NCT04497701

Evaluate the Efficacy and Safety of the Prophylactic Use of PEG-rhG-CSF in Children With Hematological Malignancies

A Multi-center, Open-label, Randomized Controlled Study to Evaluate the Efficacy and Safety of the Prophylactic Use of Pegylated Recombinant Human Granulocyte Colony Stimulating Factor After Chemotherapy in Children With Hematological Malignancies

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 139 (estimated)
• Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Lymphoma
• Leukemia

Interventions

Type	Name	Description
DRUG	PEG-rhG-CSF group	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.
DRUG	rhG-CSF group	Patients received 5μg/kg/d of rhG-CSF, on the basis of actual body weight.

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-08-01
• Completion: 2021-12-01
• First posted: 2020-08-04
• Last updated: 2020-08-04

Locations

1 site across 1 country: China