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

Study Overview
=================
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

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

Conditions
-----------------
Pediatric Cancer, Neutropenia, Lenograstim, Filgrastim, G-CSF

Intervention / Treatment
-----------------
* Device: G-CSF administration (bolus injection versus intravenous infusion)
* Drug: G-CSF administration (bolus injection versus intravenous infusion)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Investigational product(s)：G-CSF (filgrastim) Route of administration: intravenous infusion (with a 5 hours infusion period) or intravenous bolus (with an infusion period of less than one minute)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>G-CSF at a dose of 5 mcg/kg/day intravenously infused for 4 hours | Device: G-CSF administration (bolus injection versus intravenous infusion)<br>* Route of administration: intravenous infusion (with a 5 hours infusion period) or intravenous bolus (with an infusion period of less than one minute)<br>* Other names: Filgrastim, Lenograstim;Drug: G-CSF administration (bolus injection versus intravenous infusion)<br>* Route of administration: intravenous infusion (with a 5 hours infusion period) or intravenous bolus (with an infusion period of less than one minute)<br>* Other names: Filgrastim, Lenograstim;|
| Other: Control Group<br>G-CSF at a dose of 5 mcg/kg/day intravenously bolus | Device: G-CSF administration (bolus injection versus intravenous infusion)<br>* Route of administration: intravenous infusion (with a 5 hours infusion period) or intravenous bolus (with an infusion period of less than one minute)<br>* Other names: Filgrastim, Lenograstim;Drug: G-CSF administration (bolus injection versus intravenous infusion)<br>* Route of administration: intravenous infusion (with a 5 hours infusion period) or intravenous bolus (with an infusion period of less than one minute)<br>* Other names: Filgrastim, Lenograstim;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute neutrophil counts (ANC) | ANC higher than 500 cells/mm3 for three consecutive days | up to 30 days | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric cancer, Neutropenia, G-CSF