<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/NCT01692197</url>
  </required_header>
  <id_info>
    <org_study_id>2009-0570</org_study_id>
    <secondary_id>NCI-2012-02065</secondary_id>
    <nct_id>NCT01692197</nct_id>
  </id_info>
  <brief_title>E7070, Idarubicin and Cytarabine in Relapsed AML and High-Risk Myelodysplastic Syndromes</brief_title>
  <official_title>A Phase 2 Study of E7070, Idarubicin and Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia and High-risk Myelodysplastic Syndromes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eisai Inc.</agency>
      <agency_class>Industry</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>
      The goal of this clinical research study is to learn if E7070 in combination with idarubicin,&#xD;
      cytarabine, and dexamethasone can help to control the disease in patients with either AML or&#xD;
      high-risk MDS that has relapsed. The safety of the drug combination will also be studied.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Study Drugs:&#xD;
&#xD;
      E7070 is designed to stop metabolic ingredients from reaching the cancer cells and to stop&#xD;
      the cancer cell from dividing.&#xD;
&#xD;
      Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer&#xD;
      cells and stop the DNA from repairing itself.&#xD;
&#xD;
      Idarubicin is designed to cause breaks in both strands of DNA (the genetic material of&#xD;
      cells).&#xD;
&#xD;
      Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body.&#xD;
      Dexamethasone is often given to AML patients in combination with other chemotherapy to treat&#xD;
      cancer.&#xD;
&#xD;
      Study Drug Administration:&#xD;
&#xD;
      If you are found eligible to take part in this study, you will receive E7070 by vein over 1&#xD;
      hour on Day 1 and Day 8 (+/- 2 days on Day 8 only) followed by idarubicin by vein over 1 hour&#xD;
      on Days 9-11. You will also receive cytarabine by vein over 24 hours each day on Days 9-12.&#xD;
      If you are 60 years of age or older, you will only receive cytarabine on Days 9-11. On days&#xD;
      that you are receiving the cytarabine infusions, you will also receive dexamethasone by vein&#xD;
      over about 30 minutes. You will receive dexamethasone before the cytarabine infusions. Each&#xD;
      study cycle is about 28 days.&#xD;
&#xD;
      If your doctor thinks you are benefitting from taking the E7070 in combination with&#xD;
      idarubicin, cytarabine, and dexamethasone, you may receive up to 2 additional cycles of the&#xD;
      study drug combination.&#xD;
&#xD;
      Study Visits:&#xD;
&#xD;
      During Cycle 1, the following tests and procedures will be performed:&#xD;
&#xD;
        -  You will be asked about medications you are taking and side effects you may have had.&#xD;
&#xD;
        -  Blood (about 2 teaspoons) will be drawn at least 1 time every week for routine tests and&#xD;
           to check your liver and kidney function.&#xD;
&#xD;
        -  You will have a bone marrow aspirate on Day 28 (+/- 3 days) to check the status of the&#xD;
           disease. You may have additional bone marrow aspirates during Cycle 2 if the doctor&#xD;
           thinks it is necessary.&#xD;
&#xD;
        -  During Cycle 1 only, you will have an ECG on Day 2 (+/- 1 day) and Day 8 (+/- 2 days).&#xD;
&#xD;
      Treatment cycles beyond Cycle 1, the following tests and procedures will be performed:&#xD;
&#xD;
        -  You will be asked about medications you are taking and side effects you may have had.&#xD;
&#xD;
        -  Blood (about 2 teaspoons) will be drawn every 2-4 weeks for routine tests.&#xD;
&#xD;
        -  You will have a bone marrow aspirate to check the status of the disease whenever the&#xD;
           doctor feels it is necessary.&#xD;
&#xD;
      Length of Study:&#xD;
&#xD;
      If the doctor thinks you are benefitting with E7070 in combination with idarubicin,&#xD;
      cytarabine and dexamethasone, you may receive 2 additional cycles of therapy (a total of 3&#xD;
      cycles on this study.)&#xD;
&#xD;
      You will be taken off study if the disease gets worse, you experience intolerable side&#xD;
      effects, or if the study doctor thinks it is in your best interest.&#xD;
&#xD;
      End-of-Treatment Visit:&#xD;
&#xD;
      At the end of treatment, blood (about 2 teaspoons) will be drawn for routine tests within 30&#xD;
      days (+/- 5 days) of your last dose of the study drug combination. You will also be asked&#xD;
      about any side effects you may have had.&#xD;
&#xD;
      Long Term Follow-up (unless you have started on alternative therapy):&#xD;
&#xD;
      Blood (about 1 tablespoon) will be drawn for routine tests every 2-3 months for up to 2 years&#xD;
      unless the disease gets worse or you start on another treatment.&#xD;
&#xD;
      This is an investigational study. E7070 is not FDA-approved or commercially available for use&#xD;
      in patients with AML or MDS that has relapsed. Its use in this study is considered&#xD;
      investigational. Idarubicin, cytarabine, and dexamethasone are FDA-approved and commercially&#xD;
      available for use in the treatment of AML. The combination of E7070, idarubicin, cytarabine,&#xD;
      and dexamethasone in this study is investigational.&#xD;
&#xD;
      Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2013</start_date>
  <completion_date type="Actual">June 7, 2017</completion_date>
  <primary_completion_date type="Actual">June 7, 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Response</measure>
    <time_frame>2 cycles (60 days)</time_frame>
    <description>Efficacy measured by overall response - complete response plus complete response with incomplete platelet recovery, plus partial response (Complete remission (CR) + Complete remission without platelet recovery (CRp) + Partial Remission (PR)+ marrow clearance of blast) during cycle 1.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease-free Survival</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Time from date of treatment start until the date of first objective documentation of disease-relapse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Response date to loss of response or last follow up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Up to 5 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>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Leukemia</condition>
