Phase II Trial of Alisertib With Induction Chemotherapy in High-risk AML

Summary

This research study is studying a targeted therapy (a form of treatment that uses drugs or other substances to identify and attack specific types of cancer cells with less harm to normal cells) as a possible treatment for high-risk acute myeloid leukemia. The names of the study interventions involved in this study are: * Alisertib / MLN8237 * Cytarabine / Cytosine Arabinoside * Idarubicin / Idarubicin hydrochloride * Daunorubicin (Can be used in place of idarubicin)

Timeline

Start

2015-12

Primary completion

2017-10

Completion

2018-12

Publications

• Brunner AM, Blonquist TM, DeAngelo DJ, McMasters M, Fell G, Hermance NM, Winer ES, Lindsley RC, Hobbs GS, Amrein PC, Hock HR, Steensma DP, Garcia JS, Luskin MR, Stone RM, Ballen KK, Rosenblatt J, Avigan D, Nahas MR, Mendez LM, McAfee SL, Moran JA, Bergeron M, Foster J, Bertoli C, Manning AL, McGregor KL, Fishman KM, Kuo FC, Baltay MT, Macrae M, Burke M, Behnan T, Wey MC, Som TT, Ramos AY, Rae J, Lombardi Story J, Nelson N, Logan E, Connolly C, Neuberg DS, Chen YB, Graubert TA, Fathi AT. Alisertib plus induction chemotherapy in previously untreated patients with high-risk, acute myeloid leukaemia: a single-arm, phase 2 trial. Lancet Haematol. 2020 Feb;7(2):e122-e133. doi: 10.1016/S2352-3026(19)30203-0. Epub 2019 Dec 11.

Drugs

Indications