<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/NCT02971397</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00040792</org_study_id>
    <secondary_id>NCI-2016-01464</secondary_id>
    <secondary_id>CCCWFU 22616</secondary_id>
    <secondary_id>P30CA012197</secondary_id>
    <nct_id>NCT02971397</nct_id>
  </id_info>
  <brief_title>Cytarabine and Daunorubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia</brief_title>
  <official_title>Cytarabine Plus Continuous Infusion Daunorubicin Induction Therapy for Adults With Acute Myeloid Leukemia: A Feasibility Study With Cardiac MRI Monitoring</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</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 pilot clinical trial studies the side effects of cytarabine and daunorubicin&#xD;
      hydrochloride and to see how well they work in treating patients with newly diagnosed acute&#xD;
      myeloid leukemia. Drugs used in chemotherapy, such as cytarabine and daunorubicin&#xD;
      hydrochloride, work in different ways to stop the growth of cancer cells, either by killing&#xD;
      the cells, by stopping them from dividing, or by stopping them from spreading, and may be&#xD;
      safer for the heart.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the safety (at 3 months) and feasibility of administering daunorubicin&#xD;
      hydrochloride (daunorubicin) as continuous infusion under the proposed treatment regimen.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the safety (at 6 months) of administering daunorubicin as continuous infusion&#xD;
      under the proposed treatment regimen.&#xD;
&#xD;
      II. To assess treatment outcomes (including complete remission [CR] and complete remission&#xD;
      with incomplete recovery [CRi]) in patients with acute myeloid leukemia (AML) under the&#xD;
      proposed treatment regimen.&#xD;
&#xD;
      III. To compare the concordance between magnetic resonance imaging (MRI) and echocardiogram&#xD;
      (ECHO) in identifying cardiac toxicity, ie a reduction in left ventricular ejection fraction&#xD;
      (LVEF) of &gt;= 10% and ejection fraction (EF) =&lt; 50% compared to baseline LVEF.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      INDUCTION: Patients receive cytarabine intravenously (IV) continuously over 24 hours on days&#xD;
      1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence&#xD;
      of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate&#xD;
      and biopsy on day 14. Patients with bone marrow cellularity &gt;= 10% and &gt; 5% leukemic blasts,&#xD;
      may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and&#xD;
      daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of&#xD;
      disease progression or unacceptable toxicity.&#xD;
&#xD;
      CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours&#xD;
      on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of&#xD;
      disease progression or unacceptable toxicity. Patients with core-binding factor (CBF) AML may&#xD;
      receive 4 courses of therapy.&#xD;
&#xD;
      After completion of study treatment, patients are followed up for a minimum of 30 days, at 3&#xD;
      and 6 months, and then every 3 months thereafter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Anticipated">March 2020</completion_date>
  <primary_completion_date type="Actual">March 2018</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>Change in incidence of cardiac toxicity, defined as reduction in LVEF of &gt;= 10% compared to baseline LVEF and EF =&lt; 50% on the follow-up scan, assessed using MRI</measure>
    <time_frame>Baseline up to 3 months after last dose of study drug</time_frame>
    <description>In addition to point estimates of these rates, 95% confidence intervals will be calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of other unexpected toxicities, measured by Common Terminology Criteria for Adverse Events version 4.0</measure>
    <time_frame>Up to 6 months after last dose of study drug</time_frame>
    <description>In addition to point estimates of these rates, 95% confidence intervals will be calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients who complete the infusion therapy</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Will report these proportions with 95% confidence intervals.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients with study-related deviations</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Will report these proportions with 95% confidence intervals.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in incidence of cardiac toxicity, defined as reduction in LVEF of &gt;= 10% compared to baseline LVEF and EF =&lt; 50% on the follow-up scan, assessed using ECHO</measure>
    <time_frame>Baseline up to 3 months after last dose of study drug</time_frame>
    <description>In addition to point estimates of these rates, 95% confidence intervals will be calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in EF, assessed by MRI and ECHO</measure>
    <time_frame>Baseline up to 6 months after last dose of study drug</time_frame>
    <description>Will determine the correlation between ECHO and MRI assessments performed pre-chemotherapy. Will assess correlations between post-chemotherapy ECHO and MRI assessments. Will assess correlations between each of the time points. Paired t-tests will be performed to compare the actual values of each ECHO/MRI measurement to each other at each time point. Bland-Altman plots will be generated at baseline, follow-up and using the change in measure for each of the MRI/ECHO derived measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in incidence of cardiac toxicity, defined as reduction in LVEF of &gt;= 10% compared to baseline LVEF and EF =&lt; 50% on the follow-up scan, assessed using MRI and ECHO</measure>
    <time_frame>Baseline up to 6 months after last dose of study drug</time_frame>
    <description>Will determine the correlation between ECHO and MRI assessments performed pre-chemotherapy. Will assess correlations between post-chemotherapy ECHO and MRI assessments. Will assess correlations between each of the time points. Paired t-tests will be performed to compare the actual values of each ECHO/MRI measurement to each other at each time point. Bland-Altman plots will be generated at baseline, follow-up and using the change in measure for each of the MRI/ECHO derived measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in left ventricular end diastolic volume, assessed by MRI and ECHO</measure>
    <time_frame>Baseline up to 6 months after last dose of study drug</time_frame>
    <description>Will determine the correlation between ECHO and MRI assessments performed pre-chemotherapy. Will assess correlations between post-chemotherapy ECHO and MRI assessments. Will assess correlations between each of the time points. Paired t-tests will be performed to compare the actual values of each ECHO/MRI measurement to each other at each time point. Bland-Altman plots will be generated at baseline, follow-up and using the change in measure for each of the MRI/ECHO derived measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in left ventricular end systolic volume, assessed by MRI and ECHO</measure>
    <time_frame>Baseline up to 6 months after last dose of study drug</time_frame>
    <description>Will determine the correlation between ECHO and MRI assessments performed pre-chemotherapy. Will assess correlations between post-chemotherapy ECHO and MRI assessments. Will assess correlations between each of the time points. Paired t-tests will be performed to compare the actual values of each ECHO/MRI measurement to each other at each time point. Bland-Altman plots will be generated at baseline, follow-up and using the change in measure for each of the MRI/ECHO derived measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in myocardial strain, assessed by MRI and ECHO</measure>
    <time_frame>Baseline up to 6 months after last dose of study drug</time_frame>
    <description>Will determine the correlation between ECHO and MRI assessments performed pre-chemotherapy. Will assess correlations between post-chemotherapy ECHO and MRI assessments. Will assess correlations between each of the time points. Paired t-tests will be performed to compare the actual values of each ECHO/MRI measurement to each other at each time point. Bland-Altman plots will be generated at baseline, follow-up and using the change in measure for each of the MRI/ECHO derived measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival for those patients who achieve remission</measure>
    <time_frame>From the date of CR until relapse from CR or death, assessed for up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Induction death rate</measure>
    <time_frame>Up to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response rate, defined as CR + CRi</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>Treatment (cytarabine, daunorubicin hydrochloride, biopsy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity &gt;= 10% and &gt; 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity.&#xD;
CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bone Marrow Aspiration and Biopsy</intervention_name>
    <description>Undergo bone marrow aspiration and biopsy</description>
    <arm_group_label>Treatment (cytarabine, daunorubicin hydrochloride, biopsy)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cytarabine</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (cytarabine, daunorubicin hydrochloride, biopsy)</arm_group_label>
    <other_name>.beta.-Cytosine arabinoside</other_name>
    <other_name>1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone</other_name>
    <other_name>1-.beta.-D-Arabinofuranosylcytosine</other_name>
    <other_name>1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone</other_name>
    <other_name>1-Beta-D-arabinofuranosylcytosine</other_name>
    <other_name>1.beta.-D-Arabinofuranosylcytosine</other_name>
    <other_name>2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-</other_name>
    <other_name>2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-</other_name>
    <other_name>Alexan</other_name>
    <other_name>Ara-C</other_name>
    <other_name>ARA-cell</other_name>
    <other_name>Arabine</other_name>
    <other_name>Arabinofuranosylcytosine</other_name>
    <other_name>Arabinosylcytosine</other_name>
    <other_name>Aracytidine</other_name>
    <other_name>Aracytin</other_name>
    <other_name>Aracytine</other_name>
    <other_name>Beta-Cytosine Arabinoside</other_name>
    <other_name>CHX-3311</other_name>
    <other_name>Cytarabinum</other_name>
    <other_name>Cytarbel</other_name>
    <other_name>Cytosar</other_name>
    <other_name>Cytosar-U</other_name>
    <other_name>Cytosine Arabinoside</other_name>
    <other_name>Cytosine-.beta.-arabinoside</other_name>
    <other_name>Cytosine-beta-arabinoside</other_name>
    <other_name>Erpalfa</other_name>
    <other_name>Starasid</other_name>
    <other_name>Tarabine PFS</other_name>
    <other_name>U 19920</other_name>
    <other_name>U-19920</other_name>
    <other_name>Udicil</other_name>
    <other_name>WR-28453</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daunorubicin Hydrochloride</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (cytarabine, daunorubicin hydrochloride, biopsy)</arm_group_label>
    <other_name>Cerubidin</other_name>
    <other_name>Cerubidine</other_name>
    <other_name>Cloridrato de Daunorubicina</other_name>
    <other_name>Daunoblastin</other_name>
    <other_name>Daunoblastina</other_name>
    <other_name>Daunoblastine</other_name>