  <arm_group>
    <arm_group_label>E7070 + Idarubicin + Cytarabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>E7070 400 mg/m2 IV over 1 hour on day 1 and day 8 (+/- 2 days on Day 8 only) followed by, Idarubicin 8 mg/m2 IV over 1 hour daily for 3 days (days 9-11) and Cytarabine 1.0 g/m2 IV over 24 hours daily on day 9-12 (age &lt;60 years) or days 9-11 (age &gt; 60 years). Dexamethasone 10 mg IV daily for 3-4 days with cytarabine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>E7070</intervention_name>
    <description>400 mg/m2 intravenously over 1 hour on Day 1 and Day 8 every 3 weeks.</description>
    <arm_group_label>E7070 + Idarubicin + Cytarabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Idarubicin</intervention_name>
    <description>8 mg/m2 by vein over 1 hour daily for 3 days (Days 9-11).</description>
    <arm_group_label>E7070 + Idarubicin + Cytarabine</arm_group_label>
    <other_name>Idamycin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cytarabine</intervention_name>
    <description>1.0 g/m2 by vein daily on Days 9 - 12 (age &lt;60 years) or Days 9 - 11 (age &gt; 60 years).</description>
    <arm_group_label>E7070 + Idarubicin + Cytarabine</arm_group_label>
    <other_name>ARA-C</other_name>
    <other_name>Cytosar</other_name>
    <other_name>DepoCyt</other_name>
    <other_name>Cytosine Arabinosine Hydrochloride</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>10 mg by vein daily for 3 - 4 days with cytarabine.</description>
    <arm_group_label>E7070 + Idarubicin + Cytarabine</arm_group_label>
    <other_name>Decadron</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All patients with histologically or cytologically confirmed relapsed or refractory&#xD;
             acute myeloid leukemia (AML) [except acute promyelocytic leukemia], or high-risk&#xD;
             myelodysplastic syndrome (HRMDS) (Int-2 high risk by International Prostate Symptom&#xD;
             Score (IPSS) or &gt;10% blasts in marrow).&#xD;
&#xD;
          2. Patients must be 18 years or older.&#xD;
&#xD;
          3. Patients must have a performance status of 0-2 (Zubrod scale).&#xD;
&#xD;
          4. Patients must have adequate renal function (serum creatinine less than or equal to 1.3&#xD;
             mg/dL and/or creatinine clearance &gt; 40 mL/min). Patients with renal dysfunction due to&#xD;
             organ infiltration by disease may be eligible after discussion with the Principal&#xD;
             Investigator (PI) (up to creatinine less than or equal to 2.0), and appropriate dose&#xD;
             adjustments will be considered.&#xD;
&#xD;
          5. Patients must have adequate hepatic function (bilirubin less than or equal to 2.0&#xD;
             mg/dl; SGOT or Serum glutamic pyruvic transaminase (SGPT) less than or equal to 3&#xD;
             times the ULN for the reference lab unless due to leukemia or congenital hemolytic&#xD;
             disorder or bilirubin). Patients with hepatic dysfunction (SGOT/SGPT up to less than&#xD;
             or equal to 5 X ULN) due to organ infiltration by disease may be eligible after&#xD;
             discussion with the PI, and appropriate dose adjustments will be considered.&#xD;
&#xD;
          6. Patients must have normal cardiac ejection fraction&#xD;
&#xD;
          7. QTc interval &lt;/= 480 msecs.&#xD;
&#xD;
          8. Patients must sign an informed consent form indicating that they are aware of the&#xD;
             investigational nature of this study, in keeping with the policies of the hospital.&#xD;
&#xD;
          9. Female patients must not be pregnant or lactating. Female patients of childbearing&#xD;
             potential (including those &lt;1 year post-menopausal) and male patients must agree to&#xD;
             use contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients must not have untreated or uncontrolled life-threatening infection.&#xD;
&#xD;
          2. Patients must not have received chemotherapy and/or radiation therapy within 2 weeks.&#xD;
             Hydroxyurea is allowed up to 48 hours prior to starting therapy in the setting of&#xD;
             rapidly proliferating disease. Use of hydroxyurea to control proliferative disease&#xD;
             will be allowed starting from day 2 until day 7 Cycle 1. Maximum dose of hydroxyurea&#xD;
             allowed daily is 5 gram and hydroxyurea must be discontinued once administration of&#xD;
             idarubicin and cytarabine is started.&#xD;
&#xD;
          3. Any other medical condition, including mental illness or substance abuse, deemed by&#xD;
             the PI to be likely to interfere with a patient's ability to sign informed consent or&#xD;
             cooperate and participate in the study or with the interpretation of the results.&#xD;
&#xD;
          4. Patients must not have received an investigational anti-cancer drug within two weeks&#xD;
             of E7070 administration.&#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>Gautam Borthakur, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas MD 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>June 2018</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <results_first_submitted>June 4, 2018</results_first_submitted>
  <results_first_submitted_qc>June 4, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">July 3, 2018</results_first_posted>
  <last_update_submitted>June 4, 2018</last_update_submitted>
  <last_update_submitted_qc>June 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Leukemia</keyword>
  <keyword>Acute Myeloid Leukemia</keyword>
  <keyword>Acute Myelogenous Leukemia</keyword>
  <keyword>AML</keyword>
  <keyword>Relapsed or Refractory</keyword>
  <keyword>High-Risk Myelodysplastic Syndromes</keyword>
  <keyword>HRMDS</keyword>
  <keyword>E7070</keyword>
  <keyword>Idarubicin</keyword>
  <keyword>Idamycin</keyword>
  <keyword>Cytarabine</keyword>
  <keyword>Cytarabine (ARA-C)</keyword>
  <keyword>Cytosar</keyword>
  <keyword>DepoCyt</keyword>
  <keyword>Cytosine Arabinosine Hydrochloride</keyword>
  <keyword>Dexamethasone</keyword>
  <keyword>Decadron</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Preleukemia</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cytarabine</mesh_term>
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Idarubicin</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, 2013</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT01692197/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment Period: 2/2013 to 06/2014</recruitment_details>
      <pre_assignment_details>Of the 43 participants registered, three never received the study medication.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>E7070 and Idarubicin and Cytarabine</title>
          <description>E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:&#xD;
Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age &lt;60 years) or days 9-11 (age ≥ 60 years).&#xD;
Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Failed Screening</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>E7070 and Idarubicin and Cytarabine</title>
          <description>E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:&#xD;
Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age &lt;60 years) or days 9-11 (age ≥ 60 years).&#xD;
Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="43"/>
          </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="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </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="63" lower_limit="25" upper_limit="75"/>
                  </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="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </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="0"/>
                  </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="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </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="1"/>
                  </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="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Response</title>
        <description>Efficacy measured by overall response - complete response plus complete response with incomplete platelet recovery, plus partial response (Complete remission (CR) + Complete remission without platelet recovery (CRp) + Partial Remission (PR)+ marrow clearance of blast) during cycle 1.</description>
        <time_frame>2 cycles (60 days)</time_frame>
        <population>Thirty seven patients are evaluable.</population>
        <group_list>
          <group group_id="O1">
            <title>E7070 and Idarubicin and Cytarabine</title>
            <description>E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:&#xD;
Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age &lt;60 years) or days 9-11 (age ≥ 60 years).&#xD;
Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response</title>
          <description>Efficacy measured by overall response - complete response plus complete response with incomplete platelet recovery, plus partial response (Complete remission (CR) + Complete remission without platelet recovery (CRp) + Partial Remission (PR)+ marrow clearance of blast) during cycle 1.</description>
          <population>Thirty seven patients are evaluable.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease-free Survival</title>
        <description>Time from date of treatment start until the date of first objective documentation of disease-relapse.</description>
        <time_frame>Up to 5 years</time_frame>
        <population>Thirty seven patients are evaluable.</population>
        <group_list>
          <group group_id="O1">
            <title>E7070 + Idarubicin + Cytarabine</title>
            <description>E7070 400 mg/m2 IV over 1 hour on day 1 and day 8 (+/- 2 days on Day 8 only) followed by, Idarubicin 8 mg/m2 IV over 1 hour daily for 3 days (days 9-11) and Cytarabine 1.0 g/m2 IV over 24 hours daily on day 9-12 (age &lt;60 years) or days 9-11 (age &gt; 60 years). Dexamethasone 10 mg IV daily for 3-4 days with cytarabine.&#xD;
E7070: 400 mg/m2 intravenously over 1 hour on Day 1 and Day 8 every 3 weeks.&#xD;
Idarubicin: 8 mg/m2 by vein over 1 hour daily for 3 days (Days 9-11).&#xD;
Cytarabine: 1.0 g/m2 by vein daily on Days 9 - 12 (age &lt;60 years) or Days 9 - 11 (age &gt; 60 years).&#xD;
Dexamethasone: 10 mg by vein daily for 3 - 4 days with cytarabine.</description>
          </group>
        </group_list>
        <measure>
          <title>Disease-free Survival</title>
          <description>Time from date of treatment start until the date of first objective documentation of disease-relapse.</description>
          <population>Thirty seven patients are evaluable.</population>
          <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="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" lower_limit="1" upper_limit="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response</title>
        <description>Response date to loss of response or last follow up.</description>
        <time_frame>Up to 5 years</time_frame>
        <population>Thirty seven patients are evaluable.</population>
        <group_list>
          <group group_id="O1">
            <title>E7070 and Idarubicin and Cytarabine</title>
            <description>E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:&#xD;
Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age &lt;60 years) or days 9-11 (age ≥ 60 years).&#xD;
Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response</title>
          <description>Response date to loss of response or last follow up.</description>
          <population>Thirty seven patients are evaluable.</population>
          <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="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" lower_limit="1" upper_limit="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival</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 5 years</time_frame>
        <population>Thirty seven patients are evaluable.</population>
        <group_list>
          <group group_id="O1">
            <title>E7070 and Idarubicin and Cytarabine</title>
            <description>E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:&#xD;
Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age &lt;60 years) or days 9-11 (age ≥ 60 years).&#xD;
Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days).</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <description>Time from date of treatment start until date of death due to any cause or last follow-up.</description>
          <population>Thirty seven patients are evaluable.</population>
