Clinical trial · Interventional
G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor
G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor: a Prospective, Multicentre, Randomised Controlled Trial
NCT02933333CI-TRIAL-00035349unknownPhase 4ClinicalTrials.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 of this study is to explore the effect of G-CSF combination with GM-CSF on prevention and treatment of infection in children with malignant tumor.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoid Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Hepatoblastoma | Hepatoblastoma | ONTOLOGY_EXACT | 0.98 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Retinoblastoma | Retinoblastoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| G-CSF | Biological | — | UNRESOLVED |
| GM-CSF | Biological | — | UNRESOLVED |
| GM-CSF and G-CSF | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- GM-CSF
- description
- Eligible patients received subcutaneous GM-CSF 5 μg/kg per day when the first time of absolute neutrophil count \[ANC\] \<1.5\*10\^9/L after chemotherapy. GM-CSF is given daily for at least 5 days and continued until the ANC reached 1.5\*10\^9/L for two consecutive days.
- interventionNames
- Biological: GM-CSF
- type
- EXPERIMENTAL
- label
- G-CSF
- description
- Eligible patients received subcutaneous G-CSF 5 μg/kg per day when the first time of absolute neutrophil count \[ANC\] \<1.5\*10\^9/L after chemotherapy. G-CSF is given daily for at least 5 days and continued until the ANC reached 1.5\*10\^9/L for two consecutive days.
- interventionNames
- Biological: G-CSF
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with malignant tumor including acute myeloid leukemia (AML) after complete remission, acute lymphocytic leukemia (ALL) after complete remission, stage III or IV lymphoma after partial remission or complete remission, stage III or IV neuroblastoma (NB) or retinoblastoma (RB). * Eastern Cooperative Oncology Group performance status ≤ 2. * Did not receive treatment of CSFs in two weeks. * Without symptomatic infection and with normal values of C-reactive protein or procalcitonin. * The first time of ANC \< 1.5\*10\^9/L after chemotherapy. * More than 24 h after the last chemotherapy. * The function of liver was normal. Exclusion Criteria: * Allergic to GM-CSF or drugs which expressed in Escherichia coli. * Patients with infection, diabetes or primary immunodeficiency. * Patients infected with hepatitis B, hepatitis C or HIV. * Patients confirmed autoimmune thrombocytopenic purpura.
References
Publications (0)
Data not yet available
No reference posted for this study.