TelpegfilgrastTelpegfilgrastim Injection for Neutropenia Prevention in Pediatric Cancer Patients with Chemotherapy
Telpegfilgrastim
Neoplasms
Prevention Study
Summary
Study start date: December 1, 2024
Actual date on which the first participant was enrolled.This clinical study is focused on evaluating a medicine called Telpegfilgrastim, which is used to help prevent a condition known as neutropenia in children who are undergoing cancer treatment with chemotherapy. Neutropenia is a dangerous drop in white blood cells that can lead to serious infections. Telpegfilgrastim has already been approved for use in adults with certain types of cancer, but its effects and safety in children are not well understood. By studying this medicine in pediatric patients, the researchers hope to better understand its safety, effectiveness, and how it behaves in the bodies of young patients. This could potentially lead to more effective and safer treatments for children, while also reducing costs and improving access to the medicine. Participants in this study will receive Telpegfilgrastim as an injection after their chemotherapy sessions. This is to maintain a stable level of protection against infections throughout the chemotherapy cycle. The researchers will monitor the children to see how well the drug works at preventing neutropenia and will also look at how the drug is processed in the body. The study aims to reduce the side effects often seen with similar treatments, such as musculoskeletal pain, by using a lower dose of the medicine. This approach hopes to provide a safer option for young patients undergoing cancer treatment.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.97 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 14 to 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location