Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-rhG-CSF | Experimental | pegylated recombinant human granulocyte-colony stimulating factor subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegylated recombinant human granulocyte-colony stimulating factor | Drug | 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. |
| 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 |
| 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 |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yizhuo Zhang | Contact | 020-87342459 | zhangyzh@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yizhuo Zhang | Sun Yat-sen University CancerCenter | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center, | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37183837 | Derived | Huang J, Lu S, Wang J, Jiang L, Luo X, He X, Wu Y, Wang Y, Zhu X, Chen J, Tang Y, Chen K, Tian X, Shi B, Guo L, Zhu J, Sun F, Zhen Z, Zhang Y. A multicenter phase II trial of primary prophylactic PEG-rhG-CSF in pediatric patients with solid tumors and non-Hodgkin lymphoma after chemotherapy: An interim analysis. Cancer Med. 2023 Jul;12(13):14130-14137. doi: 10.1002/cam4.6079. Epub 2023 May 15. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|