<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/NCT02203773</url>
  </required_header>
  <id_info>
    <org_study_id>M14-358</org_study_id>
    <secondary_id>2014-000687-18</secondary_id>
    <nct_id>NCT02203773</nct_id>
  </id_info>
  <brief_title>Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML)</brief_title>
  <official_title>A Phase 1b Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine in Treatment-Naive Subjects With Acute Myelogenous Leukemia Who Are Greater Than or Equal to 60 Years of Age and Who Are Not Eligible for Standard Induction Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Genentech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AbbVie</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety and&#xD;
      pharmacokinetics of orally administered venetoclax (ABT-199) combined with decitabine or&#xD;
      azacitidine and the preliminary efficacy of these combinations. In addition, there is a&#xD;
      drug-drug interaction (DDI) sub-study only at a single site, to assess the pharmacokinetics&#xD;
      and safety of venetoclax (ABT-199) in combination with posaconazole.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Strategic considerations&#xD;
  </why_stopped>
  <start_date type="Actual">October 6, 2014</start_date>
  <completion_date type="Actual">June 16, 2022</completion_date>
  <primary_completion_date type="Actual">June 16, 2022</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Experiencing Adverse Events (AEs)</measure>
    <time_frame>Measured up to 1 year after the last subject last dose</time_frame>
    <description>An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum observed plasma concentration (Cmax)</measure>
    <time_frame>For approximately 5 days following a single dose of ABT-199.</time_frame>
    <description>Maximum observed concentration, occurring at Tmax.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Cmax (peak time, Tmax),</measure>
    <time_frame>For approximately 5 days following a single dose of ABT-199.</time_frame>
    <description>The time at which maximum plasma concentration (Cmax) is observed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The area under the plasma concentration-time curve (AUC) from 0 to 24 hours (AUC0-24)</measure>
    <time_frame>For approximately 5 days following a single dose of ABT-199.</time_frame>
    <description>The area under the plasma concentration-time curve (AUC) over a 24-hour dose interval.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Half-Life (t1/2)</measure>
    <time_frame>For approximately 5 days following a single dose of ABT-199.</time_frame>
    <description>The time required for the concentration of the drug to reach half of its original value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clearance (CL)</measure>
    <time_frame>For approximately 5 days following a single dose of ABT-199.</time_frame>
    <description>Clearance is defined as the rate at which drug is cleared from the blood.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complete Remission Rate</measure>
    <time_frame>Measured up to 1 year after the last subject last dose</time_frame>
    <description>Complete Remission Rate will be determined by the number of subjects who achieve a Complete Remission.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complete Remission with incomplete blood count recovery rate</measure>
    <time_frame>Measured up to 1 year after the last subject last dose</time_frame>
    <description>Complete Remission with incomplete blood count recovery rate will be determined by the number of subjects who achieve a Complete Remission with incomplete blood count recovery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Response Rate</measure>
    <time_frame>Measured up to 1 year after the last subject last dose</time_frame>
    <description>Overall response rate will be defined as the proportion of subjects who achieve a complete remission (CR), complete remission incomplete (CRi), or partial remission (PR) per the International Working Group criteria for AML.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Measured up to 1 year after the last subject last dose</time_frame>
    <description>Overall survival will be defined as the number of days from the date of first dose to the date of death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Event Free Survival</measure>
    <time_frame>Measured up to 1 year after the last subject last dose</time_frame>
    <description>Event-free survival (EFS) will be defined as the number of days from the date of first dose to the date of earliest evidence of relapse, subsequent treatment other than stem cell transplant while in composite complete response (CR + CRi), or death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response</measure>
    <time_frame>Measured up to 1 year after the last subject last dose</time_frame>
    <description>Duration of response will be defined as the number of days from the date of first response per the IWG criteria for AML to the earliest recurrence or progressive disease (PD).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">212</enrollment>
  <condition>Acute Myelogenous Leukemia</condition>
  <condition>Myelogenous Leukemia</condition>
  <condition>Treatment Naive AML</condition>
  <arm_group>
    <arm_group_label>ABT-199 + Azacitidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment Naive Acute Myelogenous Leukemia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABT-199 + Decitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment Naive Acute Myelogenous Leukemia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABT-199+Decitabine+Posaconazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment Naive Acute Myelogenous Leukemia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Posaconazole</intervention_name>
    <description>Posaconazole will be administered orally twice a day on Cycle 1 Day 21 and once daily from Cycle 1 Day 22 to Cycle 1 Day 28.</description>
    <arm_group_label>ABT-199+Decitabine+Posaconazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABT-199</intervention_name>
    <description>ABT-199 is taken orally once daily starting on Day 2 of cycle 1 and begin on day 1 of every other cycle thereafter. This is a dose escalation study, therefore the dose of ABT-199 will change.</description>
    <arm_group_label>ABT-199 + Azacitidine</arm_group_label>
    <arm_group_label>ABT-199 + Decitabine</arm_group_label>
    <arm_group_label>ABT-199+Decitabine+Posaconazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Decitabine</intervention_name>
    <description>Decitabine will be administered by IV infusion over 1 hour beginning on Day 1 thru Day 5 of each Cycle for a minimum of 4 Cycles</description>
    <arm_group_label>ABT-199 + Decitabine</arm_group_label>
    <arm_group_label>ABT-199+Decitabine+Posaconazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azacitidine</intervention_name>
    <description>Azacitidine will be administered by IV infusion over 10 to 40 minutes or subcutaneously based on the institutional guidelines, beginning on Day 1 through Day 7 of each Cycle, for a minimum of 4 Cycles.</description>
