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

Last updated: August 27, 2021
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

2

Condition

Neutropenia

Neuroblastoma

Retinoblastoma

Treatment

N/A

Clinical Study ID

NCT04547829
PEG-rhG-CSF
  • Ages 6-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 1)6 years < age < 18 years old, regardless of gender; 2)Tumor patients diagnosed byhistopathology or bone marrow cytology; 3)Patients who have not been treated for the firsttime; 4)ECoG score ≤ 2; 5)The expected survival time is more than 8 months; 6)Thehematopoietic 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 scccglymphoma, CAV / ie, VIP regimen, etc., and expect bone marrow suppression of grade III orabove after chemotherapy.

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

Exclusion

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 upperlimit of normal value; if due to liver metastasis, the above indicators were morethan 5 times of the upper limit of normal value; renal function test: Serumcreatinine (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 ofother drugs within 4 weeks before enrollment;
  5. Allergic to peg-rhG-CSF, rhG-CSF and other preparations or proteins expressed byEscherichia coli;
  6. Serious mental illness, affecting informed consent and / or expression orobservation of adverse reactions;
  7. The researcher judged the patients who were not suitable to participate.

Study Design

Total Participants: 108
Study Start date:
October 10, 2020
Estimated Completion Date:
May 10, 2023

Study 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.

Connect with a study center

  • Sun Yat-sen University Cancer Center,

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

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