New Single-Shot drug may protect kids on chemo from dangerous infections
NCT ID NCT06926751
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a single injection of Telpegfilgrastim works better than daily Filgrastim shots to prevent fever and low white blood cells in children and young adults (ages 6-24) with solid tumors receiving strong chemotherapy. About 132 participants will receive either drug after each chemo cycle and be monitored for infections, side effects, and treatment delays. The goal is to find a safer, more convenient way to manage chemotherapy side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 132 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 24 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cancer Hospital, Chinese Academy of Medical Sciences
RECRUITINGBeijing, China
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