<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/NCT02997202</url>
  </required_header>
  <id_info>
    <org_study_id>2215-CL-0304</org_study_id>
    <secondary_id>2016-001061-83</secondary_id>
    <secondary_id>BMT CTN 1506</secondary_id>
    <nct_id>NCT02997202</nct_id>
  </id_info>
  <brief_title>A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)</brief_title>
  <official_title>A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/ITD AML</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Global Development, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Blood and Marrow Transplant Clinical Trials Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Astellas Pharma 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>
      The purpose of this study is to compare relapse-free survival between participants with&#xD;
      FLT3/ITD AML in first morphologic complete remission (CR1) who undergo hematopoietic stem&#xD;
      cell transplant (HCT) and are randomized to receive gilteritinib or placebo beginning after&#xD;
      the time of engraftment for a two year period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants with FLT3/ITD AML in first morphologic complete remission (CR1) undergoing&#xD;
      allogeneic hematopoietic stem cell transplant (HCT) will be randomized to receive&#xD;
      gilteritinib or placebo 30 to 90 days after HCT for a two year period. Participants will be&#xD;
      stratified according to: 1) conditioning regimen intensity (myeloablative vs. reduced&#xD;
      intensity/non-myeloablative), 2) time from first day of hematopoietic cell infusion to&#xD;
      randomization (30-60 days vs. 61-90 days) and 3) presence vs absence of or unknown minimal&#xD;
      residual disease (MRD) from the most recent pre-registration bone marrow (BM) aspirate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 7, 2017</start_date>
  <completion_date type="Actual">May 9, 2023</completion_date>
  <primary_completion_date type="Actual">March 1, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Relapse-free survival</measure>
    <time_frame>96 months</time_frame>
    <description>Relapse-free survival (RFS) will be measured from time of randomization to either morphological relapse or death, whichever comes first. Morphological relapse will be defined as bone marrow (BM) blasts 5% or higher (not attributable to regenerating BM), any circulating blasts (not attributable to regenerating BM or growth factors), or any extra-medullary blast foci as per Revised International Working Group (R-IWG) criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability assessed by incidence and severity of adverse events</measure>
    <time_frame>25 months (24 months + 30 days)</time_frame>
    <description>All grade ≥ 3 toxicities according to CTCAE (Common Terminology Criteria for Adverse Events) version 4.03 will be tabulated for each treatment arm. The proportion of participants developing grade ≥ 3 AE across treatment arms will be compared. In addition, the incidence of all grade 1 to 4 toxicities according to CTCAE version 4.03 will be tabulated for each treatment arm and compared. Clinical laboratory evaluations and change from baseline will be described and compared. Electrocardiogram (ECG) results and change from baseline will be described and compared. Karnofsky Performance Status scores will be described and compared. The duration of drug use and dose of drug use will also be compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>66 months (5.5 years)</time_frame>
    <description>Time to OS is defined as the time to death from any cause after randomization. For surviving participants, non-events will be censored at the last known alive date.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-relapse Mortality</measure>
    <time_frame>66 months (5.5 years)</time_frame>
    <description>An event for this endpoint is death without evidence of disease progression or recurrence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-free Survival (EFS) at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>The cumulative incidence at 12 months after randomization of EFS will be described and compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-free Survival (EFS) at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>The cumulative incidence at 24 months after randomization of EFS will be described and compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Incidence of Acute Graft vs. Host Disease (GVHD)</measure>
    <time_frame>6 months</time_frame>
    <description>The cumulative incidence at 6 months after randomization of grades II-IV and grades III-IV acute GVHD will be described and compared. Acute GVHD will be graded according to diagnosis and severity scoring used by the Blood and Marrow Transplant Clinical Trial Network (BMT CTN).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Incidence of Chronic GVHD at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>The cumulative incidence at 12 months after randomization of chronic GVHD will be described and compared. Chronic GVHD will be graded according to diagnosis and severity scoring from the NIH 2014 Consensus Criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Incidence of Chronic GVHD at 24 months</measure>
    <time_frame>24 months</time_frame>
    <description>The cumulative incidence at 24 months after randomization of chronic GVHD will be described and compared. Chronic GVHD will be graded according to diagnosis and severity scoring from the NIH 2014 Consensus Criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The cumulative incidence of detection of FLT3/ITD MRD</measure>
    <time_frame>24 months</time_frame>
    <description>The cumulative incidence of detection of FLT3/ITD MRD in participants who are FLT3/ITD MRD undetectable prior to randomization will be described. Similarly, the pattern of eradication of FLT3/ITD MRD in participants who have detectable FLT3/ITD MRD prior to randomization will be described.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Severity of Infection</measure>
    <time_frame>25 months (24 months + 30 days)</time_frame>
    <description>The cumulative incidence of CTCAE grades 3 to 5 infection in participants will be described and compared.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">356</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>Gilteritinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will take gilteritinib once daily for continuous daily dosing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will take placebo once daily for continuous daily dosing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>gilteritinib</intervention_name>
    <description>oral</description>
    <arm_group_label>Gilteritinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>oral</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Registration Inclusion Criteria&#xD;
&#xD;
          -  Participant is considered a suitable candidate for HCT and has an acceptable source of&#xD;
             allogeneic donor stem cells, as defined per institutional practice (allogeneic HCT for&#xD;
             any donor source [matched sibling, unrelated donor (URD), mismatched URD, related&#xD;
             haploidentical, or umbilical cord blood] and any graft source [umbilical cord, BM,&#xD;
             peripheral blood (PB)], and any conditioning [myeloablative conditioning (MAC),&#xD;
             reduced intensity conditioning (RIC), or non-myeloablative conditioning (NMA)] will be&#xD;
             permitted).&#xD;
&#xD;
          -  Participant is considered a legal adult by local regulation at the time of signing&#xD;
             informed consent form (ICF).&#xD;
&#xD;
          -  Participant consents to allow access to diagnostic BM aspirate or PB sample and/or the&#xD;
             DNA derived from that sample, if available, that may be used to validate a companion&#xD;
             diagnostic that is being developed in parallel with gilteritinib.&#xD;
&#xD;
          -  Participant has confirmed, morphologically documented AML in CR1. For the purposes of&#xD;
             registration, CR1 will be defined as &lt; 5% blasts in the BM with no morphologic&#xD;
             characteristics of acute leukemia (e.g., Auer Rods) in the BM with no evidence of&#xD;
             extramedullary disease such as central nervous system involvement or granulocytic&#xD;
             sarcoma.&#xD;
&#xD;
               -  Participant has not received more than 2 cycles of induction chemotherapy to&#xD;
                  achieve CR1. The induction cycles can be the same regimen or different regimens.&#xD;
                  The regimen(s) may contain conventional agents, investigational agents, or a&#xD;
                  combination of both.&#xD;
&#xD;
               -  Participants with CR with incomplete count recovery (CRp or CRi) are allowed.&#xD;
                  Incomplete platelet recovery (CRp) is defined as CR with platelet count &lt; 100 x&#xD;
                  109/L. Incomplete blood count recovery (CRi) is defined as CR with residual&#xD;
                  neutropenia &lt; 1 x 109/L with or without complete platelet recovery. Red blood&#xD;
                  cell count (RBC) and platelet transfusion independence is not required.&#xD;
&#xD;
               -  The maximum time allowed from establishment of CR1 to registration is 12 months.&#xD;
&#xD;
          -  Participant has presence of the FLT3/ITD activating mutation in the BM or PB as&#xD;
             determined by the local institution at diagnosis.&#xD;
&#xD;
          -  Participant must meet the following criteria as indicated on the clinical laboratory&#xD;
             tests:&#xD;
&#xD;
               -  Serum creatinine within normal range, or if serum creatinine outside normal&#xD;
                  range, then glomerular filtration rate (GFR) &gt; 40 mL/min/1.73m2 as calculated&#xD;
                  with the Cockcroft-Gault equation with adjustment if total body weight is ≥ 125%&#xD;
                  of ideal body weight.&#xD;
&#xD;
               -  Total bilirubin (TBL) ≤ 2.5 mg/dL, except for participants with Gilbert's&#xD;
                  syndrome.&#xD;
&#xD;
               -  Serum AST and/or alanine aminotransferase (ALT) &lt; 3 x institutional upper limit&#xD;
                  of normal (ULN).&#xD;
&#xD;
          -  Participant has left ventricular ejection fraction at rest ≥ 40%.&#xD;
&#xD;
          -  Participant has diffusing capacity of the lung for carbon monoxide (DLCO) (corrected&#xD;
             for hemoglobin) ≥ 50% predicted and/or forced expiratory volume in 1 second (FEV1) ≥&#xD;
             50% predicted.&#xD;
&#xD;
          -  Female participants must either:&#xD;
&#xD;
               -  Be of non-childbearing potential:&#xD;
&#xD;
               -  postmenopausal (defined as at least 1 year without menses) prior to screening or&#xD;
&#xD;
               -  documented as surgically sterilized (at least 1 month prior to the screening&#xD;
                  visit)&#xD;
&#xD;
          -  Or, if of childbearing potential,&#xD;
&#xD;
               -  Agree not to try to become pregnant during the study for 6 months after the final&#xD;
                  study drug administration&#xD;
&#xD;
               -  And have a negative serum pregnancy test at screening&#xD;
&#xD;
               -  And, if heterosexually active, agree to consistently use highly effective&#xD;
                  contraception per locally accepted standards in addition to a barrier method&#xD;
                  starting at screening and throughout the study period and for 6 months after the&#xD;
                  final study drug administration.&#xD;
&#xD;
               -  For United Kingdom sites:&#xD;
&#xD;
               -  Highly effective forms of birth control include:&#xD;
&#xD;
               -  Consistent and correct usage of established hormonal contraceptives that inhibit&#xD;
                  ovulation&#xD;
&#xD;
               -  Established intrauterine device (IUD) or intrauterine system (IUS)&#xD;
&#xD;
          -  Female participants must agree not to breastfeed or donate ova throughout the study&#xD;
             drug treatment period and for 6 months after the final study drug administration.&#xD;
&#xD;
          -  Male participants (even if surgically sterilized), and partners who are women of&#xD;
             childbearing potential must be using highly effective contraception in addition to a&#xD;
             barrier method throughout the study drug treatment period and for 127 days after the&#xD;
             final study drug administration.&#xD;
&#xD;
               -  For United Kingdom sites:&#xD;
&#xD;
               -  Highly effective forms of birth control include:&#xD;
&#xD;
               -  Consistent and correct usage of established hormonal contraceptives that inhibit&#xD;
                  ovulation&#xD;
&#xD;
               -  Established IUD or IUS&#xD;
&#xD;
               -  Vasectomy (A vasectomy is a highly effective contraception method provided the&#xD;
                  absence of sperm has been confirmed. If not, an additional highly effective&#xD;
                  method of contraception should be used.)&#xD;
&#xD;
               -  Male is sterile due to a bilateral orchiectomy&#xD;
&#xD;
          -  Male participants must not donate sperm throughout the study drug treatment period and&#xD;
             for 127 days after the final study drug administration.&#xD;
&#xD;
          -  Participant is able to take an oral medication.&#xD;
&#xD;
          -  Participant agrees not to participate in another interventional study while on&#xD;
             treatment.&#xD;
&#xD;
        Randomization Inclusion Criteria&#xD;
&#xD;
          -  Participant is ≥ 30 days and ≤ 90 days from hematopoietic cell infusion.&#xD;
&#xD;
          -  Participant has achieved engraftment. Engraftment is defined as ANC ≥ 500 cells/μL and&#xD;
             platelets ≥ 20000/μL on 3 consecutive measurements (each occurring at least 1 day&#xD;
             apart). The participant must not have had a platelet transfusion within 7 days prior&#xD;
             to the first measurement.&#xD;
&#xD;
          -  Participant has confirmed ongoing morphologically documented AML in CR1. For the&#xD;
             purposes of randomization, CR1 will be defined as &lt; 5% blasts with no morphologic&#xD;
             characteristics of acute leukemia (e.g., Auer Rods) in the BM with no evidence of&#xD;
             extramedullary disease such as central nervous system involvement or granulocytic&#xD;
             sarcoma.&#xD;
&#xD;
          -  Participant meets the following criteria as indicated on the clinical laboratory&#xD;
             tests:&#xD;
&#xD;
               -  Serum creatinine within normal range, or if serum creatinine outside normal&#xD;
                  range, then GFR &gt; 40 mL/min/1.73m2 as calculated with the Cockcroft-Gault&#xD;
                  equation with adjustment if total body weight is ≥ 125% of ideal body weight.&#xD;
&#xD;
               -  TBL &lt; 2.5 mg/dL, except for participants with Gilbert's syndrome.&#xD;
&#xD;
               -  Serum AST and/or ALT &lt; 3 x institutional ULN.&#xD;
&#xD;
               -  Serum potassium and magnesium ≥ the institutional lower limit of normal (LLN).&#xD;
&#xD;
          -  If the participant has developed overall grades II-IV acute GVHD, the following&#xD;
             criteria must be met to be randomized:&#xD;
&#xD;
               -  No requirement of &gt; 0.5 mg/kg of prednisone (or equivalent) daily dose within 1&#xD;
                  week of randomization&#xD;
&#xD;
               -  No escalation of systemic immunosuppression in terms of increase of&#xD;
                  corticosteroids or addition of new agent / modality within 2 weeks of&#xD;
                  randomization. (Note that increasing calcineurin inhibitors or sirolimus to&#xD;
                  achieve therapeutic trough levels is allowed.) Topical skin and topical&#xD;
                  gastrointestinal steroids are allowed.&#xD;
&#xD;
          -  Participant is able to take oral medication.&#xD;
&#xD;
        Registration Exclusion Criteria&#xD;
&#xD;
          -  Participant has had a prior allogeneic transplant.&#xD;
&#xD;
          -  Participant has Karnofsky performance status score &lt; 70% .&#xD;
&#xD;
          -  Participant requires treatment with concomitant drugs that are strong inducers of&#xD;
             CYP3A within 14 days of start of study drug.&#xD;
&#xD;
          -  Participant requires treatment with concomitant drugs that target serotonin&#xD;
             5-hydroxytryptamine receptor 1 (5HT1R) or 5-hydroxytryptamine receptor 2B (5HT2BR) or&#xD;
             sigma nonspecific receptor with the exception of drugs that are considered absolutely&#xD;
             essential for the care of the participant.&#xD;
&#xD;
          -  Participant has a Fridericia-corrected QT interval (QTcF) &gt; 450 msec (average of&#xD;
             triplicate determinations) per central read.&#xD;
&#xD;
          -  Participant has long QT Syndrome at screening.&#xD;
&#xD;
          -  Participant has a known infection with human immunodeficiency virus (HIV).&#xD;
&#xD;
          -  Participant has active hepatitis B infection as determined by NAAT or surface antigen&#xD;
             assay. Participants who have acquired immunity from past exposure (HBcAb positive /&#xD;
             HBsAb positive / HBsAg negative) are eligible.&#xD;
&#xD;
          -  Participant has active hepatitis C infection as determined by NAAT. NAAT must be&#xD;
             performed if the participant has positive serology for hepatitis C. Participants who&#xD;
             have had past exposure and have no detectable virus either through spontaneous&#xD;
             clearance or treatment are eligible.&#xD;
&#xD;
          -  Participant has an uncontrolled infection. If a bacterial or viral infection is&#xD;
             present, the participant must be receiving definitive therapy and have no signs of&#xD;
             progressing infection for 72 hours prior to registration. If a fungal infection is&#xD;
             present, the participant must be receiving definitive systemic anti-fungal therapy and&#xD;
             have no signs of progressing infection for 1 week prior to registration.&#xD;
&#xD;
               -  Progressing infection is defined as hemodynamic instability attributable to&#xD;
                  sepsis or new symptoms, worsening physical signs or radiographic findings&#xD;
                  attributable to infection.&#xD;
&#xD;
               -  Persisting fever without other signs or symptoms will not be interpreted as&#xD;
                  progressing infection.&#xD;
&#xD;
          -  Participant has had a myocardial infarction within 6 months prior to registration or&#xD;
             New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina,&#xD;
             severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute&#xD;
             ischemia.&#xD;
&#xD;
          -  Participant has a serious medical or psychiatric illness likely to interfere with&#xD;
             participation in this clinical study.&#xD;
&#xD;
          -  Participant is breast feeding or pregnant.&#xD;
&#xD;
          -  Participant has prior malignancies, except lobular breast carcinoma in situ, fully&#xD;
             resected basal cell or squamous cell carcinoma of skin or treated cervical carcinoma&#xD;
             in situ.&#xD;
&#xD;
        Cancer treated with curative intent ≥ 5 years previously will be allowed. Cancer treated&#xD;
        with curative intent &lt; 5 years previously will not be allowed.&#xD;
&#xD;
        Randomization Exclusion Criteria&#xD;
&#xD;
          -  Participant requires treatment with concomitant drugs that are strong inducers of&#xD;
             CYP3A within 14 days of starting study drug.&#xD;
&#xD;
          -  Participant requires treatment with concomitant drugs that target serotonin 5HT1R or&#xD;
             5HT2BR or sigma nonspecific receptor with the exception of drugs that are considered&#xD;
             by the investigator to be absolutely essential for the care of the participant and for&#xD;
             which no acceptable alternative exists.&#xD;
&#xD;
          -  Participant has a QTcF interval &gt; 450 msec (average of triplicate determinations) by&#xD;
             central read.&#xD;
&#xD;
          -  Participant has a need for supplemental oxygen with the exception of using previously&#xD;
             existing non-invasive continuous positive airway pressure (CPAP) at night.&#xD;
&#xD;
          -  Participant has used investigational agents within 4 weeks of randomization.&#xD;
&#xD;
          -  Participant has used experimental therapy for acute GVHD within 4 weeks of&#xD;
             randomization. If unsure of the definition of &quot;experimental&quot;, discussion with one of&#xD;
             the protocol chairs is recommended.&#xD;
&#xD;
          -  Participant has an uncontrolled infection. If a bacterial or viral infection is&#xD;
             present, the participant must be receiving definitive therapy and have no signs of&#xD;
             progressing infection for 72 hours prior to randomization. If a fungal infection is&#xD;
             present, the participant must be receiving definitive systemic anti-fungal therapy and&#xD;
             have no signs of progressing infection for 1 week prior to randomization.&#xD;
&#xD;
               -  Progressing infection is defined as hemodynamic instability attributable to&#xD;
                  sepsis or new symptoms, worsening physical signs or radiographic findings&#xD;
                  attributable to infection.&#xD;
&#xD;
               -  Persisting fever without other signs or symptoms will not be interpreted as&#xD;
                  progressing infection.&#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>Senior Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Global Development, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia G Piper Cancer Center</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Lee Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Augusta University</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern Memorial Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
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  </location>
  <location>
    <facility>
      <name>Indiana Blood and Marrow Transplant</name>
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        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46237</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
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        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160-7233</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>University of Maryland Medical Systems</name>
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        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
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        <city>Baltimore</city>
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        <country>United States</country>
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  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
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        <country>United States</country>
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  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
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        <state>Massachusetts</state>
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        <country>United States</country>