    <other_name>Daunomycin Hydrochloride</other_name>
    <other_name>Daunomycin, hydrochloride</other_name>
    <other_name>Daunorubicin.HCl</other_name>
    <other_name>Daunorubicini Hydrochloridum</other_name>
    <other_name>FI-6339</other_name>
    <other_name>Ondena</other_name>
    <other_name>RP-13057</other_name>
    <other_name>Rubidomycin Hydrochloride</other_name>
    <other_name>Rubilem</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (cytarabine, daunorubicin hydrochloride, biopsy)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have morphologically confirmed newly diagnosed acute myelogenous&#xD;
             leukemia (AML) with blood or bone marrow disease; patients with only extramedullary&#xD;
             disease in the absence of bone marrow or blood involvement are eligible; note: this&#xD;
             protocol uses World Health Organization (WHO) diagnostic criteria for AML; patients&#xD;
             with acute promyelocytic leukemia (APL, French-American-British Classification [FAB],&#xD;
             M3) or blastic transformation of chronic myelogenous leukemia (CML) are not eligible&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-3&#xD;
&#xD;
          -  Patients with ECHO EF &gt;= 45% within 28 days prior to registration&#xD;
&#xD;
          -  Women of child-bearing potential and men must agree to use adequate contraception&#xD;
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for&#xD;
             the duration of study participation; should a woman become pregnant or suspect she is&#xD;
             pregnant while participating in this study, she should inform her treating physician&#xD;
             immediately&#xD;
&#xD;
          -  Ability to understand and the willingness to sign an Institutional Review Board&#xD;
             (IRB)-approved informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have received prior induction chemotherapy for AML or myelodysplastic&#xD;
             syndrome (MDS); temporary prior measures such as apheresis or hydroxyurea are allowed;&#xD;
             patients who have received a limited and short-term exposure of ATRA (all trans&#xD;
             retinoic acid) while AML-M3 (acute promyelocytic leukemia) was being ruled out, and&#xD;
             which has been discontinued, will be eligible&#xD;
&#xD;
          -  Patients receiving any other investigational agents&#xD;
&#xD;
          -  Patients with prolonged corrected QT (QTc) interval (&gt; 500 msec) determined by&#xD;
             electrocardiogram (EKG) within 28 days prior to registration&#xD;
&#xD;
          -  Patients not suitable for cardiac MRI; contraindications include:&#xD;
&#xD;
               -  Intracranial metal, pacemakers, defibrillators, functioning neurostimulator&#xD;
                  devices, or other implanted electronic devices&#xD;
&#xD;
               -  Ferromagnetic cerebral aneurysm clips, or other intraorbital/intracranial metal&#xD;
&#xD;
               -  Allergy to gadolinium or other severe drug allergies&#xD;
&#xD;
               -  Claustrophobia&#xD;
&#xD;
               -  Congestive heart failure (New York Heart Association [NYHA] class III or IV)&#xD;
&#xD;
               -  Significant valvular disease, or significant pulmonary disease requiring&#xD;
                  supplemental oxygen therapy&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to daunorubicin or cytarabine&#xD;
&#xD;
          -  Patients with documented central nervous system (CNS) involvement&#xD;
&#xD;
          -  Patients who are known to be human immunodeficiency virus (HIV) positive (+) may be&#xD;
             eligible providing they meet all of the following additional criteria within 28 days&#xD;
             prior to registration:&#xD;
&#xD;
               -  CD4 cells &gt;= 500/mm^3&#xD;
&#xD;
               -  Viral load of &lt; 50 copies HIV messenger ribonucleic acid (mRNA)/mm^3 if on&#xD;
                  combination antiretroviral therapy (cART) or &lt; 25,000 copies HIV mRNA if not on&#xD;
                  cART&#xD;
&#xD;
               -  No zidovudine or stavudine as part of cART Patients who are HIV+ and do not meet&#xD;
                  all of these criteria are not eligible for this study&#xD;
&#xD;
          -  Patients with other uncontrolled intercurrent illness or psychiatric illness/social&#xD;
             situations that would limit compliance with study requirements&#xD;
&#xD;
          -  Pregnant women are excluded from this study; breastfeeding should be discontinued&#xD;
             prior to beginning treatment&#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>Bayard Powell</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Comprehensive Cancer Center of Wake Forest University</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>October 4, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>November 1, 2018</last_update_submitted>
  <last_update_submitted_qc>November 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2018</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cytarabine</mesh_term>
    <mesh_term>Daunorubicin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02971397
org study id: IRB00040792
secondary id: NCI-2016-01464
secondary id: CCCWFU 22616
secondary id: P30CA012197
nct id: NCT02971397
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This pilot clinical trial studies the side effects of cytarabine and daunorubicin
      hydrochloride and to see how well they work in treating patients with newly diagnosed acute
      myeloid leukemia. Drugs used in chemotherapy, such as cytarabine and daunorubicin
      hydrochloride, work in different ways to stop the growth of cancer cells, either by killing
      the cells, by stopping them from dividing, or by stopping them from spreading, and may be
      safer for the heart.
PRIMARY OBJECTIVES:

