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Adding dasatinib to intensive treatment in core-binding factor acute myeloid leukemia-results of the AMLSG 11-08 trial

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Adding dasatinib to intensive treatment in core-binding factor acute myeloid leukemia-results of the AMLSG 11-08 trial. / Paschka, Peter; Schlenk, Richard F; Weber, Daniela; Benner, Axel; Bullinger, Lars; Heuser, Michael; Gaidzik, Verena I; Thol, Felicitas; Agrawal, Mridul; Teleanu, Veronica; Lübbert, Michael; Fiedler, Walter; Radsak, Markus; Krauter, Jürgen; Horst, Heinz-A; Greil, Richard; Mayer, Karin; Kündgen, Andrea; Martens, Uwe; Heil, Gerhard; Salih, Helmut R; Hertenstein, Bernd; Schwänen, Carsten; Wulf, Gerald; Lange, Elisabeth; Pfreundschuh, Michael; Ringhoffer, Mark; Girschikofsky, Michael; Heinicke, Thomas; Kraemer, Doris; Göhring, Gudrun; Ganser, Arnold; Döhner, Konstanze; Döhner, Hartmut.

In: LEUKEMIA, Vol. 32, No. 7, 09.07.2018, p. 1621-1630.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Paschka, P, Schlenk, RF, Weber, D, Benner, A, Bullinger, L, Heuser, M, Gaidzik, VI, Thol, F, Agrawal, M, Teleanu, V, Lübbert, M, Fiedler, W, Radsak, M, Krauter, J, Horst, H-A, Greil, R, Mayer, K, Kündgen, A, Martens, U, Heil, G, Salih, HR, Hertenstein, B, Schwänen, C, Wulf, G, Lange, E, Pfreundschuh, M, Ringhoffer, M, Girschikofsky, M, Heinicke, T, Kraemer, D, Göhring, G, Ganser, A, Döhner, K & Döhner, H 2018, 'Adding dasatinib to intensive treatment in core-binding factor acute myeloid leukemia-results of the AMLSG 11-08 trial', LEUKEMIA, vol. 32, no. 7, pp. 1621-1630. https://doi.org/10.1038/s41375-018-0129-6

APA

Paschka, P., Schlenk, R. F., Weber, D., Benner, A., Bullinger, L., Heuser, M., Gaidzik, V. I., Thol, F., Agrawal, M., Teleanu, V., Lübbert, M., Fiedler, W., Radsak, M., Krauter, J., Horst, H-A., Greil, R., Mayer, K., Kündgen, A., Martens, U., ... Döhner, H. (2018). Adding dasatinib to intensive treatment in core-binding factor acute myeloid leukemia-results of the AMLSG 11-08 trial. LEUKEMIA, 32(7), 1621-1630. https://doi.org/10.1038/s41375-018-0129-6

Vancouver

Paschka P, Schlenk RF, Weber D, Benner A, Bullinger L, Heuser M et al. Adding dasatinib to intensive treatment in core-binding factor acute myeloid leukemia-results of the AMLSG 11-08 trial. LEUKEMIA. 2018 Jul 9;32(7):1621-1630. https://doi.org/10.1038/s41375-018-0129-6

Bibtex

@article{91267ad4109548e6ab726fd0b8b827ba,
title = "Adding dasatinib to intensive treatment in core-binding factor acute myeloid leukemia-results of the AMLSG 11-08 trial",
abstract = "In this phase Ib/IIa study (ClinicalTrials.gov Identifier: NCT00850382) of the German-Austrian AML Study Group (AMLSG) the multikinase inhibitor dasatinib was added to intensive induction and consolidation chemotherapy and administered as single agent for 1-year maintenance in first-line treatment of adult patients with core-binding factor (CBF) acute myeloid leukemia (AML). The primary combined end point in this study was safety and feasibility, and included the rates of early (ED) and hypoplastic (HD) deaths, pleural/pericardial effusion 3°/4° and liver toxicity 3°/4°, and the rate of refractory disease. Secondary end points were cumulative incidence of relapse (CIR) and death in complete remission (CID), and overall survival (OS). Eighty-nine pts [median age 49.5 years, range: 19-73 years; t(8;21), n = 37; inv (16), n = 52] were included. No unexpected excess in toxicity was observed. The rates of ED/HD and CR/CRi were 4.5% (4/89) and 94% (84/89), respectively. The 4-year estimated CIR, CID, and OS were 33.1% [95%-CI (confidence interval), 22.7-43.4%], 6.0% (95% CI, 0.9-11.2%), and 74.7% (95% CI, 66.1-84.5%), respectively. On the basis of the acceptable toxicity profile and favorable outcome in the AMLSG 11-08 trial, a confirmatory randomized phase III trial with dasatinib in adults with CBF-AML is ongoing (ClinicalTrials.gov Identifier: NCT02013648).",
keywords = "Journal Article",
author = "Peter Paschka and Schlenk, {Richard F} and Daniela Weber and Axel Benner and Lars Bullinger and Michael Heuser and Gaidzik, {Verena I} and Felicitas Thol and Mridul Agrawal and Veronica Teleanu and Michael L{\"u}bbert and Walter Fiedler and Markus Radsak and J{\"u}rgen Krauter and Heinz-A Horst and Richard Greil and Karin Mayer and Andrea K{\"u}ndgen and Uwe Martens and Gerhard Heil and Salih, {Helmut R} and Bernd Hertenstein and Carsten Schw{\"a}nen and Gerald Wulf and Elisabeth Lange and Michael Pfreundschuh and Mark Ringhoffer and Michael Girschikofsky and Thomas Heinicke and Doris Kraemer and Gudrun G{\"o}hring and Arnold Ganser and Konstanze D{\"o}hner and Hartmut D{\"o}hner",
year = "2018",
month = jul,
day = "9",
doi = "10.1038/s41375-018-0129-6",
language = "English",
volume = "32",
pages = "1621--1630",
journal = "LEUKEMIA",
issn = "0887-6924",
publisher = "NATURE PUBLISHING GROUP",
number = "7",