          <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="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" lower_limit="1" upper_limit="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events will be collected beginning from the time the subject signs the study consent until resolution or for 30 days after the participants last study visit.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>E7070 and Idarubicin and Cytarabine</title>
          <description>E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:&#xD;
Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age &lt;60 years) or days 9-11 (age ≥ 60 years).&#xD;
Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days).</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="11" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Intracranial Hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Pulmonary edema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Heart Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic Reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Bone Marrow Hypocellular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Bone Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Multi-Organ Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infective Endocarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Febrile Neutropenia</sub_title>
                <counts group_id="E1" events="18" subjects_affected="14" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Joint Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Lung Infection</sub_title>
                <counts group_id="E1" events="15" subjects_affected="11" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Pelvic Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Skin Infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Wound Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Injection Site Reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="40"/>
              </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="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="38" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Edema</sub_title>
                <counts group_id="E1" events="16" subjects_affected="14" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Increased Cardiac Troponin I</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="6" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Sinus Tachycardia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye Disorders</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="16" subjects_affected="13" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Gastroesophageal reflux disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders</sub_title>
                <counts group_id="E1" events="11" subjects_affected="8" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hemorrhoids</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Oral Mucositis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="26" subjects_affected="21" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Sore Throat</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="12" subjects_affected="9" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="17" subjects_affected="16" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>malaise</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Nasal Congestion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Neutropenic Fever</sub_title>
                <counts group_id="E1" events="13" subjects_affected="10" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Increased Alanine Aminotransferase</sub_title>
                <counts group_id="E1" events="15" subjects_affected="9" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Increased Alkaline Phosphatase</sub_title>
                <counts group_id="E1" events="12" subjects_affected="6" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Increased Aspartate Aminotransferase</sub_title>
                <counts group_id="E1" events="11" subjects_affected="8" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinemia</sub_title>
                <counts group_id="E1" events="28" subjects_affected="14" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Increased Creatinine</sub_title>
                <counts group_id="E1" events="12" subjects_affected="9" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hypercalcemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="29" subjects_affected="13" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hypernatremia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <counts group_id="E1" events="33" subjects_affected="10" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" events="23" subjects_affected="12" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" events="33" subjects_affected="17" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hypomagnesemia</sub_title>
                <counts group_id="E1" events="20" subjects_affected="16" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="20" subjects_affected="10" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hypophosphatemia</sub_title>
                <counts group_id="E1" events="20" subjects_affected="10" subjects_at_risk="40"/>
              </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="3" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hallucinations</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
              </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="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Respiratory disorders</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Skin and Subcutaneous tissue disorders</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Surgical and Medical Procedures</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="40"/>
              </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>Borthakur,Gautam MD</name_or_title>
      <organization>UT MD Anderson Cancer Center</organization>
      <phone>713-563-1586</phone>
      <email>CR_Study_Registration@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/NCT01692197
org study id: 2009-0570
secondary id: NCI-2012-02065
nct id: NCT01692197
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The goal of this clinical research study is to learn if E7070 in combination with idarubicin,
      cytarabine, and dexamethasone can help to control the disease in patients with either AML or
      high-risk MDS that has relapsed. The safety of the drug combination will also be studied.
The Study Drugs:

