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

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  • participants needed
  • sponsor
    The First Hospital of Jilin University
Updated on 4 October 2022
granulocyte colony stimulating factor
chemotherapy regimen


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.


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.

Condition Chemotherapy-induced Neutropenia, Lymphoma
Treatment rhG-CSF, Pegylated rhG-CSF
Clinical Study IdentifierNCT04460508
SponsorThe First Hospital of Jilin University
Last Modified on4 October 2022


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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
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