<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03019939</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0373</org_study_id>
    <secondary_id>NCI-2017-00323</secondary_id>
    <secondary_id>2016-0373</secondary_id>
    <nct_id>NCT03019939</nct_id>
  </id_info>
  <brief_title>Isavuconazole in Preventing Invasive Fungal Infections in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome and Neutropenia</brief_title>
  <official_title>A Phase II Study of Isavuconazole Prophylaxis in Adult Patients With AML/MDS and Neutropenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II trial studies how well isavuconazole works in preventing invasive fungal&#xD;
      infections in adult patients with newly diagnosed acute myeloid leukemia or myelodysplastic&#xD;
      syndrome and neutropenia. Isavuconazole may help to prevent invasive fungal infections in&#xD;
      adult patients with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome and&#xD;
      neutropenia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To assess whether prophylaxis with isavuconazole effectively prevents the occurrence of&#xD;
      proven or probable invasive fungal infections (IFIs) in patients with newly diagnosed acute&#xD;
      myeloid leukemia/myelodysplastic syndrome (AML/MDS) receiving successive cycles of intensive&#xD;
      chemotherapy or other therapies for up to 100 days from prophylaxis initiation.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the incidence of invasive aspergillosis (IA) within 100 days of beginning&#xD;
      isavuconazole prophylaxis in newly diagnosed patients with AML/MDS receiving intensive&#xD;
      chemotherapy or other therapies.&#xD;
&#xD;
      II. To evaluate the incidence of other IFIs within 100 days of beginning isavuconazole&#xD;
      prophylaxis in newly diagnosed patients with AML/MDS receiving intensive chemotherapy or&#xD;
      other therapies.&#xD;
&#xD;
      III. To evaluate the composite outcome of treatment success versus (vs.) failure in this&#xD;
      patient population.&#xD;
&#xD;
      IV. To measure the overall survival (OS) of study participants. V. To measure the IFI-free&#xD;
      survival of study participants. VI. To document the time to death from any cause in the study&#xD;
      population. VII. To document the time to death related to IFI in the study population. VIII.&#xD;
      To document the time to diagnosis of proven or probable IFI in the study population.&#xD;
&#xD;
      IX. To document the time to initiation of empiric anti-fungal therapy in the study&#xD;
      population.&#xD;
&#xD;
      X. To characterize the safety, tolerability and adverse event (AE) profile of isavuconazole&#xD;
      in the prophylactic setting.&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I. To assess the potential role, if any, of therapeutic drug monitoring (TDM) of&#xD;
      isavuconazole levels in the prophylactic setting in patients with newly diagnosed AML/MDS&#xD;
      receiving cytotoxic chemotherapy or other therapies.&#xD;
&#xD;
      II. To determine the in vitro susceptibility of agents causing &quot;breakthrough&quot; IFIs to&#xD;
      antifungal agents.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive isavuconazole orally (PO) every 8 hours for 6 doses and then once daily (QD)&#xD;
      or intravenously (IV) over 1 hour every 8 hours for 6 doses and then QD for up to 4 days for&#xD;
      12 weeks in the absence of disease progression or unacceptable toxicity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 28, 2017</start_date>
  <completion_date type="Actual">August 10, 2020</completion_date>
  <primary_completion_date type="Actual">August 10, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Proven or Probable Invasive Fungal Infections (IFIs)</measure>
    <time_frame>Up to 100 days from prophylaxis initiation</time_frame>
    <description>Participants with proven or possible invasive fungal infections.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Invasive Aspergillosis</measure>
    <time_frame>Up to 100 days from prophylaxis initiation</time_frame>
    <description>Participants with invasive aspergillosissured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Other Invasive Fungal Infections (IFIs)</measure>
    <time_frame>Up to 100 days from prophylaxis initiation</time_frame>
    <description>Participants with other IFIs will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Success</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Will evaluate versus (vs.) failure (defined as Participants with proven or probable IFI, receipt of any other systemic antifungal agent for +/- 4 days for suspected IFI, occurrence of an adverse events possibly or probably related to the study drug resulting in discontinuation of treatment, or withdrawal from the study with no additional follow-up).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Failed Treatment</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Will evaluate versus success. Success is defined as Participants with proven or probable IFI, receipt of any other systemic antifungal agent for +/- 4 days for suspected IFI, occurrence of an adverse events possibly or probably related to the study drug resulting in discontinuation of treatment, or withdrawal from the study with no additional follow-up).