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

NCT03846414 | Unknown

• 1 other identifier: CSPC-JYL-RWS-07
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chemotherapy-induced Neutropenia; Myelosuppression

Keywords

PEG-rhG-CSF; Pegfilgrastim

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The incidence of febrile neutropenia

  From date of randomization until the date of the study completion,an average of 3 month

• The incidence of grade IV neutropenia

  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

  From date of randomization until the date of the study completion,an average of 3 month

• The incidence of the chemotherapy delay

  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

Other Outcomes (1)

• Incidence of adverse events

  From date of randomization until the date of the study completion,an average of 3 month

Study Arms (2)

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.

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.

Interventions

PEG-rhG-CSF DRUG

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

Also known as: Jinyouli

PEG-rhG-CSF group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.: lead

MeSH Terms

Interventions

pegylated granulocyte colony-stimulating factor

Central Study Contacts

Sun Guoping

CONTACT

13805609309; sunguoping@ahmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 19, 2019
• Study Start: February 13, 2019
• Primary Completion: April 1, 2020
• Study Completion: October 1, 2020
• Last Updated: February 19, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share