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

NCT04497701 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2020-08-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    collaborator OTHER

  • CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaowen Zhai, Doctor · Children's Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2021-08-01
Completion
2021-12-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04497701 on ClinicalTrials.gov