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Safety and Efficacy of PEG-rhG-CSF in Preventing Neutropenia in Children With Tumor After Chemotherapy

Primary Purpose

Pediatric Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
pegylated recombinant human granulocyte-colony stimulating factor
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Cancer

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- 1)6 years < age < 18 years old, regardless of gender; 2)Tumor patients diagnosed by histopathology or bone marrow cytology; 3)Patients who have not been treated for the first time; 4)ECoG score ≤ 2; 5)The expected survival time is more than 8 months; 6)The hematopoietic function of bone marrow was normal (ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L, Hb ≥ 75 g / L, WBC ≥ 3.0 × 109 / L); 7)Receive high-intensity chemotherapy, such as scccg lymphoma, CAV / ie, VIP regimen, etc., and expect bone marrow suppression of grade III or above after chemotherapy.

8)Patient's parent or guardian signs informed consent.

Exclusion Criteria:

  • Patients with any of the following items will not be enrolled in this study:

    1. Local or systemic infection without adequate control;
    2. Severe visceral dysfunction;
    3. Liver function test: total bilirubin (TBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST) were all higher than 2.5 times of the upper limit of normal value; if due to liver metastasis, the above indicators were more than 5 times of the upper limit of normal value; renal function test: Serum creatinine (CR) > 2 times of the upper limit of normal value;
    4. Those who took the same kind of other tested drugs or accepted clinical trials of other drugs within 4 weeks before enrollment;
    5. Allergic to peg-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
    6. Serious mental illness, affecting informed consent and / or expression or observation of adverse reactions;
    7. The researcher judged the patients who were not suitable to participate.

Sites / Locations

  • Sun Yat-sen University Cancer Center,Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PEG-rhG-CSF

Arm Description

pegylated recombinant human granulocyte-colony stimulating factor subcutaneous injection

Outcomes

Primary Outcome Measures

safety of PEG-rhG-CSF in the prevention of neutropenia in children with tumor after chemotherapy
The incidence and severity of adverse events;

Secondary Outcome Measures

To evaluate the effectiveness of PEG-rhG-CSF in preventing neutropenia in children with tumor after chemotherapy.
The incidence of grade III / IV ANC reduction in each chemotherapy cycle

Full Information

First Posted
September 11, 2020
Last Updated
August 27, 2021
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04547829
Brief Title
Safety and Efficacy of PEG-rhG-CSF in Preventing Neutropenia in Children With Tumor After Chemotherapy
Official Title
Safety and Efficacy of Pegylated Recombinant Human Granulocyte-colony Stimulating Factor(PEG-rhG-CSF) in Preventing Neutropenia in Children With Tumor After Chemotherapy:A Multi-center, Single Arm Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2020 (Actual)
Primary Completion Date
October 10, 2022 (Anticipated)
Study Completion Date
May 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen 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 purpose is to evaluate the safety of PEG-rhG-CSF in the prevention of neutropenia in children with tumor after chemotherapy, and then evaluate the effectiveness of PEG-rhG-CSF in preventing neutropenia in children with tumor after chemotherapy.
Detailed Description
The dosage was determined according to the patient's weight, 100 UG / kg each time; The method of administration: subcutaneous injection; The time of administration: 24-48 hours after the end of chemotherapy, once in each chemotherapy cycle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PEG-rhG-CSF
Arm Type
Experimental
Arm Description
pegylated recombinant human granulocyte-colony stimulating factor subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
pegylated recombinant human granulocyte-colony stimulating factor
Intervention Description
The dosage was determined according to the patient's weight, 100 UG / kg each time; The method of administration: subcutaneous injection; The time of administration: 24-48 hours after the end of chemotherapy, once in each chemotherapy cycle.
Primary Outcome Measure Information:
Title
safety of PEG-rhG-CSF in the prevention of neutropenia in children with tumor after chemotherapy
Description
The incidence and severity of adverse events;
Time Frame
From the beginning of observation to the end of observation(6 weeks) of the last enrolled patient
Secondary Outcome Measure Information:
Title
To evaluate the effectiveness of PEG-rhG-CSF in preventing neutropenia in children with tumor after chemotherapy.
Description
The incidence of grade III / IV ANC reduction in each chemotherapy cycle
Time Frame
From the beginning of observation to the end of observation(6 weeks) of the last enrolled patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - 1)6 years < age < 18 years old, regardless of gender; 2)Tumor patients diagnosed by histopathology or bone marrow cytology; 3)Patients who have not been treated for the first time; 4)ECoG score ≤ 2; 5)The expected survival time is more than 8 months; 6)The hematopoietic function of bone marrow was normal (ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L, Hb ≥ 75 g / L, WBC ≥ 3.0 × 109 / L); 7)Receive high-intensity chemotherapy, such as scccg lymphoma, CAV / ie, VIP regimen, etc., and expect bone marrow suppression of grade III or above after chemotherapy. 8)Patient's parent or guardian signs informed consent. Exclusion Criteria: Patients with any of the following items will not be enrolled in this study: Local or systemic infection without adequate control; Severe visceral dysfunction; Liver function test: total bilirubin (TBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST) were all higher than 2.5 times of the upper limit of normal value; if due to liver metastasis, the above indicators were more than 5 times of the upper limit of normal value; renal function test: Serum creatinine (CR) > 2 times of the upper limit of normal value; Those who took the same kind of other tested drugs or accepted clinical trials of other drugs within 4 weeks before enrollment; Allergic to peg-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli; Serious mental illness, affecting informed consent and / or expression or observation of adverse reactions; The researcher judged the patients who were not suitable to participate.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yizhuo Zhang
Phone
020-87342459
Email
zhangyzh@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yizhuo Zhang
Organizational Affiliation
Sun Yat-sen University CancerCenter
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center,
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junting Huang, Dr
Phone
+8613632483966
Email
huangjt@sysucc.org.cn

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of PEG-rhG-CSF in Preventing Neutropenia in Children With Tumor After Chemotherapy

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