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

Pediatric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06145321
• Other study ID #: CVB-1115
• Status: Recruiting
• Phase: Phase 4
• Start date: November 23, 2023
• Est. completion date: November 15, 2024

Study information

• Verified date: February 2024
• Source: Chang Gung Memorial Hospital
• Contact: Yi-Lun Wang, Bachelor
• Phone: 0978989072
• Email: mp2601[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

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

Related Conditions & MeSH terms

• G-CSF
• Neutropenia
• Pediatric Cancer

Intervention

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)

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)

Locations

Country	Name	City	State
Taiwan	Chang Gung Children Hospital	Taoyuan	ROC

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

Blayney DW, Schwartzberg L. Chemotherapy-induced neutropenia and emerging agents for prevention and treatment: A review. Cancer Treat Rev. 2022 Sep;109:102427. doi: 10.1016/j.ctrv.2022.102427. Epub 2022 Jun 21. No abstract available. — View Citation

Cainap C, Cetean-Gheorghe S, Pop LA, Leucuta DC, Piciu D, Mester A, Vlad C, Ovidiu C, Gherman A, Crisan C, Bereanu A, Balacescu O, Constantin AM, Dicu I, Balacescu L, Stan A, Achimas-Cadariu P, Cainap S. Continuous Intravenous Administration of Granulocyt — View Citation

Dale DC. How I manage children with neutropenia. Br J Haematol. 2017 Aug;178(3):351-363. doi: 10.1111/bjh.14677. Epub 2017 Apr 17. — View Citation

de Jong ME, Carbiere T, van den Heuvel-Eibrink MM. The use of an insuflon device for the administration of G-CSF in pediatric cancer patients. Support Care Cancer. 2006 Jan;14(1):98-100. doi: 10.1007/s00520-005-0872-x. Epub 2005 Aug 12. — View Citation

Stroncek DF, Matthews CL, Follmann D, Leitman SF. Kinetics of G-CSF-induced granulocyte mobilization in healthy subjects: effects of route of administration and addition of dexamethasone. Transfusion. 2002 May;42(5):597-602. doi: 10.1046/j.1537-2995.2002. — View Citation

Theyab A, Algahtani M, Alsharif KF, Hawsawi YM, Alghamdi A, Alghamdi A, Akinwale J. New insight into the mechanism of granulocyte colony-stimulating factor (G-CSF) that induces the mobilization of neutrophils. Hematology. 2021 Dec;26(1):628-636. doi: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute neutrophil counts (ANC)	ANC higher than 1500 cells/mm3 for three consecutive days	up to 30 days
Secondary	Hospitalization duration	Hospitalization duration from admission to discharge	up to 30 days
Secondary	Re-hospitalization event	14 days re-hospitalization event	up to 5 times
Secondary	Clinical sepsis	Events of severe bacterial infection during neutropenic period	up to 5 times