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
About this trial
This is an interventional prevention trial for Lymphoma
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
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
NCT ID
NCT02805218
First Posted
June 13, 2016
Last Updated
June 16, 2016
Sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
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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