Safety and Efficacy of PEG-rhG-CSF in Preventing Neutropenia in Children With Tumor After Chemotherapy

Pediatric Cancer Clinical Trial

Official title:

Safety and Efficacy of Pegylated Recombinant Human Granulocyte-colony Stimulating Factor(PEG-rhG-CSF) in Preventing Neutropenia in Children With Tumor After Chemotherapy：A Multi-center, Single Arm Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04547829
• Other study ID #: PEG-rhG-CSF
• Status: Recruiting
• Phase: Phase 2
• Start date: October 10, 2020
• Est. completion date: May 10, 2023

Study information

• Verified date: August 2021
• Source: Sun Yat-sen University
• Contact: Yizhuo Zhang
• Phone: 020-87342459
• Email: zhangyzh[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose is to evaluate the safety of PEG-rhG-CSF in the prevention of neutropenia in children with tumor after chemotherapy, and then evaluate the effectiveness of PEG-rhG-CSF in preventing neutropenia in children with tumor after chemotherapy.

Description:

The dosage was determined according to the patient's weight, 100 UG / kg each time; The method of administration: subcutaneous injection; The time of administration: 24-48 hours after the end of chemotherapy, once in each chemotherapy cycle.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: May 10, 2023
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• 1)6 years < age < 18 years old, regardless of gender; 2)Tumor patients diagnosed by histopathology or bone marrow cytology; 3)Patients who have not been treated for the first time; 4)ECoG score = 2; 5)The expected survival time is more than 8 months; 6)The hematopoietic function of bone marrow was normal (ANC = 1.5 × 109 / L, PLT = 80 × 109 / L, Hb = 75 g / L, WBC = 3.0 × 109 / L); 7)Receive high-intensity chemotherapy, such as scccg lymphoma, CAV / ie, VIP regimen, etc., and expect bone marrow suppression of grade III or above after chemotherapy.

8)Patient's parent or guardian signs informed consent.

Exclusion Criteria:

• Patients with any of the following items will not be enrolled in this study:

1. Local or systemic infection without adequate control;

2. Severe visceral dysfunction;

3. Liver function test: total bilirubin (TBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST) were all higher than 2.5 times of the upper limit of normal value; if due to liver metastasis, the above indicators were more than 5 times of the upper limit of normal value; renal function test: Serum creatinine (CR) > 2 times of the upper limit of normal value;

4. Those who took the same kind of other tested drugs or accepted clinical trials of other drugs within 4 weeks before enrollment;

5. Allergic to peg-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;

6. Serious mental illness, affecting informed consent and / or expression or observation of adverse reactions;

7. The researcher judged the patients who were not suitable to participate.

Related Conditions & MeSH terms

• Neutropenia
• Pediatric Cancer

Intervention

Drug:
• pegylated recombinant human granulocyte-colony stimulating factor
The dosage was determined according to the patient's weight, 100 UG / kg each time; The method of administration: subcutaneous injection; The time of administration: 24-48 hours after the end of chemotherapy, once in each chemotherapy cycle.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center,	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety of PEG-rhG-CSF in the prevention of neutropenia in children with tumor after chemotherapy	The incidence and severity of adverse events;	From the beginning of observation to the end of observation(6 weeks) of the last enrolled patient
Secondary	To evaluate the effectiveness of PEG-rhG-CSF in preventing neutropenia in children with tumor after chemotherapy.	The incidence of grade III / IV ANC reduction in each chemotherapy cycle	From the beginning of observation to the end of observation(6 weeks) of the last enrolled patient