Telpegfilgrastim versus filgrastim to prevent low white blood counts after chemotherapy in children and young adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, randomized, open‑label, adaptive trial comparing a long‑acting PEGylated G‑CSF (telpegfilgrastim) with daily filgrastim for secondary prevention of chemotherapy‑induced neutropenia in patients aged 6–24 with malignant solid tumors. An initial PK/safety lead‑in (20 patients) informs dose and safety before expanding to a 3:1 randomized cohort (99 vs 33) stratified by age groups. Telpegfilgrastim is given as a single subcutaneous dose after chemotherapy while filgrastim is given daily until neutrophil recovery; primary endpoints include febrile neutropenia in the first post‑randomization cycle plus duration/severity of neutropenia and treatment disruptions. The trial excludes other myelostimulatory agents and monitors ANC closely to compare efficacy and safety outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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.
2. Age ≥6 to ≤24 years.
3. Eastern Cooperative Oncology Group Performance Status ≤1.
4. 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.
5. Anticipated survival ≥8 months.
6. Willing to participate, with written informed consent signed by the patient or legal guardian.

Exclusion Criteria:

1. Bone marrow involvement at screening.
2. Uncontrolled localized or systemic infection.
3. 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.
4. Concurrent participation in any other investigational drug or device trial.
5. 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.
6. Severe psychiatric disorders affecting informed consent provision or adverse event assessment.
7. 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.

Where it's running

• Cancer Hospital, Chinese Academy of Medical Sciences
  Beijing, China Recruiting

Study contacts

• Principal investigator: Sidan Li — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Sidan Li
• Email: lisidan2006@126.com
• Phone: +86-0316-5917421

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.