PEG-rhG-CSF in Patients With Lymphoma Receiving Chemotherapy

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805218
• Other study ID #: CSPC-PGC-IV-02-1
• Status: Completed
• Phase: Phase 4
• First received: June 13, 2016
• Last updated: June 16, 2016
• Start date: September 2013
• Est. completion date: February 2016

Study information

• Verified date: June 2016
• Source: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• PEG-rhG-CSF

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence rate of adverse event		up to 30 days after the patient study completion	No
Primary	The severity of adverse event		up to 30 days after the patient study completion	No
Secondary	the occurrence rate of grade III/ IV neutropenia during chemotherapy cycles		through the study completion,an average of 5 months	No