Isavuconazole in Preventing Invasive Fungal Infections in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome and Neutropenia
Condition: Acute Myeloid Leukemia; Myelodysplastic Syndrome; Neutropenia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes; Neutropenia; Syndrome
Intervention: Isavuconazole
Intervention description: Given PO or IV
Intervention MeSH terms: Isavuconazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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)