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

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06145321

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pediatric Cancer Neutropenia Lenograstim Filgrastim G-CSF	Device: G-CSF administration (bolus injection versus intravenous infusion) Drug: G-CSF administration (bolus injection versus intravenous infusion)	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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)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)

Masking:

Single (Participant)

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.

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Nov 16, 2023

Anticipated Primary Completion Date :

Nov 15, 2024

Anticipated Study Completion Date :

Nov 15, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Absolute neutrophil counts (ANC) [up to 30 days]
ANC higher than 500 cells/mm3 for three consecutive days

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chang Gung Children Hospital	Taoyuan	ROC	Taiwan	333005

Sponsors and Collaborators

Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yi-Lun Wang, Medical doctor/Clinical physician, Chang Gung Memorial Hospital

ClinicalTrials.gov Identifier:

NCT06145321

Other Study ID Numbers:

CVB-1115

First Posted:

Nov 24, 2023

Last Update Posted:

Nov 24, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

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

Keywords provided by Yi-Lun Wang, Medical doctor/Clinical physician, Chang Gung Memorial Hospital

Pediatric cancer

Neutropenia

G-CSF

Additional relevant MeSH terms:

Neutropenia

Lenograstim

Study Results

No Results Posted as of Nov 24, 2023