A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia

Summary

The purpose of this study is to describe the dose limiting toxicities (DLT) and define the maximum tolerated dose (MTD) of ASP2215 when combined with cytarabine/idarubicin or daunorubicin remission induction in a 7+3 schedule. Safety and tolerability of ASP2215 will also be evaluated. This study will also characterize the pharmacokinetics (PK) of ASP2215 when given in combination with cytarabine/idarubicin or cytarabine/daunorubicin remission induction and high-dose cytarabine (HiDAC) consolidation therapy in newly diagnosed acute myeloid leukemia as well as evaluate the effect of ASP2215 on the PK of cytarabine.

Timeline

Start

2015-01-07

Primary completion

2021-07-26

Completion

2021-07-26

Publications

• Pratz KW, Cherry M, Altman JK, Cooper BW, Podoltsev NA, Cruz JC, Lin TL, Schiller GJ, Jurcic JG, Asch A, Wu R, Hill JE, Gill SC, James AJ, Rich ES, Hasabou N, Perl AE, Levis MJ. Gilteritinib in Combination With Induction and Consolidation Chemotherapy and as Maintenance Therapy: A Phase IB Study in Patients With Newly Diagnosed AML. J Clin Oncol. 2023 Sep 10;41(26):4236-4246. doi: 10.1200/JCO.22.02721. Epub 2023 Jun 28.

Drugs

Indications