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

Phase 4

• Conditions: Lymphoma; Bone Tumour; Gynecological Tumors; Mammary Cancer
• Interventions: Drug: PEG-rhG-CSF

• Registration Number: NCT02905916
• Lead Sponsor: Peking University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Status Verified: 2016-09
• Study First Submitted: 2016-09-14
• Study First Submitted QC: 2016-09-16
• Last Update Submitted: 2016-09-16
• Study First Posted: 2016-09-19
• Last Update Posted: 2016-09-19
• Primary Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 217

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEG-rhG-CSF	PEG-rhG-CSF	-

Primary Outcome Measures

Name	Time	Method
Incidence of febrile neutropenia (FN)	30days after PEG-rhG-CSF administration

Trial Locations

Locations (1)

Peking University Cancer Hospital; 🇨🇳 Beijing, China