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

Phase 2

• Conditions: Pediatric Cancer
• Interventions: Drug: pegylated recombinant human granulocyte-colony stimulating factor

• Registration Number: NCT04547829
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study First Submitted: 2020-09-11
• Study First Submitted QC: 2020-09-11
• Study First Posted: 2020-09-14
• Study Start: 2020-10-10
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-27
• Last Update Posted: 2021-09-02
• Primary Completion: 2022-10-10
• Study Completion: 2023-05-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEG-rhG-CSF	pegylated recombinant human granulocyte-colony stimulating factor	pegylated recombinant human granulocyte-colony stimulating factor subcutaneous injection

Primary Outcome Measures

Name	Time	Method
safety of PEG-rhG-CSF in the prevention of neutropenia in children with tumor after chemotherapy	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

Name	Time	Method
To evaluate the effectiveness of PEG-rhG-CSF in preventing neutropenia in children with tumor after chemotherapy.	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

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center,; 🇨🇳 Guangzhou, Guangdong, China