Safety and Efficacy of PEG-rhG-CSF in Preventing Neutropenia in Children With Tumor After Chemotherapy
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PEG-rhG-CSF pegylated recombinant human granulocyte-colony stimulating factor subcutaneous injection |
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.
|
Outcome Measures
Primary Outcome Measures
- safety of PEG-rhG-CSF in the prevention of neutropenia in children with tumor after chemotherapy [From the beginning of observation to the end of observation（6 weeks) of the last enrolled patient]
The incidence and severity of adverse events;
Secondary Outcome Measures
- To evaluate the effectiveness of PEG-rhG-CSF in preventing neutropenia in children with tumor after chemotherapy. [From the beginning of observation to the end of observation（6 weeks) of the last enrolled patient]
The incidence of grade III / IV ANC reduction in each chemotherapy cycle
Eligibility Criteria
Criteria
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;
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Severe visceral dysfunction;
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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;
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Those who took the same kind of other tested drugs or accepted clinical trials of other drugs within 4 weeks before enrollment;
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Allergic to peg-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
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Serious mental illness, affecting informed consent and / or expression or observation of adverse reactions;
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The researcher judged the patients who were not suitable to participate.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-sen University Cancer Center, | Guangzhou | Guangdong | China | 510060 |
Sponsors and Collaborators
- Sun Yat-sen University
Investigators
- Principal Investigator: Yizhuo Zhang, Sun Yat-sen University CancerCenter
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PEG-rhG-CSF