Clinical trial NCT04497701: Evaluate the Efficacy and Safety of the Prophylactic Use of PEG-rhG-CSF in Children With Hematological Malignancies
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphoma
Leukemia
Lead sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Children's Hospital of Fudan University
First posted: 2020-08-04
Enrollment: 139
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Incidence of febrile neutropenia (FN)
timeFrame: From date of randomization until the date of the study completion, up to 24 weeks.
Secondary outcomes:
measure: Duration of febrile neutropenia
timeFrame: From date of randomization until the date of the study completion, up to 24 weeks.
measure: Incidence and duration of grade IV neutropenia (ANC<0.5×10^9/L)
timeFrame: From date of randomization until the date of the study completion, up to 24 weeks.
measure: Recovery time of grade IV neutropenia
timeFrame: From date of randomization until the date of the study completion, up to 24 weeks.
measure: Dynamic curve of absolute neutrophil count (ANC)
timeFrame: From date of randomization until the date of the study completion, up to 24 weeks.
measure: Hospital stay
timeFrame: From date of randomization until the date of the study completion, up to 24 weeks.
measure: Incidence of infection
timeFrame: From date of randomization until the date of the study completion, up to 24 weeks.
measure: Dose adjustment of chemotherapy or delay of chemotherapy
timeFrame: From date of randomization until the date of the study completion, up to 24 weeks.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
Study officials:
affiliation: Children's Hospital of Fudan University
name: Xiaowen Zhai, Doctor
role: PRINCIPAL_INVESTIGATOR
References: