<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/NCT04493099</url>
  </required_header>
  <id_info>
    <org_study_id>2019-1053</org_study_id>
    <secondary_id>NCI-2020-05266</secondary_id>
    <secondary_id>2019-1053</secondary_id>
    <nct_id>NCT04493099</nct_id>
  </id_info>
  <brief_title>Alvocidib in Combination With Decitabine and Venetoclax in Patients With Relapsed or Refractory AML or as Frontline Therapy in Unfit Patients With AML</brief_title>
  <official_title>A Phase 1/2 Study of Alvocidib in Combination With Decitabine and Venetoclax in Patients With Relapsed or Refractory AML or as Frontline Therapy in Unfit Patients With AML</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase I/II trial investigates the side effects and best dose of alvocidib when given&#xD;
      together with decitabine and venetoclax and to see how well it works in treating patients&#xD;
      with acute myeloid leukemia that has come back (relapsed), has not responded to previous&#xD;
      treatment (refractory), or as frontline treatment for patients unable to receive other&#xD;
      therapies (unfit). Alvocidib, decitabine, and venetoclax may stop the growth of cancer cells&#xD;
      by blocking some of the enzymes needed for cell growth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the safety of alvocidib hydrochloride (alvocidib) in combination with&#xD;
      decitabine and venetoclax in relapsed or refractory patients with acute myeloid leukemia&#xD;
      (AML) or as frontline therapy in unfit/frail patients with AML. (Phase I) II. To determine&#xD;
      the efficacy alvocidib in combination with decitabine and venetoclax in relapsed or&#xD;
      refractory patients with acute myeloid leukemia (AML) or as frontline therapy in unfit/frail&#xD;
      patients with AML. (Phase II)&#xD;
&#xD;
      SECONDARY OBJECTIVE:&#xD;
&#xD;
      I. To determine the preliminary assessment of efficacy by response to revised International&#xD;
      Working Group (IWG) criteria and time to response variables, including overall survival (OS),&#xD;
      event-free survival (EFS) and duration of response (DOR) of patients treated with this&#xD;
      combination.&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I. To determine the minimal residual disease (MRD) after treatment with this combination and&#xD;
      its impact in long-term outcome.&#xD;
&#xD;
      II. To determine the effect of the level of pre-treatment expression of BCL-2 and MCL-1 (by&#xD;
      BH3 profiling) with response to this combination.&#xD;
&#xD;
      III. To determine the effect of this treatment combination on responding patients&#xD;
      transitioning to hematopoietic stem cell transplantation (HSCT).&#xD;
&#xD;
      OUTLINE: This is a phase I, dose-escalation study of alvocidib followed by a phase II study.&#xD;
&#xD;
      INDUCTION: Patients receive decitabine intravenously (IV) over 1 hour on days 1-10, alvocidib&#xD;
      hydrochloride IV over 1 hour on days 1-3, 1-5, 1-7, 1-10, or 1-14, and venetoclax orally (PO)&#xD;
      once daily (QD) on days 1-14 in the absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      CONSOLIDATION: Patients receive decitabine IV over 1 hour on days 1-5, alvocidib&#xD;
      hydrochloride IV over 1 hour on days 1-3, 1-5, 1-7, 1-10 or 1-14, and venetoclax PO QD on&#xD;
      days 1-10. Treatment repeats every 28 days for up to 24 cycles in the absence of disease&#xD;
      progression or unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 4 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The original sponsor was acquired by a new company and has elected to end funding for all&#xD;
    Investigator Sponsored Trials (ISTs)&#xD;
  </why_stopped>
  <start_date type="Anticipated">October 2020</start_date>
  <completion_date type="Actual">October 12, 2020</completion_date>
  <primary_completion_date type="Actual">October 12, 2020</primary_completion_date>
  <phase>Phase 1/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 incidence and severity of all adverse events (Phase I)</measure>
    <time_frame>Up to 6 years</time_frame>
    <description>Measured using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall response rate (ORR) (Phase II)</measure>
    <time_frame>Up to 6 years</time_frame>
    <description>Will estimate the response rate for the combination treatment, along with the 95% credible interval.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>Up to 6 years</time_frame>
    <description>The duration of response is defined as the number of days from the date of initial response (partial response [PR] or better) to the date of first documented disease progression/relapse or death, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event free survival</measure>
    <time_frame>Up to 6 years</time_frame>
    <description>Event-free survival is defined as the number of days from the date of treatment initiation (e.g., cycle 1 day 1 [C1D1]) to the date of documented treatment failure, relapses from complete response (CR), or death from any cause, whichever occurs first, and will be calculated for all patients. Will be estimated using the method of Kaplan and Meier. Comparisons of time-to-event endpoints by important subgroups will be made using the log-rank tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From treatment start till death or last follow-up, assessed up to 6 years</time_frame>
