The Multi-center,Open-label,Single Arm Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Patients With Lymphoma Receiving Chemotherapy

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.0 sites410 target enrollmentSeptember 2013

ConditionsLymphoma

InterventionsPEG-rhG-CSF

DrugsPEG-rhG-CSF

Overview

Phase: Phase 4
Intervention: PEG-rhG-CSF
Conditions: Lymphoma
Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Enrollment: 410
Primary Endpoint: The occurrence rate of adverse event
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients with lymphoma receiving chemotherapy.

Registry

clinicaltrials.gov

Start Date

September 2013

End Date

February 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

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

Intervention: PEG-rhG-CSF