Evaluate the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma

• Status: Recruiting
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The main treatments for non-Hodgkin's lymphoma are surgery, radiotherapy, chemotherapy, and bone marrow transplantation. Neutropenia is the most common and serious complication of most chemotherapy. This study is a multi-center, open-label, single-arm clinical study to evaluate the efficacy and safety of jinyouli in preventing neutropenia in patients with non Hodgkin's lymphoma after chemotherapy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
• Collaborator: Hebei Medical University Fourth Hospital

Criteria

Inclusion Criteria:

1. Age ≥ 18 years, gender is not limited;

2. Patients with lymphoma diagnosed by histopathology or cytology;

3. Patients requiring multi-cycle chemotherapy;

4. Planned chemotherapy regimen FN risk ≥ 20 % , or 10%factors ; According to the judgment of the investigator, there is a risk of FN occurrence if G-CSF support is not accepted, PEG-rhG-CSF should be used prophylactically from the first cycle;

5. Physical status (KPS) score ≥ 70 points;

6. Expected Survival period of more than 3 months;

7. Normal bone marrow hematopoietic function (ANC ≥1.5×10^9/L, PLT≥80×10^9/L, Hb≥75g/L, WBC≥3.0×10^9/L);

8. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5 times the upper limit of normal value, or≤5 times the upper limit of normal value when there is liver metastasis; total bilirubin (TBIL)≤2.5 times the upper limit of normal value; serum creatinine (Cr)≤2 times the upper limit of normal value;

9. Female patients of childbearing age must be negative in urine pregnancy test before treatment;

10. The testers (or their legal representatives/guardians) must sign an informed consent form.

Exclusion Criteria:

1. Lymphoma central involvement;

2. Hematopoietic stem cell transplantation or organ transplantation;

3. Local or systemic infection without adequate control;

4. Severe internal organ dysfunction and occurred in the last 6 months Myocardial infarction;

5. Those who used other test drugs of the same kind or accepted other clinical trials within 4 weeks before enrollmen；

6. Allergy to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;

7. Severe mental illness, affecting informed consent and/or adverse reaction expression or observation;

8. Pregnant or lactating female patients; women who refuse to accept contraceptive measures ;

9. Researchers determine unsuited to participate in this trial.