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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04547829
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : September 2, 2021
Sponsor:
Information provided by (Responsible Party):
Yizhuo Zhang, Sun Yat-sen University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pediatric Cancer Drug: pegylated recombinant human granulocyte-colony stimulating factor Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : October 10, 2020
Estimated Primary Completion Date : October 10, 2022
Estimated Study Completion Date : May 10, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: PEG-rhG-CSF
pegylated recombinant human granulocyte-colony stimulating factor subcutaneous injection
 Drug: pegylated recombinant human granulocyte-colony stimulating factor
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.


Outcome Measures
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Primary Outcome Measures :
  1. safety of PEG-rhG-CSF in the prevention of neutropenia in children with tumor after chemotherapy [ Time Frame: From the beginning of observation to the end of observation（6 weeks) of the last enrolled patient ]
    The incidence and severity of adverse events;


Secondary Outcome Measures :
  1. To evaluate the effectiveness of PEG-rhG-CSF in preventing neutropenia in children with tumor after chemotherapy. [ Time Frame: From the beginning of observation to the end of observation（6 weeks) of the last enrolled patient ]
    The incidence of grade III / IV ANC reduction in each chemotherapy cycle


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04547829


Contacts
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Contact: Yizhuo Zhang 020-87342459 zhangyzh@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center, Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Junting Huang, Dr    +8613632483966    huangjt@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Yizhuo Zhang Sun Yat-sen University CancerCenter
More Information
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Responsible Party: Yizhuo Zhang, Sun Yat-sen University Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04547829    
Other Study ID Numbers: PEG-rhG-CSF
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: September 2, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
 Sargramostim
Lenograstim
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic