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

CSPC Pharmaceutical Group

Status: Unknown

Conditions: Non Hodgkin's Lymphoma

Treatments: Drug: PEG-rhG-CSF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04497688

CSPC -JYL-NHL-03

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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% <FN risk < 20% with high risk 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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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104 participants in 1 patient group

PEG-rhG-CSF group

Experimental group

Description:

Patients received subcutaneous injection of PEG-rhG-CSF(Jinyouli®) 48 hours after the end of chemotherapy, 6mg for patients with body weight≥45kg and 3mg for patients with body weight less than 45kg, once per chemotherapy cycle

Treatment:

Drug: PEG-rhG-CSF