PEG-rhG-CSF in Patients With Lymphoma Receiving Chemotherapy
- Registration Number
- NCT02805218
- Lead Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Brief Summary
The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients with lymphoma receiving chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 410
Inclusion Criteria
- Patients with age ≥ 18 years
- diagnosis of lymphoma(Hodgkin's lymphoma and non-Hodgkin's lymphoma) patients
- Karnofsky Performance Status Z70
- life expectancy of at least 8 months
- normal white blood cell count and platelet count
- Written informed consent are acquired
Exclusion Criteria
- uncontrolled infection
- pregnancy
- Have accepted any other anti-tumor drug within 4 weeks before anticipated the study
- Other situations that investigators consider as contra-indication for this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PEG-rhG-CSF PEG-rhG-CSF patients received a single dose of 100 ug/kg of PEG-rhG-CSF(pegfilgrastim), on the basis of actual body weight, as a single subcutaneous injection on day 3 after chemotherapy
- Primary Outcome Measures
Name Time Method The occurrence rate of adverse event up to 30 days after the patient study completion The severity of adverse event up to 30 days after the patient study completion
- Secondary Outcome Measures
Name Time Method the occurrence rate of grade III/ IV neutropenia during chemotherapy cycles through the study completion,an average of 5 months