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

Phase 4Active Not RecruitingNCT06145321

Chang Gung Memorial Hospital20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Pediatric Cancer Neutropenia Lenograstim Filgrastim G-CSF

Interventions

G-CSF administration (bolus injection versus intravenous infusion)DEVICE

Route of administration: intravenous infusion (with a 5 hours infusion period) or intravenous bolus (with an infusion period of less than one minute)

G-CSF administration (bolus injection versus intravenous infusion)DRUG

Route of administration: intravenous infusion (with a 5 hours infusion period) or intravenous bolus (with an infusion period of less than one minute)

Eligibility

Sex: ALLMin age: 0 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Chang Gung Children Hospital

Taoyuan, ROC, Taiwan

Outcomes

Primary Outcomes

Absolute neutrophil counts (ANC)

ANC higher than 1500 cells/mm3 for three consecutive days

Time frame: up to 30 days

Secondary Outcomes

Hospitalization duration

Hospitalization duration from admission to discharge

Time frame: up to 30 days

Re-hospitalization event

14 days re-hospitalization event

Time frame: up to 5 times

Clinical sepsis

Events of severe bacterial infection during neutropenic period

Time frame: up to 5 times

Data from ClinicalTrials.gov

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