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

Not Applicable

• Conditions: Lymphoma; Leukemia
• Interventions: Drug: PEG-rhG-CSF group; Drug: rhG-CSF group

• Registration Number: NCT04497701
• Lead Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-27
• Study Start: 2020-08-01
• Study First Submitted QC: 2020-08-02
• Last Update Submitted: 2020-08-02
• Study First Posted: 2020-08-04
• Last Update Posted: 2020-08-04
• Primary Completion: 2021-08-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 139

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEG-rhG-CSF group	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.
rhG-CSF group	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.

Primary Outcome Measures

Name	Time	Method
Incidence of febrile neutropenia (FN)	From date of randomization until the date of the study completion, up to 24 weeks.	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.

Secondary Outcome Measures

Name	Time	Method
Duration of febrile neutropenia	From date of randomization until the date of the study completion, up to 24 weeks.	Defined as days when the FN occurs to the time when FN disappears.
Dynamic curve of absolute neutrophil count (ANC)	From date of randomization until the date of the study completion, up to 24 weeks.	Dynamic changes of ANC after chemotherapy
Incidence of infection	From date of randomization until the date of the study completion, up to 24 weeks.	Incidence of various infections
Dose adjustment of chemotherapy or delay of chemotherapy	From date of randomization until the date of the study completion, up to 24 weeks.	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.
Incidence and duration of grade IV neutropenia (ANC<0.5×10^9/L)	From date of randomization until the date of the study completion, up to 24 weeks.	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
Recovery time of grade IV neutropenia	From date of randomization until the date of the study completion, up to 24 weeks.	Time from the first day of chemotherapy to ANC≥0.5×10\^9/L
Hospital stay	From date of randomization until the date of the study completion, up to 24 weeks.	Number of days the patient was hospitalized

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, China