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

Lymphoma Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02905916
• Other study ID #: CSPC-JYL-05-07
• 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. 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

Related Conditions & MeSH terms

• Bone Neoplasms
• Bone Tumour
• Breast Neoplasms
• Gynecological Tumors
• Lymphoma
• Mammary Cancer

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