The Efficacy and Safety of PEG-rhG-CSF in Neutropenia After Chemotherapy

September 16, 2016 updated by: Jun Zhu, Peking University
The purpose of the trail is to evaluate the efficacy and safety of PEG-rhG-CSF in primary prophylaxis and secondary prophylaxis of neutropenia after chemotherapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

217

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100142
        • Recruiting
        • Peking University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with age between 18 and 70 years.
  2. Breast cancer, lymphoma, bone tumor or Gynecologic tumor patients.
  3. With multi-cycle chemotherapy.
  4. With III/IV degree neutropenia after the last cycle of chemotherapy and plans to use the same regimen in the subsequent cycles.FN risk of the chemotherapy regimens is ≥20%，or 10%≤FN risk<20% and has high risk factors associated with FN.
  5. KPS score≥ 70.
  6. Expected to survive more than 3 months.
  7. No hematologic system disease and ANC≥1.5×10E9/L, PKT≥80×10E9/L, Hb≥ 75g/L, WBC≥3×10E9/L, and no bleeding tendency.
  8. Written informed consent are acquired. -

Exclusion Criteria:

  1. With infection or systemic antibiotic therapy 72h before chemotherapy.
  2. With any abnormal hematopoietic function.
  3. Received transplantation within 3 months.
  4. Suffered from other malignant tumor or brain metastases.
  5. TBIL, ALT,AST > 2.5×ULN; if it were caused by liver metastases, TBIL, ALT,AST >5×ULN.
  6. Cr >1.5 ×ULN.
  7. Sensitive to the product or other genetically engineered biological products from Escherichia coli strains.
  8. Mental or nervous system disorders.
  9. Refused to accept contraceptive measures.

  10. Other situations that investigators consider as contra-indication for this study.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEG-rhG-CSF
Drug: PEG-rhG-CSF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of febrile neutropenia (FN)
Time Frame: 30days after PEG-rhG-CSF administration
30days after PEG-rhG-CSF administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

September 16, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Estimate)

September 19, 2016

Last Update Submitted That Met QC Criteria

September 16, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPC-JYL-05-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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