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Time from date of treatment start until date of death due to any cause or last Follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Invasive Fungal Infections (IFIs)-Free Survival</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Time measured in days from start of treatment to IFI or off study date</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Death From Any Cause</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Time to death from any cause will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Death Related to Invasive Fungal Infections (IFIs)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Death's from invasive fungal infections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Diagnosis of Proven or Probable Invasive Fungal Infections (IFIs)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Time measured in days from start of treatment to invasive fungal infections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Initiation of Empiric Anti-fungal Therapy</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Time days from start of empiric anti-fungal therapy.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <condition>Myelodysplastic Syndrome</condition>
  <condition>Neutropenia</condition>
  <arm_group>
    <arm_group_label>Prevention (isavuconazole)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive isavuconazole PO every 8 hours for 6 doses and then Once a day (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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Isavuconazole</intervention_name>
    <description>Given PO or IV</description>
    <arm_group_label>Prevention (isavuconazole)</arm_group_label>
    <other_name>BAL8557</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with either newly diagnosed AML or MDS who have either begun (within 4 days&#xD;
             of starting study drug) or are planned to begin specific treatment for their AML/MDS;&#xD;
             hydroxyurea and cytarabine used for cytoreduction while awaiting initiation of&#xD;
             definitive therapy are not considered &quot;specific&quot; treatment; patients who are&#xD;
             participating in other therapeutic clinical trials for their AML/MDS may participate&#xD;
             in this trial&#xD;
&#xD;
          -  Patients must have or be anticipated to have neutropenia (absolute neutrophil count&#xD;
             [ANC] &lt; 0.5 x 10^9/L) (75) for &gt;= 7 days as a result of treatment of their AML/MDS&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2&#xD;
&#xD;
          -  Total bilirubin =&lt; 3 x upper limit of normal (ULN)&#xD;
&#xD;
          -  Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =&lt; 5 x ULN&#xD;
&#xD;
          -  Patients must be able to take oral medications, although a brief period of IV therapy&#xD;
             (&lt; 4 days) is permitted at trial entry&#xD;
&#xD;
          -  Patients must be willing and able to provide written informed consent for the trial&#xD;
&#xD;
          -  Women of childbearing potential (WOCBP) must practice 2 effective methods of birth&#xD;
             control during the course of the study; male patients who are partners of WOCBP should&#xD;
             also practice an effective method of contraception; effective methods of birth control&#xD;
             include diaphragm or condoms with spermicidal foam or jelly, birth control pills&#xD;
             (BCPs), injections or patches, intra-uterine devices (IUDs) and surgical sterilization&#xD;
&#xD;
          -  Postmenopausal women must be amenorrheic for &gt;= 12 months to be considered of&#xD;
             non-childbearing potential&#xD;
&#xD;
          -  Women and men must continue birth control for the duration of the trial and &gt;= 3&#xD;
             months after the last dose of study drug&#xD;
&#xD;
          -  All WOCBP MUST have a negative pregnancy test prior to first receiving study&#xD;
             medication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Proven, probable or possible IFI within the previous 30 days&#xD;
&#xD;
          -  Use of any systemic antifungal therapy for &gt; 72 hours during the week prior to study&#xD;
             drug initiation&#xD;
&#xD;
          -  History of hypersensitivity or idiosyncratic reactions to azoles&#xD;
&#xD;
          -  Patients with familial short QT syndrome or with corrected QT (QTc) interval =&lt; 300 ms&#xD;
&#xD;
          -  Patients on strong CYP3A4 inducers or inhibitors that cannot be discontinued&#xD;
&#xD;
          -  Women who are pregnant or nursing, or intend to be/do so during the course of the&#xD;
             study&#xD;
&#xD;
          -  Patients with severe hepatic impairment (Child-Pugh class C)&#xD;
&#xD;
          -  Patients with known or suspected Gilbert's syndrome at the time of study enrollment&#xD;
&#xD;
          -  Patients with known gastrointestinal conditions that could potentially interfere with&#xD;
             absorption of orally administered medications&#xD;
&#xD;
          -  Any condition that, in the opinion of the investigator, may interfere with the&#xD;
             objectives of the study, e.g., any condition requiring the use of prohibited drugs or&#xD;
             unstable medical conditions other than AML/MDS, such as a cardiac or neurologic&#xD;
             disorder expected to be unstable or progressive during the course of the study (e.g.,&#xD;
             seizures or demyelinating syndromes, acute myocardial infarction within 3 months of&#xD;
             study entry, myocardial ischemia or unstable congestive heart failure, unstable&#xD;
             arrhythmias)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Prithviraj Bose</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <results_first_submitted>August 30, 2021</results_first_submitted>
