Population Pharmacokinetics of PEGylated Asparaginase in Children with Acute Lymphoblastic Leukemia: Treatment Phase Dependency and Predictivity in Case of Missing Data.

ABSTRACT:

Background and objectives

The pharmacokinetics of polyethylene glycol-conjugated asparaginase (PEG-ASNase) are characterized by an increase in elimination over time, a marked increase in ASNase activity levels from induction to reinduction, and high inter- and intraindividual variability. A population pharmacokinetic (PopPK) model is required to estimate individual dose intensity, despite gaps in monitoring compliance.

Methods

In the AIEOP-BFM ALL 2009 trial, two PEG-ASNase administrations (2500 U/m² intravenously) during induction (14-day interval) and one administration during reinduction were administered in children with acute lymphoblastic leukemia. ASNase activity levels were monitored weekly. A PopPK model was used for covariate modeling and external valida

SUBMITTER: Wurthwein G 

PROVIDER: S-EPMC7935823 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature