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

NCT04497701 | Unknown

• 1 other identifier: CSPC-JYL-CHIL-01
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Duration of febrile neutropenia

  From date of randomization until the date of the study completion, up to 24 weeks.

• 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.

• Recovery time of grade IV neutropenia

  From date of randomization until the date of the study completion, up to 24 weeks.

• Dynamic curve of absolute neutrophil count (ANC)

  From date of randomization until the date of the study completion, up to 24 weeks.

• Hospital stay

  From date of randomization until the date of the study completion, up to 24 weeks.

Study Arms (2)

PEG-rhG-CSF group

EXPERIMENTAL

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

Drug: PEG-rhG-CSF group

rhG-CSF group

ACTIVE COMPARATOR

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.

Drug: rhG-CSF group

Interventions

PEG-rhG-CSF group 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.

PEG-rhG-CSF group

rhG-CSF group DRUG

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

rhG-CSF group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Under the age of 18, no gender limit;
• Children with hematological malignancies, leukemia or lymphoma, diagnosed by bone marrow pathology or cytology;
• 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;
• The effect of chemotherapy in leukemia patients was complete remission, while that in lymphoma patients was complete remission or partial remission;
• The expected survival time is more than 8 months;
• 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;
• Eastern Cooperative Oncology Group(ECOG) performance status(PS) \<2;
• The subjects had good mental consciousness, and the subject's legal guardian must sign an informed consent form;
• Researchers believe that the subject can benefit;

You may not qualify if:

• Severe internal organ dysfunction;
• Those who used other test drugs of the same kind or accepted other clinical trials within 4 weeks before enrollment;
• Allergy to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
• Researchers determine unsuited to participate in this trial.

Sponsors & Collaborators

• CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.: lead
• Children's Hospital of Fudan University: collaborator

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Lymphoma; Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases

Study Officials

• Xiaowen Zhai, Doctor

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaowen Zhai, Doctor

CONTACT

86-18017590808; zhaixiaowendy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: August 4, 2020
• Study Start: August 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 4, 2020

Record last verified: 2020-07

Locations

CN (1)