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

CSPC Pharmaceutical Group

Status: Unknown

Conditions: Lymphoma; Leukemia

Treatments: Drug: PEG-rhG-CSF group; Drug: rhG-CSF group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04497701

CSPC-JYL-CHIL-01

Details and patient eligibility

About

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.

Enrollment: 139 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

139 participants in 2 patient groups

PEG-rhG-CSF group

Experimental group

Description:

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

Treatment:

Drug: PEG-rhG-CSF group

rhG-CSF group

Active Comparator group

Description:

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.

Treatment:

Drug: rhG-CSF group