Pediatric CancerPhase 4NCT06145321
Continuous Versus Bolus Administration of G-CSF in Children With Cancer
A Phase 4 study testing G-CSF administration (bolus injection versus intravenous infusion) in people with Pediatric Cancer and Neutropenia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Pediatric Cancer, Neutropenia, Lenograstim
- What is being tested?
- G-CSF administration (bolus injection versus intravenous infusion)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Nov 2023to 15 Nov 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients with an age between 0 to 18 years old will be included
- Hematologic and oncologic malignancies
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Infusion of Granulocyte Colony-stimulating Factor is Associated With an Advantage in Neutrophil Recovery in Hematologic and Oncologic Disorders
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
Read the 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
- Conditions
- Pediatric Cancer, Neutropenia, Lenograstim, Filgrastim, G-CSF
- Being tested
- G-CSF administration (bolus injection versus intravenous infusion)
- Keywords
- Pediatric cancer, Neutropenia, G-CSF
- Medical subject headings
- Neoplasms, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CSF administration (bolus injection versus intravenous infusion)Device
Also called Filgrastim, Lenograstim
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)Drug
Also called Filgrastim, Lenograstim
Route of administration: intravenous infusion (with a 5 hours infusion period) or intravenous bolus (with an infusion period of less than one minute)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | G-CSF at a dose of 5 mcg/kg/day intravenously infused for 4 hours Receives: Device: G-CSF administration (bolus injection versus intravenous infusion); Drug: G-CSF administration (bolus injection versus intravenous infusion) |
| Control Group | Other | G-CSF at a dose of 5 mcg/kg/day intravenously bolus Receives: Device: G-CSF administration (bolus injection versus intravenous infusion); Drug: G-CSF administration (bolus injection versus intravenous infusion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute neutrophil counts (ANC)
ANC higher than 1500 cells/mm3 for three consecutive days
Measured: up to 30 days
Secondary outcomes (3)
Hospitalization duration
Hospitalization duration from admission to discharge
Measured: up to 30 days
Re-hospitalization event
14 days re-hospitalization event
Measured: up to 5 times
Clinical sepsis
Events of severe bacterial infection during neutropenic period
Measured: up to 5 times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start23 Nov 2023
- Primary completion15 Nov 2024 (estimated)
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Lun Wang, MD, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145321
- Sponsor's protocol ID
- CVB-1115
- Status last verified
- Sep 2024
- First submitted
- 15 Nov 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Detailed informations should be shared if indicated.
Publications
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.
PubMed 34494505Dale 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.
PubMed 28419427Blayney 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.
PubMed 35785754Stroncek 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.
PubMed 12084168Cainap 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.
PubMed 34208815de 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.
PubMed 16096770
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Infusion of Granulocyte Colony-stimulating Factor is Associated With an Advantage in Neutrophil Recovery in Hematologic and Oncologic Disorders
- ClinicalTrials.gov ID
- NCT06145321
- Acronym / sponsor ID
- CVB-1115
- Conditions
- Pediatric Cancer, Neutropenia, Lenograstim, Filgrastim, G-CSF
- Keywords
- Pediatric cancer, Neutropenia, G-CSF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: G-CSF administration (bolus injection versus intravenous infusion), Drug: G-CSF administration (bolus injection versus intravenous infusion)G-CSF at a dose of 5 mcg/kg/day intravenously infused for 4 hours |
| Control Group | Other | Device: G-CSF administration (bolus injection versus intravenous infusion), Drug: G-CSF administration (bolus injection versus intravenous infusion)G-CSF at a dose of 5 mcg/kg/day intravenously bolus |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Pediatric patients with an age between 0 to 18 years old will be included
- Hematologic and oncologic malignancies
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G-CSF administration (bolus injection versus intravenous infusion)Also: Filgrastim, LenograstimRoute of administration: intravenous infusion (with a 5 hours infusion period) or intravenous bolus (with an infusion period of less than one minute) | Device | Control Group, Experimental Group |
| G-CSF administration (bolus injection versus intravenous infusion)Also: Filgrastim, LenograstimRoute of administration: intravenous infusion (with a 5 hours infusion period) or intravenous bolus (with an infusion period of less than one minute) | Drug | Control Group, Experimental Group |
Primary outcome
Absolute neutrophil counts (ANC)
Time frame: up to 30 days
ANC higher than 1500 cells/mm3 for three consecutive days
3 secondary outcomes
Hospitalization duration
Time frame: up to 30 days
Re-hospitalization event
Time frame: up to 5 times
Clinical sepsis
Time frame: up to 5 times
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 34494505Theyab 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.
- Results publication: PubMed 28419427Dale 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.
- Results publication: PubMed 35785754Blayney 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.
- Results publication: PubMed 12084168Stroncek 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.
- Results publication: PubMed 34208815Cainap 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.
- Results publication: PubMed 16096770de 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.
- Individual participant dataSharing planned: Yes. Detailed informations should be shared if indicated.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing G-CSF administration (bolus injection versus intravenous infusion) in people with Pediatric Cancer and Neutropenia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute neutrophil counts (ANC) (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06145321, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.