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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Pediatric Cancer

Intervention / Treatment
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* Drug: pegylated recombinant human granulocyte-colony stimulating factor


Participation Criteria
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Eligibility Criteria
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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: Local or systemic infection without adequate control; Severe visceral dysfunction; 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; Those who took the same kind of other tested drugs or accepted clinical trials of other drugs within 4 weeks before enrollment; Allergic to peg-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli; Serious mental illness, affecting informed consent and / or expression or observation of adverse reactions; The researcher judged the patients who were not suitable to participate.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG-rhG-CSF<br>pegylated recombinant human granulocyte-colony stimulating factor subcutaneous injection | Drug: pegylated recombinant human granulocyte-colony stimulating factor<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |