Real World Study of PEG-rhG-CSF in Prevention of Chemotherapy-induced Neutropenia

Chemotherapy-induced Neutropenia Clinical Trial

Official title:

Real World Study of PEGylated Recombinant Human Granulocyte Stimulating Factor(PEG-rhG-CSF) in Prevention of Chemotherapy-induced Neutropenia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03846414
• Other study ID #: CSPC-JYL-RWS-07
• Status: Not yet recruiting
• Start date: February 13, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: February 2019
• Source: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
• Contact: Sun Guoping
• Phone: 13805609309
• Email: sunguoping[@]ahmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: October 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients' age=18 years old, male or female

2. Diagnosis of non-myeloid malignant solid tumors

3. Patients are planned to perform chemotherapy and preventive use the PEG-rhG-CSF or preventive or therapeutic use of rhG-CSF after chemotherapy

4. Patients' mental status are well, could understand the study and willing to participate the study, sign the informed consent form

5. The investigator believes that patients can benefit from this study

Exclusion Criteria:

1. Patients who have been confirmed to be allergic to Jinyouli® or rhG-CSF or its excipients

2. Pregnant or lactating women and women who plan to be pregnant during clinical observation

3. Other patients that the doctor believe not suitable for inclusion

Related Conditions & MeSH terms

• Chemotherapy-induced Neutropenia
• Myelosuppression
• Neutropenia

Intervention

Drug:
• PEG-rhG-CSF
PEG-rhG-CSF was administered 24 hours after the end of chemotherapy for each chemotherapy cycle.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of adverse events	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
Primary	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)	through the chemotherapy cycles of PEG-rhG-CSF or rhG-CSF treatment,an average of 3 month
Secondary	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	From date of randomization until the date of the study completion,an average of 3 month
Secondary	The incidence of grade IV neutropenia	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
Secondary	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	From date of randomization until the date of the study completion,an average of 3 month
Secondary	The incidence of the chemotherapy delay	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
Secondary	The duration of the chemotherapy delay in every chemotherapy cycle	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
Secondary	The incidence of the dose reduction	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
Secondary	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	From date of randomization until the date of the study completion,an average of 3 month