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Completed

NCT Number: NCT02805218

PEG-rhG-CSF in Patients With Lymphoma Receiving Chemotherapy

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

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEG-rhG-CSF

Drug

Other names: pegfilgrastim

Primary outcomes

  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 outcomes

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

    Time frame: through the study completion,an average of 5 months

Sponsors and collaborators

Lead sponsor

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 17, 2016
Registry last updated
Jun 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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