PEG-rhG-CSF in Patients With Lymphoma Receiving Chemotherapy

Phase 4

Completed

• Conditions: Lymphoma
• Interventions: Drug: PEG-rhG-CSF

• 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

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-06
• Study First Submitted: 2016-06-13
• Study First Submitted QC: 2016-06-15
• Last Update Submitted: 2016-06-16
• Study First Posted: 2016-06-17
• Last Update Posted: 2016-06-20

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