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.
Patients with 14≤ age < 18 years;
Newly diagnosed patients with non-myeloid malignancies who are confirmed by histopathology or cytology to require intensive chemotherapy (first course of chemotherapy or second course of chemotherapy);
Primary prevention (G-CSF 24 to 72 hours after the first use of chemotherapy agents with myelosuppression to prevent the occurrence of febrile neutropenia (FN)) or secondary prevention (if FN or dose-restricted neutropenia occurred in a patient during a previous chemotherapy cycle) is required. Prophylactic use of G-CSF can be considered for the next chemotherapy cycle.
KPS score ≥50 or Lansky (LPS) score ≥50;
Received any rhG-CSF within 3 weeks prior to study participation;
Received any antibody coupling drug (ADC) drugs with potential blood toxicity within 3 weeks before participating in the study;
Recipients of hematopoietic stem cell transplantation or organ transplantation;
Clinical trials of other drugs were being conducted within 2 months before enrollment;
Single group
Telpegfilgrastim
DrugExperimental 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.
overall incidence of adverse reactions
The overall incidence of adverse reactions after prophylactic drug use during this period
Incidence of grade 3-4 neutropenia
Incidence of grade 3-4 neutropenia during this period after prophylactic administration
Incidence of febrile neutropenia (FN)
Incidence of febrile neutropenia (FN) in this period after prophylaxis
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