Chemotherapy-Induced NeutropeniaPhase 2TelpegfilgrastNCT06857292
Clinical Study on the Safety, Efficacy and Pharmacokinetics of Telpegfilgrastim in Pediatric Cancer Patients with Chemotherapy
A Phase 2 study testing Telpegfilgrastim in people with Chemotherapy-Induced Neutropenia, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study is a multicenter, single-arm, prospective study. The study population includes children with cancer who require high-intensity chemotherapy. The study aims to evaluate the safety and effectiveness of Telpegfilgrastim in preventing neutropenia in children with cancer (neuroblastoma, sarcoma, lymphoma, etc.)… Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Chemotherapy-Induced Neutropenia
- What is being tested?
- Telpegfilgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
SunYat-senU
Guangzhou, Guangdong, 510060
Yizhuo Zhang, 020-87342460, zhangyzh@sysucc.org.cn
About this study
Official title: Clinical Study on the Safety, Efficacy and Pharmacokinetics of Telpegfilgrastim Injection in Pediatric Cancer Patients with Chemotherapy
This study is a multicenter, single-arm, prospective study. The study population includes children with cancer who require high-intensity chemotherapy. The study aims to evaluate the safety and effectiveness of Telpegfilgrastim in preventing neutropenia in children with cancer (neuroblastoma, sarcoma, lymphoma, etc.) undergoing chemotherapy, while also studying the pharmacokinetic characteristics of Telpegfilgrastim in children with cancer.
Read the 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.
- Conditions
- Chemotherapy-Induced Neutropenia
- Being tested
- Telpegfilgrastim
- Keywords
- Telpegfilgrastim, pediatric cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelpegfilgrastimDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Use Telpegfilgrastim to prevent chemotherapy-induced neutropenia Receives: Drug: Telpegfilgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall incidence of adverse reactions
The overall incidence of adverse reactions after prophylactic drug use during this period
Measured: 1 year
Secondary outcomes (2)
Incidence of grade 3-4 neutropenia
Incidence of grade 3-4 neutropenia during this period after prophylactic administration
Measured: 3 weeks
Incidence of febrile neutropenia (FN)
Incidence of febrile neutropenia (FN) in this period after prophylaxis
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start1 Dec 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced NeutropeniaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yizhuo Zhang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857292
- Sponsor's protocol ID
- Telpegfilgrastim
- Acronym
- Telpegfilgrast
- Status last verified
- Feb 2025
- First submitted
- 2 Dec 2024
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety, Efficacy and Pharmacokinetics of Telpegfilgrastim Injection in Pediatric Cancer Patients with Chemotherapy
- ClinicalTrials.gov ID
- NCT06857292
- Acronym / sponsor ID
- Telpegfilgrast / Telpegfilgrastim
- Conditions
- Chemotherapy-Induced Neutropenia
- Keywords
- Telpegfilgrastim, pediatric cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multicenter, single-arm, prospective study. The study population includes children with cancer who require high-intensity chemotherapy. The study aims to evaluate the safety and effectiveness of Telpegfilgrastim in preventing neutropenia in children with cancer (neuroblastoma, sarcoma, lymphoma, etc.) undergoing chemotherapy, while also studying the pharmacokinetic characteristics of Telpegfilgrastim in children with cancer.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: TelpegfilgrastimUse Telpegfilgrastim to prevent chemotherapy-induced neutropenia |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Patients with 14≤ age < 18 years;
- 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;
Key exclusion criteria (5 listed)
- Received any rhG-CSF within 3 weeks prior to study participation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelpegfilgrastimExperimental 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. | Drug | Experimental group |
Primary outcome
overall incidence of adverse reactions
Time frame: 1 year
The overall incidence of adverse reactions after prophylactic drug use during this period
2 secondary outcomes
Incidence of grade 3-4 neutropenia
Time frame: 3 weeks
Incidence of febrile neutropenia (FN)
Time frame: 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telpegfilgrastim in people with Chemotherapy-Induced Neutropenia, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yizhuo Zhang (020-87342460, zhangyzh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall incidence of adverse reactions (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.