drugset / Trial / NCT04460508

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

NCT04460508

Phase 2 Unknown 170 enrolled The First Hospital of Jilin University
RandomizedParallel-groupOpen-labelPrevention

Summary

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.

Timeline

Start
2020-12-20
Primary completion
2022-12-20
Completion
2023-03-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Mecapegfilgrastim Protein / enzyme biologic 6 mg
Comparator filgrastim Protein / enzyme biologic 5 ug/kg

Indications