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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.

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.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038246
Enrollment
Unknown
Registered
2020-09-15
Start date
2020-10-10
Completion date
Unknown
Last updated
2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric tumors

Interventions

Trial group:PEG-rhG-CSF

Sponsors

Sun Yat-Sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. The patients with 6-18 years old had no gender limitation; 2. Tumor patients diagnosed by histopathology or bone marrow cytology; 3. The patients were evaluated by scccg regimen; 4. Patients with ECoG score = 1.5 x 10^9 / L, PLT >= 80 x 10^9 / L, Hb >= 75 g / L, WBC >= 3.0 x 10^9 / L); 7. Patients receiving high-intensity chemotherapy, such as scccg lymphoma regimen, CAV / ie, VIP regimen, etc., are expected to have grade III bone marrow suppression after chemotherapy. 8. The legal guardian of the subjects must sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with local or systemic infection without adequate control; 2. Patients with severe visceral dysfunction; 3. Liver function test: total bilirubin (TBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST) were more 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. Patients who took the same kind of other tested drugs or accepted other clinical trials within 4 weeks before enrollment; 5. Patients who are allergic to peg rhG CSF, rhG CSF and other preparations or proteins expressed by Escherichia coli; 6. Patients with severe mental illness, which affect informed consent and / or adverse reaction expression or observation; 7. The researcher judged the patients who were not suitable to participate.

Design outcomes

Primary

MeasureTime frame
To evaluate the safety of PEG-rhG-CSF in the prevention of neutropenia in children with tumor after chemotherapy.;To evaluate the effectiveness of PEG-rhG-CSF in preventing neutropenia in children with tumor after chemotherapy.;

Countries

China

Contacts

Public ContactYizhuo Zhang

Sun Yat-Sen University Cancer Center

zhangyzh@sysucc.org.cn+86 20-87342459

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026