Population Pharmacokinetics of Inotuzumab Ozogamicin in Pediatric Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia: Results of Study ITCC-059

Table 1 Covariates examined in a pediatric population pharmacokinetic analysis of inotuzumab ozogamicin

Pharmacokinetic parameter	Covariate
CL₁	BBSA/BWT/ LBM, age, BHGRADE, BALB, BALT
V₁	BBSA/BWT/ LBM
CL₂	BBSA/BWT/ LBM, age, ALL effect, BLSTABL
k_des	BLSTPB/ BLSTABL, age

ALL acute lymphoblastic leukemia, ALL effect disease type (ALL/NHL) and/or analytical methods, BALB baseline albumin, BALT baseline alanine aminotransferase, BAST baseline aspartate aminotransferase, BBSA baseline body surface area calculated by the DuBois method for adults, estimated by the Mosteller formula for children, BHGRADE baseline hepatic impairment grades, BLSTABL baseline absolute blast counts in peripheral blood, BLSTPB baseline percentage of blasts in the peripheral blood, BWT baseline body weight, CL₁ linear clearance, CL₂ initial value of time-dependent clearance, k_des decay coefficient of time-dependent clearance, LBM baseline lean body mass (estimated by Boer’s equations for adults, and by the equation established by Peters et al. for children), NHL non-Hodgkin lymphoma, V₁ volume of distribution in the central compartment