Mecapegfilgrastim(PEG-G-CSF) for Prophylaxis of Chemotherapy-induced Neutropenia in Patients With Lymphoma

Study Overview
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Brief Summary
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Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy.A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with ﬁlgrastim. This study is to evaluate efficacy and safety in chemotherapy-induced neutropenia of once-per-cycle Mecapegfilgrastim Injection(PEG-G-CSF) and daily G-CSF in Patients with lymphoma patients.

Detailed Description
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This is a randomized, controlled study. A total of 170 lymphoma patients who are eligible are planned to randomized assigned into two groups to receive mecapegfilgrastim fixed dose of 6 mg or filgrastim 5 µg/kg/day during chemotherapy. The primary endpoint is the duration of grade ≥3 neutropenia in cycle 1. The secondary endpoints include incidence of grade ≥3 neutropenia and febrile neutropenia (FN) in cycle 1-4, The pharmacoeconomics and safety profile are also evaluated.

Official Title
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Efficacy and Safety of Mecapegfilgrastim(PEG-G-CSF) for Prophylaxis of Chemotherapy-induced Neutropenia in Patients With Lymphoma: a Randomized, Open-label, Active-controlled Trial

Conditions
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Chemotherapy-induced Neutropenia, Lymphoma

Intervention / Treatment
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* Drug: Pegylated rhG-CSF
* Drug: rhG-CSF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 75 years; Patients with primary malignant lymphoma confirmed by histopathology or immunomolecular biology and requiring treatment with multi-cycle high-intensity chemotherapy regimen; ECOG performance status ≤ 1; ANC ≥1.5×109/L, PLT≥80×109 /L, Hb≥ 75g/L, WBC ≥3.0×109/L; Subjects with pregnancy ability must agree to use reliable contraceptive measures from screening to 1 year after treatment; Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedul. Exclusion Criteria: Lymphoma central involvement; Recipients of hematopoietic stem cell transplantation or organ transplantation; Currently conducting clinical trials of other drugs; There is an uncontrollable infection with body temperature ≥38℃; liver function examination: total bilirubin (TBIL., alanine aminotransferase (ALT. and ascetic aminotransferase (AST. were all 2.5 times the upper limit of the normal value of >; if they were caused by liver metastasis, the upper limit of the normal value of > was 5 times;Renal function test: serum creatinine (Cr. >2 times the upper limit of normal value Patients with serious chronic diseases of heart, kidney, liver and other important organs; Patients with severe uncontrolled diabetes; Pregnant or lactating female patients.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mecapegfilgrastim<br>Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle. | Drug: Pegylated rhG-CSF<br>* Pegylated rhG-CSF:6mg<br>|
| Active Comparator: rhG-CSF<br>Patients were administered pegylated rhG-CSF 6 ug/kg/day from the 3rd day of every chemotherapy cycle. | Drug: rhG-CSF<br>* rhG-CSF:5ug/kg/d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of grade ≥3 neutropenia in cycle 1 | Duration of subjects developing ANC lower than 1.0 × 109/L | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of grade ≥3 neutropenia in cycle 1-4 | Proportion of subjects developing ANC lower than 1.0 × 109/L from cycle 1 to cycle 4 | 84 days | 
| Incidenc of febrile neutropenia (FN) in cycle 1-4 | Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.5 degrees celsius from cycle 1 to cycle 4 | 84 days | 
| Incidence of adverse events (AEs) | Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) according to the Common Terminology Criteria for Adverse Events, version 5.0 | 84 days |