Can a new protein drug shield kids with cancer from dangerous infections?
NCT ID NCT07724756
First seen Jul 24, 2026 · Last updated Jul 24, 2026
Summary
This trial tests whether a new drug called albipagrastim alfa can prevent severe neutropenia (dangerously low white blood cell counts) in children with sarcoma who are receiving chemotherapy. The drug is designed to stimulate the body's production of infection-fighting neutrophils. Researchers will measure how the drug behaves in the body, how well it protects against fever and infection, and whether it is safe for young patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a new drug called albipagrastim alfa (QLC2519) that stimulates white blood cell production
- What this could lead to
- If it works, this could offer a safer, more convenient way to prevent dangerous infections in children undergoing chemotherapy for sarcoma.
- What could go wrong
- This is a small, early-phase trial with only 18 participants, so results may not apply broadly. The drug could cause side effects or fail to prevent neutropenia as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 18 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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0 to 18 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: * Age 0-18 years (excluding boundary values), any gender; * Participant diagnosed with pediatric sarcoma based on pathological histology; * Participant was suitable for receiving the VDC/IE chemotherapy regimen, and planning to receive at least 3 chemotherapy cycles (VDC: vincristine, doxorubicin, cyclophosphamide; IE: ifosfamide, etoposide); * ECOG ≤1; * Expected survival ≥3 months, and expected to complete the 3 chemotherapy cycles specified in the regimen; * Hematology, liver function, and renal function before the first administration of chemotherapy drugs meet the following requirements: * Hematology: absolute neutrophil count (ANC) in peripheral blood ≥2.0×10\^9/L (or above the lower limit of normal); platelet count (PLT) ≥100×10\^9/L; hemoglobin (HGB) ≥90 g/L; white blood cell count (WBC) ≥4.0×10\^9/L; * Liver function: total bilirubin (TBIL) ≤1.5×ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×ULN; for patients with liver metastasis, ALT and AST ≤2.5×ULN; * Renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance rate (CCr) ≥60 mL/min; * Normal bone marrow hematopoietic function, no bleeding tendency (INR \<1.5); * Female participants of potential reproductive ability (post-menarche) are neither pregnant nor breastfeeding; participants of potential reproductive ability (e.g., females post-menarche or males post-spermarche) must agree to use effective contraception from the time of signing the informed consent until at least 3 months after the last administration. Exclusion Criteria: * Tumor had metastasized to or invaded the bone marrow; * Previously received chemotherapy or radiotherapy; * Planned surgery or radiotherapy during the trial (excluding the follow-up period); * Presence of other malignant tumors besides sarcoma (participants with previously cured malignant tumors with no recurrence within the past 5 years may be included in this study); * Primary central nervous system tumor or existing central nervous system involvement, or suspected central nervous system metastasis based on clinical manifestations, deemed unsuitable for participation in this study by the investigator; * History of primary hematologic diseases, including but not limited to leukemia, myelodysplastic syndromes, aplastic anemia, sickle cell anemia, congenital neutropenia, or cyclic neutropenia; * Previously received or planned to undergo bone marrow transplantation, hematopoietic stem cell transplantation, or organ transplantation during the trial; * Diseases with severe cardiac dysfunction, including but not limited to poorly controlled arrhythmia or heart failure; * Diseases with severe pulmonary dysfunction, including but not limited to pulmonary embolism, lung abscess, or acute respiratory distress syndrome; * Presence of splenomegaly or diseases that may cause splenomegaly (such as liver cirrhosis, Gaucher disease, glycogen storage disease, Niemann-Pick disease, etc.), considered unsuitable for participation in this study by the investigator; * Presence of acute infectious disease or chronic infectious disease in the active phase at screening, such as hepatitis B patients who are hepatitis B surface antigen (HbsAg) positive with detectable HBV-DNA indicating viral replication, hepatitis C patients who are anti-HCV antibody positive with detectable HCV-RNA indicating viral replication; positive syphilis screening (positive specific antibody test, negative nonspecific antibody test, and confirmed as non-active infection based on clinical judgment is excluded); * History of human immunodeficiency virus (HIV) infection, or HIV positive at screening; * Undergoing major surgery within 1 month prior to screening (high-risk, complex, or difficult procedures, such as thoracoscopic pulmonary bulla resection or thoracoscopic esophageal atresia surgery); * Received or planned to use recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) within 1 week prior to screening or during the trial; * Received glucocorticoid (oral or intravenous) or lithium treatment within 1 week prior to screening; * Received whole blood, white blood cells, or platelet transfusion within 2 weeks prior to screening; * Received human granulocyte colony-stimulating factor (G-CSF) treatment within 3 months prior to screening; * Received systemic anti-infective therapy (oral or intravenous) within 72 hours prior to screening; * History of drug or alcohol abuse, or history of substance abuse; * Received other clinical trial drugs or treatments within 4 weeks prior to screening; * History of allergic diseases, being of an allergic constitution, or known allergy to any drug or component of this trial.
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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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Beijing Children's Hospital
RECRUITINGBeijing, China
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- Pedaling through chemo: could exercise boost tumor blood flow?
- Can a structured recovery plan speed healing after sarcoma surgery?