      E7070 is designed to stop metabolic ingredients from reaching the cancer cells and to stop
      the cancer cell from dividing.

      Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer
      cells and stop the DNA from repairing itself.

      Idarubicin is designed to cause breaks in both strands of DNA (the genetic material of
      cells).

      Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body.
      Dexamethasone is often given to AML patients in combination with other chemotherapy to treat
      cancer.

      Study Drug Administration:

      If you are found eligible to take part in this study, you will receive E7070 by vein over 1
      hour on Day 1 and Day 8 (+/- 2 days on Day 8 only) followed by idarubicin by vein over 1 hour
      on Days 9-11. You will also receive cytarabine by vein over 24 hours each day on Days 9-12.
      If you are 60 years of age or older, you will only receive cytarabine on Days 9-11. On days
      that you are receiving the cytarabine infusions, you will also receive dexamethasone by vein
      over about 30 minutes. You will receive dexamethasone before the cytarabine infusions. Each
      study cycle is about 28 days.

      If your doctor thinks you are benefitting from taking the E7070 in combination with
      idarubicin, cytarabine, and dexamethasone, you may receive up to 2 additional cycles of the
      study drug combination.

      Study Visits:

      During Cycle 1, the following tests and procedures will be performed:

        -  You will be asked about medications you are taking and side effects you may have had.

        -  Blood (about 2 teaspoons) will be drawn at least 1 time every week for routine tests and
           to check your liver and kidney function.

