Continuous Versus Bolus Administration of G-CSF in Children With Cancer
NCT ID: NCT06145321
Last Updated: 2024-09-19
Study Results
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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ACTIVE_NOT_RECRUITING
PHASE4
20 participants
INTERVENTIONAL
2023-11-23
2024-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
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Experimental Group
G-CSF at a dose of 5 mcg/kg/day intravenously infused for 4 hours
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)
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)
Control Group
G-CSF at a dose of 5 mcg/kg/day intravenously bolus
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)
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)
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)
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hematologic and oncologic malignancies
Exclusion Criteria
* 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
0 Years
18 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Yi-Lun Wang, MD
Medical doctor/Clinical physician
Locations
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Chang Gung Children Hospital
Taoyuan District, ROC, Taiwan
Countries
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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.
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.
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.
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.
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.
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.
Other Identifiers
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CVB-1115
Identifier Type: -
Identifier Source: org_study_id
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