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

NCT06926751 | Not Yet Recruiting Phase 2

• 1 other identifier: PJ-B-241113
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of febrile neutropenia in Cycle 1

  Incidence of febrile neutropenia in Cycle 1 (i.e., the first chemotherapy cycle post-enrollment)

  21-28 days

Secondary Outcomes (7)

• Incidence of grade 3 neutropenia during Cycles 1-2

  42-56 days

• Time to recovery of grade 3 neutropenia during Cycles 1-2

  42-56 days

• Time to recovery of grade 4 neutropenia during Cycles 1-2

  42-56 days

• Incidence of grade 4 neutropenia during Cycles 1-2

  42-56 days

• Incidence of febrile neutropenia during Cycle 2

  21-28 days

Study Arms (2)

Telpegfilgrastim

EXPERIMENTAL

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

Drug: Telpegfilgrastim Injection

Filgrastim

ACTIVE COMPARATOR

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

Drug: filgrastim

Interventions

Telpegfilgrastim Injection DRUG

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

Also known as: Y-branched pegylated recombinant human granulocyte colony stimulating factor, YPEG-G-CSF, Peijin

Telpegfilgrastim

filgrastim DRUG

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

Also known as: Recombinant Human Granulocyte-Colony Stimulating Factor, rhG-CSF, Topneuter

Filgrastim

Eligibility Criteria

• Age: 6 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Histologically or cytologically confirmed malignant solid tumor requiring high-intensity chemotherapy, with ≥2 remaining chemotherapy cycles, and either:
• Previous febrile neutropenia(FN) or dose-limiting neutropenia in the prior chemotherapy cycle without prophylactic granulocyte colony-stimulating factor (G-CSF);
• Previous FN or dose-limiting neutropenia in the prior chemotherapy cycle despite prophylactic G-CSF.
• Age ≥6 to ≤24 years.
• Eastern Cooperative Oncology Group Performance Status ≤1.
• Normal bone marrow hematopoietic function: hemoglobin ≥75 g/L, white blood cell count ≥3.0×10\^9/L, platelets ≥80×10\^9/L, and neutrophils ≥1.5×10\^9/L.
• Anticipated survival ≥8 months.
• Willing to participate, with written informed consent signed by the patient or legal guardian.

You may not qualify if:

• Bone marrow involvement at screening.
• Uncontrolled localized or systemic infection.
• Known hypersensitivity to Telpegfilgrastim, recombinant human granulocyte-colony stimulating factor(rhG-CSF), or other pegylated recombinant human granulocyte colony stimulating factor(PEG-rhG-CSF) agents.
• Concurrent participation in any other investigational drug or device trial.
• Severe organ dysfunction: total bilirubin, alanine aminotransferase(ALT), or aspartate transaminase(AST) \>2.5 × upper limit of normal(ULN) (or \>5 × ULN in patients with liver metastases), serum creatinine \>5 × ULN.
• Severe psychiatric disorders affecting informed consent provision or adverse event assessment.
• Any condition deemed by the investigator to compromise patient safety or interfere with study outcomes, including risks from the investigational product or confounding adverse event evaluation.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

MeSH Terms

Interventions

Filgrastim; pegylated granulocyte colony-stimulating factor

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Sidan Li

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sidan Li

CONTACT

+86-0316-5917421; lisidan2006@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: This study is a multicenter, open-label, randomized controlled trial. It plans to enroll 132 children and adolescent patients with malignant solid tumors receiving high-density chemotherapy regimens. Patients will be randomized in a 3:1 ratio to receive Telpegfilgrastim or filgrastim for the prevention of chemotherapy-induced neutropenia (CIN), with observation of efficacy and safety in both groups. Patient data from all centers will be collected through an Electronic Data Capture (EDC) system. The trial employs a stratified randomization method based on subjects' age (6-12 years, 13-18 years, and 19-24 years). After signing the informed consent form, each subject will be assigned a unique screening number for identification throughout the study period.

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: April 15, 2025
• Study Start: April 7, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)