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

NCT06857292 | Recruiting Phase 2 DMC

• 1 other identifier: Telpegfilgrastim
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chemotherapy-Induced Neutropenia

Keywords

Telpegfilgrastim; pediatric cancer

Outcome Measures

Primary Outcomes (1)

• overall incidence of adverse reactions

  The overall incidence of adverse reactions after prophylactic drug use during this period

  1 year

Secondary Outcomes (2)

• Incidence of grade 3-4 neutropenia

  3 weeks

• Incidence of febrile neutropenia (FN)

  3 weeks

Study Arms (1)

Experimental group

EXPERIMENTAL

Use Telpegfilgrastim to prevent chemotherapy-induced neutropenia

Drug: Telpegfilgrastim

Interventions

Telpegfilgrastim DRUG

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.

Experimental group

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

SunYat-senU

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Yizhuo Zhang

CONTACT

020-87342460; zhangyzh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: March 4, 2025
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-02

Locations

CN (1)