Granulocyte Colony-Stimulating FactorPhase 4NCT03823950
Starting Granulocyte Colony-Stimulating Factor at 1 Day vs 3 Days Following Chemotherapy in Pediatric Cancer Patients
A Phase 4 study testing Granulocyte Colony-Stimulating Factor in people with Granulocyte Colony-Stimulating Factor and Chemotherapy-induced Neutropenia, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
Chemotherapy places patients at an increased risk of infection. A medication called granulocyte colony-stimulating factor is given as a daily injection in order to help decrease the risk of infection. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Granulocyte Colony-Stimulating Factor, Chemotherapy-induced Neutropenia, Chemotherapy-Induced Febrile Neutropenia
- What is being tested?
- Granulocyte Colony-Stimulating Factor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to Jun 2022
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric oncology patients will be eligible to participate in this study if they meet the following inclusion criteria:
- are between the ages of birth and 21 years old
- is diagnosed with an oncologic disease
- is being treated at UMMC Children's Cancer Clinic
- will receive G-CSF as part of their standard or experimental oncology treatment protocol between January 1, 2019 and December 31, 2019. Oncology treatment protocols are typically derived from the Children's Oncology Group standard of care or patients can be enrolled on a Children's Oncology Group treatment study.
- is within first four courses of chemotherapy treatment
Who cannot join
- Patients will be excluded from the current study if:
- G-CSF was added to their oncology treatment protocol due to previous complications but for whom G-CSF was not part of their original treatment protocol.
- are being treated for relapsed disease
- has clinical evidence of bone marrow involvement
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Univeristy of Mississippi Medical Center
Jackson, Mississippi, 39216
Jessica M Seaborn, MD, 601-984-5221, jseaborn@umc.edu
About this study
Official title: A Pilot Study of Granulocyte Colony-Stimulating Factor Starting at 24 Hours vs 72 Hours in Pediatric Oncology Patients
Chemotherapy places patients at an increased risk of infection. A medication called granulocyte colony-stimulating factor is given as a daily injection in order to help decrease the risk of infection. The purpose of this study is to determine the best time to begin granulocyte colony-stimulating factor while maintaining the same clinical benefits. The current study aims to fill these research gaps and address the general question: Can G-CSF safely be given 72 hours following the last day of chemotherapy without increasing the incidence of febrile neutropenia, the duration of neutropenia, or causing increased delays in the next course of chemotherapy.
- Conditions
- Granulocyte Colony-Stimulating Factor, Chemotherapy-induced Neutropenia, Chemotherapy-Induced Febrile Neutropenia, Pediatric Cancer
- Being tested
- Granulocyte Colony-Stimulating Factor
- Medical subject headings
- Chemotherapy-Induced Febrile Neutropenia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granulocyte Colony-Stimulating FactorDrug
Also called G-CSF
Begin G-CSF 72 hours following chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Receive G-CSF 72 hours following chemotherapy | Experimental | Children will be enrolled during the first four rounds of chemotherapy. Upon enrollment, children will receive G-CSF at 24 hours following chemotherapy. G-CSF will be discontinued when absolute neutrophil count (ANC) has increased post nadir in accord with G-CSF administration guidelines. Parents and children will then complete questionnaires to determine rates of side effects and needle distress at the end of G-CSF during their next regular outpatient oncology clinic visit.
