Last updated: August 27, 2021
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting
Phase
2
Condition
Neutropenia
Neuroblastoma
Retinoblastoma
Treatment
N/AClinical Study ID
NCT04547829
PEG-rhG-CSF
Ages 6-18 All Genders
Study Summary
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:
- 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 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;
- Those who took the same kind of other tested drugs or accepted clinical trials ofother drugs within 4 weeks before enrollment;
- Allergic to peg-rhG-CSF, rhG-CSF and other preparations or proteins expressed byEscherichia coli;
- Serious mental illness, affecting informed consent and / or expression orobservation of adverse reactions;
- 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
Connect with a study center
Sun Yat-sen University Cancer Center,
Guangzhou, Guangdong 510060
ChinaActive - Recruiting

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