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PEG-rhG-CSF in Patients With Lymphoma Receiving Chemotherapy

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ClinicalTrials.gov Identifier: NCT02805218
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : June 20, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: PEG-rhG-CSF Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 410 participants
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 : September 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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 Name: pegfilgrastim




Primary Outcome Measures :
  1. The occurrence rate of adverse event [ Time Frame: up to 30 days after the patient study completion ]
  2. The severity of adverse event [ Time Frame: up to 30 days after the patient study completion ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02805218     History of Changes
Other Study ID Numbers: CSPC-PGC-IV-02-1
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases