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

Peking University

Status and phase: Unknown; Phase 4

Conditions: Bone Tumour; Mammary Cancer; Gynecological Tumors; Lymphoma

Treatments: Drug: PEG-rhG-CSF

Study type: Interventional

Funder types: Other

Identifiers

NCT02905916

CSPC-JYL-05-07

Details and patient eligibility

About

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.

Enrollment: 217 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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217 participants in 1 patient group

PEG-rhG-CSF

Experimental group

Treatment:

Drug: PEG-rhG-CSF