Clinical trial NCT04497688: Evaluate the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma
Official title: A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of PEG-rhG-CSF(Jinyouli®) in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non Hodgkin's Lymphoma
Lead sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Hebei Medical University Fourth Hospital
First posted: 2020-08-04
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


Eligibility 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% \<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.

Primary outcomes:
measure: The incidence of grade Ⅲ/Ⅳ neutropenia
timeFrame: From date of randomization until the date of the study completion，up to 24 weeks
Secondary outcomes:
measure: Incidence of febrile neutropenia (FN)
timeFrame: From date of randomization until the date of the study completion，up to 24 weeks
measure: Antibiotic use rate
timeFrame: From date of randomization until the date of the study completion，up to 24 weeks
measure: Incidence of dose adjustment of chemotherapy or delay of chemotherapy
timeFrame: From date of randomization until the date of the study completion，up to 24 weeks
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: The fourth hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: Hebei Medical University Fourth Hospital
name: Lihong Liu, PHD
role: PRINCIPAL_INVESTIGATOR
References: