<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/NCT03793478</url>
  </required_header>
  <id_info>
    <org_study_id>AC220-A-U202</org_study_id>
    <secondary_id>2016-002919-18</secondary_id>
    <nct_id>NCT03793478</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood</brief_title>
  <official_title>A Phase 1/2, Multicenter, Dose-Escalating Study To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy Of Quizartinib Administered in Combination With Re-Induction Chemotherapy, and as a Single-Agent Continuation Therapy, in Pediatric Relapsed/Refractory AML Subjects Aged 1 Month to &lt;18 Years (and Young Adults Aged up to 21 Years) With FLT3-ITD Mutations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daiichi Sankyo, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Innovative Therapies For Children with Cancer Consortium</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Oncology Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Daiichi Sankyo, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Quizartinib is an experimental drug. It is not approved for regular use. It can only be used&#xD;
      in medical research.&#xD;
&#xD;
      Children or young adults with a certain kind of blood cancer (FLT3-ITD AML) might be able to&#xD;
      join this study if it has come back after remission or is not responding to treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The medical condition being investigated is relapsed or refractory AML in participants aged&#xD;
      ≥1 month to ≤21 years with Feline McDonough Sarcoma (FMS)-like tyrosine kinase 3&#xD;
      (FLT3)-internal tandem duplication (ITD) mutations (FLT3-ITD AML), following failure of&#xD;
      front-line intensive chemotherapy.&#xD;
&#xD;
      The trial will be conducted in multiple phases. An independent data monitoring committee&#xD;
      (DMC) will protect the rights, safety, and well-being of participants by monitoring the&#xD;
      progress and results. The DMC will comprise qualified physicians and scientists who are not&#xD;
      Investigators in the study and not otherwise directly associated with the Sponsor and will be&#xD;
      convened at the end of Phase 1.&#xD;
&#xD;
      A. Dose Escalation/De-escalation Phase:&#xD;
&#xD;
      Number of participants is determined by age group. Participants will be enrolled by&#xD;
      dose-level to determine the recommended Phase 2 dose (RP2D) of quizartinib for pediatric&#xD;
      participants that provides similar exposure to adult patients treated at the target adult&#xD;
      dose of 60 mg orally once daily.&#xD;
&#xD;
      B. Dose-Expansion Phase:&#xD;
&#xD;
      Participants will receive the RP2D of quizartinib for their respective age group.&#xD;
&#xD;
      During both dose escalation and dose expansion phases, participants will receive:&#xD;
&#xD;
      Re-Induction Therapy&#xD;
&#xD;
        -  Intrathecal (IT) triple chemotherapy prophylaxis prior to and between cycles&#xD;
&#xD;
        -  In re-induction Cycles 1 and 2, fludarabine/cytarabine (FLA) followed by quizartinib as&#xD;
           a single agent&#xD;
&#xD;
      Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) Period:&#xD;
&#xD;
      After re-induction therapy, participants will be evaluated for eligibility to undergo&#xD;
      allogeneic hematopoietic stem cell transplant (HSCT). Eligible participants may receive a&#xD;
      single 28-day cycle of consolidation therapy (standard of care chemotherapy with or without&#xD;
      quizartinib) if an allogeneic HSCT is not available immediately. The options for&#xD;
      consolidation therapy are as follows:&#xD;
&#xD;
        -  High intensity chemotherapy with quizartinib, or&#xD;
&#xD;
        -  Low intensity chemotherapy alone, or&#xD;
&#xD;
        -  Low intensity therapy with quizartinib as a single agent&#xD;
&#xD;
      Continuation Therapy:&#xD;
&#xD;
      Participants in remission after HSCT, or who are not eligible for HSCT but achieve at least a&#xD;
      partial remission (PR) after re-induction, will receive up to 12 continuous 28-day cycles of&#xD;
      quizartinib continuation therapy at the same dose received during re-induction in the dose&#xD;
      expansion phase.&#xD;
&#xD;
      Long-term Follow-up:&#xD;
&#xD;
      The long-term follow-up phase begins upon completion of 12 cycles of quizartinib Continuation&#xD;
      Therapy or permanent discontinuation of quizartinib at any time. After completion of the&#xD;
      30-day safety follow-up visit, subsequent visits will occur at the following frequencies to&#xD;
      assess survival and anti-leukemic treatments:&#xD;
&#xD;
        -  every 3 months for the first 2 years, and then&#xD;
&#xD;
        -  once a year thereafter until the last participant enrolled has been followed for three&#xD;
           years from the date of enrollment&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 15, 2018</start_date>
  <completion_date type="Anticipated">May 1, 2027</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2027</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>Sequential Assignment</intervention_model>
