Chemotherapy Induced NeutropeniaPhase 2NCT02787876
Pegteograstim in Children With Solid Tumors
A Phase 2 study testing Pegteograstim in people with Chemotherapy Induced Neutropenia and Pediatric Solid Tumor, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
To evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Chemotherapy Induced Neutropenia, Pediatric Solid Tumor
- What is being tested?
- Pegteograstim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Oct 2016to Nov 2018
- Phase
- Phase 2
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with solid tumor who undergo chemotherapy with carboplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen
Who cannot join
- Patients with organ dysfunction (creatinine > 2mg/dL, ejection fraction <40% or severe arrhythmia/conduction disorder, other severe organ dysfunction)
- Hypersensitivity to pegteograstim, protein originated from E-coli, pegfilgrastim, filgrastim or latex.
- Patients with bleeding tendency to whom subcutaneous injection should be avoided.
- Active infection or infectious fever during the screening period.
- Genetic problem to fructose tolerance.
- Patients who participated in other clinical trial within 4 weeks before enrollment.
- Pregnant and nursing women
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Ki Woong Sung, 82-2-3410-3529, kwsped@skku.edu
Ki Woong Sung
About this study
Official title: Efficacy and Safety of Pegteograstim on Chemotherapy-induced Neutropenia in Children With Solid Tumors
To evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors
Read the detailed description
Children with solid tumor experience neutropenia after cytotoxic chemotherapy, and they usually receive granulocyte colony-stimulating factor (G-CSF) to stimulate neutrophil recovery. However it needs daily injection of G-CSF. Pegteograstim is a new formulation of PEGylated recombinant human G-CSF analogue pegfilgrastim. In this study, investigators aimed to evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors.
- Being tested
- Pegteograstim
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegteograstimDrug
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy induced neutropenia | Experimental | Pegteograstim 100 ug/kg (maximum 6 mg) on day 7 of the chemotherapy cycle Receives: Drug: Pegteograstim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adverse events
Measured: Up to 3 weeks after the injection of pegteograsim
Duration of neutropenia (absolute neutrophil count (ANC) < 500/uL)
Measured: Up to 6 weeks
Secondary outcomes (3)
Duration of severe neutropenia (ANC < 100/uL)
Measured: Up to 6 weeks
Lowest value of ANC
Measured: Up to 6 weeks
Days with neutropenic fever
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study start4 Oct 2016
- Primary completionOct 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy Induced NeutropeniaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Green Cross Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787876
- Sponsor's protocol ID
- 2015-12-121
- Status last verified
- Sep 2017
- First submitted
- 24 May 2016
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Cho HW, Lee JW, Ju HY, Hyun JK, Yoo KH, Koo HH, Kim K, Sung KW. Safety and Efficacy of Pegteograstim on Chemotherapy-induced Neutropenia in Children and Adolescents With Solid Tumors. J Pediatr Hematol Oncol. 2022 Mar 1;44(2):e362-e367. doi: 10.1097/MPH.0000000000002206.
PubMed 34010932
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Pegteograstim on Chemotherapy-induced Neutropenia in Children With Solid Tumors
- ClinicalTrials.gov ID
- NCT02787876
- Acronym / sponsor ID
- 2015-12-121
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Green Cross Corporation
- Study start
- 4 Oct 2016 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 1 Jun 2016 (estimated)
- 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.
To evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors
Detailed description
Children with solid tumor experience neutropenia after cytotoxic chemotherapy, and they usually receive granulocyte colony-stimulating factor (G-CSF) to stimulate neutrophil recovery. However it needs daily injection of G-CSF. Pegteograstim is a new formulation of PEGylated recombinant human G-CSF analogue pegfilgrastim. In this study, investigators aimed to evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy induced neutropenia | Experimental | Drug: PegteograstimPegteograstim 100 ug/kg (maximum 6 mg) on day 7 of the chemotherapy cycle |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with solid tumor who undergo chemotherapy with carboplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen
Key exclusion criteria (7 listed)
- Patients with organ dysfunction (creatinine > 2mg/dL, ejection fraction <40% or severe arrhythmia/conduction disorder, other severe organ dysfunction)
- Hypersensitivity to pegteograstim, protein originated from E-coli, pegfilgrastim, filgrastim or latex.
- Patients with bleeding tendency to whom subcutaneous injection should be avoided.
- Active infection or infectious fever during the screening period.
- Genetic problem to fructose tolerance.
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 |
|---|---|---|
| Pegteograstim | Drug | Chemotherapy induced neutropenia |
Primary outcome
Rate of adverse events
Time frame: Up to 3 weeks after the injection of pegteograsim
Duration of neutropenia (absolute neutrophil count (ANC) < 500/uL)
Time frame: Up to 6 weeks
3 secondary outcomes
Duration of severe neutropenia (ANC < 100/uL)
Time frame: Up to 6 weeks
Lowest value of ANC
Time frame: Up to 6 weeks
Days with neutropenic fever
Time frame: Up to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Derived from this study: PubMed 34010932Cho HW, Lee JW, Ju HY, Hyun JK, Yoo KH, Koo HH, Kim K, Sung KW. Safety and Efficacy of Pegteograstim on Chemotherapy-induced Neutropenia in Children and Adolescents With Solid Tumors. J Pediatr Hematol Oncol. 2022 Mar 1;44(2):e362-e367. doi: 10.1097/MPH.0000000000002206.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pegteograstim in people with Chemotherapy Induced Neutropenia and Pediatric Solid Tumor, run by Samsung Medical Center 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 1 inclusion and 7 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 18 Sep 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Ki Woong Sung, MD, PhD (82-2-3410-3529, kiwoong.sung@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of adverse events (time frame: Up to 3 weeks after the injection of pegteograsim). The study lists 2 primary outcomes in all. 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 NCT02787876, which also lists 1 linked publication.
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 18 Sep 2018.