<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/NCT04493164</url>
  </required_header>
  <id_info>
    <org_study_id>2020-0096</org_study_id>
    <secondary_id>NCI-2020-05258</secondary_id>
    <secondary_id>2020-0096</secondary_id>
    <nct_id>NCT04493164</nct_id>
  </id_info>
  <brief_title>CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome</brief_title>
  <official_title>Phase II Investigator Sponsored Study of CPX-351 in Combination With Ivosidenib for Patients With IDH1 Mutated Acute Myeloid Leukemia or High-Risk MDS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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 II trial investigates how well CPX-351 and ivosidenib work in treating patients&#xD;
      with acute myeloid leukemia or high-risk myelodysplastic syndrome that has IDH1 mutation. The&#xD;
      safety of this drug combination will also be studied. IDH1 is a type of genetic mutation&#xD;
      (change). Chemotherapy drugs, such as CPX-351, work in different ways to stop the growth of&#xD;
      cancer cells, either by killing the cells, by stopping them from dividing, or by stopping&#xD;
      them from spreading. Ivosidenib may stop the growth of cancer cells by blocking some of the&#xD;
      enzymes needed for cell growth. The purpose of this trial is to learn if CPX-351 in&#xD;
      combination with ivosidenib can help to control IDH1-mutated acute myeloid leukemia or&#xD;
      high-risk myelodysplastic syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To determine the overall response rate (ORR) including complete remission (CR), complete&#xD;
      remission with hematologic recovery (CRh), complete remission with incomplete blood count&#xD;
      recovery (CRi), morphologic leukemia-free state (MLFS), and partial remission (PR) of the&#xD;
      combination of liposome-encapsulated daunorubicin-cytarabine (CPX-351) and ivosidenib in&#xD;
      IDH1-mutated patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome&#xD;
      (MDS).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To assess safety of CPX-351 in combination with ivosidenib. II. To determine time to event&#xD;
      endpoints including duration of response (DOR), event free survival (EFS) and overall&#xD;
      survival (OS).&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I. Evaluate minimal residual disease (MRD) using multiparameter flow cytometry, cytogenetics&#xD;
      and molecular evaluation.&#xD;
&#xD;
      II. To evaluate molecular and cellular biomarkers that may be predictive of antitumor&#xD;
      activity and/or resistance to treatment including evaluation of 2HG, IDH1 and other&#xD;
      co-occurring mutations and VAF levels before, during and after treatment.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      INDUCTION: Patients receive CPX-351 intravenously (IV) over 90 minutes on days 1, 3, and 5,&#xD;
      and ivosidenib orally (PO) once daily (QD) on days 1-28. Patients who do not achieve complete&#xD;
      remission may receive a second cycle of induction therapy in the absence of disease&#xD;
      progression or unacceptable toxicity. Patients achieving complete remission proceed to&#xD;
      consolidation.&#xD;
&#xD;
      CONSOLIDATION: Patients receive CPX-351 IV over 90 minutes on days 1 and 3, and ivosidenib PO&#xD;
      QD on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease&#xD;
      progression or unacceptable toxicity.&#xD;
&#xD;
      MAINTENANCE: Patients receive ivosidenib PO QD for up to 2 years in the absence of disease&#xD;
      progression or unacceptable toxicity. Patients who are experiencing clinical benefit and who&#xD;
      have not experienced excessive toxicity after completion of 2 years of maintenance may be&#xD;
      eligible to continue therapy after discussion with the principal investigator.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 30 days, then monthly for 3&#xD;
      years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 30, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2024</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>Overall response rate (ORR)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Defined as complete remission (CR) + complete remission with hematologic recovery (CRh) + complete remission with incomplete blood count recovery (CRi) + morphologic leukemia-free state (MLFS) + and partial remission (PR). Will be assessed based on revised International Working Group (IWG) response criteria for acute myeloid leukemia (AML). Estimated along 95% confidence interval.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Defined as the number of days from the date of initial 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 3 years</time_frame>
