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PEG-rhG-CSF in Patients With Lymphoma Receiving Chemotherapy

Sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02805218
Collaborator
(none)
410
Enrollment
1
Arm
29
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
410 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Study Start Date :
Sep 1, 2013
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Drug: PEG-rhG-CSF
Other Names:
  • pegfilgrastim

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The occurrence rate of adverse event [up to 30 days after the patient study completion]

    2. The severity of adverse event [up to 30 days after the patient study completion]

    Secondary Outcome Measures

    1. the occurrence rate of grade III/ IV neutropenia during chemotherapy cycles [through the study completion,an average of 5 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02805218
    Other Study ID Numbers:
    • CSPC-PGC-IV-02-1
    First Posted:
    Jun 17, 2016
    Last Update Posted:
    Jun 20, 2016
    Last Verified:
    Jun 1, 2016
    Additional relevant MeSH terms:
    Lymphoma

    Study Results

    No Results Posted as of Jun 20, 2016