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

Laborértékek

• 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;
  • There is no control of infection, body temperature ≥38℃; ⑥ Liver function test: total bilirubin (TBIL) alanine aminotransferase (ALT.) and aspartate aminotransferase (AST.) were more than 2.5 times the upper limit of normal value; ⑦ Renal function test: serum creatinine (Cr.) > 1.5 times the upper limit of normal value; ⑧Other conditions considered by the researchers to be contraindications for this study.

• 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.
  • Febrile neutropenia (FN) : Oral temperature >38.3 ° C (axillary temperature >38.1 ° C) or oral temperature >38.0 ° C (axillary temperature >37.8 ° C) with ANC<0.5×10\^9/L for 2 consecutive measurements within 2 hours, or ANC is expected to decrease to <0.5×10\^9/L within 48 hours.
• KPS score ≥50 or Lansky (LPS) score ≥50;
  • Normal hematopoietic function of bone marrow (ANC≥1.5×10\^9/L, PLT≥80×10\^9 /L, Hb≥75g/L, WBC≥3.0×10\^9/L, and not exceeding the upper limit of normal value);
  • Life expectancy of at least 6 months; ⑦ Obtain written informed consent.