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

Phase 4

Recruiting

• Conditions: Pediatric Cancer; Neutropenia; Lenograstim; Filgrastim; G-CSF
• Interventions: Drug: G-CSF administration (bolus injection versus intravenous infusion)

• Registration Number: NCT06145321
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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

Study Timeline

• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-21
• Study Start: 2023-11-23
• Study First Posted: 2023-11-24
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-25
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-11-15
• Study Completion: 2024-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Pediatric patients with an age between 0 to 18 years old will be included
• Hematologic and oncologic malignancies

Exclusion Criteria

• Patients with a diagnosis of myelodysplastic syndrome or severe aplastic anemia will be excluded
• Patients receiving G-CSF treatment 7 days before enrollment will be excluded
• Patients concurrently receiving cytokine therapy or thrombopoietin receptor agonist therapy will be excluded

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control Group	G-CSF administration (bolus injection versus intravenous infusion)	G-CSF at a dose of 5 mcg/kg/day intravenously bolus
Experimental Group	G-CSF administration (bolus injection versus intravenous infusion)	G-CSF at a dose of 5 mcg/kg/day intravenously infused for 4 hours

Primary Outcome Measures

Name	Time	Method
Absolute neutrophil counts (ANC)	up to 30 days	ANC higher than 1500 cells/mm3 for three consecutive days

Secondary Outcome Measures

Name	Time	Method
Hospitalization duration	up to 30 days	Hospitalization duration from admission to discharge
Re-hospitalization event	up to 5 times	14 days re-hospitalization event
Clinical sepsis	up to 5 times	Events of severe bacterial infection during neutropenic period

Trial Locations

Locations (1)

Chang Gung Children Hospital; 🇨🇳 Taoyuan, ROC, Taiwan