    <description>Defined as the number of days from the date of treatment initiation (i.e., cycle 1 days 1 [C1D1]) to the date of documented treatment failure, relapses from 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Will be estimated using the method of Kaplan and Meier.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>The severity of the adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. The number and percent of subjects with treatment-emergent adverse events will be summarized according to intensity and drug relationship, and categorized by System Organ Class and preferred term by dose level/part.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Minimal residual disease (MRD) status</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>The association between cellular biomarker, MRD, etc. and antitumor activity will be compared using Wilcoxon's rank sum test or Fisher's exact test, as appropriate. MRD negative status and exploratory biomarkers will be summarized graphically and with descriptive statistics.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Acute Myeloid Leukemia With Gene Mutations</condition>
  <condition>Myelodysplastic Syndrome</condition>
  <condition>Myeloproliferative Neoplasm</condition>
  <condition>Recurrent Acute Myeloid Leukemia</condition>
  <condition>Refractory Acute Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>Treatment (CPX-351, ivosidenib)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>INDUCTION: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, and ivosidenib PO QD on days 1-28. Patients who do not achieve complete remission may receive a second cycle of induction therapy in the absence of disease progression or unacceptable toxicity. Patients achieving complete remission proceed to consolidation.&#xD;
CONSOLIDATION: Patients receive CPX-351 IV over 90 minutes on days 1 and 3, and ivosidenib PO QD on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.&#xD;
MAINTENANCE: Patients receive ivosidenib PO QD for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients who are experiencing clinical benefit and who have not experienced excessive toxicity after completion of 2 years of maintenance may be eligible to continue therapy after discussion with the principal investigator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ivosidenib</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (CPX-351, ivosidenib)</arm_group_label>
    <other_name>AG-120</other_name>
    <other_name>Tibsovo</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, ivosidenib)</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;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of =&lt; 2&#xD;
&#xD;
          -  IDH1-R132 mutated disease status as assessed by local laboratory. 2HG-producing IDH1&#xD;
             variants outside of R132 (i.e. R100) may be eligible after discussion with the&#xD;
             principal investigator (PI)&#xD;
&#xD;
          -  Treatment naive or relapsed/refractory AML who are eligible for intensive&#xD;
             chemotherapy. Patients with high-risk MDS or MPN (defined as &gt;= 10% bone marrow&#xD;
             blasts, or intermediate or high risk by International Prognostic Scoring System&#xD;
             [IPSS], revised [R]-IPSS or dynamic [D]-IPSS) may also be eligible after discussion&#xD;
             with the PI&#xD;
&#xD;
          -  Direct bilirubin =&lt; 2 x upper limit of normal (ULN) unless deemed to be related to&#xD;
             underlying leukemia&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) =&lt; 3 x ULN&#xD;
             unless deemed to be related to underlying leukemia&#xD;
&#xD;
          -  Creatinine clearance &gt;= 30 ml/min based on the Cockcroft-Gault equation&#xD;
&#xD;
          -  Willing and able to provide informed consent&#xD;
&#xD;
          -  In the absence of rapidly proliferative disease, the interval from prior treatment to&#xD;
             time of initiation will be at least 7 days for cytotoxic or non-cytotoxic&#xD;
             (immunotherapy) agents&#xD;
&#xD;
          -  Male subjects must agree to refrain from unprotected sex and sperm donation from&#xD;
             initial study drug administration until 90 days after the last dose of study drug&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have previously received either ivosidenib or CPX-351&#xD;
&#xD;
          -  Patients with any concurrent uncontrolled clinically significant medical condition&#xD;
             including infection, laboratory abnormality, or psychiatric illness, which could place&#xD;
             the patient at unacceptable risk of study treatment&#xD;
&#xD;