    <intervention_model_description>A single group will progress through a multiple phase study design as described in the detailed description.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of dose-limiting toxicities (Phase 1)</measure>
    <time_frame>Re-induction Cycle 1 Day 1 up to Day 28 (each cycle is 28 days)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Composite complete remission (CRc) rate among participants with acute myeloid leukemia (AML) (Phase 1 and 2)</measure>
    <time_frame>within 8 years, 8 months</time_frame>
    <description>CRc rate is defined as percentage of participants with best response of complete remission (CR) or CR with incomplete hematological recovery (CRi) after completion of up to 2 re-induction cycles</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameter area under the concentration curve for quizartinib and AC886 (Phase 1 and 2)</measure>
    <time_frame>Re-induction Phase 1 and 2,Cycle 1: Days 6, 20:Predose, 1 hour (Phase 1 only), 2, 4, and 6 hours; Days 7 and 21:24 hours; Phase 1 and 2 Cycle 2: Days 6 and 20:predose, 3 hours; Continuation Cycle 1 Days 1 and 15:predose, 2-4 hours (each cycle, 28 days)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameter apparent clearance (CL/F) for quizartinib and AC886 (Phase 1 and 2)</measure>
    <time_frame>Re-induction Phase 1 and 2,Cycle 1: Days 6, 20:Predose, 1 hour (Phase 1 only), 2, 4, and 6 hours; Days 7 and 21:24 hours; Phase 1 and 2 Cycle 2: Days 6 and 20:predose, 3 hours; Continuation Cycle 1 Days 1 and 15:predose, 2-4 hours (each cycle, 28 days)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameter apparent volume of distribution (Vz/F) for quizartinib and AC886 (Phase 1 and 2)</measure>
    <time_frame>Re-induction Phase 1 and 2,Cycle 1: Days 6, 20:Predose, 1 hour (Phase 1 only), 2, 4, and 6 hours; Days 7 and 21:24 hours; Phase 1 and 2 Cycle 2: Days 6 and 20:predose, 3 hours; Continuation Cycle 1 Days 1 and 15:predose, 2-4 hours (each cycle, 28 days)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complete remission (CR) rate among participants with AML (Phase 1 and 2)</measure>
    <time_frame>on Day 56 (± 3 Days) for the last subject, within 4 years</time_frame>
    <description>CR rate is defined as the percentage of participants achieving CR after completion of up to 2 re-induction cycles</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete remission with incomplete recovery (CRi) rate among participants with AML (Phase 1 and 2)</measure>
    <time_frame>on Day 56 (± 3 Days) for the last subject, within 4 years</time_frame>
    <description>CRi rate is defined as the percentage of participants achieving CRi after completion of up to 2 re-induction cycles</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of CR among participants with AML (Phase 1 and 2)</measure>
    <time_frame>within 8 years, 8 months</time_frame>
    <description>Duration of CR is defined as the time from the first documented CR until documented relapse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of CRi among participants with AML (Phase 1 and 2)</measure>
    <time_frame>within 8 years, 8 months</time_frame>
    <description>Duration of CRi is defined as the time from the first documented CRi until documented relapse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of composite complete remission (CRc) among participants with AML (Phase 1 and 2)</measure>
    <time_frame>within 8 years, 8 months</time_frame>
    <description>Duration of CRc is defined as the time from the first documented CR or CRi until documented relapse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete remission (CR) rate after completion of re-induction Cycle 1 among participants with AML (Phase 1 and 2)</measure>
    <time_frame>on Day 56 (± 3 Days) for the last subject, within 4 years</time_frame>
    <description>CR rate after completion of re-induction Cycle 1 is defined as the percentage of participants achieving a CR after completion of re-induction Cycle 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete remission with incomplete recovery (CRi) rate after completion of re-induction Cycle 1 among participants with AML (Phase 1 and 2)</measure>
    <time_frame>on Day 56 (± 3 Days) for the last subject, within 4 years</time_frame>
    <description>CRi rate after completion of re-induction Cycle 1 is defined as the percentage of participants achieving a CRi after completion of re-induction Cycle 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite complete remission (CRc) rate after completion of re-induction Cycle 1 among participants with AML (Phase 1 and 2)</measure>
    <time_frame>on Day 56 (± 3 Days) for the last subject, within 4 years</time_frame>
    <description>CRc rate after completion of re-induction Cycle 1 is defined as the percentage of participants achieving CRc after completion of re-induction Cycle 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to relapse among participants with AML (Phase 1 and 2)</measure>
    <time_frame>within 8 years, 8 months</time_frame>
    <description>Time to relapse is defined as the time from the first documented response (CR, CRi) until documented relapse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of relapse among participants with AML after 1, 2 and 3 years (Phase 1 and 2)</measure>
    <time_frame>within 8 years, 8 months</time_frame>
    <description>Rate of relapse is defined as the percentage of participants who achieved CRc at the end of re-induction and had relapsed at 3 categorical time points Categories: 1 year, 2 years, 3 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of relapse among participants with AML at the end of study (Phase 1 and 2)</measure>
    <time_frame>within 8 years, 8 months</time_frame>
    <description>Cumulative incidence of relapse at the end of the study is defined as the percentage of participants who achieved CRc at the end of re-induction and relapsed by the end of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival among participants with AML at 1, 2, and 3 years (Phase 1 and 2)</measure>
    <time_frame>within 8 years, 8 months</time_frame>
    <description>Overall survival is defined as the time from the start of re-induction therapy until death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-free survival among participants with AML at 1, 2, and 3 years (Phase 1 and 2)</measure>
    <time_frame>within 8 years, 8 months</time_frame>
    <description>Event-free survival is defined as the time from the start of re-induction therapy until the earliest date of the following:&#xD;
Refractory disease at the end of re-induction&#xD;
Relapse after CR or CRi&#xD;
Death from any cause at any time during the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants proceeding to high-dose conditioning therapy/allogeneic hematopoietic stem cell transplantation (HSCT) (including transplant-related mortality) among participants with AML (Phase 1 and 2)</measure>
    <time_frame>within 8 years, 8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of CRc (CR or CRi) without minimal residual disease (MRD) using next generation sequencing among participants with AML (Phase 1 and 2)</measure>
    <time_frame>within 8 years, 8 months</time_frame>
    <description>MRD is defined as the presence of leukemic cells in the bone marrow detected above a predefined cut-off level by a validated assay in participants who achieved a CR or CRi&#xD;
Categories: at screening, at re-induction cycle 1, at re-induction cycle 2, at time of relapse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability of including the palatability of quizartinib formulations among participants with AML (Phase 1 and 2)</measure>
    <time_frame>within 8 years, 8 months</time_frame>
    <description>Acceptability is assessed by palatability using a 5-point hedonic scale (from &quot;Super bad&quot; to &quot;Super good&quot;) for participants who are developmentally able to answer. If unable, the caregiver provides information in a free text field stating whether the participant spit it out, may not have liked the flavor, etc.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">65</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>All Participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will receive re-induction therapy that includes fludarabine and cytarabine in combination with experimental drug quizartinib. For prophylaxis, IT chemotherapy with cytarabine, methotrexate and prednisolone/hydrocortisone will be given prior to or between re-induction cycles. After completing re-induction therapy, eligible participants may also receive optional consolidation chemotherapy which includes cytarabine, etoposide and quizartinib, if HSCT is not available immediately. After completing re-induction or HSCT successfully, eligible participants can go on to receive continuation therapy with quizartinib.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Quizartinib</intervention_name>
    <description>Administered orally once daily starting on Day 6 and continuing through Day 28;&#xD;
Optional low intensity consolidation with chemotherapy:&#xD;
Administered orally once daily starting on Day 1 and continuing through Day 28</description>
    <arm_group_label>All Participants</arm_group_label>
    <other_name>Quizartinib dihydrochloride</other_name>
    <other_name>Vanflyta</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fludarabine</intervention_name>
    <description>30 mg/m^2/day IV infusion given over 30 minutes on Days 1 through 5 (administered based on body weight)</description>
    <arm_group_label>All Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cytarabine</intervention_name>
    <description>2000 mg/m^2/day IV infusion given over 3 hours on Days 1 through 5 (begin 4 hours after the start of fludarabine) (administered in accordance with standard of care);&#xD;
Optional high intensity consolidation with chemotherapy and quizartinib:&#xD;
500 mg/m^2/day as a continuous 96-hour IV infusion on Days 1 through 4;&#xD;
Optional low intensity consolidation with chemotherapy:&#xD;
75 mg/m^2/day as once daily subcutaneous or IV on Days 1 through 4 and Days 15 through 18</description>
    <arm_group_label>All Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intrathecal (IT) triple chemotherapy prophylaxis</intervention_name>
    <description>IT cytarabine, methotrexate, and either prednisolone or hydrocortisone; doses are based on the participant's age and standard practice at each site</description>
    <arm_group_label>All Participants</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etoposide</intervention_name>
    <description>Optional high intensity consolidation with chemotherapy and quizartinib:&#xD;
100 mg/m^2/dose once daily as an IV infusion over 3 hours on Days 1 through 5</description>
    <arm_group_label>All Participants</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants must meet all of the following criteria to be eligible for enrollment into the&#xD;
        study:&#xD;
&#xD;
          -  Has diagnosis of AML according to the World Health Organization (WHO) 2008&#xD;
             classification with ≥5% blasts in bone marrow, with or without extramedullary disease&#xD;
&#xD;
          -  In first relapse or refractory to first-line high-dose chemotherapy with no more than&#xD;
             1 attempt (1 to 2 cycles of induction chemotherapy) at remission induction - prior&#xD;
             HSCT is permitted&#xD;
&#xD;
          -  Has presence of the FLT3-ITD activating mutation in bone marrow or peripheral blood as&#xD;
             defined in the protocol&#xD;
&#xD;
          -  Is between 1 month and 21 years of age at the time the Informed Consent/Assent form is&#xD;
             signed&#xD;
&#xD;
          -  Has protocol-defined adequate performance status score&#xD;
&#xD;
          -  Has fully recovered from the acute clinically significant toxicity effects of all&#xD;
             prior chemotherapy, immunotherapy, or radiotherapy, per protocol guidelines&#xD;
&#xD;
          -  Has protocol-defined adequate renal, hepatic and cardiac functions&#xD;
&#xD;
          -  If of reproductive potential, is permanently sterile or agrees to use highly effective&#xD;
             birth control upon enrollment, during the period of therapy, and for 6 months&#xD;
             following the last dose of quizartinib, etoposide, fludarabine, methotrexate, or&#xD;
             cytarabine, whichever is later&#xD;
&#xD;
          -  If female of child-bearing potential, tests negative for pregnancy and agrees not to&#xD;
             breast feed&#xD;
&#xD;
          -  Male participants must be surgically sterile or willing to use highly effective birth&#xD;
             control during the treatment period, and for 6 months following the last dose of&#xD;
             quizartinib, etoposide, fludarabine, methotrexate, or cytarabine, whichever is later.&#xD;
&#xD;
          -  Participant/legal representative is capable of understanding the investigational&#xD;
             nature of the study, potential risks, and benefits, and the patient (and/or legal&#xD;
             representative) signs a written assent/informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants who meet any of the following criteria will be disqualified from entering the&#xD;
        study:&#xD;
&#xD;
          -  Has been diagnosed with isolated central nervous system relapse, acute promyelocytic&#xD;
             leukemia (APL), juvenile myelomonocytic leukemia, French-American-British&#xD;
             classification M3 or WHO classification of APL with translocation, or with myeloid&#xD;
             proliferations related to Down syndrome&#xD;
&#xD;
          -  Has uncontrolled or pre-defined significant cardiovascular disease as detailed in the&#xD;
             protocol&#xD;
&#xD;
          -  Has systemic fungal, bacterial, viral or other infection that is exhibiting ongoing&#xD;
             signs/symptoms related to the infection without improvement despite appropriate&#xD;
             antibiotics or other treatment. The patient must be off vasopressors and have negative&#xD;
             blood cultures for at least 48 hours prior to the start of systematic protocol&#xD;
             therapy.&#xD;
&#xD;
          -  Has known active clinically relevant liver disease (e.g., active hepatitis B or active&#xD;
             hepatitis C)&#xD;
&#xD;
          -  Has known history of human immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Has history of hypersensitivity to any of the study medications or their excipients&#xD;
&#xD;
          -  Is receiving or is anticipated to receive concomitant chemotherapy, radiation, or&#xD;
             immunotherapy other than as specified in the protocol&#xD;
&#xD;
          -  Has any significant concurrent disease, illness, psychiatric disorder or social issue&#xD;
             that would compromise subject safety or compliance, interfere with consent/assent,&#xD;
             study participation, follow up, or interpretation of study results&#xD;
&#xD;
          -  Is currently participating in another investigative interventional procedure&#xD;
             (observational or long-term interventional follow-up is allowed)&#xD;
&#xD;
          -  Is otherwise considered inappropriate for the study by the Investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Global Clinical Leader</last_name>
    <role>Study Director</role>
    <affiliation>Daiichi Sankyo, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daiichi Sankyo Contact for Clinical Information</last_name>
    <phone>908-992-6400</phone>
    <email>CTRinfo@dsi.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Loma Linda University Cancer Center</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>A.I. duPont Hospital for Children</name>
      <address>
        <city>Wilmington</city>
        <state>Delaware</state>
        <zip>19803</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Children's National Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Children's Healthcare of Atlanta</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Riley Hospital for Children - Indiana University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Minnesota/Masonic Cancer Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Columbia University/Herbert Irving Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>New York Medical College</name>
      <address>
        <city>Valhalla</city>
        <state>New York</state>
        <zip>10595</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>UPMC Children's Hospital of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The University of Texas Southwestern Medical Center Children's Health</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Principal Investigator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Montreal Children's Hospital</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H4A3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>British Columbia Children's Hospital</name>
      <address>
        <city>Vancouver</city>
        <zip>V6H 3V4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Principal Investigator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Léon Bérard</name>
      <address>
        <city>Lyon</city>
        <zip>69008</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Principal Investigator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Armand-Trousseau</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Principal Investigator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital des Enfants</name>
      <address>
        <city>Toulouse</city>
        <zip>31300</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Principal Investigator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Rambam Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>31096</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Principal Investigator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Schneider Children's Medical Center of Israel</name>
      <address>
        <city>Petah Tikva</city>
        <zip>49202</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv-Yafo</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Principal Investigator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fondazione MBBM - Clinica Pediatrica</name>
      <address>
        <city>Monza</city>
        <zip>20900</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Principal Investigator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>IRCCS Ospedale Pediatrico Bambino Gesù</name>
      <address>
        <city>Rome</city>
        <zip>00165</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Principal Investigator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ospedale Infantile Regina Margherita</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Principal Investigator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Prinses Maxima Centrum voor Kinderoncologie</name>
      <address>
        <city>Utrecht</city>
        <zip>3584 EA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Principal Investigator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Infantil Universitario Nino Jesus</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Principal Investigator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Principal Investigator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sahlgrenska Universitetssjukhuset - Drottning Silvias Barn- och Ungdomssjukhus</name>
      <address>
        <city>Göteborg</city>
        <zip>41685</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Principal Investigator</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>NHS Greater Glasgow and Clyde - The Queen Elizabeth University Hospital</name>
      <address>
        <city>Glasgow</city>
        <zip>G51 4TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>August 8, 2023</last_update_submitted>
  <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute myeloid leukemia recurrent</keyword>
  <keyword>Relapsed or refractory</keyword>
  <keyword>FMS-like tyrosine kinase 3 positive</keyword>
  <keyword>Cancer of the blood</keyword>
  <keyword>AML</keyword>
  <keyword>FLT3-ITD mutation</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>Cytarabine</mesh_term>
    <mesh_term>Fludarabine</mesh_term>
    <mesh_term>Etoposide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.</ipd_time_frame>
    <ipd_access_criteria>Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/daiichi-sankyo/</ipd_url>
  </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/NCT03793478
org study id: AC220-A-U202
secondary id: 2016-002919-18
nct id: NCT03793478
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Quizartinib is an experimental drug. It is not approved for regular use. It can only be used
      in medical research.

