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

Inclusion Criteria:

• Patients with 14≤ age < 18 years;

• Newly diagnosed patients with non-myeloid malignancies who are confirmed byhistopathology or cytology to require intensive chemotherapy (first course ofchemotherapy or second course of chemotherapy);

• Primary prevention (G-CSF 24 to 72 hours after the first use ofchemotherapy agents with myelosuppression to prevent the occurrence offebrile neutropenia (FN)) or secondary prevention (if FN ordose-restricted neutropenia occurred in a patient during a previouschemotherapy cycle) is required. Prophylactic use of G-CSF can beconsidered 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.

Exclusion Criteria:

• Received any rhG-CSF within 3 weeks prior to study participation;

• Received any antibody coupling drug (ADC) drugs with potential blood toxicitywithin 3 weeks before participating in the study;

• Recipients of hematopoietic stem cell transplantation or organtransplantation;

• Clinical trials of other drugs were being conducted within 2 monthsbefore enrollment;

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