<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/NCT03825796</url>
  </required_header>
  <id_info>
    <org_study_id>18-001416</org_study_id>
    <secondary_id>NCI-2018-02998</secondary_id>
    <nct_id>NCT03825796</nct_id>
  </id_info>
  <brief_title>CPX-351 Plus Enasidenib for Relapsed AML</brief_title>
  <official_title>CPX-351 Plus Enasidenib for Relapsed Acute Myelogenous Leukemia Characterized by the IDH2 Mutation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jonsson Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jazz Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Jonsson Comprehensive Cancer Center</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial evaluates how well CPX-351 and enasidenib work in treating patients with acute&#xD;
      myeloid leukemia characterized by IHD2 mutation. Drugs used in chemotherapy, such as CPX-351,&#xD;
      work in different ways to stop the growth of cancer cells, either by killing the cells, by&#xD;
      stopping them from dividing, or by stopping them from spreading. Enasidenib may stop the&#xD;
      growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving CPX-351&#xD;
      and enasidenib may work better in treating patients with acute myeloid leukemia, compared to&#xD;
      giving only one of these therapies alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To estimate the remission rate (defined as complete remission [CR]/ CR with incomplete&#xD;
      hematologic recovery [CRi]) of the combination of liposome-encapsulated&#xD;
      daunorubicin-cytarabine (CPX-351) plus enasidenib mesylate (enasidenib) in adults with&#xD;
      relapsed acute myeloid leukemia (AML) characterized by a 2-hydroxyglutarate (2-HG) producing&#xD;
      IDH2 mutations that include IDH2^R172 and IDH2^R140.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate persistent severe hematologic toxicity at induction day 60 in patients with a&#xD;
      morphologic leukemia-free state (bone marrow blasts &lt; 5%).&#xD;
&#xD;
      II. To evaluate delayed CR/CRi with enasidenib maintenance in participants with stable&#xD;
      disease after induction with CPX-351.&#xD;
&#xD;
      III. To estimate the rate of CR plus complete remission with partial hematologic recovery&#xD;
      (CRp) of the combination of CPX-351 plus enasidenib.&#xD;
&#xD;
      IV. To evaluate time to return of normal hematopoiesis after induction therapy. V. To&#xD;
      evaluate 30- and 60-day survival. VI. To evaluate CPX-351 plus enasidenib as a bridge to&#xD;
      allogeneic hematopoietic stem cell transplantation (HSCT).&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I. To determine the co-existing mutations that are present with the IDH2 mutation and&#xD;
      describe those that are present in patients who achieve CR/CRi.&#xD;
&#xD;
      II. To determine the depth of molecular response to induction by minimal residual disease&#xD;
      (MRD) using next generation sequencing.&#xD;
&#xD;
      III. To estimate the subclinical cardiotoxicity of CPX-351 as measured by troponin I,&#xD;
      electrocardiography (ECG), and echocardiography.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine intravenously (IV)&#xD;
      over 90 minutes on days 1, 3, and 5, and enasidenib mesylate orally (PO) on days 10-60 in the&#xD;
      absence of disease progression or unacceptable toxicity. Patients whose bone marrow is not&#xD;
      hypoplastic receive re-induction including liposome-encapsulated daunorubicin-cytarabine IV&#xD;
      on days 1 and 3, and enasidenib mesylate PO on days 8-60 in the absence of disease&#xD;
      progression or unacceptable toxicity.&#xD;
&#xD;
      CONSOLIDATION: Participants who achieve CR/CRi may proceed directly to allogeneic HSCT or&#xD;
      receive up to 4 cycles of consolidation. Patients &lt; 60 years receive cytarabine twice daily&#xD;
      (BID) on days 1, 3, and 5, and patients &gt;= 60 years receive cytarabine IV once daily on days&#xD;
      1-5. Patients also receive enasidenib mesylate PO on days 6-55. Treatment repeats every 28-55&#xD;
      days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.&#xD;
      Patients who maintain CR/CRi after completion of consolidation therapy undergo allogeneic&#xD;
      HSCT at the discretion of the treating physician.&#xD;
&#xD;
      MAINTENANCE: Participants who have stable disease (not meeting criteria for progressive&#xD;
      disease, but also not achieving CR/CRi) at day 60 receive enasidenib mesylate PO daily in the&#xD;
      absence of disease progression or unacceptable toxicity. Routine follow-up visits will be&#xD;
      conducted at least once every 3 months for the duration of the trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Accrual&#xD;
  </why_stopped>
  <start_date type="Actual">April 12, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <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>Complete remission (CR)/CR with incomplete hematologic recovery (CRi) after induction therapy</measure>
    <time_frame>Up to day 60</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with persistent grade 4 hematologic toxicity per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03</measure>
    <time_frame>At day 60</time_frame>
    <description>The proportion along with the exact 95% confidence interval will reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who achieve CR/CRi during maintenance therapy</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>This is calculated only among patients who had stable disease after induction therapy and have received maintenance enasidenib monotherapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who achieve CR/complete remission with partial hematologic recovery (CRp) after induction therapy</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to return of normal hematopoiesis</measure>
    <time_frame>From day 1 of induction assessed up to 2 years</time_frame>
    <description>Defined as time from day 1 of induction to absolute neutrophil count (ANC) &gt;= 1000/uL and platelet count &gt;= 100,000/uL. The median time to return of normal hematopoiesis will be reported along with the corresponding range.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From day 1 of induction therapy, assessed at day 30 and 60</time_frame>
    <description>Will be estimated using Kaplan-Meier methods. The survival estimate at these two time points will be reported along with a 95% confidence interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who go on to receive allogeneic hematopoietic stem cell transplantation (HSCT) after achieving CR/CRi</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Will be reported along with an exact 95% confidence interval.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Proportion of patients who have a particular co-occurring mutation with an allelic frequency &gt;= 10% along with the IDH2 mutation, and have achieved CR/CRi</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Will be reported along with an exact 95% confidence interval.</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of patients who achieved CR/CRi then achieve minimal residual disease negativity based on Invivoscribe assay</measure>