      Children or young adults with a certain kind of blood cancer (FLT3-ITD AML) might be able to
      join this study if it has come back after remission or is not responding to treatment.
The medical condition being investigated is relapsed or refractory AML in participants aged
      ≥1 month to ≤21 years with Feline McDonough Sarcoma (FMS)-like tyrosine kinase 3
      (FLT3)-internal tandem duplication (ITD) mutations (FLT3-ITD AML), following failure of
      front-line intensive chemotherapy.

      The trial will be conducted in multiple phases. An independent data monitoring committee
      (DMC) will protect the rights, safety, and well-being of participants by monitoring the
      progress and results. The DMC will comprise qualified physicians and scientists who are not
      Investigators in the study and not otherwise directly associated with the Sponsor and will be
      convened at the end of Phase 1.

      A. Dose Escalation/De-escalation Phase:

      Number of participants is determined by age group. Participants will be enrolled by
      dose-level to determine the recommended Phase 2 dose (RP2D) of quizartinib for pediatric
      participants that provides similar exposure to adult patients treated at the target adult
      dose of 60 mg orally once daily.

      B. Dose-Expansion Phase:

      Participants will receive the RP2D of quizartinib for their respective age group.

      During both dose escalation and dose expansion phases, participants will receive:

      Re-Induction Therapy

        -  Intrathecal (IT) triple chemotherapy prophylaxis prior to and between cycles

        -  In re-induction Cycles 1 and 2, fludarabine/cytarabine (FLA) followed by quizartinib as
           a single agent

      Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) Period:

      After re-induction therapy, participants will be evaluated for eligibility to undergo
      allogeneic hematopoietic stem cell transplant (HSCT). Eligible participants may receive a
      single 28-day cycle of consolidation therapy (standard of care chemotherapy with or without
      quizartinib) if an allogeneic HSCT is not available immediately. The options for
      consolidation therapy are as follows:

        -  High intensity chemotherapy with quizartinib, or

        -  Low intensity chemotherapy alone, or

        -  Low intensity therapy with quizartinib as a single agent

      Continuation Therapy:

      Participants in remission after HSCT, or who are not eligible for HSCT but achieve at least a
      partial remission (PR) after re-induction, will receive up to 12 continuous 28-day cycles of
      quizartinib continuation therapy at the same dose received during re-induction in the dose
      expansion phase.

      Long-term Follow-up:

      The long-term follow-up phase begins upon completion of 12 cycles of quizartinib Continuation
      Therapy or permanent discontinuation of quizartinib at any time. After completion of the
      30-day safety follow-up visit, subsequent visits will occur at the following frequencies to
      assess survival and anti-leukemic treatments:

