Telpegfilgrastim vs Filgrastim for Secondary Prevention of Chemotherapy-Induced Neutropenia in Pediatric Solid Tumors
A Multicenter, Randomized, Controlled Study of Telpegfilgrastim Versus Filgrastim for Secondary Prevention of Chemotherapy-Induced Neutropenia in Children and Adolescents With Solid Tumors Receiving High-Intensity Chemotherapy Regimens
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
132 participants
Jun 12, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to evaluate the efficacy and safety of Telpegfilgrastim (a PEGylated recombinant human granulocyte colony-stimulating factor, PEG-rhG-CSF) compared to Filgrastim (short-acting rhG-CSF) in preventing chemotherapy-induced neutropenia (CIN) in children and adolescents aged 6-24 years with malignant solid tumors receiving high-intensity chemotherapy regimens. The main questions it aims to answer are: * Does Tuopefilgrastim reduce the incidence of febrile neutropenia (FN) in the first chemotherapy cycle (Cx+1) compared to Filgrastim? * How do the two treatments compare in terms of duration and severity of neutropenia, chemotherapy delays/dose reductions, antibiotic use, and bone pain incidence? Researchers will compare the Telpegfilgrastim group (3:1 ratio, 99 participants) with the Filgrastim group (33 participants) to determine if Telpegfilgrastim demonstrates superior efficacy and safety. Participants will: * Receive subcutaneous injections of either Telpegfilgrastim (33 μg/kg, single dose) or Filgrastim (5 μg/kg/day, multiple doses) 24 hours after each chemotherapy cycle. * Undergo blood tests, physical exams, and temperature monitoring during follow-up visits. * Be assessed for bone pain severity using age-appropriate scales (FLACC or Wong-Baker). * Complete two chemotherapy cycles with close safety and efficacy monitoring.
Eligibility
Plain Language Summary
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Interventions
subcutaneous injections of Telpegfilgrastim (33 μg/kg, single dose) 24 hours after each chemotherapy cycle
subcutaneous injections of Filgrastim (5 μg/kg/day, multiple doses) 24 hours after each chemotherapy cycle
Locations(1)
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NCT06926751