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

NCT ID: NCT06145321

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-23

Study Completion Date

2024-11-15

Brief Summary

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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

Detailed Description

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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

Conditions

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Pediatric Cancer Neutropenia Lenograstim Filgrastim G-CSF

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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)
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Experimental Group

G-CSF at a dose of 5 mcg/kg/day intravenously infused for 4 hours

Group Type EXPERIMENTAL

G-CSF administration (bolus injection versus intravenous infusion)

Intervention Type DEVICE

Route of administration: intravenous infusion (with a 5 hours infusion period) or intravenous bolus (with an infusion period of less than one minute)

G-CSF administration (bolus injection versus intravenous infusion)

Intervention Type DRUG

Route of administration: intravenous infusion (with a 5 hours infusion period) or intravenous bolus (with an infusion period of less than one minute)

Control Group

G-CSF at a dose of 5 mcg/kg/day intravenously bolus

Group Type OTHER

G-CSF administration (bolus injection versus intravenous infusion)

Intervention Type DEVICE

Route of administration: intravenous infusion (with a 5 hours infusion period) or intravenous bolus (with an infusion period of less than one minute)

G-CSF administration (bolus injection versus intravenous infusion)

Intervention Type DRUG

Route of administration: intravenous infusion (with a 5 hours infusion period) or intravenous bolus (with an infusion period of less than one minute)

Interventions

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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)

Intervention Type 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)

Intervention Type DRUG

Other Intervention Names

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Filgrastim, Lenograstim Filgrastim, Lenograstim

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yi-Lun Wang, MD

Medical doctor/Clinical physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chang Gung Children Hospital

Taoyuan District, ROC, Taiwan

Site Status

Countries

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Taiwan

References

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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: 10.1080/16078454.2021.1965725.

Reference Type RESULT
PMID: 34494505 (View on PubMed)

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.

Reference Type RESULT
PMID: 28419427 (View on PubMed)

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.

Reference Type RESULT
PMID: 35785754 (View on PubMed)

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.1537-2995.2002.00091.x.

Reference Type RESULT
PMID: 12084168 (View on PubMed)

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 Granulocyte-Colony-Stimulating Factors-A Breakthrough in the Treatment of Cancer Patients with Febrile Neutropenia. Medicina (Kaunas). 2021 Jun 30;57(7):675. doi: 10.3390/medicina57070675.

Reference Type RESULT
PMID: 34208815 (View on PubMed)

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.

Reference Type RESULT
PMID: 16096770 (View on PubMed)

Other Identifiers

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CVB-1115

Identifier Type: -

Identifier Source: org_study_id

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