Clinical trial · Interventional
Starting Granulocyte Colony-Stimulating Factor at 1 Day vs 3 Days Following Chemotherapy in Pediatric Cancer Patients
A Pilot Study of Granulocyte Colony-Stimulating Factor Starting at 24 Hours vs 72 Hours in Pediatric Oncology Patients
- 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)
Chemotherapy places patients at an increased risk of infection. A medication called granulocyte colony-stimulating factor is given as a daily injection in order to help decrease the risk of infection. The purpose of this study is to determine the best time to begin granulocyte colony-stimulating factor while maintaining the same clinical benefits. The current study aims to fill these research gaps and address the general question: Can G-CSF safely be given 72 hours following the last day of chemotherapy without increasing the incidence of febrile neutropenia, the duration of neutropenia, or causing increased delays in the next course of chemotherapy.
Conditions
Conditions (4)
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 Febrile Neutropenia | — | UNRESOLVED | — |
| Chemotherapy-induced Neutropenia | — | UNRESOLVED | — |
| Granulocyte Colony-Stimulating Factor | — | UNRESOLVED | — |
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Granulocyte Colony-Stimulating Factor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Receive G-CSF 72 hours following chemotherapy
- description
- Children will be enrolled during the first four rounds of chemotherapy. Upon enrollment, children will receive G-CSF at 24 hours following chemotherapy. G-CSF will be discontinued when absolute neutrophil count (ANC) has increased post nadir in accord with G-CSF administration guidelines. Parents and children will then complete questionnaires to determine rates of side effects and needle distress at the end of G-CSF during their next regular outpatient oncology clinic visit. Following children's next course of chemotherapy, G-CSF will be started 72 hours after completion of chemotherapy.
- interventionNames
- Drug: Granulocyte Colony-Stimulating Factor
- type
- NO_INTERVENTION
- label
- Historical Controls
- description
- Four matched historical controls who received G-CSF at 24 hours following chemotherapy for each patient enrolled will be selected as each enrolled patient completes G-CSF therapy.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Pediatric oncology patients will be eligible to participate in this study if they meet the following inclusion criteria: 1. are between the ages of birth and 21 years old 2. is diagnosed with an oncologic disease 3. is being treated at UMMC Children's Cancer Clinic 4. will receive G-CSF as part of their standard or experimental oncology treatment protocol between January 1, 2019 and December 31, 2019. Oncology treatment protocols are typically derived from the Children's Oncology Group standard of care or patients can be enrolled on a Children's Oncology Group treatment study. 5. is within first four courses of chemotherapy treatment Exclusion Criteria: * Patients will be excluded from the current study if: 1. G-CSF was added to their oncology treatment protocol due to previous complications but for whom G-CSF was not part of their original treatment protocol. 2. are being treated for relapsed disease 3. has clinical evidence of bone marrow involvement
References
Publications (0)
Data not yet available