At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 65 enrolled
Drug / intervention
Isavuconazoledrug
Likely dose
Isavuconazole, oral or intravenous (specific dose not stated)AI-extracted
Key inclusion· 6
- ✓Newly diagnosed AML or MDS with initiation of specific treatment (within 4 days of study drug start or planned)
- ✓Expected neutropenia (ANC <0.5×10⁹/L) for ≥7 days as a result of AML/MDS treatment
- ✓ECOG performance status 0, 1, or 2
- ✓Total bilirubin ≤3× ULN
Key exclusion· 9
- ✕Proven, probable, or possible invasive fungal infection within previous 30 days
- ✕Systemic antifungal therapy for >72 hours in the week prior to study drug initiation
- ✕History of hypersensitivity or idiosyncratic reactions to azoles
- ✕Familial short QT syndrome or QTc interval ≤300 ms
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Isavuconazole Prophylaxis in Adult Patients With AML/MDS and Neutropenia
In Brief
A Phase 2 clinical trial evaluating Isavuconazole for Acute Myeloid Leukemia and 2 related conditions. Completed, enrolled 65 participants across 1 site.
Detailed Summary
This phase II trial studies how well isavuconazole works in preventing invasive fungal infections in adult patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome and neutropenia. Isavuconazole may help to prevent invasive fungal infections in adult patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome and neutropenia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 2017
Enrollment StartMar 2017
Primary CompletionAug 2020
TodayJul 2026
First PostedJan 13, 2017
Enrollment StartMar 28, 2017
Primary CompletionAug 10, 2020
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 9.5 years ago
Interventions
Isavuconazoledrug
Given PO or IV