Intervention: Isavuconazonium
Trial phase: Phase 2
SMILES: [H]C(C)(OC(=O)N(C)c1ncccc1COC(=O)CNC)[n+]1cnn(C[C@](O)(c2cc(F)ccc2F)[C@@]([H])(C)c2nc(-c3ccc(C#N)cc3)cs2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 65
Group description: Patients receive isavuconazole PO every 8 hours for 6 doses and then QD or IV over 1 hour every 8 hours for 6 doses and then QD for up to 4 days for 12 weeks in the absence of disease progression or unacceptable toxicity.

Isavuconazole: Given PO or IV
Eligibility criteria:
Inclusion Criteria:

Patients with either newly diagnosed AML or MDS who have either begun (within 4 days of starting study drug) or are planned to begin specific treatment for their AML/MDS; hydroxyurea and cytarabine used for cytoreduction while awaiting initiation of definitive therapy are not considered "specific" treatment; patients who are participating in other therapeutic clinical trials for their AML/MDS may participate in this trial
Patients must have or be anticipated to have neutropenia (absolute neutrophil count [ANC] < 0.5 x 10^9/L) (75) for >= 7 days as a result of treatment of their AML/MDS
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
Total bilirubin =< 3 x upper limit of normal (ULN)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 5 x ULN
Patients must be able to take oral medications, although a brief period of IV therapy (< 4 days) is permitted at trial entry
Patients must be willing and able to provide written informed consent for the trial
Women of childbearing potential (WOCBP) must practice 2 effective methods of birth control during the course of the study; male patients who are partners of WOCBP should also practice an effective method of contraception; effective methods of birth control include diaphragm or condoms with spermicidal foam or jelly, birth control pills (BCPs), injections or patches, intra-uterine devices (IUDs) and surgical sterilization
Postmenopausal women must be amenorrheic for >= 12 months to be considered of non-childbearing potential
Women and men must continue birth control for the duration of the trial and >= 3 months after the last dose of study drug
All WOCBP MUST have a negative pregnancy test prior to first receiving study medication

Exclusion Criteria:

Proven, probable or possible IFI within the previous 30 days
Use of any systemic antifungal therapy for > 72 hours during the week prior to study drug initiation
History of hypersensitivity or idiosyncratic reactions to azoles
Patients with familial short QT syndrome or with corrected QT (QTc) interval =< 300 ms
Patients on strong CYP3A4 inducers or inhibitors that cannot be discontinued
Women who are pregnant or nursing, or intend to be/do so during the course of the study
Patients with severe hepatic impairment (Child-Pugh class C)
Patients with known or suspected Gilbert's syndrome at the time of study enrollment
Patients with known gastrointestinal conditions that could potentially interfere with absorption of orally administered medications
Any condition that, in the opinion of the investigator, may interfere with the objectives of the study, e.g., any condition requiring the use of prohibited drugs or unstable medical conditions other than AML/MDS, such as a cardiac or neurologic disorder expected to be unstable or progressive during the course of the study (e.g., seizures or demyelinating syndromes, acute myocardial infarction within 3 months of study entry, myocardial ischemia or unstable congestive heart failure, unstable arrhythmias)