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

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · Apr 11, 2025

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ClinConnect Summary

This clinical trial is looking at two different treatments, Telpegfilgrastim and Filgrastim, to see which one is better at preventing a condition called chemotherapy-induced neutropenia (CIN) in children and adolescents with solid tumors. Neutropenia is a drop in white blood cells that can leave patients more vulnerable to infections, especially after chemotherapy. The researchers want to find out if Telpegfilgrastim can reduce the chances of a serious infection (called febrile neutropenia) during the first round of chemotherapy compared to Filgrastim, as well as how these treatments compare in terms of side effects and overall effectiveness.

To be eligible for this trial, participants must be between 6 and 24 years old and have a confirmed solid tumor that requires strong chemotherapy. They should have had issues with low white blood cell counts in previous treatments or be at risk of having these problems again. Participants will receive an injection of either Telpegfilgrastim or Filgrastim after each chemotherapy cycle and will have regular check-ups to monitor their blood counts, side effects, and any pain they experience. This study is not yet recruiting participants, but it is an important step in finding safer and more effective ways to support young cancer patients during treatment.

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Eligibility criteria

• 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.