      I. To assess the safety (at 3 months) and feasibility of administering daunorubicin
      hydrochloride (daunorubicin) as continuous infusion under the proposed treatment regimen.

      SECONDARY OBJECTIVES:

      I. To assess the safety (at 6 months) of administering daunorubicin as continuous infusion
      under the proposed treatment regimen.

      II. To assess treatment outcomes (including complete remission [CR] and complete remission
      with incomplete recovery [CRi]) in patients with acute myeloid leukemia (AML) under the
      proposed treatment regimen.

      III. To compare the concordance between magnetic resonance imaging (MRI) and echocardiogram
      (ECHO) in identifying cardiac toxicity, ie a reduction in left ventricular ejection fraction
      (LVEF) of >= 10% and ejection fraction (EF) =< 50% compared to baseline LVEF.

      OUTLINE:

      INDUCTION: Patients receive cytarabine intravenously (IV) continuously over 24 hours on days
      1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence
      of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate
      and biopsy on day 14. Patients with bone marrow cellularity >= 10% and > 5% leukemic blasts,
      may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and
      daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of
      disease progression or unacceptable toxicity.

      CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours
      on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of
      disease progression or unacceptable toxicity. Patients with core-binding factor (CBF) AML may
      receive 4 courses of therapy.

      After completion of study treatment, patients are followed up for a minimum of 30 days, at 3
      and 6 months, and then every 3 months thereafter.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in incidence of cardiac toxicity, defined as reduction in LVEF of >= 10% compared to baseline LVEF and EF =< 50% on the follow-up scan, assessed using MRI
time frame: Baseline up to 3 months after last dose of study drug
description: In addition to point estimates of these rates, 95% confidence intervals will be calculated.
measure: Incidence of other unexpected toxicities, measured by Common Terminology Criteria for Adverse Events version 4.0
time frame: Up to 6 months after last dose of study drug
description: In addition to point estimates of these rates, 95% confidence intervals will be calculated.
measure: Proportion of patients who complete the infusion therapy
time frame: Up to 4 months
description: Will report these proportions with 95% confidence intervals.
measure: Proportion of patients with study-related deviations
time frame: Up to 2 years
description: Will report these proportions with 95% confidence intervals.
measure: Change in incidence of cardiac toxicity, defined as reduction in LVEF of >= 10% compared to baseline LVEF and EF =< 50% on the follow-up scan, assessed using ECHO
time frame: Baseline up to 3 months after last dose of study drug
description: In addition to point estimates of these rates, 95% confidence intervals will be calculated.
measure: Change in EF, assessed by MRI and ECHO
time frame: Baseline up to 6 months after last dose of study drug
description: Will determine the correlation between ECHO and MRI assessments performed pre-chemotherapy. Will assess correlations between post-chemotherapy ECHO and MRI assessments. Will assess correlations between each of the time points. Paired t-tests will be performed to compare the actual values of each ECHO/MRI measurement to each other at each time point. Bland-Altman plots will be generated at baseline, follow-up and using the change in measure for each of the MRI/ECHO derived measures.
measure: Change in incidence of cardiac toxicity, defined as reduction in LVEF of >= 10% compared to baseline LVEF and EF =< 50% on the follow-up scan, assessed using MRI and ECHO
time frame: Baseline up to 6 months after last dose of study drug
description: Will determine the correlation between ECHO and MRI assessments performed pre-chemotherapy. Will assess correlations between post-chemotherapy ECHO and MRI assessments. Will assess correlations between each of the time points. Paired t-tests will be performed to compare the actual values of each ECHO/MRI measurement to each other at each time point. Bland-Altman plots will be generated at baseline, follow-up and using the change in measure for each of the MRI/ECHO derived measures.
measure: Change in left ventricular end diastolic volume, assessed by MRI and ECHO
time frame: Baseline up to 6 months after last dose of study drug
