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

Primary Purpose

Mammary Cancer, Lymphoma, Bone Tumour

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

PEG-rhG-CSF

About this trial

This is an interventional prevention trial for Mammary Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with age between 18 and 70 years.
Breast cancer, lymphoma, bone tumor or Gynecologic tumor patients.
With multi-cycle chemotherapy.
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.
KPS score≥ 70.
Expected to survive more than 3 months.
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.
Written informed consent are acquired. -

Exclusion Criteria:

With infection or systemic antibiotic therapy 72h before chemotherapy.
With any abnormal hematopoietic function.
Received transplantation within 3 months.
Suffered from other malignant tumor or brain metastases.
TBIL, ALT,AST > 2.5×ULN; if it were caused by liver metastases, TBIL, ALT,AST >5×ULN.
Cr >1.5 ×ULN.
Sensitive to the product or other genetically engineered biological products from Escherichia coli strains.
Mental or nervous system disorders.
Refused to accept contraceptive measures.
Other situations that investigators consider as contra-indication for this study.
-

Sites / Locations

Peking University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PEG-rhG-CSF

Arm Description

Outcomes

Primary Outcome Measures

Incidence of febrile neutropenia (FN)

Secondary Outcome Measures

Full Information

NCT ID

NCT02905916

First Posted

September 14, 2016

Last Updated

September 16, 2016

Sponsor

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT02905916

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Unknown status

Study Start Date

June 2016 (undefined)

Primary Completion Date

June 2018 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mammary Cancer, Lymphoma, Bone Tumour, Gynecological Tumors

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

217 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PEG-rhG-CSF

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

PEG-rhG-CSF

Primary Outcome Measure Information:

Title

Incidence of febrile neutropenia (FN)

Time Frame

30days after PEG-rhG-CSF administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with age between 18 and 70 years. Breast cancer, lymphoma, bone tumor or Gynecologic tumor patients. With multi-cycle chemotherapy. 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. KPS score≥ 70. Expected to survive more than 3 months. 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. Written informed consent are acquired. - Exclusion Criteria: With infection or systemic antibiotic therapy 72h before chemotherapy. With any abnormal hematopoietic function. Received transplantation within 3 months. Suffered from other malignant tumor or brain metastases. TBIL, ALT,AST > 2.5×ULN; if it were caused by liver metastases, TBIL, ALT,AST >5×ULN. Cr >1.5 ×ULN. Sensitive to the product or other genetically engineered biological products from Escherichia coli strains. Mental or nervous system disorders. Refused to accept contraceptive measures. Other situations that investigators consider as contra-indication for this study. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jun Zhu, MD

Phone

+86-10-88196596

zj@bjcancer.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun Zhu, MD

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking University Cancer Hospital

City

Beijing

ZIP/Postal Code

100142

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jun Zhu, MD

Phone

+86-10-88196596

zj@bjcancer.org

12. IPD Sharing Statement

Learn more about this trial

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

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