  <results_first_submitted_qc>August 30, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 24, 2021</results_first_posted>
  <last_update_submitted>October 6, 2021</last_update_submitted>
  <last_update_submitted_qc>October 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
    <mesh_term>Preleukemia</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
    <mesh_term>Neutropenia</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Isavuconazole</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT03019939/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment Period: April 28, 2017 to July 26, 2019</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Prevention (Isavuconazole)</title>
          <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.&#xD;
Isavuconazole: Given PO or IV</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Prevention (Isavuconazole)</title>
          <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.&#xD;
Isavuconazole: Given PO or IV</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="65"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67" lower_limit="21" upper_limit="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Proven or Probable Invasive Fungal Infections (IFIs)</title>
        <description>Participants with proven or possible invasive fungal infections.</description>
        <time_frame>Up to 100 days from prophylaxis initiation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prevention (Isavuconazole)</title>
            <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.&#xD;
Isavuconazole: Given PO or IV</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Proven or Probable Invasive Fungal Infections (IFIs)</title>
          <description>Participants with proven or possible invasive fungal infections.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Invasive Aspergillosis</title>
        <description>Participants with invasive aspergillosissured.</description>
        <time_frame>Up to 100 days from prophylaxis initiation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prevention (Isavuconazole)</title>
            <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.&#xD;
Isavuconazole: Given PO or IV</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Invasive Aspergillosis</title>
          <description>Participants with invasive aspergillosissured.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Other Invasive Fungal Infections (IFIs)</title>
        <description>Participants with other IFIs will be measured.</description>
        <time_frame>Up to 100 days from prophylaxis initiation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prevention (Isavuconazole)</title>
            <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.&#xD;
Isavuconazole: Given PO or IV</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Other Invasive Fungal Infections (IFIs)</title>
          <description>Participants with other IFIs will be measured.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Success</title>
        <description>Will evaluate versus (vs.) failure (defined as Participants with proven or probable IFI, receipt of any other systemic antifungal agent for +/- 4 days for suspected IFI, occurrence of an adverse events possibly or probably related to the study drug resulting in discontinuation of treatment, or withdrawal from the study with no additional follow-up).</description>
        <time_frame>Up to 3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prevention (Isavuconazole)</title>
            <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.&#xD;
Isavuconazole: Given PO or IV</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Success</title>
          <description>Will evaluate versus (vs.) failure (defined as Participants with proven or probable IFI, receipt of any other systemic antifungal agent for +/- 4 days for suspected IFI, occurrence of an adverse events possibly or probably related to the study drug resulting in discontinuation of treatment, or withdrawal from the study with no additional follow-up).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Failed Treatment</title>
        <description>Will evaluate versus success. Success is defined as Participants with proven or probable IFI, receipt of any other systemic antifungal agent for +/- 4 days for suspected IFI, occurrence of an adverse events possibly or probably related to the study drug resulting in discontinuation of treatment, or withdrawal from the study with no additional follow-up).</description>
        <time_frame>Up to 3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prevention (Isavuconazole)</title>
            <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.&#xD;
Isavuconazole: Given PO or IV</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Failed Treatment</title>
          <description>Will evaluate versus success. Success is defined as Participants with proven or probable IFI, receipt of any other systemic antifungal agent for +/- 4 days for suspected IFI, occurrence of an adverse events possibly or probably related to the study drug resulting in discontinuation of treatment, or withdrawal from the study with no additional follow-up).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>Time from date of treatment start until date of death due to any cause or last Follow-up.</description>
        <time_frame>Up to 3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prevention (Isavuconazole)</title>
