Clinical trial · Interventional
Pegteograstim in Children With Solid Tumors
Efficacy and Safety of Pegteograstim on Chemotherapy-induced Neutropenia in Children With Solid Tumors
NCT02787876CI-TRIAL-00034934unknownPhase 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)
To evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Induced Neutropenia | — | UNRESOLVED | — |
| Pediatric Solid Tumor | Childhood Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pegteograstim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemotherapy induced neutropenia
- description
- Pegteograstim 100 ug/kg (maximum 6 mg) on day 7 of the chemotherapy cycle
- interventionNames
- Drug: Pegteograstim
Primary outcomes (2)
- measure
- Rate of adverse events
- timeFrame
- Up to 3 weeks after the injection of pegteograsim
- measure
- Duration of neutropenia (absolute neutrophil count (ANC) < 500/uL)
- timeFrame
- Up to 6 weeks
Secondary outcomes (3)
- measure
- Duration of severe neutropenia (ANC < 100/uL)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with solid tumor who undergo chemotherapy with carboplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen Exclusion Criteria: * Patients with organ dysfunction (creatinine \> 2mg/dL, ejection fraction \<40% or severe arrhythmia/conduction disorder, other severe organ dysfunction) * Hypersensitivity to pegteograstim, protein originated from E-coli, pegfilgrastim, filgrastim or latex. * Patients with bleeding tendency to whom subcutaneous injection should be avoided. * Active infection or infectious fever during the screening period. * Genetic problem to fructose tolerance. * Patients who participated in other clinical trial within 4 weeks before enrollment. * Pregnant and nursing women
References
Publications (1)
- DERIVEDCho HW, Lee JW, Ju HY, Hyun JK, Yoo KH, Koo HH, Kim K, Sung KW. Safety and Efficacy of Pegteograstim on Chemotherapy-induced Neutropenia in Children and Adolescents With Solid Tumors. J Pediatr Hematol Oncol. 2022 Mar 1;44(2):e362-e367. doi: 10.1097/MPH.0000000000002206. PMID 34010932