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Clinical Trial
. 2018 Jul;32(7):1621-1630.
doi: 10.1038/s41375-018-0129-6. Epub 2018 Apr 17.

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

Peter Paschka  1 , Richard F Schlenk  2 , Daniela Weber  2 , Axel Benner  3 , Lars Bullinger  2 , Michael Heuser  4 , Verena I Gaidzik  2 , Felicitas Thol  4 , Mridul Agrawal  2 , Veronica Teleanu  2 , Michael Lübbert  5 , Walter Fiedler  6 , Markus Radsak  7 , Jürgen Krauter  8 , Heinz-A Horst  9 , Richard Greil  10 , Karin Mayer  11 , Andrea Kündgen  12 , Uwe Martens  13 , Gerhard Heil  14 , Helmut R Salih  15 , Bernd Hertenstein  16 , Carsten Schwänen  17 , Gerald Wulf  18 , Elisabeth Lange  19 , Michael Pfreundschuh  20 , Mark Ringhoffer  21 , Michael Girschikofsky  22 , Thomas Heinicke  23 , Doris Kraemer  24 , Gudrun Göhring  25 , Arnold Ganser  4 , Konstanze Döhner  2 , Hartmut Döhner  2
Affiliations
Clinical Trial

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

Peter Paschka et al. Leukemia. 2018 Jul.

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).

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