Effect of inotuzumab ozogamicin on the QT interval in patients with haematologic malignancies using QTc-concentration modelling.

ABSTRACT:

Aim

The aim of this study was to characterize the effect of inotuzumab ozogamicin on QT interval in patients with B-cell malignancies.

Methods

Data were pooled from three clinical studies including 250 patients (n = 2743) who received inotuzumab ozogamicin monotherapy. Patients with relapsed/refractory acute lymphoblastic leukaemia (NCT01564784 and NCT01363297) received 1.8 mg m^-2 per cycle in divided doses (mean C_max 371 ng ml^-1 ; considered therapeutic) and patients with relapsed/refractory non-Hodgkin lymphoma (NCT00868608) received 1.8 mg m^-2 per cycle as a single dose (mean C_max 569 ng ml^-1 ; considered supratherapeutic). Triplicate 12-lead electrocardiograms were performed at baseline and predefined time

SUBMITTER: Hibma JE 

PROVIDER: S-EPMC6379221 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature