Pediatric Cancer
Conditions
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.
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.
Interventions
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.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactYizhuo Zhang
Outcome results
None listed