    <time_frame>Up to 2 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of abnormal troponin levels without concurrent elevated creatinine</measure>
    <time_frame>Up to 2 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of abnormal electrocardiogram (ECG) findings (new T-wave inversions or new ST segment abnormalities)</measure>
    <time_frame>Up to 2 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of echocardiogram findings with left ventricular ejection fraction reduction by &gt;= 25%</measure>
    <time_frame>Up to 2 years</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Recurrent Acute Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>Treatment (CPX-351, enasidenib mesylate)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>See detailed description</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enasidenib Mesylate</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (CPX-351, enasidenib mesylate)</arm_group_label>
    <other_name>2-Methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol Methanesulfonate</other_name>
    <other_name>2-Propanol, 2-Methyl-1-((4-(6-(trifluoromethyl)-2-pyridinyl)-6-((2-(trifluoromethyl)-4-pyridinyl)amino)-1,3,5-triazin-2-yl)amino)-, Methanesulfonate (1:1)</other_name>
    <other_name>AG-221 Mesylate</other_name>
    <other_name>CC-90007</other_name>
    <other_name>Enasidenib Methanesulfonate</other_name>
    <other_name>Idhifa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Liposome-encapsulated Daunorubicin-Cytarabine</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (CPX-351, enasidenib mesylate)</arm_group_label>
    <other_name>CPX-351</other_name>
    <other_name>Cytarabine-Daunorubicin Liposome for Injection</other_name>
    <other_name>Liposomal AraC-Daunorubicin CPX-351</other_name>
    <other_name>Liposomal Cytarabine-Daunorubicin</other_name>
    <other_name>Liposome-encapsulated Combination of Daunorubicin and Cytarabine</other_name>
    <other_name>Vyxeos</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Bone marrow blasts &gt;= 5% that develops after CR/CRi in patient with prior history of&#xD;
             AML, no restriction on prior number of relapses or regimens&#xD;
&#xD;
          -  AML characterized by the IDH2 gene mutation, without requirement for a particular&#xD;
             allelic frequency&#xD;
&#xD;
          -  Patients previously treated with IDH2 inhibitor can be enrolled&#xD;
&#xD;
          -  At least a 3-month duration of CR/CRi prior to relapse&#xD;
&#xD;
          -  Relapses after allogeneic HSCT are included with a minimum of 3 from the date of&#xD;
             allogeneic HSCT&#xD;
&#xD;
          -  Up to 1 cycle of hypomethylating agent monotherapy at time of relapse is allowed, must&#xD;
             be discontinued at least 14 days prior to start of salvage induction&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2&#xD;
&#xD;
          -  Serum total bilirubin &lt; 2.0 mg/dL, unless considered due to Gilbert's disease or&#xD;
             leukemic involvement&#xD;
&#xD;
          -  Aspartate aminotransferase (AST), alanine aminotransferase (ALT) &lt; 3 times the upper&#xD;
             limit of normal, unless considered due to leukemic involvement&#xD;
&#xD;
          -  Alkaline phosphatase &lt; 3 times the upper limit of normal, unless considered due to&#xD;
             leukemic involvement&#xD;
&#xD;
          -  Serum creatinine =&lt; 2.0 mg/dL, or creatinine clearance &gt; 40 mL/min based on&#xD;
             Cockcroft-Gault glomerular filtration rate (GFR)&#xD;
&#xD;
          -  Females of reproductive potential as well as fertile men and their partners who are&#xD;
             female of reproductive potential must agree to abstain from sexual intercourse or to&#xD;
             use two highly effective forms of contraception from the time of giving informed&#xD;
             consent, during the study, and for four months (females and males) following the last&#xD;
             dose of IDH inhibitor. A highly effective form of contraception is defined as hormonal&#xD;
             oral contraceptives, injectables, patches, intrauterine devices, double-barrier method&#xD;
             (eg, synthetic condoms, diaphragm or cervical cap with spermicidal foam, cream, or&#xD;
             gel) or male partner sterilization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concurrent FLT3 mutation that the treating physician deems necessary to treat with&#xD;
             FLT3-targeted therapy; whereas, patients with FLT3-mutated AML not treated with&#xD;
             FLT3-targeted therapy can be enrolled&#xD;
&#xD;
          -  Acute promyelocytic leukemia&#xD;
&#xD;
          -  Inability to swallow medications or history of gastrointestinal (GI) malabsorptive&#xD;
             disease&#xD;
&#xD;
          -  Active malignancy that would limit survival by less than two years&#xD;
&#xD;
          -  New York Heart Association class III or VI&#xD;
&#xD;
          -  Left ventricular ejection fraction &lt; 40%&#xD;
&#xD;
          -  History of coronary stent placement that require mandatory continuation of&#xD;
             dual-antiplatelet therapy&#xD;
&#xD;
          -  Baseline QT corrected interval based on Fridericia's formula (QTcF) interval &gt; 450 ms&#xD;
&#xD;
          -  History of Wilson's disease or other copper handling disorders&#xD;
&#xD;
          -  Hypersensitivity to cytarabine, daunorubicin, or liposomal products&#xD;
&#xD;
          -  Active invasive fungal infection&#xD;
&#xD;
          -  Active bacterial or viral infection manifesting as fevers or hemodynamic instability&#xD;
             within the past 72 hours&#xD;
&#xD;
          -  Lifetime cumulative daunorubicin-equivalent anthracycline dose &gt; 368 mg/m^2&#xD;
&#xD;
          -  Pregnant or breast feeding&#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>Caspian Oliai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCLA / Jonsson Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA / Jonsson Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Davis Comprehensive Cancer Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>May 5, 2023</last_update_submitted>
  <last_update_submitted_qc>May 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</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>
  </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/NCT03825796
org study id: 18-001416
secondary id: NCI-2018-02998
nct id: NCT03825796
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This trial evaluates how well CPX-351 and enasidenib work in treating patients with acute
      myeloid leukemia characterized by IHD2 mutation. Drugs used in chemotherapy, such as CPX-351,
      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. Enasidenib may stop the
      growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving CPX-351
      and enasidenib may work better in treating patients with acute myeloid leukemia, compared to
      giving only one of these therapies alone.
PRIMARY OBJECTIVE:

      I. To estimate the remission rate (defined as complete remission [CR]/ CR with incomplete
      hematologic recovery [CRi]) of the combination of liposome-encapsulated
      daunorubicin-cytarabine (CPX-351) plus enasidenib mesylate (enasidenib) in adults with
      relapsed acute myeloid leukemia (AML) characterized by a 2-hydroxyglutarate (2-HG) producing
      IDH2 mutations that include IDH2^R172 and IDH2^R140.

      SECONDARY OBJECTIVES:

      I. To evaluate persistent severe hematologic toxicity at induction day 60 in patients with a
      morphologic leukemia-free state (bone marrow blasts < 5%).

      II. To evaluate delayed CR/CRi with enasidenib maintenance in participants with stable
      disease after induction with CPX-351.

      III. To estimate the rate of CR plus complete remission with partial hematologic recovery
      (CRp) of the combination of CPX-351 plus enasidenib.

      IV. To evaluate time to return of normal hematopoiesis after induction therapy. V. To
      evaluate 30- and 60-day survival. VI. To evaluate CPX-351 plus enasidenib as a bridge to
      allogeneic hematopoietic stem cell transplantation (HSCT).

      EXPLORATORY OBJECTIVES:

      I. To determine the co-existing mutations that are present with the IDH2 mutation and
      describe those that are present in patients who achieve CR/CRi.

      II. To determine the depth of molecular response to induction by minimal residual disease
      (MRD) using next generation sequencing.

      III. To estimate the subclinical cardiotoxicity of CPX-351 as measured by troponin I,
      electrocardiography (ECG), and echocardiography.

