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Springer, International Journal of Hematology, 3(99), p. 272-278, 2014

DOI: 10.1007/s12185-014-1503-4

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Phase I study of cladribine, cytarabine, granulocyte colony stimulating factor (CLAG regimen) and midostaurin and all-trans retinoic acid in relapsed/refractory AML

Journal article published in 2014 by Giridharan Ramsingh, Peter Westervelt, Ali McBride, Keith Stockerl-Goldstein, Ravi Vij, Mark Fiala, Geoffrey Uy ORCID, Amanda Cashen, John F. DiPersio, Camille N. Abboud
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This paper is available in a repository.

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Abstract

We conducted a phase 1 study using midostaurin (25 mg or 50 mg orally twice daily), all-trans retinoic acid (ATRA) and CLAG chemotherapy to target multiple pathways in relapsed/refractory AML. 10 patients received the combination and no dose limiting toxicities were observed. Two patients (22%) achieved complete remission and 1 patient (11%) achieved complete remission with incomplete count recovery. Pharmacokinetic data showed that the 25 mg dosing of midostaurin achieved therapeutic levels with no significant interaction between midostaurin and ATRA. With evidence of activity of ATRA in NPM1 mutated AML and midostaurin in FLT3-ITD AML this combination warrants further investigation.