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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age14-18
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Telpegfilgrastim

Treatment groups

97 Participants
are divided into 1 treatment group

Sponsors and collaborators