Following children's next course of chemotherapy, G-CSF will be started 72 hours after completion of chemotherapy. Receives: Drug: Granulocyte Colony-Stimulating Factor |
| Historical Controls | No intervention | Four matched historical controls who received G-CSF at 24 hours following chemotherapy for each patient enrolled will be selected as each enrolled patient completes G-CSF therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hospital admissions for febrile neutropenia
Febrile neutropenia is defined as a temperature greater than or equal to 38 degrees Celsius and ANC less than or equal to 500
Measured: From date of completion of course of chemotherapy until date of the initiation of next chemotherapy course, assessed up to 1 year
Secondary outcomes (2)
Duration of neutropenia
The number of days between the first documented ANC less than or equal to 500 and the first documented ANC greater than 500 following nadir
Measured: From date of first recorded ANC following chemotherapy until date of first ANC that is greater than 500 following nadir, assessed up to 1 year
Days delayed in beginning the next course of chemotherapy
A delay in chemotherapy is defined when the initiation of the next course of chemotherapy is delayed due to neutropenia
Measured: Will be assessed weekly until the next course of chemotherapy is initiated, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start1 Feb 2019
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Granulocyte Colony-Stimulating FactorStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anderson B Collier, MD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823950
- Sponsor's protocol ID
- 2018-0082
- Status last verified
- Mar 2020
- First submitted
- 8 Jan 2019
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Granulocyte Colony-Stimulating Factor Starting at 24 Hours vs 72 Hours in Pediatric Oncology Patients
- ClinicalTrials.gov ID
- NCT03823950
- Acronym / sponsor ID
- 2018-0082
- Conditions
- Granulocyte Colony-Stimulating Factor, Chemotherapy-induced Neutropenia, Chemotherapy-Induced Febrile Neutropenia, Pediatric Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 31 Jan 2019 (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.
Chemotherapy places patients at an increased risk of infection. A medication called granulocyte colony-stimulating factor is given as a daily injection in order to help decrease the risk of infection. The purpose of this study is to determine the best time to begin granulocyte colony-stimulating factor while maintaining the same clinical benefits. The current study aims to fill these research gaps and address the general question: Can G-CSF safely be given 72 hours following the last day of chemotherapy without increasing the incidence of febrile neutropenia, the duration of neutropenia, or causing increased delays in the next course of chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receive G-CSF 72 hours following chemotherapy | Experimental | Drug: Granulocyte Colony-Stimulating FactorChildren will be enrolled during the first four rounds of chemotherapy. Upon enrollment, children will receive G-CSF at 24 hours following chemotherapy. G-CSF will be discontinued when absolute neutrophil count (ANC) has increased post nadir in accord with G-CSF administration guidelines. Parents and children will then complete questionnaires to determine rates of side effects and needle distress at the end of G-CSF during their next regular outpatient oncology clinic visit. Following children's next course of chemotherapy, G-CSF will be started 72 hours after completion of chemotherapy. |
| Historical Controls | No intervention | –Four matched historical controls who received G-CSF at 24 hours following chemotherapy for each patient enrolled will be selected as each enrolled patient completes G-CSF therapy. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Pediatric oncology patients will be eligible to participate in this study if they meet the following inclusion criteria:
Key exclusion criteria (4 listed)
- Patients will be excluded from the current study if:
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 |
|---|---|---|
| Granulocyte Colony-Stimulating FactorAlso: G-CSFBegin G-CSF 72 hours following chemotherapy | Drug | Receive G-CSF 72 hours following chemotherapy |
Primary outcome
Incidence of hospital admissions for febrile neutropenia
Time frame: From date of completion of course of chemotherapy until date of the initiation of next chemotherapy course, assessed up to 1 year
Febrile neutropenia is defined as a temperature greater than or equal to 38 degrees Celsius and ANC less than or equal to 500
2 secondary outcomes
Duration of neutropenia
Time frame: From date of first recorded ANC following chemotherapy until date of first ANC that is greater than 500 following nadir, assessed up to 1 year
Days delayed in beginning the next course of chemotherapy
Time frame: Will be assessed weekly until the next course of chemotherapy is initiated, up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Anderson B Collier, MD principal investigator
University of Mississippi Medical Center
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 Granulocyte Colony-Stimulating Factor in people with Granulocyte Colony-Stimulating Factor and Chemotherapy-induced Neutropenia, run by University of Mississippi Medical Center at 1 site in United States.
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 6 inclusion and 4 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 Mar 2020. 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 United States. 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?
Contact Anderson B Collier, MD (601-984-5221, acollier@umc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hospital admissions for febrile neutropenia (time frame: From date of completion of course of chemotherapy until date of the initiation of next chemotherapy course, assessed up to 1 year). 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 Mar 2020.