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OpenTrials
Active, Not Recruiting

NCT Number: NCT06145321

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pediatric Cancer Agranulocytosis Cytopenia Filgrastim G-CSF Hematologic Diseases Hemic and Lymphatic Diseases Lenograstim Leukocyte Disorders Leukopenia Neoplasms Neutropenia

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chang Gung Children Hospital

Taoyuan, ROC, 333005, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: Filgrastim, Lenograstim

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)

Other names: Filgrastim, Lenograstim

Primary outcomes

  1. Absolute neutrophil counts (ANC)

    Time frame: up to 30 days

    ANC higher than 1500 cells/mm3 for three consecutive days

Secondary outcomes

  1. Hospitalization duration

    Time frame: up to 30 days

    Hospitalization duration from admission to discharge

  2. Re-hospitalization event

    Time frame: up to 5 times

    14 days re-hospitalization event

  3. Clinical sepsis

    Time frame: up to 5 times

    Events of severe bacterial infection during neutropenic period

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 24, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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