    <arm_group_label>ABT-199 + Azacitidine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must have confirmation of Acute Myeloid Leukemia (AML) by WHO criteria and be&#xD;
             ineligible for treatment with a standard cytarabine and anthracycline induction&#xD;
             regimen due to co-morbidity or other factors.&#xD;
&#xD;
          -  Subject must have received no prior treatment for AML with the exception of&#xD;
             hydroxyurea&#xD;
&#xD;
          -  Subjects must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0&#xD;
             to 2 for subjects greater than or equal to 75 years of age, or 0 to 3 for subjects&#xD;
             greater than or equal to 60 to 74 years of age&#xD;
&#xD;
          -  Subject must have adequate kidney and liver function as described in the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has received treatment with the following hypomethylating agent and/or chemo&#xD;
             therapeutic agent for for an antecedent hematologic disorder (AHD) (Subjects may have&#xD;
             been treated with other agents for AHD i.e., Myelodysplastic syndrome [MDS])&#xD;
&#xD;
          -  Subject has history of Myeloproliferative Neoplasm (MPN).&#xD;
&#xD;
          -  Subject has favorable risk cytogenetics as categorized by the National Comprehensive&#xD;
             Cancer Network Guidelines Version 2, 2014 for AML.&#xD;
&#xD;
          -  Subject has t(8;21), inv(16), t(16;16) or t(15;17) karyotype abnormalities.&#xD;
&#xD;
          -  Subject has acute promyelocytic leukemia.&#xD;
&#xD;
          -  Subject has known active central nervous system involvement with AML.&#xD;
&#xD;
          -  Subject has received a strong and/or moderate CYP3A inducer within 7 days prior to the&#xD;
             initiation of study treatment.&#xD;
&#xD;
          -  Subject has a history of other malignancies prior to study entry, with the exception&#xD;
             of:&#xD;
&#xD;
               -  Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of&#xD;
                  breast;&#xD;
&#xD;
               -  Basal cell carcinoma of the skin or localized squamous cell carcinoma of the&#xD;
                  skin;&#xD;
&#xD;
               -  Previous malignancy confined and surgically resected (or treated with other&#xD;
                  modalities) with curative intent.&#xD;
&#xD;
          -  Subject has a white blood cell count &gt; 25 × 10^9/L. Note: Hydroxyurea is permitted to&#xD;
             meet this criterion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ABBVIE INC.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope /ID# 129718</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, Davis Comprehensive Cancer Center /ID# 129719</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ of Colorado Cancer Center /ID# 127859</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory Midtown Infectious Disease Clinic /ID# 129715</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University Feinberg School of Medicine /ID# 128741</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611-2927</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Chicago Medical Center /ID# 128742</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637-1443</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University /ID# 129699</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute /ID# 127857</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center /ID# 130289</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032-3729</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Cancer Center /ID# 129720</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710-3000</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center /ID# 127860</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center /ID# 141581</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington /ID# 129717</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George Hospital /ID# 130356</name>
      <address>
        <city>Kogarah</city>
        <state>New South Wales</state>
        <zip>2217</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peter MacCallum Cancer Ctr /ID# 130352</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alfred Health /ID# 130353</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Haut-Lévêque /ID# 134388</name>
      <address>
        <city>Pessac CEDEX</city>
        <state>Gironde</state>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duplicate_Hopital Universitaire Purpan /ID# 134389</name>
      <address>
        <city>Toulouse</city>
        <state>Haute-Garonne</state>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AP-HP - Hopital Saint-Louis /ID# 130349</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Ulm /ID# 130341</name>
      <address>
        <city>Ulm</city>
        <state>Baden-Wuerttemberg</state>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Leipzig /ID# 130346</name>
      <address>
        <city>Leipzig</city>
        <state>Sachsen</state>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 130342</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duplicate_Klinikum Rechts der Isar /ID# 130347</name>
      <address>
        <city>Munich</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>France</country>
    <country>Germany</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.abbvieclinicaltrials.com/study/?id=M14-358&amp;Latitude=&amp;Longitude=&amp;LocationName=#additional-resources-section</url>
    <description>clinical study report synopsis</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>May 12, 2023</last_update_submitted>
  <last_update_submitted_qc>May 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute Myelogenous Leukemia</keyword>
  <keyword>AML</keyword>
  <keyword>Myelogenous Leukemia</keyword>
  <keyword>ABT-199</keyword>
  <keyword>GDC-0199</keyword>
  <keyword>Treatment Naive AML</keyword>
  <keyword>Untreated AML</keyword>
  <keyword>Venetoclax</keyword>
  <keyword>Venclexta</keyword>
  <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>Posaconazole</mesh_term>
    <mesh_term>Azacitidine</mesh_term>
    <mesh_term>Decitabine</mesh_term>
    <mesh_term>Venetoclax</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02203773
org study id: M14-358
secondary id: 2014-000687-18
nct id: NCT02203773
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety and
      pharmacokinetics of orally administered venetoclax (ABT-199) combined with decitabine or
      azacitidine and the preliminary efficacy of these combinations. In addition, there is a
      drug-drug interaction (DDI) sub-study only at a single site, to assess the pharmacokinetics
      and safety of venetoclax (ABT-199) in combination with posaconazole.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants Experiencing Adverse Events (AEs)
time frame: Measured up to 1 year after the last subject last dose
description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug.