          -  The use of other chemotherapeutic agents or anti-leukemic agents is not permitted&#xD;
             during study with the following exceptions (1) intrathecal chemotherapy for&#xD;
             prophylactic use or for controlled central nervous system (CNS) leukemia. (2) use of&#xD;
             hydroxyurea, and/or cytarabine (1 or 2 doses; up to 2 g/m^2) for patients with rapidly&#xD;
             proliferative disease is allowed before the start of study therapy&#xD;
&#xD;
          -  Patients with active graft-versus-host-disease (GVHD) status post stem cell transplant&#xD;
             (patients without active GVHD on chronic suppressive immunosuppression and/or&#xD;
             phototherapy for chronic skin GVHD are permitted after discussion with the PI)&#xD;
&#xD;
          -  Patients with any severe gastrointestinal or metabolic condition which could interfere&#xD;
             with the absorption of oral study medications&#xD;
&#xD;
          -  Patients with symptomatic congestive heart failure (New York Heart Association [NYHA]&#xD;
             class III or IV), unstable angina, or an ejection fraction &lt; 45%&#xD;
&#xD;
          -  Patients with prior anthracycline exposure of &gt; 360 mg/m^2 daunorubicin (or&#xD;
             equivalent) or &gt; 210 mg/m^2 daunorubicin (or equivalent) in patients with prior&#xD;
             mediastinal radiation&#xD;
&#xD;
          -  Corrected QT (QTc) interval using Fridericia's formula (QTcF) &gt;= 470 msec. A prolonged&#xD;
             QTc interval in the setting of right bundle branch block is permitted after discussion&#xD;
             with the PI&#xD;
&#xD;
          -  Nursing women, women of childbearing potential (WOCBP) with positive urine or serum&#xD;
             pregnancy test, or women of childbearing potential who are not willing to maintain&#xD;
             adequate contraception&#xD;
&#xD;
               -  Appropriate highly effective method(s) of contraception include oral or&#xD;
                  injectable hormonal birth control, intrauterine device (IUD), and double barrier&#xD;
                  methods (for example a condom in combination with a spermicide)&#xD;
&#xD;
          -  Subjects with a known medical history of progressive multifocal leukoencephalopathy&#xD;
             (PML)&#xD;
&#xD;
          -  Subjects taking strong CYP3A4 inducers are excluded from the study unless they can be&#xD;
             transferred to other medications within &gt;= 5 half lives prior to dosing&#xD;
&#xD;
          -  Patients with a diagnosis of acute promyelocytic leukemia (APL)&#xD;
&#xD;
          -  Unresolved toxicities &gt; grade 1 from prior treatment including chemotherapy, targeted&#xD;
             therapy, immunotherapy, experimental agents, radiation, or surgery&#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>Courtney DiNardo</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Courtney DiNardo</last_name>
    <phone>713-794-1141</phone>
    <email>cdinardo@mdanderson.org</email>
  </overall_contact>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Courtney DiNardo</last_name>
      <phone>713-794-1141</phone>
      <email>cdinardo@mdanderson.org</email>
    </contact>
    <investigator>
      <last_name>Courtney DiNardo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>August 2023</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>August 29, 2023</last_update_submitted>
  <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 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>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
    <mesh_term>Preleukemia</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
    <mesh_term>Myeloproliferative Disorders</mesh_term>
    <mesh_term>Syndrome</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>
    <mesh_term>Ivosidenib</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/NCT04493164
org study id: 2020-0096
secondary id: NCI-2020-05258
secondary id: 2020-0096
nct id: NCT04493164
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This phase II trial investigates how well CPX-351 and ivosidenib work in treating patients
      with acute myeloid leukemia or high-risk myelodysplastic syndrome that has IDH1 mutation. The
      safety of this drug combination will also be studied. IDH1 is a type of genetic mutation
      (change). Chemotherapy drugs, 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. Ivosidenib may stop the growth of cancer cells by blocking some of the
      enzymes needed for cell growth. The purpose of this trial is to learn if CPX-351 in
      combination with ivosidenib can help to control IDH1-mutated acute myeloid leukemia or
      high-risk myelodysplastic syndrome.
PRIMARY OBJECTIVE:

