Clinical trial · Interventional
Voriconazole in Preventing Fungal Infections in Children With Neutropenia After Chemotherapy
An Open-Label, Intravenous To Oral Switch, Multiple Dose, Multi-Center Study To Investigate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Hospitalized Children Aged 2 - <12 Years Who Require Treatment For The Prevention Of Systemic Fungal Infection
- 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)
RATIONALE: Voriconazole may be effective in preventing systemic fungal infections following chemotherapy. PURPOSE: Phase II trial to study the effectiveness of voriconazole in preventing systemic fungal infections in children who have neutropenia after receiving chemotherapy for leukemia, lymphoma, or aplastic anemia or in preparation for bone marrow or stem cell transplantation.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Neutropenia | — | UNRESOLVED | — |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| voriconazole | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 11 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Expected to develop neutropenia (absolute neutrophil count less than 500/mm\^3) lasting for more than 10 days after chemotherapy for 1 of the following conditions: * Leukemia * Lymphoma * Aplastic anemia * Preparation for a bone marrow or stem cell transplantation * Requiring treatment for the prevention of systemic fungal infection PATIENT CHARACTERISTICS: Age * 2 to 11 Performance status * Not specified Life expectancy * More than 3 months Hematopoietic * See Disease Characteristics Hepatic * AST and ALT no greater than 5 times upper limit of normal (ULN) * Bilirubin no greater than 5 times ULN Renal * Creatinine clearance at least 30 mL/min Cardiovascular * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * No severe hypokalemia (potassium less than 3.2 mmol/L) * No prior hypersensitivity to or severe intolerance of azole antifungal agents * No other concurrent condition that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * At least 24 hours since prior use of any of the following: * Terfenadine * Pimozide * Quinidine * Astemizole * Cisapride * Omeprazole * More than 14 days since prior use of any of the following: * Rifampin * Rifabutin * Carbamazepine * Phenytoin * Nevirapine * Long-acting barbiturates * No prior sirolimus * No prior enrollment on this study * No concurrent use of any of the following: * Terfenadine * Pimozide * Quinidine * Astemizole * Cisapride * Omeprazole * No other concurrent investigational drugs except any of the following: * Drugs used as treatment for cancer * Antiretroviral agents * Drugs used for the treatment of any AIDS-defining opportunistic infections * No concurrent enrollment in investigational anticancer drug trials that exclude the use of other investigational agents
References
Publications (0)
Data not yet available