            <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.&#xD;
Isavuconazole: Given PO or IV</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>Time from date of treatment start until date of death due to any cause or last Follow-up.</description>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.9" lower_limit="0.9" upper_limit="19.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Invasive Fungal Infections (IFIs)-Free Survival</title>
        <description>Time measured in days from start of treatment to IFI or off study date</description>
        <time_frame>Up to 3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prevention (Isavuconazole)</title>
            <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.&#xD;
Isavuconazole: Given PO or IV</description>
          </group>
        </group_list>
        <measure>
          <title>Invasive Fungal Infections (IFIs)-Free Survival</title>
          <description>Time measured in days from start of treatment to IFI or off study date</description>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86" lower_limit="7" upper_limit="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Death From Any Cause</title>
        <description>Time to death from any cause will be measured.</description>
        <time_frame>Up to 3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prevention (Isavuconazole)</title>
            <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.&#xD;
Isavuconazole: Given PO or IV</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Death From Any Cause</title>
          <description>Time to death from any cause will be measured.</description>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="1.1" upper_limit="16.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Death Related to Invasive Fungal Infections (IFIs)</title>
        <description>Death's from invasive fungal infections</description>
        <time_frame>Up to 3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prevention (Isavuconazole)</title>
            <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.&#xD;
Isavuconazole: Given PO or IV</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Death Related to Invasive Fungal Infections (IFIs)</title>
          <description>Death's from invasive fungal infections</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Diagnosis of Proven or Probable Invasive Fungal Infections (IFIs)</title>
        <description>Time measured in days from start of treatment to invasive fungal infections</description>
        <time_frame>Up to 3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prevention (Isavuconazole)</title>
            <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.&#xD;
Isavuconazole: Given PO or IV</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Diagnosis of Proven or Probable Invasive Fungal Infections (IFIs)</title>
          <description>Time measured in days from start of treatment to invasive fungal infections</description>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24" lower_limit="7" upper_limit="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Initiation of Empiric Anti-fungal Therapy</title>
        <description>Time days from start of empiric anti-fungal therapy.</description>
        <time_frame>Up to 3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Prevention (Isavuconazole)</title>
            <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.&#xD;
Isavuconazole: Given PO or IV</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Initiation of Empiric Anti-fungal Therapy</title>
          <description>Time days from start of empiric anti-fungal therapy.</description>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22" lower_limit="7" upper_limit="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 3 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Prevention (Isavuconazole)</title>
          <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.&#xD;
Isavuconazole: Given PO or IV</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenic Fever</sub_title>
                <counts group_id="E1" events="19" subjects_affected="17" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Supraventricular Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Pain Extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Lung Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Skin Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Kidney Injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenic Fever</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Other</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Oral Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="65"/>
              </event>
              <event>
                <sub_title>Aspartate Aminotransferase Increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Tumor Lysis Syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Enlarged Prostate</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="65"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Prithviraj Bose MD/Associate Porfessor</name_or_title>
      <organization>The University of Texas MD Anderson Cancer Center</organization>
      <phone>713-792-7747</phone>
      <email>PBose@mdanderson.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03019939
org study id: 2016-0373
secondary id: NCI-2017-00323
secondary id: 2016-0373
nct id: NCT03019939
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
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.
PRIMARY OBJECTIVES:

      I. To assess whether prophylaxis with isavuconazole effectively prevents the occurrence of
      proven or probable invasive fungal infections (IFIs) in patients with newly diagnosed acute
      myeloid leukemia/myelodysplastic syndrome (AML/MDS) receiving successive cycles of intensive
      chemotherapy or other therapies for up to 100 days from prophylaxis initiation.

      SECONDARY OBJECTIVES:

      I. To evaluate the incidence of invasive aspergillosis (IA) within 100 days of beginning
      isavuconazole prophylaxis in newly diagnosed patients with AML/MDS receiving intensive
      chemotherapy or other therapies.

      II. To evaluate the incidence of other IFIs within 100 days of beginning isavuconazole
      prophylaxis in newly diagnosed patients with AML/MDS receiving intensive chemotherapy or
      other therapies.

      III. To evaluate the composite outcome of treatment success versus (vs.) failure in this
      patient population.

      IV. To measure the overall survival (OS) of study participants. V. To measure the IFI-free
      survival of study participants. VI. To document the time to death from any cause in the study
      population. VII. To document the time to death related to IFI in the study population. VIII.
      To document the time to diagnosis of proven or probable IFI in the study population.

      IX. To document the time to initiation of empiric anti-fungal therapy in the study
      population.

      X. To characterize the safety, tolerability and adverse event (AE) profile of isavuconazole
      in the prophylactic setting.

      EXPLORATORY OBJECTIVES:

      I. To assess the potential role, if any, of therapeutic drug monitoring (TDM) of
      isavuconazole levels in the prophylactic setting in patients with newly diagnosed AML/MDS
      receiving cytotoxic chemotherapy or other therapies.

      II. To determine the in vitro susceptibility of agents causing "breakthrough" IFIs to
      antifungal agents.

      OUTLINE:

      Patients receive isavuconazole orally (PO) every 8 hours for 6 doses and then once daily (QD)
      or intravenously (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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Participants With Proven or Probable Invasive Fungal Infections (IFIs)
time frame: Up to 100 days from prophylaxis initiation
description: Participants with proven or possible invasive fungal infections.
measure: Number of Participants With Invasive Aspergillosis
time frame: Up to 100 days from prophylaxis initiation
description: Participants with invasive aspergillosissured.
measure: Number of Participants With Other Invasive Fungal Infections (IFIs)
time frame: Up to 100 days from prophylaxis initiation
description: Participants with other IFIs will be measured.
measure: Number of Participants With Treatment Success
time frame: Up to 3 years
description: Will evaluate versus (vs.) failure (defined as Participants with proven or probable IFI, receipt of any other systemic antifungal agent for +/- 4 days for suspected IFI, occurrence of an adverse events possibly or probably related to the study drug resulting in discontinuation of treatment, or withdrawal from the study with no additional follow-up).
measure: Number of Participants Who Failed Treatment
time frame: Up to 3 years
description: Will evaluate versus success. Success is defined as Participants with proven or probable IFI, receipt of any other systemic antifungal agent for +/- 4 days for suspected IFI, occurrence of an adverse events possibly or probably related to the study drug resulting in discontinuation of treatment, or withdrawal from the study with no additional follow-up).
measure: Overall Survival (OS)
time frame: Up to 3 years
description: Time from date of treatment start until date of death due to any cause or last Follow-up.
measure: Invasive Fungal Infections (IFIs)-Free Survival
time frame: Up to 3 years
description: Time measured in days from start of treatment to IFI or off study date
measure: Time to Death From Any Cause
time frame: Up to 3 years
description: Time to death from any cause will be measured.
measure: Number of Participants With Death Related to Invasive Fungal Infections (IFIs)
time frame: Up to 3 years
description: Death's from invasive fungal infections
measure: Time to Diagnosis of Proven or Probable Invasive Fungal Infections (IFIs)
time frame: Up to 3 years
description: Time measured in days from start of treatment to invasive fungal infections
measure: Time to Initiation of Empiric Anti-fungal Therapy
time frame: Up to 3 years
description: Time days from start of empiric anti-fungal therapy.
arm group label: Prevention (isavuconazole)
arm group type: Experimental
description: Patients receive isavuconazole PO every 8 hours for 6 doses and then Once a day (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.
intervention type: Drug
intervention name: Isavuconazole
description: Given PO or IV
arm group label: Prevention (isavuconazole)
other name: BAL8557
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Prithviraj Bose
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Preleukemia
mesh term: Myelodysplastic Syndromes
mesh term: Neutropenia
mesh term: Syndrome
mesh term: Isavuconazole
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 