        -  every 3 months for the first 2 years, and then

        -  once a year thereafter until the last participant enrolled has been followed for three
           years from the date of enrollment
allocation: N/A
intervention model: Sequential Assignment
intervention model description: A single group will progress through a multiple phase study design as described in the detailed description.
primary purpose: Treatment
masking: None (Open Label)
measure: Number of dose-limiting toxicities (Phase 1)
time frame: Re-induction Cycle 1 Day 1 up to Day 28 (each cycle is 28 days)
measure: Composite complete remission (CRc) rate among participants with acute myeloid leukemia (AML) (Phase 1 and 2)
time frame: within 8 years, 8 months
description: CRc rate is defined as percentage of participants with best response of complete remission (CR) or CR with incomplete hematological recovery (CRi) after completion of up to 2 re-induction cycles
measure: Pharmacokinetic parameter area under the concentration curve for quizartinib and AC886 (Phase 1 and 2)
time frame: Re-induction Phase 1 and 2,Cycle 1: Days 6, 20:Predose, 1 hour (Phase 1 only), 2, 4, and 6 hours; Days 7 and 21:24 hours; Phase 1 and 2 Cycle 2: Days 6 and 20:predose, 3 hours; Continuation Cycle 1 Days 1 and 15:predose, 2-4 hours (each cycle, 28 days)
measure: Pharmacokinetic parameter apparent clearance (CL/F) for quizartinib and AC886 (Phase 1 and 2)
time frame: Re-induction Phase 1 and 2,Cycle 1: Days 6, 20:Predose, 1 hour (Phase 1 only), 2, 4, and 6 hours; Days 7 and 21:24 hours; Phase 1 and 2 Cycle 2: Days 6 and 20:predose, 3 hours; Continuation Cycle 1 Days 1 and 15:predose, 2-4 hours (each cycle, 28 days)
measure: Pharmacokinetic parameter apparent volume of distribution (Vz/F) for quizartinib and AC886 (Phase 1 and 2)
time frame: Re-induction Phase 1 and 2,Cycle 1: Days 6, 20:Predose, 1 hour (Phase 1 only), 2, 4, and 6 hours; Days 7 and 21:24 hours; Phase 1 and 2 Cycle 2: Days 6 and 20:predose, 3 hours; Continuation Cycle 1 Days 1 and 15:predose, 2-4 hours (each cycle, 28 days)
measure: Complete remission (CR) rate among participants with AML (Phase 1 and 2)
time frame: on Day 56 (± 3 Days) for the last subject, within 4 years
description: CR rate is defined as the percentage of participants achieving CR after completion of up to 2 re-induction cycles
measure: Complete remission with incomplete recovery (CRi) rate among participants with AML (Phase 1 and 2)
time frame: on Day 56 (± 3 Days) for the last subject, within 4 years
description: CRi rate is defined as the percentage of participants achieving CRi after completion of up to 2 re-induction cycles
measure: Duration of CR among participants with AML (Phase 1 and 2)
time frame: within 8 years, 8 months
description: Duration of CR is defined as the time from the first documented CR until documented relapse
measure: Duration of CRi among participants with AML (Phase 1 and 2)
time frame: within 8 years, 8 months
description: Duration of CRi is defined as the time from the first documented CRi until documented relapse
measure: Duration of composite complete remission (CRc) among participants with AML (Phase 1 and 2)
time frame: within 8 years, 8 months
description: Duration of CRc is defined as the time from the first documented CR or CRi until documented relapse
measure: Complete remission (CR) rate after completion of re-induction Cycle 1 among participants with AML (Phase 1 and 2)
time frame: on Day 56 (± 3 Days) for the last subject, within 4 years
description: CR rate after completion of re-induction Cycle 1 is defined as the percentage of participants achieving a CR after completion of re-induction Cycle 1
measure: Complete remission with incomplete recovery (CRi) rate after completion of re-induction Cycle 1 among participants with AML (Phase 1 and 2)
time frame: on Day 56 (± 3 Days) for the last subject, within 4 years
description: CRi rate after completion of re-induction Cycle 1 is defined as the percentage of participants achieving a CRi after completion of re-induction Cycle 1
measure: Composite complete remission (CRc) rate after completion of re-induction Cycle 1 among participants with AML (Phase 1 and 2)
time frame: on Day 56 (± 3 Days) for the last subject, within 4 years
description: CRc rate after completion of re-induction Cycle 1 is defined as the percentage of participants achieving CRc after completion of re-induction Cycle 1
measure: Time to relapse among participants with AML (Phase 1 and 2)
time frame: within 8 years, 8 months
description: Time to relapse is defined as the time from the first documented response (CR, CRi) until documented relapse
measure: Rate of relapse among participants with AML after 1, 2 and 3 years (Phase 1 and 2)
time frame: within 8 years, 8 months
description: Rate of relapse is defined as the percentage of participants who achieved CRc at the end of re-induction and had relapsed at 3 categorical time points Categories: 1 year, 2 years, 3 years
measure: Cumulative incidence of relapse among participants with AML at the end of study (Phase 1 and 2)
time frame: within 8 years, 8 months
description: Cumulative incidence of relapse at the end of the study is defined as the percentage of participants who achieved CRc at the end of re-induction and relapsed by the end of the study
