Safety, pharmacokinetics, and pharmacodynamics of panobinostat in children, adolescents, and young adults with relapsed acute myeloid leukemia.

ABSTRACT:

Background

Novel therapies are urgently needed for pediatric patients with relapsed acute myeloid leukemia (AML).

Methods

To determine whether the histone deacetylase inhibitor panobinostat could be safely given in combination with intensive chemotherapy, a phase 1 trial was performed in which 17 pediatric patients with relapsed or refractory AML received panobinostat (10, 15, or 20 mg/m² ) before and in combination with fludarabine and cytarabine.

Results

All dose levels were tolerated, with no dose-limiting toxicities observed at any dose level. Pharmacokinetic studies demonstrated that exposure to panobinostat was proportional to the dose given, with no associations between pharmacokinetic parameters and age, weight, or body surface area. Among the 9 pat

SUBMITTER: Karol SE 

PROVIDER: S-EPMC7722063 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature