NCT06857292

Clinical Study on the Safety, Efficacy and Pharmacokinetics of Telpegfilgrastim in Pediatric Cancer Patients with Chemotherapy

Clinical Study on the Safety, Efficacy and Pharmacokinetics of Telpegfilgrastim Injection in Pediatric Cancer Patients with Chemotherapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 97 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 14 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, single-arm, prospective study. The study population includes children with cancer who require high-intensity chemotherapy. The study aims to evaluate the safety and effectiveness of Telpegfilgrastim in preventing neutropenia in children with cancer (neuroblastoma, sarcoma, lymphoma, etc.) undergoing chemotherapy, while also studying the pharmacokinetic characteristics of Telpegfilgrastim in children with cancer.

Detailed description

Compared with the currently available straight chain PEG-rhG-CSF, the structure of its Y-type branch chain affects the activity and metabolic rate of the drug to a certain extent. While prolonging the half-life of the drug, the dosage of the drug is also significantly lower than that of the long-acting products on the market. It can be prophylactically administered once after chemotherapy to maintain the effective blood concentration of the whole cycle and effectively prevent the occurrence of neutropenia. Due to the reduction of the dose, the incidence of side effects such as musculoskeletal pain is correspondingly reduced, and there may be a better safety. At the same time, the accessibility of clinical PEG-rhG-CSF can be further solved, and the treatment cost is also expected to decrease, so that more patients can benefit from PEG-rhG-CSF. Telpegfilgrastim was approved on June 30, 2023 for "reducing the incidence of infection characterized by febrile neutropenia in patients with non-myeloid malignants who are treated with myelosuppressive anticancer agents that tend to cause clinically significant febrile neutropenia." At present, although Telpegfilgrastim has been approved for neutropenia induced by chemotherapy for non-myeloid malignant tumors, the safety and efficacy data in pediatric patients are lacking, and the pharmacokinetic characteristics in children are still unclear. The aim of this study was to evaluate the safety and efficacy of Telpegfilgrastim in the prevention of neutropenia in pediatric cancer patients receiving chemotherapy, and to investigate the pharmacokinetics of Telpegfilgrastim in pediatric cancer patients.

Conditions

• Chemotherapy-Induced Neutropenia

Interventions

Type	Name	Description
DRUG	Telpegfilgrastim	Experimental group: Patients were subcutaneously injected with Telpegfilgrastim 33μg/kg (maximum dose ≤2mg) 24h after chemotherapy, 21 days for one chemotherapy cycle, and only one chemotherapy cycle was observed. Pharmacokinetic determination: Among them, 8 patients underwent pharmacokinetic determination. The pharmacokinetic sampling time points were blood samples taken before administration, 12 h, 24 h, 48 h, 120h, 168 h, 336 h, 480h after administration. A total of 8 blood samples were collected, and the pharmacokinetic characteristics of the experimental drugs were analyzed by ELISA.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-03-04
• Last updated: 2025-03-04

Locations

1 site across 1 country: China