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  <location>
    <facility>
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        <zip>02215</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>University of Massachusetts</name>
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        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>University of Minnesota School of Medicine</name>
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        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
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  <location>
    <facility>
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        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Washington University in St. Louis</name>
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        <city>Saint Louis</city>
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        <zip>63110</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
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        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
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    <facility>
      <name>Memorial Sloan Kettering</name>
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        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
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    <facility>
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        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
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        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Duke University Medical Center</name>
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        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
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    <facility>
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        <country>United States</country>
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    <facility>
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        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
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    <facility>
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        <zip>44195</zip>
        <country>United States</country>
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    <facility>
      <name>Ohio State University, The</name>
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        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
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    <facility>
      <name>Oregon Health and Science University</name>
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        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
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    <facility>
      <name>Vanderbilt University Medical Center</name>
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        <state>Tennessee</state>
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        <country>United States</country>
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    <facility>
      <name>Baylor College of Medicine</name>
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        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
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        <country>United States</country>
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        <country>United States</country>
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  <location>
    <facility>
      <name>West Virginia University Hospital</name>
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        <state>West Virginia</state>
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        <country>United States</country>
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  <location>
    <facility>
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        <country>United States</country>
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      <name>Medical College of Wisconsin</name>
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        <state>Wisconsin</state>
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  </location>
  <location>
    <facility>
      <name>Site GB44003</name>
      <address>
        <city>Bristol</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site GB44009</name>
      <address>
        <city>Glasgow</city>
        <zip>G12 0YN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site GB44004</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site GB44002</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site GB44001</name>
      <address>
        <city>Sutton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>New Zealand</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>July 27, 2023</last_update_submitted>
  <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gilteritinib</keyword>
  <keyword>ASP2215</keyword>
  <keyword>Safety and Efficacy</keyword>
  <keyword>Acute Myeloid Leukemia</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.</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>Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.</ipd_time_frame>
    <ipd_access_criteria>Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.</ipd_access_criteria>
    <ipd_url>http://www.clinicalstudydatarequest.com</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/NCT02997202
org study id: 2215-CL-0304
secondary id: 2016-001061-83
secondary id: BMT CTN 1506
nct id: NCT02997202
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to compare relapse-free survival between participants with
      FLT3/ITD AML in first morphologic complete remission (CR1) who undergo hematopoietic stem
      cell transplant (HCT) and are randomized to receive gilteritinib or placebo beginning after
      the time of engraftment for a two year period.
