Randomized Phase III Study of Intensive Chemotherapy With or Without Dasatinib (Sprycel™)

Summary

This is a randomized phase III open-label, multicenter trial evaluating standard induction therapy (daunorubicin \[DNR\] and cytarabine \[Ara-C\]) and consolidation therapy (high-dose cytarabine \[HDAC\]) with or without dasatinib in adult patients with newly diagnosed CBF-AML

Timeline

Start

2014-07

Primary completion

2024-02

Completion

2024-02

Outcome

Missed primary endpoint

paper There was no statistically significant difference in EFS (hazard ratio, 0.92; 95% confidence interval, 0.63-1.33; P = .66) PMID 41490515 ↗

Publications

• Dohner H, Spath D, Saadati M, Fiedler W, Gotze K, Koller E, Westermann J, Vogel W, Heuser M, Lubbert M, Tischler HJ, Germing U, Teichmann LL, Fransecky L, Wolfler A, Nachbaur D, Hertenstein B, Schroers R, Martens U, von Harsdorf S, Radsak M, Aschauer G, Weisshaar S, Corbacioglu A, Schrade A, Gaidzik VI, Thol F, Paschka P, Bullinger L, Benner A, Dohner K, Ganser A. A phase 3 study of intensive chemotherapy with or without dasatinib in core-binding factor acute myeloid leukemia. Blood. 2026 Apr 9;147(15):1735-1748. doi: 10.1182/blood.2025030722.
• Paschka P, Schlenk RF, Weber D, Benner A, Bullinger L, Heuser M, Gaidzik VI, Thol F, Agrawal M, Teleanu V, Lubbert M, Fiedler W, Radsak M, Krauter J, Horst HA, Greil R, Mayer K, Kundgen A, Martens U, Heil G, Salih HR, Hertenstein B, Schwanen C, Wulf G, Lange E, Pfreundschuh M, Ringhoffer M, Girschikofsky M, Heinicke T, Kraemer D, Gohring G, Ganser A, Dohner K, Dohner H. Adding dasatinib to intensive treatment in core-binding factor acute myeloid leukemia-results of the AMLSG 11-08 trial. Leukemia. 2018 Jul;32(7):1621-1630. doi: 10.1038/s41375-018-0129-6. Epub 2018 Apr 17.

Drugs

Indications