PEG-rhG-CSF in Patients With Lymphoma Receiving Chemotherapy

NCT ID: NCT02805218

Last Updated: 2016-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

410 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-02-29

Brief Summary

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

Detailed Description

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Conditions

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Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

PEG-rhG-CSF

Intervention Type DRUG

Interventions

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PEG-rhG-CSF

Intervention Type DRUG

Other Intervention Names

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pegfilgrastim

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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CSPC-PGC-IV-02-1

Identifier Type: -

Identifier Source: org_study_id

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