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Trial Title:
Continuous Versus Bolus Administration of G-CSF in Children With Cancer
NCT ID:
NCT06145321
Condition:
Pediatric Cancer
Neutropenia
Lenograstim
Filgrastim
G-CSF
Conditions: Official terms:
Neutropenia
Lenograstim
Conditions: Keywords:
Pediatric cancer
Neutropenia
G-CSF
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Intervention 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)
Primary purpose:
Supportive Care
Masking:
Single (Participant)
Masking description:
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.
Intervention:
Intervention type:
Device
Intervention name:
G-CSF administration (bolus injection versus intravenous infusion)
Description:
Route of administration: intravenous infusion (with a 5 hours infusion period) or
intravenous bolus (with an infusion period of less than one minute)
Arm group label:
Control Group
Arm group label:
Experimental Group
Other name:
Filgrastim, Lenograstim
Intervention type:
Drug
Intervention name:
G-CSF administration (bolus injection versus intravenous infusion)
Description:
Route of administration: intravenous infusion (with a 5 hours infusion period) or
intravenous bolus (with an infusion period of less than one minute)
Arm group label:
Control Group
Arm group label:
Experimental Group
Other name:
Filgrastim, Lenograstim
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
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
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
0 Years
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chang Gung Children Hospital
Address:
City:
Taoyuan
Zip:
333005
Country:
Taiwan
Start date:
November 23, 2023
Completion date:
November 15, 2024
Lead sponsor:
Agency:
Chang Gung Memorial Hospital
Agency class:
Other
Source:
Chang Gung Memorial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06145321
