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

NCT06145321 | Active Not Recruiting Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: CVB-1115
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pediatric Cancer; Neutropenia; Lenograstim; Filgrastim; G-CSF

Keywords

Pediatric cancer; Neutropenia; G-CSF

Outcome Measures

Primary Outcomes (1)

• Absolute neutrophil counts (ANC)

  ANC higher than 1500 cells/mm3 for three consecutive days

  up to 30 days

Secondary Outcomes (3)

• Hospitalization duration

  up to 30 days

• Re-hospitalization event

  up to 5 times

• Clinical sepsis

  up to 5 times

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

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

Device: G-CSF administration (bolus injection versus intravenous infusion); Drug: G-CSF administration (bolus injection versus intravenous infusion)

Interventions

G-CSF administration (bolus injection versus intravenous infusion) DEVICE

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

Also known as: Filgrastim, Lenograstim

Control Group; Experimental Group

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pediatric patients with an age between 0 to 18 years old will be included
• Hematologic and oncologic malignancies

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Children Hospital

Taoyuan District, ROC, 333005, Taiwan

Location

Related Publications (6)

• 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.

  PMID: 34494505 RESULT

• 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.

  PMID: 28419427 RESULT

• 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.

  PMID: 35785754 RESULT

• 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.

  PMID: 12084168 RESULT

• 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.

  PMID: 34208815 RESULT

• 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.

  PMID: 16096770 RESULT

MeSH Terms

Conditions

Neoplasms; Neutropenia

Interventions

Filgrastim; Lenograstim

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor/Clinical physician

Model Details: 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)

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 24, 2023
• Study Start: November 23, 2023
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: up to one year
• Access Criteria: All subjects for this study will be provided a consent form describing this study and providing sufficient information for subjects to make an informed decision about their participation in this study. This consent form will be submitted with the protocol for review and approval by the IRB. The formal consent of a subject, using the IRB-approved consent form, will be obtained before that subject is submitted to any study procedure. This consent form must be signed by the subject or legally acceptable surrogate, and the investigator-designated research professional obtaining the consent. Clinical samples will be collected at Chang Gung Medical Foundation. The sequencing data will be stored in the computers of a laboratory with electronic encryption. The clinical and source data can only be assessed by clinical doctors and investigators of the study.

Locations

TW (1)