    <description>Will be estimated using the method of Kaplan and Meier. Comparisons of time-to-event endpoints by important subgroups will be made using the log-rank tests.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Recurrent Acute Myeloid Leukemia</condition>
  <condition>Refractory Acute Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>Treatment (decitabine, alvocidib hydrochloride, venetoclax)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>INDUCTION: Patients receive decitabine IV over 1 hour on days 1-10, alvocidib hydrochloride IV over 1 hour on days 1-3, 1-5, 1-7, 1-10, or 1-14, and venetoclax PO QD on days 1-14 in the absence of disease progression or unacceptable toxicity.&#xD;
CONSOLIDATION: Patients receive decitabine IV over 1 hour on days 1-5, alvocidib hydrochloride IV over 1 hour on days 1-3, 1-5, 1-7, 1-10 or 1-14, and venetoclax PO QD on days 1-10. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alvocidib Hydrochloride</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (decitabine, alvocidib hydrochloride, venetoclax)</arm_group_label>
    <other_name>4H-1-Benzopyran-4-one, 2-(2-chlorophenyl)-5, 7-dihydroxy-8-(3-hydroxy-1-methyl-4-piperidinyl)-, hydrochloride, (-)-cis-</other_name>
    <other_name>Flavopiridol Hydrochloride</other_name>
    <other_name>HL-275</other_name>
    <other_name>HMR 1275</other_name>
    <other_name>L-86-8275</other_name>
    <other_name>L-868275</other_name>
    <other_name>MDL 107,826A</other_name>
    <other_name>MDL-107826A</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Decitabine</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (decitabine, alvocidib hydrochloride, venetoclax)</arm_group_label>
    <other_name>5-Aza-2''-deoxycytidine</other_name>
    <other_name>Dacogen</other_name>
    <other_name>Decitabine for Injection</other_name>
    <other_name>Deoxyazacytidine</other_name>
    <other_name>Dezocitidine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Venetoclax</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (decitabine, alvocidib hydrochloride, venetoclax)</arm_group_label>
    <other_name>ABT-0199</other_name>
    <other_name>ABT-199</other_name>
    <other_name>ABT199</other_name>
    <other_name>GDC-0199</other_name>
    <other_name>RG7601</other_name>
    <other_name>Venclexta</other_name>
    <other_name>Venclyxto</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of relapsed or refractory acute myeloid leukemia by World Health&#xD;
             Organization (WHO) criteria. Unfit/frail patients with newly diagnosed AML are also&#xD;
             eligible if not considered good candidates to receive a higher intensity therapy&#xD;
&#xD;
               -  A patient is considered unfit or frail if has three or more of the five factor&#xD;
                  below:&#xD;
&#xD;
                    -  Unintentional weight loss of 10 pounds or more in a year&#xD;
&#xD;
                    -  General feeling of exhaustion&#xD;
&#xD;
                    -  Weakness as measured by grip strength&#xD;
&#xD;
                    -  Slow walking speed&#xD;
&#xD;
                    -  Low levels of physical activity&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status score of =&lt; 3&#xD;
&#xD;
          -  Total serum bilirubin =&lt; 2 x upper limit of normal (ULN). Patients with known&#xD;
             Gilbert's syndrome may have a total bilirubin up to =&lt; 3 x ULN&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) =&lt; 3 x ULN; or&#xD;
             =&lt; 5 x ULN in case of suspected leukemic liver involvement&#xD;
&#xD;
          -  Serum creatinine =&lt; 2.0 mg/dl&#xD;
&#xD;
          -  Females of childbearing potential must have a negative serum or urine beta human&#xD;
             chorionic gonadotropin (B-HCG) pregnancy test result within 1 week (+/-3 days) prior&#xD;
             to the first dose of study drugs and must agree to use one of the following effective&#xD;
             contraception methods during the study and for 30 days following the last dose of&#xD;
             study drug. Effective methods of birth control include:&#xD;
&#xD;
               -  Birth control pills, shots, implants (placed under the skin by a health care&#xD;
                  provider) or patches (placed on the skin)&#xD;
&#xD;
               -  Intrauterine devices (IUDs)&#xD;
&#xD;
               -  Condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicide&#xD;
&#xD;
               -  Abstinence&#xD;
&#xD;
               -  Females of non-childbearing potential are those who are postmenopausal greater&#xD;
                  than 1 year or who have had a bilateral tubal ligation, oophorectomy, and/or&#xD;
                  hysterectomy&#xD;
&#xD;
          -  Males who have partners of childbearing potential must agree to use an effective&#xD;
             contraceptive method (such as condom used with spermicide or abstinence) during the&#xD;
             study and for 30 days following the last dose of study drug&#xD;
&#xD;
          -  Patients or their legally authorized representative must provide written informed&#xD;
             consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with t(15;17) karyotype abnormality or acute promyelocytic leukemia&#xD;
&#xD;
          -  History of another primary invasive malignancy that has not been definitively treated&#xD;
             and in remission. Patients with non-melanoma skin cancers or with carcinomas in situ&#xD;
             are eligible regardless of the time from diagnosis (including concomitant diagnoses)&#xD;
&#xD;
          -  Presence of clinically significant uncontrolled central nervous system (CNS) pathology&#xD;
             such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain&#xD;
             injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome,&#xD;
             or psychosis&#xD;
&#xD;
          -  Evidence of active cerebral/meningeal disease. Patients may have history of CNS&#xD;
             leukemic involvement if definitively treated with prior therapy and no evidence of&#xD;
             active disease at the time of consent with at least 2 consecutive spinal fluid&#xD;
             negative assessments for residual leukemia and negative imaging (imaging required only&#xD;
             if previously showing evidence of CNS leukemia not otherwise documented by spinal&#xD;
             fluid assessment)&#xD;
&#xD;
          -  Patients with active unstable angina, concomitant clinically significant active&#xD;
             arrhythmias, myocardial infarction within 6 months, or congestive heart failure New&#xD;
             York Heart Association class III-IV. Patients with a cardiac ejection fraction (as&#xD;
             measured by either multigated acquisition scan [MUGA] or echocardiogram) &lt; 45% are&#xD;
             excluded&#xD;
&#xD;
          -  Patients with uncontrolled, active infections (viral, bacterial, or fungal)&#xD;
&#xD;
          -  Known active hepatitis B or C infection, or known seropositivity for human&#xD;
             immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Patients with liver cirrhosis or other serious active liver disease or with suspected&#xD;
             active alcohol abuse&#xD;
&#xD;
          -  Allogeneic hematopoietic cell transplantation (HSCT) within 6 months before the start&#xD;
             of protocol-specified therapy, or with active acute/chronic graft-versus-host disease&#xD;
             (GvHD) requiring systemic treatment; or receiving immunosuppression for GvHD&#xD;
             prophylaxis within 2 weeks from the start of study therapy&#xD;
&#xD;
          -  Prior chemotherapy/radiotherapy/investigational therapy within 2 weeks before the&#xD;
             start of study drugs with the following exception:&#xD;
&#xD;
               -  To reduce tumor burden, leukocytosis (circulating blast count) or palliation:&#xD;
                  Intravenous cytarabine and/or hydroxyurea. No washout is necessary for these&#xD;
                  agents. Patients must have recovered from acute non hematologic toxicity (to =&lt;&#xD;
                  grade 1) of all previous therapy prior to enrollment&#xD;
&#xD;
          -  Females who are pregnant or lactating&#xD;
&#xD;
          -  Male or female subjects of childbearing potential, unwilling to use an approved,&#xD;
             effective means of contraception in accordance with institution's standards&#xD;
&#xD;
          -  Other severe, uncontrolled acute or chronic medical or psychiatric condition or&#xD;
             laboratory abnormality that in the opinion of the investigator may increase the risk&#xD;
             associated with study participation or investigational product administration or may&#xD;
             interfere with the interpretation of study results and/or would make the patient&#xD;
             inappropriate for enrollment into this study&#xD;
&#xD;
          -  Prior treatment with alvocidib&#xD;
&#xD;
               -  Prior use of venetoclax single agent or any venetoclax-based combination therapy&#xD;
                  is allowed&#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>Yesid Alvarado-Valero</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>http://www.mdanderson.org</description>
  </link>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>November 9, 2020</last_update_submitted>
  <last_update_submitted_qc>November 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 12, 2020</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>Decitabine</mesh_term>
    <mesh_term>Venetoclax</mesh_term>
    <mesh_term>Alvocidib</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/NCT04493099
org study id: 2019-1053
secondary id: NCI-2020-05266
secondary id: 2019-1053
nct id: NCT04493099
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This phase I/II trial investigates the side effects and best dose of alvocidib when given
      together with decitabine and venetoclax and to see how well it works in treating patients
      with acute myeloid leukemia that has come back (relapsed), has not responded to previous
      treatment (refractory), or as frontline treatment for patients unable to receive other
      therapies (unfit). Alvocidib, decitabine, and venetoclax may stop the growth of cancer cells
      by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:

      I. To determine the safety of alvocidib hydrochloride (alvocidib) in combination with
      decitabine and venetoclax in relapsed or refractory patients with acute myeloid leukemia
      (AML) or as frontline therapy in unfit/frail patients with AML. (Phase I) II. To determine
      the efficacy alvocidib in combination with decitabine and venetoclax in relapsed or
      refractory patients with acute myeloid leukemia (AML) or as frontline therapy in unfit/frail
      patients with AML. (Phase II)

      SECONDARY OBJECTIVE:

      I. To determine the preliminary assessment of efficacy by response to revised International
      Working Group (IWG) criteria and time to response variables, including overall survival (OS),
      event-free survival (EFS) and duration of response (DOR) of patients treated with this
      combination.

      EXPLORATORY OBJECTIVES:

      I. To determine the minimal residual disease (MRD) after treatment with this combination and
      its impact in long-term outcome.

      II. To determine the effect of the level of pre-treatment expression of BCL-2 and MCL-1 (by
      BH3 profiling) with response to this combination.

      III. To determine the effect of this treatment combination on responding patients
      transitioning to hematopoietic stem cell transplantation (HSCT).

      OUTLINE: This is a phase I, dose-escalation study of alvocidib followed by a phase II study.

      INDUCTION: Patients receive decitabine intravenously (IV) over 1 hour on days 1-10, alvocidib
      hydrochloride IV over 1 hour on days 1-3, 1-5, 1-7, 1-10, or 1-14, and venetoclax orally (PO)
      once daily (QD) on days 1-14 in the absence of disease progression or unacceptable toxicity.

      CONSOLIDATION: Patients receive decitabine IV over 1 hour on days 1-5, alvocidib
      hydrochloride IV over 1 hour on days 1-3, 1-5, 1-7, 1-10 or 1-14, and venetoclax PO QD on
      days 1-10. Treatment repeats every 28 days for up to 24 cycles in the absence of disease
      progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up at 4 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall incidence and severity of all adverse events (Phase I)
time frame: Up to 6 years
description: Measured using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
measure: Overall response rate (ORR) (Phase II)
time frame: Up to 6 years
description: Will estimate the response rate for the combination treatment, along with the 95% credible interval.
measure: Duration of response
time frame: Up to 6 years
description: The duration of response is defined as the number of days from the date of initial response (partial response [PR] or better) to the date of first documented disease progression/relapse or death, whichever occurs first.
measure: Event free survival
time frame: Up to 6 years
description: Event-free survival is defined as the number of days from the date of treatment initiation (e.g., cycle 1 day 1 [C1D1]) to the date of documented treatment failure, relapses from complete response (CR), or death from any cause, whichever occurs first, and will be calculated for all patients. Will be estimated using the method of Kaplan and Meier. Comparisons of time-to-event endpoints by important subgroups will be made using the log-rank tests.
measure: Overall survival
time frame: From treatment start till death or last follow-up, assessed up to 6 years
description: Will be estimated using the method of Kaplan and Meier. Comparisons of time-to-event endpoints by important subgroups will be made using the log-rank tests.
arm group label: Treatment (decitabine, alvocidib hydrochloride, venetoclax)
arm group type: Experimental
description: INDUCTION: Patients receive decitabine IV over 1 hour on days 1-10, alvocidib hydrochloride IV over 1 hour on days 1-3, 1-5, 1-7, 1-10, or 1-14, and venetoclax PO QD on days 1-14 in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients receive decitabine IV over 1 hour on days 1-5, alvocidib hydrochloride IV over 1 hour on days 1-3, 1-5, 1-7, 1-10 or 1-14, and venetoclax PO QD on days 1-10. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
intervention type: Drug
intervention name: Alvocidib Hydrochloride
description: Given IV
arm group label: Treatment (decitabine, alvocidib hydrochloride, venetoclax)
other name: 4H-1-Benzopyran-4-one, 2-(2-chlorophenyl)-5, 7-dihydroxy-8-(3-hydroxy-1-methyl-4-piperidinyl)-, hydrochloride, (-)-cis-
other name: Flavopiridol Hydrochloride
other name: HL-275
other name: HMR 1275
other name: L-86-8275
other name: L-868275
other name: MDL 107,826A
other name: MDL-107826A
intervention type: Drug
intervention name: Decitabine
description: Given IV
arm group label: Treatment (decitabine, alvocidib hydrochloride, venetoclax)
other name: 5-Aza-2''-deoxycytidine
other name: Dacogen
other name: Decitabine for Injection
other name: Deoxyazacytidine
other name: Dezocitidine
intervention type: Drug
intervention name: Venetoclax
description: Given PO
arm group label: Treatment (decitabine, alvocidib hydrochloride, venetoclax)
other name: ABT-0199
other name: ABT-199
other name: ABT199
other name: GDC-0199
other name: RG7601
other name: Venclexta
other name: Venclyxto
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yesid Alvarado-Valero
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: http://www.mdanderson.org
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Decitabine
mesh term: Venetoclax
mesh term: Alvocidib