      I. To determine the overall response rate (ORR) including complete remission (CR), complete
      remission with hematologic recovery (CRh), complete remission with incomplete blood count
      recovery (CRi), morphologic leukemia-free state (MLFS), and partial remission (PR) of the
      combination of liposome-encapsulated daunorubicin-cytarabine (CPX-351) and ivosidenib in
      IDH1-mutated patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome
      (MDS).

      SECONDARY OBJECTIVES:

      I. To assess safety of CPX-351 in combination with ivosidenib. II. To determine time to event
      endpoints including duration of response (DOR), event free survival (EFS) and overall
      survival (OS).

      EXPLORATORY OBJECTIVES:

      I. Evaluate minimal residual disease (MRD) using multiparameter flow cytometry, cytogenetics
      and molecular evaluation.

      II. To evaluate molecular and cellular biomarkers that may be predictive of antitumor
      activity and/or resistance to treatment including evaluation of 2HG, IDH1 and other
      co-occurring mutations and VAF levels before, during and after treatment.

      OUTLINE:

      INDUCTION: Patients receive CPX-351 intravenously (IV) over 90 minutes on days 1, 3, and 5,
      and ivosidenib orally (PO) once daily (QD) on days 1-28. Patients who do not achieve complete
      remission may receive a second cycle of induction therapy in the absence of disease
      progression or unacceptable toxicity. Patients achieving complete remission proceed to
      consolidation.

      CONSOLIDATION: Patients receive CPX-351 IV over 90 minutes on days 1 and 3, and ivosidenib PO
      QD on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease
      progression or unacceptable toxicity.

      MAINTENANCE: Patients receive ivosidenib PO QD for up to 2 years in the absence of disease
      progression or unacceptable toxicity. Patients who are experiencing clinical benefit and who
      have not experienced excessive toxicity after completion of 2 years of maintenance may be
      eligible to continue therapy after discussion with the principal investigator.

      After completion of study treatment, patients are followed up at 30 days, then monthly for 3
      years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall response rate (ORR)
time frame: Up to 3 years
description: Defined as complete remission (CR) + complete remission with hematologic recovery (CRh) + complete remission with incomplete blood count recovery (CRi) + morphologic leukemia-free state (MLFS) + and partial remission (PR). Will be assessed based on revised International Working Group (IWG) response criteria for acute myeloid leukemia (AML). Estimated along 95% confidence interval.
measure: Duration of response
time frame: Up to 3 years
description: Defined as the number of days from the date of initial 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 3 years
description: Defined as the number of days from the date of treatment initiation (i.e., cycle 1 days 1 [C1D1]) to the date of documented treatment failure, relapses from 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.
measure: Overall survival
time frame: Up to 3 years
description: Will be estimated using the method of Kaplan and Meier.
measure: Incidence of adverse events
time frame: Up to 3 years
description: The severity of the adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. The number and percent of subjects with treatment-emergent adverse events will be summarized according to intensity and drug relationship, and categorized by System Organ Class and preferred term by dose level/part.
measure: Minimal residual disease (MRD) status
time frame: Up to 3 years
description: The association between cellular biomarker, MRD, etc. and antitumor activity will be compared using Wilcoxon's rank sum test or Fisher's exact test, as appropriate. MRD negative status and exploratory biomarkers will be summarized graphically and with descriptive statistics.
arm group label: Treatment (CPX-351, ivosidenib)
arm group type: Experimental
description: INDUCTION: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, and ivosidenib PO QD on days 1-28. Patients who do not achieve complete remission may receive a second cycle of induction therapy in the absence of disease progression or unacceptable toxicity. Patients achieving complete remission proceed to consolidation.
CONSOLIDATION: Patients receive CPX-351 IV over 90 minutes on days 1 and 3, and ivosidenib PO QD on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive ivosidenib PO QD for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients who are experiencing clinical benefit and who have not experienced excessive toxicity after completion of 2 years of maintenance may be eligible to continue therapy after discussion with the principal investigator.
intervention type: Drug
intervention name: Ivosidenib
description: Given PO
arm group label: Treatment (CPX-351, ivosidenib)
other name: AG-120
other name: Tibsovo
intervention type: Drug
intervention name: Liposome-encapsulated Daunorubicin-Cytarabine
description: Given IV
arm group label: Treatment (CPX-351, ivosidenib)
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: Courtney DiNardo
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
last name: Courtney DiNardo
phone: 713-794-1141
email: cdinardo@mdanderson.org
facility: 
status: Recruiting
contact: 
investigator: 
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: Preleukemia
mesh term: Myelodysplastic Syndromes
mesh term: Myeloproliferative Disorders
mesh term: Syndrome
mesh term: Cytarabine
mesh term: Daunorubicin
mesh term: Ivosidenib