Clinical Study on the Safety, Efficacy and Pharmacokinetics of Telpegfilgrastim in Pediatric Cancer Patients with Chemotherapy (Telpegfilgrast)
Clinical Study on the Safety, Efficacy and Pharmacokinetics of Telpegfilgrastim Injection in Pediatric Cancer Patients with Chemotherapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Compared with the currently available straight chain PEG-rhG-CSF, the structure of its Y-type branch chain affects the activity and metabolic rate of the drug to a certain extent. While prolonging the half-life of the drug, the dosage of the drug is also significantly lower than that of the long-acting products on the market. It can be prophylactically administered once after chemotherapy to maintain the effective blood concentration of the whole cycle and effectively prevent the occurrence of neutropenia. Due to the reduction of the dose, the incidence of side effects such as musculoskeletal pain is correspondingly reduced, and there may be a better safety. At the same time, the accessibility of clinical PEG-rhG-CSF can be further solved, and the treatment cost is also expected to decrease, so that more patients can benefit from PEG-rhG-CSF.
Telpegfilgrastim was approved on June 30, 2023 for "reducing the incidence of infection characterized by febrile neutropenia in patients with non-myeloid malignants who are treated with myelosuppressive anticancer agents that tend to cause clinically significant febrile neutropenia." At present, although Telpegfilgrastim has been approved for neutropenia induced by chemotherapy for non-myeloid malignant tumors, the safety and efficacy data in pediatric patients are lacking, and the pharmacokinetic characteristics in children are still unclear. The aim of this study was to evaluate the safety and efficacy of Telpegfilgrastim in the prevention of neutropenia in pediatric cancer patients receiving chemotherapy, and to investigate the pharmacokinetics of Telpegfilgrastim in pediatric cancer patients.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Yizhuo Zhang
- Phone Number: 020-87342460
- Email: zhangyzh@sysucc.org.cn
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Recruiting
- SunYat-senU
-
Contact:
- Yizhuo Zhang
- Phone Number: 020-87342460
- Email: zhangyzh@sysucc.org.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
Use Telpegfilgrastim to prevent chemotherapy-induced neutropenia
|
Experimental group: Patients were subcutaneously injected with Telpegfilgrastim 33μg/kg (maximum dose ≤2mg) 24h after chemotherapy, 21 days for one chemotherapy cycle, and only one chemotherapy cycle was observed. Pharmacokinetic determination: Among them, 8 patients underwent pharmacokinetic determination. The pharmacokinetic sampling time points were blood samples taken before administration, 12 h, 24 h, 48 h, 120h, 168 h, 336 h, 480h after administration. A total of 8 blood samples were collected, and the pharmacokinetic characteristics of the experimental drugs were analyzed by ELISA. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
overall incidence of adverse reactions
Time Frame: 1 year
|
The overall incidence of adverse reactions after prophylactic drug use during this period
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of grade 3-4 neutropenia
Time Frame: 3 weeks
|
Incidence of grade 3-4 neutropenia during this period after prophylactic administration
|
3 weeks
|
|
Incidence of febrile neutropenia (FN)
Time Frame: 3 weeks
|
Incidence of febrile neutropenia (FN) in this period after prophylaxis
|
3 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Telpegfilgrastim
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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