      OUTLINE:

      INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine intravenously (IV)
      over 90 minutes on days 1, 3, and 5, and enasidenib mesylate orally (PO) on days 10-60 in the
      absence of disease progression or unacceptable toxicity. Patients whose bone marrow is not
      hypoplastic receive re-induction including liposome-encapsulated daunorubicin-cytarabine IV
      on days 1 and 3, and enasidenib mesylate PO on days 8-60 in the absence of disease
      progression or unacceptable toxicity.

      CONSOLIDATION: Participants who achieve CR/CRi may proceed directly to allogeneic HSCT or
      receive up to 4 cycles of consolidation. Patients < 60 years receive cytarabine twice daily
      (BID) on days 1, 3, and 5, and patients >= 60 years receive cytarabine IV once daily on days
      1-5. Patients also receive enasidenib mesylate PO on days 6-55. Treatment repeats every 28-55
      days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
      Patients who maintain CR/CRi after completion of consolidation therapy undergo allogeneic
      HSCT at the discretion of the treating physician.

      MAINTENANCE: Participants who have stable disease (not meeting criteria for progressive
      disease, but also not achieving CR/CRi) at day 60 receive enasidenib mesylate PO daily in the
      absence of disease progression or unacceptable toxicity. Routine follow-up visits will be
      conducted at least once every 3 months for the duration of the trial.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complete remission (CR)/CR with incomplete hematologic recovery (CRi) after induction therapy
time frame: Up to day 60
measure: Proportion of patients with persistent grade 4 hematologic toxicity per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
time frame: At day 60
description: The proportion along with the exact 95% confidence interval will reported.
measure: Proportion of patients who achieve CR/CRi during maintenance therapy
time frame: Up to 2 years
description: This is calculated only among patients who had stable disease after induction therapy and have received maintenance enasidenib monotherapy.
measure: Proportion of patients who achieve CR/complete remission with partial hematologic recovery (CRp) after induction therapy
time frame: Up to 2 years
measure: Time to return of normal hematopoiesis
time frame: From day 1 of induction assessed up to 2 years
description: Defined as time from day 1 of induction to absolute neutrophil count (ANC) >= 1000/uL and platelet count >= 100,000/uL. The median time to return of normal hematopoiesis will be reported along with the corresponding range.
measure: Overall survival
time frame: From day 1 of induction therapy, assessed at day 30 and 60
description: Will be estimated using Kaplan-Meier methods. The survival estimate at these two time points will be reported along with a 95% confidence interval.
measure: Proportion of patients who go on to receive allogeneic hematopoietic stem cell transplantation (HSCT) after achieving CR/CRi
time frame: Up to 2 years
description: Will be reported along with an exact 95% confidence interval.
measure: Proportion of patients who have a particular co-occurring mutation with an allelic frequency >= 10% along with the IDH2 mutation, and have achieved CR/CRi
time frame: Up to 2 years
description: Will be reported along with an exact 95% confidence interval.
measure: Proportion of patients who achieved CR/CRi then achieve minimal residual disease negativity based on Invivoscribe assay
time frame: Up to 2 years
measure: Proportion of abnormal troponin levels without concurrent elevated creatinine
time frame: Up to 2 years
measure: Proportion of abnormal electrocardiogram (ECG) findings (new T-wave inversions or new ST segment abnormalities)
time frame: Up to 2 years
measure: Proportion of echocardiogram findings with left ventricular ejection fraction reduction by >= 25%
time frame: Up to 2 years
arm group label: Treatment (CPX-351, enasidenib mesylate)
arm group type: Experimental
description: See detailed description
intervention type: Drug
intervention name: Enasidenib Mesylate
description: Given PO
arm group label: Treatment (CPX-351, enasidenib mesylate)
other name: 2-Methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol Methanesulfonate
other name: 2-Propanol, 2-Methyl-1-((4-(6-(trifluoromethyl)-2-pyridinyl)-6-((2-(trifluoromethyl)-4-pyridinyl)amino)-1,3,5-triazin-2-yl)amino)-, Methanesulfonate (1:1)
other name: AG-221 Mesylate
other name: CC-90007
other name: Enasidenib Methanesulfonate
other name: Idhifa
intervention type: Drug
intervention name: Liposome-encapsulated Daunorubicin-Cytarabine
description: Given IV
arm group label: Treatment (CPX-351, enasidenib mesylate)
other name: CPX-351
other name: Cytarabine-Daunorubicin Liposome for Injection
other name: Liposomal AraC-Daunorubicin CPX-351
other name: Liposomal Cytarabine-Daunorubicin
other name: Liposome-encapsulated Combination of Daunorubicin and Cytarabine
other name: Vyxeos
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Caspian Oliai, MD
role: Principal Investigator
affiliation: UCLA / Jonsson Comprehensive Cancer Center
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Cytarabine
mesh term: Daunorubicin