Filgrastim, G-CSF, Lenograstim, Neutropenia, Pediatric Cancer
Conditions
Keywords
Pediatric cancer, Neutropenia, G-CSF
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
Interventions
DEVICEG-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)
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
We 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.
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute neutrophil counts (ANC) | up to 30 days | ANC higher than 1500 cells/mm3 for three consecutive days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Taiwan
Outcome results
None listed