Clinical trial · Interventional
Safety, Efficacy and Pharmacokinetics of an Antifungal in Patients Undergoing Chemotherapy
Open Label, Multi-center, Sequential Group Clinical Study to Determine the Safety and Efficacy of Escalating Dosing Regimens of Intravenous BAL8557 in the Prophylaxis of Patients Undergoing Chemotherapy for Acute Myeloid Leukemia
NCT00413439CI-TRIAL-00066303completedPhase 2 / Phase 3ClinicalTrials.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)
Patients who undergo chemotherapy for leukemia will receive study medication for prevention of fungal infections. The study investigates the safety and tolerability of two different dosages, the efficacy in prevention of fungal diseases.
Conditions
Conditions (1)
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 Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Isavuconazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Low dose isavuconazole intravenous solution
- interventionNames
- Drug: Isavuconazole
- type
- EXPERIMENTAL
- label
- High dose isavuconazole intravenous solution or oral capsules
- interventionNames
- Drug: Isavuconazole
Primary outcomes (1)
- measure
- Safety assessed by the recording of adverse events, laboratory tests, and electrocardiograms (ECGs)
- timeFrame
- Up to Day 28
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * diagnosis of acute myeloid leukemia * patients entering first induction treatment; or subsequent chemotherapy if no prior invasive fungal infection was observed * expected to be neutropenic for \>9 and \<28 days after enrollment * women of childbearing potential must have a negative pregnancy test Exclusion Criteria: * patients who received any systemic antifungal therapy for more than 72 hours prior to first administration of study medication. Topical polyenes or nystatin are acceptable but should be discontinued during the study * patients who received systemic antifungal therapy for proven or probable fungal infection in the last 12 months * patients with fever defined as central body temperature of \> 38°C * known hypersensitivity to azoles or any component of the study medication * concomitant use of rifampicin, rifabutin, ergots alkaloids, terfenadine, astemizole, cisapride, pimozide, quinidine, long acting barbiturates, neostigmine, and carbamazepine * hepatic or severe renal dysfunction * patients with a medical history of oliguria unresponsive to fluid challenge * patients with a concomitant medical condition that may be an unacceptable additional risk to the patient should he/she participate in the study * treatment with any investigational drug within 30 days prior to the first administration of study medication except open label chemotherapy protocols * suspected other or additional cause for neutropenia or immunosuppression
References
Publications (1)
- DERIVEDCornely OA, Bohme A, Schmitt-Hoffmann A, Ullmann AJ. Safety and pharmacokinetics of isavuconazole as antifungal prophylaxis in acute myeloid leukemia patients with neutropenia: results of a phase 2, dose escalation study. Antimicrob Agents Chemother. 2015 Apr;59(4):2078-85. doi: 10.1128/AAC.04569-14. Epub 2015 Jan 26. PMID 25624327