description: Will determine the correlation between ECHO and MRI assessments performed pre-chemotherapy. Will assess correlations between post-chemotherapy ECHO and MRI assessments. Will assess correlations between each of the time points. Paired t-tests will be performed to compare the actual values of each ECHO/MRI measurement to each other at each time point. Bland-Altman plots will be generated at baseline, follow-up and using the change in measure for each of the MRI/ECHO derived measures.
measure: Change in left ventricular end systolic volume, assessed by MRI and ECHO
time frame: Baseline up to 6 months after last dose of study drug
description: Will determine the correlation between ECHO and MRI assessments performed pre-chemotherapy. Will assess correlations between post-chemotherapy ECHO and MRI assessments. Will assess correlations between each of the time points. Paired t-tests will be performed to compare the actual values of each ECHO/MRI measurement to each other at each time point. Bland-Altman plots will be generated at baseline, follow-up and using the change in measure for each of the MRI/ECHO derived measures.
measure: Change in myocardial strain, assessed by MRI and ECHO
time frame: Baseline up to 6 months after last dose of study drug
description: Will determine the correlation between ECHO and MRI assessments performed pre-chemotherapy. Will assess correlations between post-chemotherapy ECHO and MRI assessments. Will assess correlations between each of the time points. Paired t-tests will be performed to compare the actual values of each ECHO/MRI measurement to each other at each time point. Bland-Altman plots will be generated at baseline, follow-up and using the change in measure for each of the MRI/ECHO derived measures.
measure: Disease-free survival for those patients who achieve remission
time frame: From the date of CR until relapse from CR or death, assessed for up to 2 years
measure: Induction death rate
time frame: Up to 28 days
measure: Overall response rate, defined as CR + CRi
time frame: Up to 2 years
arm group label: Treatment (cytarabine, daunorubicin hydrochloride, biopsy)
arm group type: Experimental
description: INDUCTION: Patients receive cytarabine IV continuously over 24 hours on days 1-7 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-3 in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 14. Patients with bone marrow cellularity >= 10% and > 5% leukemic blasts, may receive a second induction of cytarabine IV continuously over 24 hours on days 1-5 and daunorubicin hydrochloride IV continuously over 24 hours on days 1-2 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving remission receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with CBF AML may receive 4 courses of therapy.
intervention type: Procedure
intervention name: Bone Marrow Aspiration and Biopsy
description: Undergo bone marrow aspiration and biopsy
arm group label: Treatment (cytarabine, daunorubicin hydrochloride, biopsy)
intervention type: Drug
intervention name: Cytarabine
description: Given IV
arm group label: Treatment (cytarabine, daunorubicin hydrochloride, biopsy)
other name: .beta.-Cytosine arabinoside
other name: 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
other name: 1-.beta.-D-Arabinofuranosylcytosine
other name: 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
other name: 1-Beta-D-arabinofuranosylcytosine
other name: 1.beta.-D-Arabinofuranosylcytosine
other name: 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
other name: 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
other name: Alexan
other name: Ara-C
other name: ARA-cell
other name: Arabine
other name: Arabinofuranosylcytosine
other name: Arabinosylcytosine
other name: Aracytidine
other name: Aracytin
other name: Aracytine
other name: Beta-Cytosine Arabinoside
other name: CHX-3311
other name: Cytarabinum
other name: Cytarbel
other name: Cytosar
other name: Cytosar-U
other name: Cytosine Arabinoside
other name: Cytosine-.beta.-arabinoside
other name: Cytosine-beta-arabinoside
other name: Erpalfa
other name: Starasid
other name: Tarabine PFS
other name: U 19920
other name: U-19920
other name: Udicil
other name: WR-28453
intervention type: Drug
intervention name: Daunorubicin Hydrochloride
description: Given IV
arm group label: Treatment (cytarabine, daunorubicin hydrochloride, biopsy)
other name: Cerubidin
other name: Cerubidine
other name: Cloridrato de Daunorubicina
other name: Daunoblastin
other name: Daunoblastina
other name: Daunoblastine
other name: Daunomycin Hydrochloride
other name: Daunomycin, hydrochloride
other name: Daunorubicin.HCl
other name: Daunorubicini Hydrochloridum
other name: FI-6339
other name: Ondena
other name: RP-13057
other name: Rubidomycin Hydrochloride
other name: Rubilem
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Treatment (cytarabine, daunorubicin hydrochloride, biopsy)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bayard Powell
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Cytarabine
mesh term: Daunorubicin