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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04497701
• Other study ID #: CSPC-JYL-CHIL-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: July 2020
• Source: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
• Contact: Xiaowen Zhai, Doctor
• Phone: 86-18017590808
• Email: zhaixiaowendy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 139
• Est. completion date: December 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

1. Under the age of 18, no gender limit;

2. Children with hematological malignancies, leukemia or lymphoma, diagnosed by bone marrow pathology or cytology;

3. The prophylactic use of PEG-rhG-CSF or rhG-CSF after chemotherapy is intended to prevent neutropenia, and the chemotherapy regimen must meet the interval between two chemotherapy sessions at least 12 days;

4. The effect of chemotherapy in leukemia patients was complete remission, while that in lymphoma patients was complete remission or partial remission;

5. The expected survival time is more than 8 months;

6. Liver and kidney function: Liver function: total bilirubin (TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 times the upper limit of normal value, or=5 times the upper limit of normal value when there is liver metastasis; renal function test: serum creatinine (Cr) = 1.5 times the upper limit of normal value;

7. Eastern Cooperative Oncology Group(ECOG) performance status(PS) <2;

8. The subjects had good mental consciousness, and the subject's legal guardian must sign an informed consent form;

9. Researchers believe that the subject can benefit;

Exclusion Criteria:

1. Severe internal organ dysfunction;

2. Those who used other test drugs of the same kind or accepted other clinical trials within 4 weeks before enrollment;

3. Allergy to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;

4. Researchers determine unsuited to participate in this trial.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Leukemia
• Lymphoma

Intervention

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.
• rhG-CSF group
Patients received 5µg/kg/d of rhG-CSF, on the basis of actual body weight.

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.	Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.
Secondary	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	From date of randomization until the date of the study completion, up to 24 weeks.
Secondary	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.
Secondary	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.
Secondary	Hospital stay	Number of days the patient was hospitalized	From date of randomization until the date of the study completion, up to 24 weeks.
Secondary	Incidence of infection	Incidence of various infections	From date of randomization until the date of the study completion, up to 24 weeks.
Secondary	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.