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PEG-rhG-CSF in Patients With Lymphoma Receiving Chemotherapy

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
PEG-rhG-CSF
Sponsored by
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    PEG-rhG-CSF

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    The occurrence rate of adverse event
    The severity of adverse event

    Secondary Outcome Measures

    the occurrence rate of grade III/ IV neutropenia during chemotherapy cycles

    Full Information

    First Posted
    June 13, 2016
    Last Updated
    June 16, 2016
    Sponsor
    CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02805218
    Brief Title
    PEG-rhG-CSF in Patients With Lymphoma Receiving Chemotherapy
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    February 2016 (Actual)
    Study Completion Date
    February 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

    4. Oversight

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphoma

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    410 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PEG-rhG-CSF
    Arm Type
    Experimental
    Arm Description
    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 Type
    Drug
    Intervention Name(s)
    PEG-rhG-CSF
    Other Intervention Name(s)
    pegfilgrastim
    Primary Outcome Measure Information:
    Title
    The occurrence rate of adverse event
    Time Frame
    up to 30 days after the patient study completion
    Title
    The severity of adverse event
    Time Frame
    up to 30 days after the patient study completion
    Secondary Outcome Measure Information:
    Title
    the occurrence rate of grade III/ IV neutropenia during chemotherapy cycles
    Time Frame
    through the study completion,an average of 5 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

    PEG-rhG-CSF in Patients With Lymphoma Receiving Chemotherapy

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