Chemotherapy-induced NeutropeniaNCT03846414
Real World Study of PEG-rhG-CSF in Prevention of Chemotherapy-induced Neutropenia
An observational study of Chemotherapy-induced Neutropenia and Myelosuppression, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd..
Trial summary
The aim of this study is to observe and evaluate the cost-effectiveness,efficacy and safety of PEG-rhG-CSF in preventing chemotherapy-induced neutropenia(CIN) of cancer patients in the real world.1000 patients with non-myeloid malignancy who is planned to receive PEG-rhG-CSF for CIN prevention and 500 patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Neutropenia, Myelosuppression
- What is being tested?
- PEG-rhG-CSF
- Type of treatment
- Injection or infusion
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 13 Feb 2019to 1 Oct 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1000 patients with non-myeloid malignancy who is planned to receive PEG-rhG-CSF for CIN prevention and 500 patients with non-myeloid malignancy who is planned to receive rhG-CSF for CIN prevention or treatment were prospectively recruited.
Who may be able to join
- Patients' age≥18 years old, male or female
- Diagnosis of non-myeloid malignant solid tumors
- Patients are planned to perform chemotherapy and preventive use the PEG-rhG-CSF or preventive or therapeutic use of rhG-CSF after chemotherapy
- Patients' mental status are well, could understand the study and willing to participate the study, sign the informed consent form
- The investigator believes that patients can benefit from this study
Who cannot join
- Patients who have been confirmed to be allergic to Jinyouli® or rhG-CSF or its excipients
- Pregnant or lactating women and women who plan to be pregnant during clinical observation
- Other patients that the doctor believe not suitable for inclusion
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Real World Study of PEGylated Recombinant Human Granulocyte Stimulating Factor(PEG-rhG-CSF) in Prevention of Chemotherapy-induced Neutropenia
The aim of this study is to observe and evaluate the cost-effectiveness,efficacy and safety of PEG-rhG-CSF in preventing chemotherapy-induced neutropenia(CIN) of cancer patients in the real world.1000 patients with non-myeloid malignancy who is planned to receive PEG-rhG-CSF for CIN prevention and 500 patients with non-myeloid malignancy who is planned to receive rhG-CSF for CIN prevention or treatment were prospectively recruited.The primary outcome was cost-effectiveness and second outcome was febrile neutropenia,the incidence and duration of grade IV neutropenia,chemotherapy delay,incidence of reduced dose of chemotherapy and relative dose intensity of chemotherapy.
- Conditions
- Chemotherapy-induced Neutropenia, Myelosuppression
- Being tested
- PEG-rhG-CSF
- Keywords
- PEG-rhG-CSF, Pegfilgrastim
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rhG-CSFDrug
Also called Jinyouli
PEG-rhG-CSF was administered 24 hours after the end of chemotherapy for each chemotherapy cycle.
| Study group | Role | What they receive |
|---|---|---|
| PEG-rhG-CSF group | This group comprised 1000 patients who received a single subcutaneous injection of PEG-rhG-CSF 24 hours after the end of chemotherapy for each chemotherapy cycle. The dose of PEG-rhG-CSF is determined by the patients' body weight, patients with body weight ≥45 kg is given to PEG-rhG-CSF 6 mg each time, patients<45 kg is given to PEG-rhG-CSF 3 mg each time. Receives: Drug: PEG-rhG-CSF | |
| rhG-CSF group | This group comprised 500 patients who received rhG-CSF 5 μg/kg/day by subcutaneous injection 24 hours after the end of chemotherapy or the appearance of CIN until the ANC was ≥2.0x109/L for each chemotherapy cycle. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-Effectiveness
Based on the results of the incidence of febrile neutropenia(FN) and the cost perFN in each group, the incremental cost-effectiveness ratio were estimated using the following formula: (CostA-CostB)/(OutcomeA-OutcomeB)
Measured: through the chemotherapy cycles of PEG-rhG-CSF or rhG-CSF treatment,an average of 3 month
Secondary outcomes (7)
The incidence of febrile neutropenia
Febrile neutropenia (FN) is defined as oral temperature >38.3 ℃(under arm temperature >38.1 ℃) or continuous measurement of oral temperature >38℃(under arm temperature >37.8℃) in 2h, and absolute neutrophil count(ANC) <0.5×10^9/L, or expected to be <0.5×10^9/L
Measured: From date of randomization until the date of the study completion,an average of 3 month
The incidence of grade IV neutropenia
Grade IV neutropenia is defined as the absolute neutrophil count(ANC)<0.5×10^9/L
Measured: From date of randomization until the date of the study completion,an average of 3 month
The duration of grade IV neutropenia in every chemotherapy cycle
Defined as days when the ANC<2.0×10^9/L occurs to the time when the ANC≥2.0×10^9/L, take the median
Measured: From date of randomization until the date of the study completion,an average of 3 month
The incidence of the chemotherapy delay
Chemotherapy delay is defined as the delay in starting the next planned chemotherapy for more than 3 days.
