NCT06145321

Continuous Versus Bolus Administration of G-CSF in Children With Cancer

Continuous Infusion of Granulocyte Colony-stimulating Factor is Associated With an Advantage in Neutrophil Recovery in Hematologic and Oncologic Disorders

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 0 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators hypothesized that in terms of granulocyte colony-stimulating factor (G-CSF) administration, the route of continuous infusion would lead to a faster neutrophil recovery compared to that of bolus administration

Detailed description

The investigators aimed to enroll 40 hospitalized patients in this phase 4 clinical trial. Patients with an ANC lower than 500 cells/mm3 will be randomly categorized into experimental and controlled arms. The experimental arm was designed to receive G-CSF intravenous infusion for 5 hours at a dose of 5 mcg/kg. The controlled arm was designed to receive a G-CSF bolus injection within one minute at a dose of 5 mcg/kg. Three days after treatment initiation, serum white blood cell and differential counts will be followed daily to determine the timing of steady neutrophil recovery. In the following time of another neutropenia event, the experimental arm would cross-switch to the controlled arm and receive corresponding G-CSF according to the study design

Conditions

• Pediatric Cancer
• Neutropenia
• Lenograstim
• Filgrastim
• G-CSF

Interventions

Type	Name	Description
DEVICE	G-CSF administration (bolus injection versus intravenous infusion)	Route of administration: intravenous infusion (with a 5 hours infusion period) or intravenous bolus (with an infusion period of less than one minute)
DRUG	G-CSF administration (bolus injection versus intravenous infusion)	Route of administration: intravenous infusion (with a 5 hours infusion period) or intravenous bolus (with an infusion period of less than one minute)

Timeline

• Start date: 2023-11-23
• Primary completion: 2024-11-15
• Completion: 2024-11-15
• First posted: 2023-11-24
• Last updated: 2024-09-19

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study
• FDA-regulated device study