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

February 25, 2024 updated by: Yi-Lun Wang, Chang Gung Memorial Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • ROC
      • Taoyuan, ROC, Taiwan, 333005
        • Recruiting
        • Chang Gung Children Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
G-CSF at a dose of 5 mcg/kg/day intravenously infused for 4 hours
Device: G-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)
Other Names:
  • Filgrastim, Lenograstim
Drug: G-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)
Other Names:
  • Filgrastim, Lenograstim
Other: Control Group
G-CSF at a dose of 5 mcg/kg/day intravenously bolus
Device: G-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)
Other Names:
  • Filgrastim, Lenograstim
Drug: G-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)
Other Names:
  • Filgrastim, Lenograstim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute neutrophil counts (ANC)
Time Frame: up to 30 days
ANC higher than 1500 cells/mm3 for three consecutive days
up to 30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2023

Primary Completion (Estimated)

November 15, 2024

Study Completion (Estimated)

November 15, 2024

Study Registration Dates

First Submitted

November 15, 2023

First Submitted That Met QC Criteria

November 21, 2023

First Posted (Actual)

November 24, 2023

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 25, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVB-1115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Detailed informations should be shared if indicated.

IPD Sharing Time Frame

up to one year

IPD Sharing Access Criteria

All subjects for this study will be provided a consent form describing this study and providing sufficient information for subjects to make an informed decision about their participation in this study. This consent form will be submitted with the protocol for review and approval by the IRB. The formal consent of a subject, using the IRB-approved consent form, will be obtained before that subject is submitted to any study procedure. This consent form must be signed by the subject or legally acceptable surrogate, and the investigator-designated research professional obtaining the consent.

Clinical samples will be collected at Chang Gung Medical Foundation. The sequencing data will be stored in the computers of a laboratory with electronic encryption. The clinical and source data can only be assessed by clinical doctors and investigators of the study.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe