Clinical trial · Interventional
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.
NCT04547829CI-TRIAL-00053641unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pegylated recombinant human granulocyte-colony stimulating factor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PEG-rhG-CSF
- description
- pegylated recombinant human granulocyte-colony stimulating factor subcutaneous injection
- interventionNames
- Drug: pegylated recombinant human granulocyte-colony stimulating factor
Primary outcomes (1)
- measure
- safety of PEG-rhG-CSF in the prevention of neutropenia in children with tumor after chemotherapy
- timeFrame
- From the beginning of observation to the end of observation(6 weeks) of the last enrolled patient
- description
- The incidence and severity of adverse events;
Secondary outcomes (1)
- measure
- To evaluate the effectiveness of PEG-rhG-CSF in preventing neutropenia in children with tumor after chemotherapy.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDHuang J, Lu S, Wang J, Jiang L, Luo X, He X, Wu Y, Wang Y, Zhu X, Chen J, Tang Y, Chen K, Tian X, Shi B, Guo L, Zhu J, Sun F, Zhen Z, Zhang Y. A multicenter phase II trial of primary prophylactic PEG-rhG-CSF in pediatric patients with solid tumors and non-Hodgkin lymphoma after chemotherapy: An interim analysis. Cancer Med. 2023 Jul;12(13):14130-14137. doi: 10.1002/cam4.6079. Epub 2023 May 15. PMID 37183837