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Compares treatment options for Solid Tumors
Official title Telpegfilgrastim vs Filgrastim for Secondary Prevention of Chemotherapy-Induced Neutropenia in Pediatric Solid Tumors
ClinicalTrials.gov ID: NCT06926751
What this study is testing
What is Telpegfilgrastim Injection?
Telpegfilgrastim Injection is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for solid tumors.
Also referred to as Y-branched pegylated recombinant human granulocyte colony stimulating factor, YPEG-G-CSF.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 24
You may be able to join if
- Histologically or cytologically confirmed malignant solid tumor requiring high-intensity chemotherapy, with ≥2 remaining chemotherapy cycles, and...
- Previous febrile neutropenia(FN) or dose-limiting neutropenia in the prior chemotherapy cycle without prophylactic granulocyte colony-stimulating...
- 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.
You likely can't join 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...
- 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 ×...
- Severe psychiatric disorders affecting informed consent provision or adverse event assessment.
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 24 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.