measure: Maximum observed plasma concentration (Cmax)
time frame: For approximately 5 days following a single dose of ABT-199.
description: Maximum observed concentration, occurring at Tmax.
measure: Time to Cmax (peak time, Tmax),
time frame: For approximately 5 days following a single dose of ABT-199.
description: The time at which maximum plasma concentration (Cmax) is observed.
measure: The area under the plasma concentration-time curve (AUC) from 0 to 24 hours (AUC0-24)
time frame: For approximately 5 days following a single dose of ABT-199.
description: The area under the plasma concentration-time curve (AUC) over a 24-hour dose interval.
measure: Half-Life (t1/2)
time frame: For approximately 5 days following a single dose of ABT-199.
description: The time required for the concentration of the drug to reach half of its original value.
measure: Clearance (CL)
time frame: For approximately 5 days following a single dose of ABT-199.
description: Clearance is defined as the rate at which drug is cleared from the blood.
measure: Complete Remission Rate
time frame: Measured up to 1 year after the last subject last dose
description: Complete Remission Rate will be determined by the number of subjects who achieve a Complete Remission.
measure: Complete Remission with incomplete blood count recovery rate
time frame: Measured up to 1 year after the last subject last dose
description: Complete Remission with incomplete blood count recovery rate will be determined by the number of subjects who achieve a Complete Remission with incomplete blood count recovery.
measure: Overall Response Rate
time frame: Measured up to 1 year after the last subject last dose
description: Overall response rate will be defined as the proportion of subjects who achieve a complete remission (CR), complete remission incomplete (CRi), or partial remission (PR) per the International Working Group criteria for AML.
measure: Overall Survival
time frame: Measured up to 1 year after the last subject last dose
description: Overall survival will be defined as the number of days from the date of first dose to the date of death.
measure: Event Free Survival
time frame: Measured up to 1 year after the last subject last dose
description: Event-free survival (EFS) will be defined as the number of days from the date of first dose to the date of earliest evidence of relapse, subsequent treatment other than stem cell transplant while in composite complete response (CR + CRi), or death.
measure: Duration of Response
time frame: Measured up to 1 year after the last subject last dose
description: Duration of response will be defined as the number of days from the date of first response per the IWG criteria for AML to the earliest recurrence or progressive disease (PD).
arm group label: ABT-199 + Azacitidine
arm group type: Experimental
description: Treatment Naive Acute Myelogenous Leukemia
arm group label: ABT-199 + Decitabine
arm group type: Experimental
description: Treatment Naive Acute Myelogenous Leukemia
arm group label: ABT-199+Decitabine+Posaconazole
arm group type: Experimental
description: Treatment Naive Acute Myelogenous Leukemia
intervention type: Drug
intervention name: Posaconazole
description: Posaconazole will be administered orally twice a day on Cycle 1 Day 21 and once daily from Cycle 1 Day 22 to Cycle 1 Day 28.
arm group label: ABT-199+Decitabine+Posaconazole
intervention type: Drug
intervention name: ABT-199
description: ABT-199 is taken orally once daily starting on Day 2 of cycle 1 and begin on day 1 of every other cycle thereafter. This is a dose escalation study, therefore the dose of ABT-199 will change.
arm group label: ABT-199 + Azacitidine
arm group label: ABT-199 + Decitabine
arm group label: ABT-199+Decitabine+Posaconazole
intervention type: Drug
intervention name: Decitabine
description: Decitabine will be administered by IV infusion over 1 hour beginning on Day 1 thru Day 5 of each Cycle for a minimum of 4 Cycles
arm group label: ABT-199 + Decitabine
arm group label: ABT-199+Decitabine+Posaconazole
intervention type: Drug
intervention name: Azacitidine
description: Azacitidine will be administered by IV infusion over 10 to 40 minutes or subcutaneously based on the institutional guidelines, beginning on Day 1 through Day 7 of each Cycle, for a minimum of 4 Cycles.
arm group label: ABT-199 + Azacitidine
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: ABBVIE INC.
role: Study Director
affiliation: AbbVie
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country: Australia
country: France
country: Germany
country: United States
url: https://www.abbvieclinicaltrials.com/study/?id=M14-358&Latitude=&Longitude=&LocationName=#additional-resources-section
description: clinical study report synopsis
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Posaconazole
mesh term: Azacitidine
mesh term: Decitabine
mesh term: Venetoclax
sharing ipd: No