Telpegfilgrastim to prevent neutropenia in people with solid tumors

A Real World Study on the Efficacy and Safety of Telpegfilgrastim Injection for Prophylaxis of Chemotherapy-Induced Neutropenia in Patients With Solid Tumor

This project will test whether telpegfilgrastim injections can prevent chemotherapy-related low neutrophil counts in adults with solid tumors who are at increased risk.

Quick facts

• Study type: Observational
• Enrollment: 318 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Anhui Provincial Hospital (Government)
• Drugs / interventions: chemotherapy, radiation, immunotherapy
• Locations: 2 sites (Hefei, Anhui and 1 other locations)
• Trial ID: NCT07096479 on ClinicalTrials.gov

What this trial studies

This is a real-world observational study collecting safety and effectiveness data on telpegfilgrastim given to adults with confirmed malignant solid tumors receiving 3-week chemotherapy regimens and judged to be at high risk for febrile neutropenia or at intermediate risk with additional risk factors. Eligible participants are 18–69 years old, weigh at least 45 kg, have KPS ≥70, and have normal baseline WBC and ANC. Investigators will record incidence of neutropenia, febrile neutropenia, infections, chemotherapy dose delays or reductions, and adverse events during routine clinical care. Data will be used to confirm whether telpegfilgrastim reduces clinically meaningful neutropenia and is well tolerated in this patient population.

Who should consider this trial

Good fit: Adults aged 18 to 69 with histologically confirmed solid tumors on 3-week chemotherapy regimens who are assessed as high risk for febrile neutropenia or moderate risk with added risk factors, weigh ≥45 kg, have KPS ≥70, and normal baseline WBC/ANC are ideal candidates.

Not a fit: Patients older than 69, those under 45 kg, patients with hematologic malignancies, or those receiving chemotherapy regimens not associated with elevated neutropenia risk are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, telpegfilgrastim could reduce episodes of low neutrophils and related infections, helping patients stay on planned chemotherapy schedules.

How similar studies have performed: Granulocyte colony-stimulating factors such as pegfilgrastim have a well-established record of preventing chemotherapy-induced neutropenia, while real-world safety and efficacy data specifically for telpegfilgrastim are more limited.

Eligibility criteria

Inclusion Criteria:

1. Male or female, age ranging from 18 to 70 years old (excluding 70 years old);
2. body weight ≥45 kg;
3. Histologically or cytologically confirmed diagnosis of malignant solid tumor;
4. Solid tumor patients who receive a 3-week chemotherapy regimen have been evaluated as high-risk for FN or evaluated as having moderate risk for FN, but with an increased risk factor for neutropenia associated with the chemotherapy regimen;(The risk assessment of FN in tumor chemotherapy is based on " Chinese Society of Clinical Oncology (CSCO) guidelines for standardized management of tumor chemoradiotherapy related neutropenia(2021 edition)" and " Consensus on clinical diagnosis, treatment, and prevention of chemotherapy-induced neutropenia in China(2023 edition)";
5. Karnofsky Performance Scale(KPS) score≥70;
6. The total number of white blood cells and absolute value of neutrophils before chemotherapy should not be lower than normal values: WBC ≥ 3.5 × 109/L, ANC ≥ 1.5 × 109/L;
7. Subject has a life Expectation of at least 6 month；
8. Subjects voluntarily and strictly comply with the research protocol requirements and sign a written informed consent for.

Exclusion Criteria:

1. Received any other PEG-rhG-CSF within 4 weeks prior to participating in this study;
2. Patients receiving intermittent or continuous chemotherapy regimens such as albumin paclitaxel and capecitabine;
3. Previously or expected to receive extensive radiation therapy (\>25% of total bone marrow);
4. Individuals with significant functional impairments in important organs such as the heart, lungs, liver, and kidneys:

   Liver function indicators (ALT, TBil)\>2.5 ULN; Tumor patients with liver metastasis have liver function indicators (ALT,TBil)\>5ULN; Hepatitis B virus infection, hepatitis C virus infection, or cirrhosis; Renal function Cr\>1.5ULN;
5. Pregnant or breastfeeding woman ;
6. hypersensitive to rhG-CSF or other biological agents;
7. Investigators judged other situations that may affect the progress and results of clinical research.

Where this trial is running

Hefei, Anhui and 1 other locations

• Anhui province hospital — Hefei, Anhui, China (Recruiting)
• Anhui province hospital — Hefei, Anhui, China (Recruiting)

Conditions Chemotherapy-induced Neutropenia; Drug Therapy