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

Chang Gung Medical Foundation

Status and phase: Active, not recruiting; Phase 4

Conditions: G-CSF; Neutropenia; Filgrastim; Lenograstim; Pediatric Cancer

Treatments: Drug: G-CSF administration (bolus injection versus intravenous infusion)

Study type: Interventional

Funder types: Other

Identifiers

NCT06145321

CVB-1115

Details and patient eligibility

About

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

Full 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

Enrollment: 20 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Experimental Group

Experimental group

Description:

G-CSF at a dose of 5 mcg/kg/day intravenously infused for 4 hours

Treatment:

Drug: G-CSF administration (bolus injection versus intravenous infusion)

Drug: G-CSF administration (bolus injection versus intravenous infusion)

Control Group

Other group

Description:

G-CSF at a dose of 5 mcg/kg/day intravenously bolus

Treatment:

Drug: G-CSF administration (bolus injection versus intravenous infusion)

Drug: G-CSF administration (bolus injection versus intravenous infusion)