NeutropeniaNCT03498248
Efficacy of Granulocyte-Colony Stimulating Factor (G-CSF)
A study testing lenograstim in people with Neutropenia, run by DERSHENG SUN at 1 site in South Korea.
Trial summary
The purpose of this study was to analyze the clinical factors associated with the effect of Granulocyte-Colony Stimulating Factor (G-CSF). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neutropenia
- What is being tested?
- lenograstim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Feb 2018to 31 Aug 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with solid cancer and blood cancer
- Patients who received chemotherapy with moderate risk (Appendix 1, Appendix 2)
- CTCAE version 4.0 showed grade 4 neutropenia, grade 3 neutropenia (blood cancer), Decreased grade 3 neutrophils with fever (solid cancer)
- Those who understand and agree with the purpose of the research
Who cannot join
- 1) Patients with hypersensitivity to G-CSF 2) Patients not diagnosed with hematologic tumor 3) grade 1, grade 2 or more neutropenia 4) Patients who did not sign a consent agreement
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
the Catholic university of Korea
Seoul, Gyounggido, 480-130
SUN DER SHENG, MD, PhD, +82318203584, sundersheng@gmail.com
About this study
Official title: Efficacy of Granulocyte-Colony Stimulating Factor (G-CSF) Related Clinical Implications in Cytotoxic Chemotherapy Induced Neutropenia
The purpose of this study was to analyze the clinical factors associated with the effect of Granulocyte-Colony Stimulating Factor (G-CSF).
Read the detailed description
- Granulocyte-Colony Stimulating Factor (G-CSF) G-CSF is known to be a synthetic cytokine that induces neutrophil differentiation and proliferation survival during leukocyte differentiation, and increases the activity in the periphery of mature neutrophils, which play an important role in human immunity. Cytotoxic chemotherapy inhibits bone marrow hematopoiesis. Inhibition of bone marrow hematopoiesis causes anemia, thrombocytopenia and leukopenia, and significant leukocytopenia causes opportunistic infection. G-CSF is an indispensable drug for the treatment of leukopenia caused by cytotoxic chemotherapy in solid and blood cancer patients receiving chemotherapy.
- Chemotherapy with chemotherapy and G-CSF The severity of neutropenia induced by chemotherapy was grade 1 (<1500 / mm3), grade 2 (<1500-1000 / mm3) and grade 3 (<1000) based on the Common Terminology Criteria for Adverse Events To 500 / mm3) and grade 4 (<500 / mm3). Cytotoxic anticancer drugs used in general chemotherapy cause neutropenia, and febrile neutropenia occurs in 10-20% of patients. In order to recover this, grade 4 neutropenia with an absolute neutrophil count (ANC) of less than 500 and neutrophil to grade 2 or higher with G-CSF in case of febrile grade 3 neutropenia.
- G-CSF dose and timing G-CSF (Renoglass team lenograstim 250 ug) was subcutaneously injected to a solid tumor (grade 3 or higher regardless of fever) with grade 3 or grade 4 neutropenia with fever Until then, take medication daily. It is used regardless of gender, age, weight, body mass index, method of using anticancer, and injection time.
However, the actual timing and extent of neutrophil recovery after G-CSF administration varies from patient to patient. G-CSF is a cytokine that is currently used in clinical trials. However, there are insufficient studies to investigate the clinical factors involved in the recovery of neutrophils in bone marrow after G-CSF administration in domestic cancer patients. Therefore, this study aims to analyze the clinical factors for the recovery of bone marrow hematopoietic function of G-CSF administered in neutropenia following cytotoxic chemotherapy.
- Conditions
- Neutropenia
- Being tested
- lenograstim
- Medical subject headings
- Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenograstimDrug
injection of lenograstim in patients with neutropenia after cytotoxic chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Neutropenia in chemotherapy | Experimental | Neutropenia after cytotoxic chemotherapy Receives: Drug: lenograstim |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of severe neutropenia
count days of neutrophils increased above 1,000
Measured: at least in 1 wk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start19 Feb 2018
- Primary completion31 Aug 2018 (estimated)
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeutropeniaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- neutropenia after cytotoxic chemotherapy
- Masking
- None (open label)
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DERSHENG SUN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, DERSHENG SUN, The Catholic University of Korea
- Investigators
- Yoon Ho Ko, Principal investigator, Uijeongbu St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498248
- Sponsor's protocol ID
- Granulocyte-Colony Stimulating
- Status last verified
- Apr 2018
- First submitted
- 7 Apr 2018
- Last updated
- 13 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Granulocyte-Colony Stimulating Factor (G-CSF) Related Clinical Implications in Cytotoxic Chemotherapy Induced Neutropenia
- ClinicalTrials.gov ID
- NCT03498248
- Acronym / sponsor ID
- Granulocyte-Colony Stimulating
- Conditions
- Neutropenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- DERSHENG SUNUniversity, hospital or other
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 31 Aug 2018 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 13 Apr 2018 (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 purpose of this study was to analyze the clinical factors associated with the effect of Granulocyte-Colony Stimulating Factor (G-CSF).
