Evaluating Telpegfilgrastim for preventing neutropenia in pediatric cancer patients undergoing chemotherapy
Clinical Study on the Safety, Efficacy and Pharmacokinetics of Telpegfilgrastim Injection in Pediatric Cancer Patients with Chemotherapy
This study is testing if a new drug called Telpegfilgrastim can help prevent low white blood cell counts in teenagers with cancer who are getting strong chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 97 (estimated) |
| Ages | 14 Years to 18 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06857292 on ClinicalTrials.gov |
What this trial studies
This multicenter, single-arm, prospective study focuses on children aged 14 to 18 years with cancer who require high-intensity chemotherapy. The study aims to assess the safety and efficacy of Telpegfilgrastim in preventing chemotherapy-induced neutropenia, while also examining its pharmacokinetic properties in this population. By administering Telpegfilgrastim prophylactically after chemotherapy, the study seeks to maintain effective blood concentrations and reduce the incidence of side effects compared to existing treatments. The research is particularly significant as it addresses a gap in safety and efficacy data for pediatric patients.
Who should consider this trial
Good fit: Ideal candidates are children aged 14 to 18 years with newly diagnosed non-myeloid malignancies requiring intensive chemotherapy.
Not a fit: Patients who are not undergoing chemotherapy or those with malignancies not requiring intensive treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective option for preventing neutropenia in pediatric cancer patients undergoing chemotherapy.
How similar studies have performed: While Telpegfilgrastim has been approved for adult patients, this study is novel as it specifically evaluates its safety and efficacy in pediatric patients, an area where data is currently lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Patients with 14≤ age \< 18 years;
* Newly diagnosed patients with non-myeloid malignancies who are confirmed by histopathology or cytology to require intensive chemotherapy (first course of chemotherapy or second course of chemotherapy);
* Primary prevention (G-CSF 24 to 72 hours after the first use of chemotherapy agents with myelosuppression to prevent the occurrence of febrile neutropenia (FN)) or secondary prevention (if FN or dose-restricted neutropenia occurred in a patient during a previous chemotherapy cycle) is required. Prophylactic use of G-CSF can be considered for the next chemotherapy cycle.
Febrile neutropenia (FN) : Oral temperature \>38.3 ° C (axillary temperature \>38.1 ° C) or oral temperature \>38.0 ° C (axillary temperature \>37.8 ° C) with ANC\<0.5×10\^9/L for 2 consecutive measurements within 2 hours, or ANC is expected to decrease to \<0.5×10\^9/L within 48 hours.
* KPS score ≥50 or Lansky (LPS) score ≥50;
* Normal hematopoietic function of bone marrow (ANC≥1.5×10\^9/L, PLT≥80×10\^9 /L, Hb≥75g/L, WBC≥3.0×10\^9/L, and not exceeding the upper limit of normal value);
* Life expectancy of at least 6 months; ⑦ Obtain written informed consent.
Exclusion Criteria:
* Received any rhG-CSF within 3 weeks prior to study participation;
* Received any antibody coupling drug (ADC) drugs with potential blood toxicity within 3 weeks before participating in the study;
* Recipients of hematopoietic stem cell transplantation or organ transplantation;
* Clinical trials of other drugs were being conducted within 2 months before enrollment;
* There is no control of infection, body temperature ≥38℃; ⑥ Liver function test: total bilirubin (TBIL) alanine aminotransferase (ALT.) and aspartate aminotransferase (AST.) were more than 2.5 times the upper limit of normal value; ⑦ Renal function test: serum creatinine (Cr.) \> 1.5 times the upper limit of normal value; ⑧Other conditions considered by the researchers to be contraindications for this study.
Where this trial is running
Guangzhou, Guangdong
- SunYat-senU — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Yizhuo Zhang
- Email: zhangyzh@sysucc.org.cn
- Phone: 020-87342460
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.