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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02905916
Other study ID # CSPC-JYL-05-07
Secondary ID
Status Recruiting
Phase Phase 4
First received September 14, 2016
Last updated September 16, 2016
Start date June 2016

Study information

Verified date September 2016
Source Peking University
Contact Jun Zhu, MD
Phone +86-10-88196596
Email zj@bjcancer.org
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 217
Est. completion date
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Drug:
PEG-rhG-CSF


Locations

Country Name City State
China Peking University Cancer Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of febrile neutropenia (FN) 30days after PEG-rhG-CSF administration No
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