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

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

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.

Study Overview

• Status: Unknown
• Conditions: Lymphoma; Leukemia
• Intervention / Treatment: Drug: PEG-rhG-CSF group; Drug: rhG-CSF group

• Study Type: Interventional
• Enrollment (Anticipated): 139
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 14 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Active Comparator: 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.	Drug: rhG-CSF group; Patients received 5μg/kg/d of rhG-CSF, on the basis of actual body weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
• Collaborators: Children's Hospital of Fudan University
• Investigators: Principal Investigator: Xiaowen Zhai, Doctor, Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: August 2, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: August 2, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: CSPC-JYL-CHIL-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No