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

NCT ID: NCT03846414

Last Updated: 2019-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-13
• Study Completion Date: 2020-10-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Intervention Type: DRUG

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

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.

No interventions assigned to this group

Interventions

PEG-rhG-CSF

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

Intervention Type: DRUG

Other Intervention Names

Jinyouli

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Sun Guoping

Role: CONTACT

sunguoping@ahmu.edu.cn

13805609309

Other Identifiers

CSPC-JYL-RWS-07

Identifier Type: -

Identifier Source: org_study_id