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| Name | Class |
|---|---|
| Children's Hospital of Fudan University | OTHER |
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The incidence of infectious complications in hematological malignancies is higher than that in children with solid tumors, which may be related to the type and dose intensity of chemotherapy regimens used in hematological tumors. The treatment of childhood cancer has changed in the past few decades: intensive treatment and good supportive treatment can improve the 5-year survival rate of children. The aim of this study was to evaluate the efficacy and safety of prophylactic use of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) after chemotherapy in children with hematological malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-rhG-CSF group | Experimental | Patients received subcutaneous injection of PEG-rhG-CSF(Jinyouli®)24~72 hours after the end of chemotherapy, 100µg/kg, once in each chemotherapy cycle. |
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| rhG-CSF group | Active Comparator | Patients received subcutaneous injection of rhG-CSF 24~72 hours after the end of chemotherapy, 100µg/kg/d, and stop using it until the ANC value exceeds the lowest value for 2 consecutive days> 0.5×10^9/L. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-rhG-CSF group | Drug | Patients received a single dose of 100 ug/kg of PEG-rhG-CSF（Jinyouli®）, on the basis of actual body weight. Peg-rhG-CSF can be used prophylactically only when the interval between two chemotherapy regimens is no less than 12 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of febrile neutropenia (FN) | ANC<0.5×10^9/L or ANC (0.5-0.9)×10^9/L, and predicted to drop to ≤0.5×10^9/L in the next 48 hours, and the oral cavity temperature is ≥38.3℃ or ≥38.0℃ for more than 1 hour. | From date of randomization until the date of the study completion, up to 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of febrile neutropenia | Defined as days when the FN occurs to the time when FN disappears. | From date of randomization until the date of the study completion, up to 24 weeks. |
| Incidence and duration of grade IV neutropenia (ANC<0.5×10^9/L) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaowen Zhai, Doctor | Contact | 86-18017590808 | zhaixiaowendy@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaowen Zhai, Doctor | Children's Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Fudan University | Shanghai | China |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| rhG-CSF group | Drug | Patients received 5μg/kg/d of rhG-CSF, on the basis of actual body weight. |
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Grade IV neutropenia is defined as the absolute neutrophil count(ANC)<0.5×10^9/L; Duration of grade IV neutropenia is defined as days when the ANC<0.5×10^9/L occurs to the time when the ANC≥0.5×10^9/L
| From date of randomization until the date of the study completion, up to 24 weeks. |
| Recovery time of grade IV neutropenia | Time from the first day of chemotherapy to ANC≥0.5×10^9/L | From date of randomization until the date of the study completion, up to 24 weeks. |
| Dynamic curve of absolute neutrophil count (ANC) | Dynamic changes of ANC after chemotherapy | From date of randomization until the date of the study completion, up to 24 weeks. |
| Hospital stay | Number of days the patient was hospitalized | From date of randomization until the date of the study completion, up to 24 weeks. |
| Incidence of infection | Incidence of various infections | From date of randomization until the date of the study completion, up to 24 weeks. |
| Dose adjustment of chemotherapy or delay of chemotherapy | Dose adjustment of chemotherapy is defined as incidence of the reduction of planned dose of chemotherapy；Chemotherapy delay is defined as the delay in starting the next planned chemotherapy for more than 3 days. | From date of randomization until the date of the study completion, up to 24 weeks. |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006402 | Hematologic Diseases |