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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
139
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.
Patients received 5μg/kg/d of rhG-CSF, on the basis of actual body weight.
Children's Hospital of Fudan University
Shanghai, China
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.
Time frame: From date of randomization until the date of the study completion, up to 24 weeks.
Duration of febrile neutropenia
Defined as days when the FN occurs to the time when FN disappears.
Time frame: 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)
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
Time frame: 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
Time frame: 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
Time frame: From date of randomization until the date of the study completion, up to 24 weeks.
Hospital stay
Number of days the patient was hospitalized
Time frame: From date of randomization until the date of the study completion, up to 24 weeks.
Incidence of infection
Incidence of various infections
Time frame: 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.
Time frame: From date of randomization until the date of the study completion, up to 24 weeks.
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