Participants with FLT3/ITD AML in first morphologic complete remission (CR1) undergoing
      allogeneic hematopoietic stem cell transplant (HCT) will be randomized to receive
      gilteritinib or placebo 30 to 90 days after HCT for a two year period. Participants will be
      stratified according to: 1) conditioning regimen intensity (myeloablative vs. reduced
      intensity/non-myeloablative), 2) time from first day of hematopoietic cell infusion to
      randomization (30-60 days vs. 61-90 days) and 3) presence vs absence of or unknown minimal
      residual disease (MRD) from the most recent pre-registration bone marrow (BM) aspirate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Relapse-free survival
time frame: 96 months
description: Relapse-free survival (RFS) will be measured from time of randomization to either morphological relapse or death, whichever comes first. Morphological relapse will be defined as bone marrow (BM) blasts 5% or higher (not attributable to regenerating BM), any circulating blasts (not attributable to regenerating BM or growth factors), or any extra-medullary blast foci as per Revised International Working Group (R-IWG) criteria.
measure: Safety and tolerability assessed by incidence and severity of adverse events
time frame: 25 months (24 months + 30 days)
description: All grade ≥ 3 toxicities according to CTCAE (Common Terminology Criteria for Adverse Events) version 4.03 will be tabulated for each treatment arm. The proportion of participants developing grade ≥ 3 AE across treatment arms will be compared. In addition, the incidence of all grade 1 to 4 toxicities according to CTCAE version 4.03 will be tabulated for each treatment arm and compared. Clinical laboratory evaluations and change from baseline will be described and compared. Electrocardiogram (ECG) results and change from baseline will be described and compared. Karnofsky Performance Status scores will be described and compared. The duration of drug use and dose of drug use will also be compared.
measure: Overall Survival (OS)
time frame: 66 months (5.5 years)
description: Time to OS is defined as the time to death from any cause after randomization. For surviving participants, non-events will be censored at the last known alive date.
measure: Non-relapse Mortality
time frame: 66 months (5.5 years)
description: An event for this endpoint is death without evidence of disease progression or recurrence.
measure: Event-free Survival (EFS) at 12 months
time frame: 12 months
description: The cumulative incidence at 12 months after randomization of EFS will be described and compared.
measure: Event-free Survival (EFS) at 24 months
time frame: 24 months
description: The cumulative incidence at 24 months after randomization of EFS will be described and compared.
measure: Cumulative Incidence of Acute Graft vs. Host Disease (GVHD)
time frame: 6 months
description: The cumulative incidence at 6 months after randomization of grades II-IV and grades III-IV acute GVHD will be described and compared. Acute GVHD will be graded according to diagnosis and severity scoring used by the Blood and Marrow Transplant Clinical Trial Network (BMT CTN).
measure: Cumulative Incidence of Chronic GVHD at 12 months
time frame: 12 months
description: The cumulative incidence at 12 months after randomization of chronic GVHD will be described and compared. Chronic GVHD will be graded according to diagnosis and severity scoring from the NIH 2014 Consensus Criteria.
measure: Cumulative Incidence of Chronic GVHD at 24 months
time frame: 24 months
description: The cumulative incidence at 24 months after randomization of chronic GVHD will be described and compared. Chronic GVHD will be graded according to diagnosis and severity scoring from the NIH 2014 Consensus Criteria.
measure: The cumulative incidence of detection of FLT3/ITD MRD
time frame: 24 months
description: The cumulative incidence of detection of FLT3/ITD MRD in participants who are FLT3/ITD MRD undetectable prior to randomization will be described. Similarly, the pattern of eradication of FLT3/ITD MRD in participants who have detectable FLT3/ITD MRD prior to randomization will be described.
measure: Incidence of Severity of Infection
time frame: 25 months (24 months + 30 days)
description: The cumulative incidence of CTCAE grades 3 to 5 infection in participants will be described and compared.
arm group label: Gilteritinib
arm group type: Experimental
description: Participants will take gilteritinib once daily for continuous daily dosing.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will take placebo once daily for continuous daily dosing.
intervention type: Drug
intervention name: gilteritinib
description: oral
arm group label: Gilteritinib
intervention type: Drug
intervention name: Placebo
description: oral
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Senior Medical Director
role: Study Director
affiliation: Astellas Pharma Global Development, Inc.
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country: Australia
country: Belgium
country: Canada
country: Denmark
country: France
country: Germany
country: Greece
country: Italy
country: Japan
country: Korea, Republic of
country: New Zealand
country: Poland
country: Spain
country: Taiwan
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
sharing ipd: Yes
ipd description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
ipd access criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
ipd url: http://www.clinicalstudydatarequest.com