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

Recruiting
- 18 years of age
Both
Phase 4

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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

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

Eligibility

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 details

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

NCT06145321

Chang Gung Memorial Hospital

26 January 2024

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