        -  You will have a bone marrow aspirate on Day 28 (+/- 3 days) to check the status of the
           disease. You may have additional bone marrow aspirates during Cycle 2 if the doctor
           thinks it is necessary.

        -  During Cycle 1 only, you will have an ECG on Day 2 (+/- 1 day) and Day 8 (+/- 2 days).

      Treatment cycles beyond Cycle 1, the following tests and procedures will be performed:

        -  You will be asked about medications you are taking and side effects you may have had.

        -  Blood (about 2 teaspoons) will be drawn every 2-4 weeks for routine tests.

        -  You will have a bone marrow aspirate to check the status of the disease whenever the
           doctor feels it is necessary.

      Length of Study:

      If the doctor thinks you are benefitting with E7070 in combination with idarubicin,
      cytarabine and dexamethasone, you may receive 2 additional cycles of therapy (a total of 3
      cycles on this study.)

      You will be taken off study if the disease gets worse, you experience intolerable side
      effects, or if the study doctor thinks it is in your best interest.

      End-of-Treatment Visit:

      At the end of treatment, blood (about 2 teaspoons) will be drawn for routine tests within 30
      days (+/- 5 days) of your last dose of the study drug combination. You will also be asked
      about any side effects you may have had.

      Long Term Follow-up (unless you have started on alternative therapy):

      Blood (about 1 tablespoon) will be drawn for routine tests every 2-3 months for up to 2 years
      unless the disease gets worse or you start on another treatment.

      This is an investigational study. E7070 is not FDA-approved or commercially available for use
      in patients with AML or MDS that has relapsed. Its use in this study is considered
      investigational. Idarubicin, cytarabine, and dexamethasone are FDA-approved and commercially
      available for use in the treatment of AML. The combination of E7070, idarubicin, cytarabine,
      and dexamethasone in this study is investigational.

      Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Response
time frame: 2 cycles (60 days)
description: Efficacy measured by overall response - complete response plus complete response with incomplete platelet recovery, plus partial response (Complete remission (CR) + Complete remission without platelet recovery (CRp) + Partial Remission (PR)+ marrow clearance of blast) during cycle 1.
measure: Disease-free Survival
time frame: Up to 5 years
description: Time from date of treatment start until the date of first objective documentation of disease-relapse.
measure: Duration of Response
time frame: Up to 5 years
description: Response date to loss of response or last follow up.
measure: Overall Survival
time frame: Up to 5 years
description: Time from date of treatment start until date of death due to any cause or last follow-up.
arm group label: E7070 + Idarubicin + Cytarabine
arm group type: Experimental
description: E7070 400 mg/m2 IV over 1 hour on day 1 and day 8 (+/- 2 days on Day 8 only) followed by, Idarubicin 8 mg/m2 IV over 1 hour daily for 3 days (days 9-11) and Cytarabine 1.0 g/m2 IV over 24 hours daily on day 9-12 (age <60 years) or days 9-11 (age > 60 years). Dexamethasone 10 mg IV daily for 3-4 days with cytarabine.
intervention type: Drug
intervention name: E7070
description: 400 mg/m2 intravenously over 1 hour on Day 1 and Day 8 every 3 weeks.
arm group label: E7070 + Idarubicin + Cytarabine
intervention type: Drug
intervention name: Idarubicin
description: 8 mg/m2 by vein over 1 hour daily for 3 days (Days 9-11).
arm group label: E7070 + Idarubicin + Cytarabine
other name: Idamycin
intervention type: Drug
intervention name: Cytarabine
description: 1.0 g/m2 by vein daily on Days 9 - 12 (age <60 years) or Days 9 - 11 (age > 60 years).
arm group label: E7070 + Idarubicin + Cytarabine
other name: ARA-C
other name: Cytosar
other name: DepoCyt
other name: Cytosine Arabinosine Hydrochloride
intervention type: Drug
intervention name: Dexamethasone
description: 10 mg by vein daily for 3 - 4 days with cytarabine.
arm group label: E7070 + Idarubicin + Cytarabine
other name: Decadron
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gautam Borthakur, MBBS
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: Preleukemia
mesh term: Myelodysplastic Syndromes
mesh term: Cytarabine
mesh term: Dexamethasone
mesh term: Idarubicin
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 