A Study to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Tripegfilgrastim in Pediatric Solid Tumor/Lymphoma Patients

Dong-A ST Co., Ltd.27 enrolled

Overview

This is an open-label, single ascending dose study to evaluate safety, tolerability, and pharmacokinetics/pharmacodynamics of Tripegfilgrastim in pediatric solid tumor/lymphoma patients

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Solid Tumor Lymphoma

Interventions

TripegfilgrastimDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * \>=6 and \<19-year-old pediatrics with solid tumor/lymphoma * Scheduled for chemotherapy requiring G-CSF support or having given an experience of ANC \< 0.5x10\^9/L * ANC \> 0.75x10\^9/L, platelet \> 75x10\^9/L * ECOG performance status 0 or 1 Exclusion Criteria: * Patients with leukemia, myelodysplastic syndrome or uncontrolled infectious/nervous diseases * History of allergy to filgrastim, pegfilgrastim or known hypersensitivity to E-coli derived proteins. * Women who are pregnant or lactating

Locations (1)

Seoul National University Hospital

Seoul, South Korea