Evaluate the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: PEG-rhG-CSF group 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 |
Drug: PEG-rhG-CSF
Patients received a single dose of PEG-rhG-CSF per cycle. The chemotherapy regimen must meet the interval between two chemotherapy sessions at least 12 days.
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Outcome Measures
Primary Outcome Measures
- The incidence of grade Ⅲ/Ⅳ neutropenia [From date of randomization until the date of the study completion,up to 24 weeks]
Grade Ⅲ neutropenia is defined as ANC≥0.5×10^9/L, and <1×10^9/L; Grade Ⅳ neutropenia is defined as ANC<0.5×10^9/L
Secondary Outcome Measures
- Incidence of febrile neutropenia (FN) [From date of randomization until the date of the study completion,up to 24 weeks]
A single oral temperature is 38.3℃ or ≥38℃ for more than 1 h, and the absolute value of neutrophils is less than 0.5×10^9/L or the absolute value of neutrophils is less than 1.0×10^9/L but it is expected to drop to less than 0.5×10^9/L within 48 hours
- Antibiotic use rate [From date of randomization until the date of the study completion,up to 24 weeks]
Antibiotic use rate during the treatment cycle
- Incidence of dose adjustment of chemotherapy or delay of chemotherapy [From date of randomization until the date of the study completion,up to 24 weeks]
Dose adjustment is defined as the reduction of planned dose of chemotherapy; Chemotherapy delay is defined as the delay in starting the next planned chemotherapy for more than 3 days.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years, gender is not limited;
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Patients with lymphoma diagnosed by histopathology or cytology;
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Patients requiring multi-cycle chemotherapy;
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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;
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Physical status (KPS) score ≥ 70 points;
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Expected Survival period of more than 3 months;
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Normal bone marrow hematopoietic function (ANC ≥1.5×109/L, PLT≥80×109/L, Hb≥75g/L, WBC≥3.0×10^9/L);
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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;
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Female patients of childbearing age must be negative in urine pregnancy test before treatment;
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The testers (or their legal representatives/guardians) must sign an informed consent form.
Exclusion Criteria:
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Lymphoma central involvement;
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Hematopoietic stem cell transplantation or organ transplantation;
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Local or systemic infection without adequate control;
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Severe internal organ dysfunction and occurred in the last 6 months Myocardial infarction;
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Those who used other test drugs of the same kind or accepted other clinical trials within 4 weeks before enrollmen;
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Allergy to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
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Severe mental illness, affecting informed consent and/or adverse reaction expression or observation;
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Pregnant or lactating female patients; women who refuse to accept contraceptive measures ;
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Researchers determine unsuited to participate in this trial.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | The fourth hospital of Hebei Medical University | Shijiazhuang | Hebei | China | 050019 |
Sponsors and Collaborators
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Hebei Medical University Fourth Hospital
Investigators
- Principal Investigator: Lihong Liu, PHD, The Fourth Hospital of Hebei Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CSPC -JYL-NHL-03