Telpegfilgrastim vs Filgrastim for Secondary Prevention of Chemotherapy-Induced Neutropenia in Pediatric Solid Tumors

• Status: NOT_YET_RECRUITING
• Trial end date: 2027-09-01

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 g/kg, single dose) or Filgrastim (5 g/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.

• Phase: PHASE2

Details

• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Treatments: Filgrastim; pegylated granulocyte colony-stimulating factor