- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03846414
Real World Study of PEG-rhG-CSF in Prevention of Chemotherapy-induced Neutropenia
February 18, 2019 updated by: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
1500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sun Guoping
- Phone Number: 13805609309
- Email: sunguoping@ahmu.edu.cn
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
PEG-rhG-CSF was administered 24 hours after the end of chemotherapy for each chemotherapy cycle.
Other Names:
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
through the chemotherapy cycles of PEG-rhG-CSF or rhG-CSF treatment,an average of 3 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of febrile neutropenia
Time Frame: From date of randomization until the date of the study completion,an average of 3 month
|
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
|
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
|
Grade IV neutropenia is defined as the absolute neutrophil count(ANC)<0.5×10^9/L
|
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
|
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
|
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
|
Chemotherapy delay is defined as the delay in starting the next planned chemotherapy for more than 3 days.
|
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 duration of the chemotherapy delay in every chemotherapy cycle
|
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
|
The incidence of the reduction of planned dose of chemotherapy
|
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
|
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
|
From date of randomization until the date of the study completion,an average of 3 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events
Time Frame: From date of randomization until the date of the study completion,an average of 3 month
|
All adverse events will be recorded from the time of patients signing the informed consent form up to 30 days after the last Intervention drug is applied.
the adverse event that associated with the study drug will be specially recorded.
|
From date of randomization until the date of the study completion,an average of 3 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 13, 2019
Primary Completion (Anticipated)
April 1, 2020
Study Completion (Anticipated)
October 1, 2020
Study Registration Dates
First Submitted
February 14, 2019
First Submitted That Met QC Criteria
February 18, 2019
First Posted (Actual)
February 19, 2019
Study Record Updates
Last Update Posted (Actual)
February 19, 2019
Last Update Submitted That Met QC Criteria
February 18, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSPC-JYL-RWS-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
IPD will only be shared by the investigators in this study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chemotherapy-induced Neutropenia
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University of Mississippi Medical CenterUnknownPediatric Cancer | Chemotherapy-Induced Febrile Neutropenia | Chemotherapy-induced Neutropenia | Granulocyte Colony-Stimulating FactorUnited States
-
Hospira, now a wholly owned subsidiary of PfizerCompletedSolid Tumors | Malignant Hemopathy | Chemotherapy-induced Febrile Neutropenia (FN)France
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Enzychem Lifesciences CorporationCompletedChemotherapy-Induced NeutropeniaKorea, Republic of
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Enzychem Lifesciences CorporationCompletedChemotherapy-Induced NeutropeniaKorea, Republic of
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Green Cross CorporationSymyooCompleted
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Shantha Biotechnics LimitedCompletedChemotherapy-Induced NeutropeniaIndia
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PfizerHospira, now a wholly owned subsidiary of PfizerTerminatedChemotherapy-Induced NeutropeniaFrance
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Tianjin SinoBiotech Ltd.CompletedChemotherapy-induced NeutropeniaChina
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BeyondSpring Pharmaceuticals Inc.CompletedChemotherapy-induced NeutropeniaChina, Russian Federation, United States, Ukraine
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Jiangsu T-Mab Biopharma Co.,LtdCompletedChemotherapy-induced NeutropeniaChina
Clinical Trials on PEG-rhG-CSF
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Peking UniversityUnknown
-
Chongqing University Cancer HospitalCSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Recruiting
-
Air Force Military Medical University, ChinaUnknown
-
Sun Yat-sen UniversityJiangsu HengRui Medicine Co., Ltd.Not yet recruiting
-
Xiamen Amoytop Biotech Co., Ltd.Cancer Institute and Hospital, Chinese Academy of Medical SciencesCompletedNon-Myeloid MalignancyChina
-
Adello Biologics, LLCinVentiv Health ClinicalCompletedHealthy VolunteersUnited States
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CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Hebei Medical University Fourth HospitalUnknown
-
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Peking University Cancer Hospital & InstituteUnknownSmall Cell Lung Cancer | PEG-rhG-CSFChina
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CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.Beijing Friendship HospitalUnknownHemophagocytic SyndromeChina
-
Mabwell (Shanghai) Bioscience Co., Ltd.Completed