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

NCT ID: NCT04497701

Last Updated: 2020-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2021-12-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PEG-rhG-CSF group

Patients received subcutaneous injection of PEG-rhG-CSF(Jinyouli®)24\~72 hours after the end of chemotherapy, 100µg/kg, once in each chemotherapy cycle.

Group Type: EXPERIMENTAL

PEG-rhG-CSF group

Intervention Type: 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.

rhG-CSF group

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.

Group Type: ACTIVE_COMPARATOR

rhG-CSF group

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

rhG-CSF group

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Fudan University

OTHER

Sponsor Role: collaborator

CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaowen Zhai, Doctor

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University

Locations

Children's Hospital of Fudan University

Shanghai, , China

Countries

China

Central Contacts

Xiaowen Zhai, Doctor

Role: CONTACT

zhaixiaowendy@163.com

86-18017590808

Facility Contacts

Xiaowen Zhai, Doctor

Role: primary

zhaixiaowendy@163.com

86-18017590808

Other Identifiers

CSPC-JYL-CHIL-01

Identifier Type: -

Identifier Source: org_study_id