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

Primary Purpose

Lymphoma, Leukemia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PEG-rhG-CSF group
rhG-CSF group
Sponsored by
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lymphoma

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Children's Hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PEG-rhG-CSF group

rhG-CSF group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Duration of febrile neutropenia
Defined as days when the FN occurs to the time when FN disappears.
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
Recovery time of grade IV neutropenia
Time from the first day of chemotherapy to ANC≥0.5×10^9/L
Dynamic curve of absolute neutrophil count (ANC)
Dynamic changes of ANC after chemotherapy
Hospital stay
Number of days the patient was hospitalized
Incidence of infection
Incidence of various infections
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.

Full Information

First Posted
July 27, 2020
Last Updated
August 2, 2020
Sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Collaborators
Children's Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT04497701
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Anticipated)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Collaborators
Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Leukemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
139 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PEG-rhG-CSF group
Arm Type
Experimental
Arm 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.
Arm Title
rhG-CSF group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
PEG-rhG-CSF group
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
rhG-CSF group
Intervention Description
Patients received 5μg/kg/d of rhG-CSF, on the basis of actual body weight.
Primary Outcome Measure Information:
Title
Incidence of febrile neutropenia (FN)
Description
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.
Time Frame
From date of randomization until the date of the study completion, up to 24 weeks.
Secondary Outcome Measure Information:
Title
Duration of febrile neutropenia
Description
Defined as days when the FN occurs to the time when FN disappears.
Time Frame
From date of randomization until the date of the study completion, up to 24 weeks.
Title
Incidence and duration of grade IV neutropenia (ANC<0.5×10^9/L)
Description
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
Time Frame
From date of randomization until the date of the study completion, up to 24 weeks.
Title
Recovery time of grade IV neutropenia
Description
Time from the first day of chemotherapy to ANC≥0.5×10^9/L
Time Frame
From date of randomization until the date of the study completion, up to 24 weeks.
Title
Dynamic curve of absolute neutrophil count (ANC)
Description
Dynamic changes of ANC after chemotherapy
Time Frame
From date of randomization until the date of the study completion, up to 24 weeks.
Title
Hospital stay
Description
Number of days the patient was hospitalized
Time Frame
From date of randomization until the date of the study completion, up to 24 weeks.
Title
Incidence of infection
Description
Incidence of various infections
Time Frame
From date of randomization until the date of the study completion, up to 24 weeks.
Title
Dose adjustment of chemotherapy or delay of chemotherapy
Description
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.
Time Frame
From date of randomization until the date of the study completion, up to 24 weeks.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaowen Zhai, Doctor
Phone
86-18017590808
Email
zhaixiaowendy@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaowen Zhai, Doctor
Organizational Affiliation
Children's Hospital of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Fudan University
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaowen Zhai, Doctor
Phone
86-18017590808
Email
zhaixiaowendy@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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