Clinical trial · Interventional
Continuous Versus Bolus Administration of G-CSF in Children With Cancer
Continuous Infusion of Granulocyte Colony-stimulating Factor is Associated With an Advantage in Neutrophil Recovery in Hematologic and Oncologic Disorders
NCT06145321CI-TRIAL-00080741active not recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Filgrastim | — | UNRESOLVED | — |
| G-CSF | — | UNRESOLVED | — |
| Lenograstim | — | UNRESOLVED | — |
| Neutropenia | — | UNRESOLVED | — |
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| G-CSF administration (bolus injection versus intravenous infusion) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental Group
- description
- G-CSF at a dose of 5 mcg/kg/day intravenously infused for 4 hours
- interventionNames
- Device: G-CSF administration (bolus injection versus intravenous infusion)
- Drug: G-CSF administration (bolus injection versus intravenous infusion)
- type
- OTHER
- label
- Control Group
- description
- G-CSF at a dose of 5 mcg/kg/day intravenously bolus
- interventionNames
- Device: G-CSF administration (bolus injection versus intravenous infusion)
- Drug: G-CSF administration (bolus injection versus intravenous infusion)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (6)
- RESULTTheyab 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. PMID 34494505
- RESULTDale 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. PMID 28419427
- RESULTBlayney 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. PMID 35785754
- RESULTStroncek 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. PMID 12084168
- RESULTCainap 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. PMID 34208815
- RESULTde 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. PMID 16096770