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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Cancer
• Intervention / Treatment: Drug: pegylated recombinant human granulocyte-colony stimulating factor

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 Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yizhuo Zhang; Phone Number: 020-87342459; Email: zhangyzh@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center,
      • Contact: Junting Huang, Dr; Phone Number: +8613632483966; Email: huangjt@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From the beginning of observation to the end of observation（6 weeks) of the last enrolled patient

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2020
• Primary Completion (Anticipated): October 10, 2022
• Study Completion (Anticipated): May 10, 2023

Study Registration Dates

• First Submitted: September 11, 2020
• First Submitted That Met QC Criteria: September 11, 2020
• First Posted (Actual): September 14, 2020

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: August 27, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neutropenia; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Lenograstim
• Other Study ID Numbers: PEG-rhG-CSF

Drug and device information, study documents

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