}

RIS

TY - JOUR

T1 - Adding dasatinib to intensive treatment in core-binding factor acute myeloid leukemia-results of the AMLSG 11-08 trial

AU - Paschka, Peter

AU - Schlenk, Richard F

AU - Weber, Daniela

AU - Benner, Axel

AU - Bullinger, Lars

AU - Heuser, Michael

AU - Gaidzik, Verena I

AU - Thol, Felicitas

AU - Agrawal, Mridul

AU - Teleanu, Veronica

AU - Lübbert, Michael

AU - Fiedler, Walter

AU - Radsak, Markus

AU - Krauter, Jürgen

AU - Horst, Heinz-A

AU - Greil, Richard

AU - Mayer, Karin

AU - Kündgen, Andrea

AU - Martens, Uwe

AU - Heil, Gerhard

AU - Salih, Helmut R

AU - Hertenstein, Bernd

AU - Schwänen, Carsten

AU - Wulf, Gerald

AU - Lange, Elisabeth

AU - Pfreundschuh, Michael

AU - Ringhoffer, Mark

AU - Girschikofsky, Michael

AU - Heinicke, Thomas

AU - Kraemer, Doris

AU - Göhring, Gudrun

AU - Ganser, Arnold

AU - Döhner, Konstanze

AU - Döhner, Hartmut

PY - 2018/7/9

Y1 - 2018/7/9

N2 - In this phase Ib/IIa study (ClinicalTrials.gov Identifier: NCT00850382) of the German-Austrian AML Study Group (AMLSG) the multikinase inhibitor dasatinib was added to intensive induction and consolidation chemotherapy and administered as single agent for 1-year maintenance in first-line treatment of adult patients with core-binding factor (CBF) acute myeloid leukemia (AML). The primary combined end point in this study was safety and feasibility, and included the rates of early (ED) and hypoplastic (HD) deaths, pleural/pericardial effusion 3°/4° and liver toxicity 3°/4°, and the rate of refractory disease. Secondary end points were cumulative incidence of relapse (CIR) and death in complete remission (CID), and overall survival (OS). Eighty-nine pts [median age 49.5 years, range: 19-73 years; t(8;21), n = 37; inv (16), n = 52] were included. No unexpected excess in toxicity was observed. The rates of ED/HD and CR/CRi were 4.5% (4/89) and 94% (84/89), respectively. The 4-year estimated CIR, CID, and OS were 33.1% [95%-CI (confidence interval), 22.7-43.4%], 6.0% (95% CI, 0.9-11.2%), and 74.7% (95% CI, 66.1-84.5%), respectively. On the basis of the acceptable toxicity profile and favorable outcome in the AMLSG 11-08 trial, a confirmatory randomized phase III trial with dasatinib in adults with CBF-AML is ongoing (ClinicalTrials.gov Identifier: NCT02013648).

AB - In this phase Ib/IIa study (ClinicalTrials.gov Identifier: NCT00850382) of the German-Austrian AML Study Group (AMLSG) the multikinase inhibitor dasatinib was added to intensive induction and consolidation chemotherapy and administered as single agent for 1-year maintenance in first-line treatment of adult patients with core-binding factor (CBF) acute myeloid leukemia (AML). The primary combined end point in this study was safety and feasibility, and included the rates of early (ED) and hypoplastic (HD) deaths, pleural/pericardial effusion 3°/4° and liver toxicity 3°/4°, and the rate of refractory disease. Secondary end points were cumulative incidence of relapse (CIR) and death in complete remission (CID), and overall survival (OS). Eighty-nine pts [median age 49.5 years, range: 19-73 years; t(8;21), n = 37; inv (16), n = 52] were included. No unexpected excess in toxicity was observed. The rates of ED/HD and CR/CRi were 4.5% (4/89) and 94% (84/89), respectively. The 4-year estimated CIR, CID, and OS were 33.1% [95%-CI (confidence interval), 22.7-43.4%], 6.0% (95% CI, 0.9-11.2%), and 74.7% (95% CI, 66.1-84.5%), respectively. On the basis of the acceptable toxicity profile and favorable outcome in the AMLSG 11-08 trial, a confirmatory randomized phase III trial with dasatinib in adults with CBF-AML is ongoing (ClinicalTrials.gov Identifier: NCT02013648).

KW - Journal Article

U2 - 10.1038/s41375-018-0129-6

DO - 10.1038/s41375-018-0129-6

M3 - SCORING: Journal article

C2 - 29720733

VL - 32

SP - 1621

EP - 1630

JO - LEUKEMIA

JF - LEUKEMIA

SN - 0887-6924

IS - 7

ER -