Detailed description
- Granulocyte-Colony Stimulating Factor (G-CSF) G-CSF is known to be a synthetic cytokine that induces neutrophil differentiation and proliferation survival during leukocyte differentiation, and increases the activity in the periphery of mature neutrophils, which play an important role in human immunity. Cytotoxic chemotherapy inhibits bone marrow hematopoiesis. Inhibition of bone marrow hematopoiesis causes anemia, thrombocytopenia and leukopenia, and significant leukocytopenia causes opportunistic infection. G-CSF is an indispensable drug for the treatment of leukopenia caused by cytotoxic chemotherapy in solid and blood cancer patients receiving chemotherapy.
- Chemotherapy with chemotherapy and G-CSF The severity of neutropenia induced by chemotherapy was grade 1 (<1500 / mm3), grade 2 (<1500-1000 / mm3) and grade 3 (<1000) based on the Common Terminology Criteria for Adverse Events To 500 / mm3) and grade 4 (<500 / mm3). Cytotoxic anticancer drugs used in general chemotherapy cause neutropenia, and febrile neutropenia occurs in 10-20% of patients. In order to recover this, grade 4 neutropenia with an absolute neutrophil count (ANC) of less than 500 and neutrophil to grade 2 or higher with G-CSF in case of febrile grade 3 neutropenia.
- G-CSF dose and timing G-CSF (Renoglass team lenograstim 250 ug) was subcutaneously injected to a solid tumor (grade 3 or higher regardless of fever) with grade 3 or grade 4 neutropenia with fever Until then, take medication daily. It is used regardless of gender, age, weight, body mass index, method of using anticancer, and injection time.
However, the actual timing and extent of neutrophil recovery after G-CSF administration varies from patient to patient. G-CSF is a cytokine that is currently used in clinical trials. However, there are insufficient studies to investigate the clinical factors involved in the recovery of neutrophils in bone marrow after G-CSF administration in domestic cancer patients. Therefore, this study aims to analyze the clinical factors for the recovery of bone marrow hematopoietic function of G-CSF administered in neutropenia following cytotoxic chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- neutropenia after cytotoxic chemotherapy
| Arm | Type | Receives |
|---|---|---|
| Neutropenia in chemotherapy | Experimental | Drug: lenograstimNeutropenia after cytotoxic chemotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with solid cancer and blood cancer
- Patients who received chemotherapy with moderate risk (Appendix 1, Appendix 2)
- CTCAE version 4.0 showed grade 4 neutropenia, grade 3 neutropenia (blood cancer), Decreased grade 3 neutrophils with fever (solid cancer)
- Those who understand and agree with the purpose of the research
Key exclusion criteria (1 listed)
- 1) Patients with hypersensitivity to G-CSF 2) Patients not diagnosed with hematologic tumor 3) grade 1, grade 2 or more neutropenia 4) Patients who did not sign a consent agreement
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 |
|---|---|---|
| lenograstiminjection of lenograstim in patients with neutropenia after cytotoxic chemotherapy | Drug | Neutropenia in chemotherapy |
Primary outcome
duration of severe neutropenia
Time frame: at least in 1 wk
count days of neutrophils increased above 1,000
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
Related trials for Neutropenia
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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.
Yoon Ho Ko principal investigator
Uijeongbu St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lenograstim in people with Neutropenia, run by DERSHENG SUN at 1 site in South Korea.
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 4 inclusion and 1 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 13 Apr 2018. 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 South Korea. 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.
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?
Contact DER SHENG SUN (318203584, sundersheng@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of severe neutropenia (time frame: at least in 1 wk). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2018; AzTrials last refreshed its copy on 6 Nov 2026.