measure: Overall survival among participants with AML at 1, 2, and 3 years (Phase 1 and 2)
time frame: within 8 years, 8 months
description: Overall survival is defined as the time from the start of re-induction therapy until death from any cause
measure: Event-free survival among participants with AML at 1, 2, and 3 years (Phase 1 and 2)
time frame: within 8 years, 8 months
description: Event-free survival is defined as the time from the start of re-induction therapy until the earliest date of the following:
Refractory disease at the end of re-induction
Relapse after CR or CRi
Death from any cause at any time during the study
measure: Number of participants proceeding to high-dose conditioning therapy/allogeneic hematopoietic stem cell transplantation (HSCT) (including transplant-related mortality) among participants with AML (Phase 1 and 2)
time frame: within 8 years, 8 months
measure: Rate of CRc (CR or CRi) without minimal residual disease (MRD) using next generation sequencing among participants with AML (Phase 1 and 2)
time frame: within 8 years, 8 months
description: MRD is defined as the presence of leukemic cells in the bone marrow detected above a predefined cut-off level by a validated assay in participants who achieved a CR or CRi
Categories: at screening, at re-induction cycle 1, at re-induction cycle 2, at time of relapse
measure: Acceptability of including the palatability of quizartinib formulations among participants with AML (Phase 1 and 2)
time frame: within 8 years, 8 months
description: Acceptability is assessed by palatability using a 5-point hedonic scale (from "Super bad" to "Super good") for participants who are developmentally able to answer. If unable, the caregiver provides information in a free text field stating whether the participant spit it out, may not have liked the flavor, etc.
arm group label: All Participants
arm group type: Experimental
description: All participants will receive re-induction therapy that includes fludarabine and cytarabine in combination with experimental drug quizartinib. For prophylaxis, IT chemotherapy with cytarabine, methotrexate and prednisolone/hydrocortisone will be given prior to or between re-induction cycles. After completing re-induction therapy, eligible participants may also receive optional consolidation chemotherapy which includes cytarabine, etoposide and quizartinib, if HSCT is not available immediately. After completing re-induction or HSCT successfully, eligible participants can go on to receive continuation therapy with quizartinib.
intervention type: Drug
intervention name: Quizartinib
description: Administered orally once daily starting on Day 6 and continuing through Day 28;
Optional low intensity consolidation with chemotherapy:
Administered orally once daily starting on Day 1 and continuing through Day 28
arm group label: All Participants
other name: Quizartinib dihydrochloride
other name: Vanflyta
intervention type: Drug
intervention name: Fludarabine
description: 30 mg/m^2/day IV infusion given over 30 minutes on Days 1 through 5 (administered based on body weight)
arm group label: All Participants
intervention type: Drug
intervention name: Cytarabine
description: 2000 mg/m^2/day IV infusion given over 3 hours on Days 1 through 5 (begin 4 hours after the start of fludarabine) (administered in accordance with standard of care);
Optional high intensity consolidation with chemotherapy and quizartinib:
500 mg/m^2/day as a continuous 96-hour IV infusion on Days 1 through 4;
Optional low intensity consolidation with chemotherapy:
75 mg/m^2/day as once daily subcutaneous or IV on Days 1 through 4 and Days 15 through 18
arm group label: All Participants
intervention type: Drug
intervention name: Intrathecal (IT) triple chemotherapy prophylaxis
description: IT cytarabine, methotrexate, and either prednisolone or hydrocortisone; doses are based on the participant's age and standard practice at each site
arm group label: All Participants
intervention type: Drug
intervention name: Etoposide
description: Optional high intensity consolidation with chemotherapy and quizartinib:
100 mg/m^2/dose once daily as an IV infusion over 3 hours on Days 1 through 5
arm group label: All Participants
criteria: 
gender: All
minimum age: 1 Month
maximum age: 21 Years
healthy volunteers: No
last name: Global Clinical Leader
role: Study Director
affiliation: Daiichi Sankyo, Inc.
last name: Daiichi Sankyo Contact for Clinical Information
phone: 908-992-6400
email: CTRinfo@dsi.com
facility: 
status: Recruiting
contact: 
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
contact: 
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status: Withdrawn
facility: 
status: Recruiting
contact: 
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status: Withdrawn
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
country: Belgium
country: Canada
country: Denmark
country: France
country: Israel
country: Italy
country: Netherlands
country: Spain
country: Sweden
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Cytarabine
mesh term: Fludarabine
mesh term: Etoposide
sharing ipd: Yes
ipd description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
ipd access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
ipd url: https://vivli.org/ourmember/daiichi-sankyo/