Measured: From date of randomization until the date of the study completion,an average of 3 month
The duration of the chemotherapy delay in every chemotherapy cycle
The duration of the chemotherapy delay in every chemotherapy cycle
Measured: From date of randomization until the date of the study completion,an average of 3 month
The incidence of the dose reduction
The incidence of the reduction of planned dose of chemotherapy
Measured: From date of randomization until the date of the study completion,an average of 3 month
Relative chemotherapy dose intensity in every chemotherapy cycle
Relative chemotherapy dose intensity is defined as the actual chemotherapy dose the patient used divided by the planned chemotherapy dose,or the actual chemotherapy time divided by the planned chemotherapy time
Measured: From date of randomization until the date of the study completion,an average of 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start13 Feb 2019 (estimated)
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846414
- Sponsor's protocol ID
- CSPC-JYL-RWS-07
- Status last verified
- Feb 2019
- First submitted
- 14 Feb 2019
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will only be shared by the investigators in this study
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Study of PEGylated Recombinant Human Granulocyte Stimulating Factor(PEG-rhG-CSF) in Prevention of Chemotherapy-induced Neutropenia
- ClinicalTrials.gov ID
- NCT03846414
- Acronym / sponsor ID
- CSPC-JYL-RWS-07
- Conditions
- Chemotherapy-induced Neutropenia, Myelosuppression
- Keywords
- PEG-rhG-CSF, Pegfilgrastim
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2019 (estimated)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 19 Feb 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.
The aim of this study is to observe and evaluate the cost-effectiveness,efficacy and safety of PEG-rhG-CSF in preventing chemotherapy-induced neutropenia(CIN) of cancer patients in the real world.1000 patients with non-myeloid malignancy who is planned to receive PEG-rhG-CSF for CIN prevention and 500 patients with non-myeloid malignancy who is planned to receive rhG-CSF for CIN prevention or treatment were prospectively recruited.The primary outcome was cost-effectiveness and second outcome was febrile neutropenia,the incidence and duration of grade IV neutropenia,chemotherapy delay,incidence of reduced dose of chemotherapy and relative dose intensity of chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-rhG-CSF group | – | Drug: PEG-rhG-CSFThis group comprised 1000 patients who received a single subcutaneous injection of PEG-rhG-CSF 24 hours after the end of chemotherapy for each chemotherapy cycle. The dose of PEG-rhG-CSF is determined by the patients' body weight, patients with body weight ≥45 kg is given to PEG-rhG-CSF 6 mg each time, patients<45 kg is given to PEG-rhG-CSF 3 mg each time. |
| rhG-CSF group | – | –This group comprised 500 patients who received rhG-CSF 5 μg/kg/day by subcutaneous injection 24 hours after the end of chemotherapy or the appearance of CIN until the ANC was ≥2.0x109/L for each chemotherapy cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1000 patients with non-myeloid malignancy who is planned to receive PEG-rhG-CSF for CIN prevention and 500 patients with non-myeloid malignancy who is planned to receive rhG-CSF for CIN prevention or treatment were prospectively recruited.
Key inclusion criteria (5 listed)
- Patients' age≥18 years old, male or female
- Diagnosis of non-myeloid malignant solid tumors
- Patients are planned to perform chemotherapy and preventive use the PEG-rhG-CSF or preventive or therapeutic use of rhG-CSF after chemotherapy
- Patients' mental status are well, could understand the study and willing to participate the study, sign the informed consent form
- The investigator believes that patients can benefit from this study
Key exclusion criteria (3 listed)
- Patients who have been confirmed to be allergic to Jinyouli® or rhG-CSF or its excipients
- Pregnant or lactating women and women who plan to be pregnant during clinical observation
- Other patients that the doctor believe not suitable for inclusion
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 |
|---|---|---|
| PEG-rhG-CSFAlso: JinyouliPEG-rhG-CSF was administered 24 hours after the end of chemotherapy for each chemotherapy cycle. | Drug | PEG-rhG-CSF group |
Primary outcome
Cost-Effectiveness
Time frame: through the chemotherapy cycles of PEG-rhG-CSF or rhG-CSF treatment,an average of 3 month
Based on the results of the incidence of febrile neutropenia(FN) and the cost perFN in each group, the incremental cost-effectiveness ratio were estimated using the following formula: (CostA-CostB)/(OutcomeA-OutcomeB)
7 secondary outcomes
The incidence of febrile neutropenia
Time frame: From date of randomization until the date of the study completion,an average of 3 month
The incidence of grade IV neutropenia
Time frame: From date of randomization until the date of the study completion,an average of 3 month
The duration of grade IV neutropenia in every chemotherapy cycle
Time frame: From date of randomization until the date of the study completion,an average of 3 month
The incidence of the chemotherapy delay
Time frame: From date of randomization until the date of the study completion,an average of 3 month
The duration of the chemotherapy delay in every chemotherapy cycle
Time frame: From date of randomization until the date of the study completion,an average of 3 month
The incidence of the dose reduction
Time frame: From date of randomization until the date of the study completion,an average of 3 month
Relative chemotherapy dose intensity in every chemotherapy cycle
Time frame: From date of randomization until the date of the study completion,an average of 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Individual participant dataSharing planned: No. IPD will only be shared by the investigators in this study
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Neutropenia and Myelosuppression, run by CSPC Baike (Shandong) Biopharmaceutical Co., Ltd..
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 5 inclusion and 3 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 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Sun Guoping (13805609309, sunguoping@ahmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-Effectiveness (time frame: through the chemotherapy cycles of PEG-rhG-CSF or rhG-CSF treatment,an average of 3 month). 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 19 Feb 2019.