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Telpegfilgrastim vs Filgrastim for Secondary Prevention of Chemotherapy-Induced Neutropenia in Pediatric Solid Tumors

NCT06926751 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2026-05-07

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of Telpegfilgrastim (a PEGylated recombinant human granulocyte colony-stimulating factor, PEG-rhG-CSF) compared to Filgrastim (short-acting rhG-CSF) in preventing chemotherapy-induced neutropenia (CIN) in children and adolescents aged 6-24 years with malignant solid tumors receiving high-intensity chemotherapy regimens. The main questions it aims to answer are:

* Does Tuopefilgrastim reduce the incidence of febrile neutropenia (FN) in the first chemotherapy cycle (Cx+1) compared to Filgrastim?
* How do the two treatments compare in terms of duration and severity of neutropenia, chemotherapy delays/dose reductions, antibiotic use, and bone pain incidence? Researchers will compare the Telpegfilgrastim group (3:1 ratio, 99 participants) with the Filgrastim group (33 participants) to determine if Telpegfilgrastim demonstrates superior efficacy and safety.

Participants will:

* Receive subcutaneous injections of either Telpegfilgrastim (33 μg/kg, single dose) or Filgrastim (5 μg/kg/day, multiple doses) 24 hours after each chemotherapy cycle.
* Undergo blood tests, physical exams, and temperature monitoring during follow-up visits.
* Be assessed for bone pain severity using age-appropriate scales (FLACC or Wong-Baker).
* Complete two chemotherapy cycles with close safety and efficacy monitoring.

Conditions

  • Solid Tumors
  • Children
  • Adolescent
  • Chemotherapy Induced Neutropenia

Interventions

DRUG

Telpegfilgrastim Injection

subcutaneous injections of Telpegfilgrastim (33 μg/kg, single dose) 24 hours after each chemotherapy cycle

DRUG

filgrastim

subcutaneous injections of Filgrastim (5 μg/kg/day, multiple doses) 24 hours after each chemotherapy cycle

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Sidan Li · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-12
Primary Completion
2027-04-01
Completion
2027-09-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06926751 on ClinicalTrials.gov