | _ | |a Ganser, Arnold |b 30 |
700 | 1 | _ | |a Döhner, Konstanze |b 31 |
700 | 1 | _ | |a Döhner, Hartmut |b 32 |
773 | _ | _ | |a 10.1200/JCO.19.01406 |g Vol. 38, no. 6, p. 623 - 632 |0 PERI:(DE-600)2005181-5 |n 6 |p 623 - 632 |t Journal of clinical oncology |v 38 |y 2020 |x 1527-7755 |
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