Status:
UNKNOWN
Evaluate the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma
Lead Sponsor:
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Collaborating Sponsors:
Hebei Medical University Fourth Hospital
Conditions:
Non Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
NA
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. T...
Eligibility Criteria
Inclusion
- Age ≥ 18 years, gender is not limited;
- Patients with lymphoma diagnosed by histopathology or cytology;
- Patients requiring multi-cycle chemotherapy;
- 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;
- Physical status (KPS) score ≥ 70 points;
- Expected Survival period of more than 3 months;
- 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);
- 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;
- Female patients of childbearing age must be negative in urine pregnancy test before treatment;
- The testers (or their legal representatives/guardians) must sign an informed consent form.
Exclusion
- Lymphoma central involvement;
- Hematopoietic stem cell transplantation or organ transplantation;
- Local or systemic infection without adequate control;
- Severe internal organ dysfunction and occurred in the last 6 months Myocardial infarction;
- Those who used other test drugs of the same kind or accepted other clinical trials within 4 weeks before enrollmen；
- Allergy to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
- Severe mental illness, affecting informed consent and/or adverse reaction expression or observation;
- Pregnant or lactating female patients; women who refuse to accept contraceptive measures ;
- Researchers determine unsuited to participate in this trial.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2020
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04497688
Start Date
January 1 2019
End Date
October 1 2020
Last Update
August 4 2020
Active Locations (1)
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1
The fourth hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050019