<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/NCT03820908</url>
  </required_header>
  <id_info>
    <org_study_id>5792-18 - SMC</org_study_id>
    <nct_id>NCT03820908</nct_id>
  </id_info>
  <brief_title>Bisantrene for Relapsed /Refractory AML</brief_title>
  <official_title>Bisantrene for Relapsed /Refractory Acute Myelogenous Leukemia (AML)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Race Oncology Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Induction of response in patients with AML that are either primary resistant (failed&#xD;
      induction and or salvage therapy) or relapsed including post allogeneic stem cell&#xD;
      transplantation and failed salvage therapy or cannot receive additional anthracycline .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 18, 2019</start_date>
  <completion_date type="Actual">July 22, 2020</completion_date>
  <primary_completion_date type="Actual">May 19, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>The patientswith Rel /Ref AML will receive bisantrene in conjunction with the conventional supportive care. In the event of a CR, patients will receive a 3-day consolidation course of bisantrene 250mg/m2/d (optional).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>24 months</time_frame>
    <description>Overall survival will be calculated from the day of bisantrene administration until death or last follow-up.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Leukemia-free survival</measure>
    <time_frame>24 months</time_frame>
    <description>Leukemia-free survival will be calculated from the day of bisantrene administration until relapse, death of any cause, or last follow-up.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Acute Myelogenous Leukemia</condition>
  <condition>Allogeneic Stem Cell Transplantation</condition>
  <arm_group>
    <arm_group_label>Bisantrene</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients will receive bisantrene 250mg/m2/d for 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bisantrene</intervention_name>
    <description>The patients will receive bisantrene 250mg/m2/d for 7 days in conjunction with the conventional supportive care.</description>
    <arm_group_label>Bisantrene</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must meet all of the following inclusion criteria to be eligible to enroll in&#xD;
             this study.&#xD;
&#xD;
        Disease-related:&#xD;
&#xD;
          1. Patients with Rel/Ref/AML&#xD;
&#xD;
          2. Adequate birth control in fertile patients.&#xD;
&#xD;
          3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2&#xD;
&#xD;
        Demographic:&#xD;
&#xD;
          1. Age ≥ 18 years and willing and able to comply with the protocol requirements&#xD;
&#xD;
          2. Life expectancy ≥ 3 months Ethical/Other&#xD;
&#xD;
          3. Written informed consent in accordance with federal, local, and institutional&#xD;
             guidelines.&#xD;
&#xD;
          4. Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and&#xD;
             to practice contraception.&#xD;
&#xD;
          5. Male subjects must agree to practice contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Disease-related&#xD;
&#xD;
               1. Patients with other type of basic disease other than Rel/Ref AML.&#xD;
&#xD;
               2. Patients with respiratory failure (DLCO &lt; 30%).&#xD;
&#xD;
               3. Patients with active congestive heart failure (New York Heart Association [NYHA]&#xD;
                  Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled&#xD;
                  by conventional intervention.&#xD;
&#xD;
               4. Patients with &gt; grade II liver renal toxicity.&#xD;
&#xD;
               5. Psychiatric conditions/disease that impair the ability to give informed consent&#xD;
                  or to adequately co-operate&#xD;
&#xD;
               6. Bilirubin &gt; 3.0 mg/dl, transaminases &gt; 3 times upper normal limit&#xD;
&#xD;
               7. Creatinine &gt; 2.0 mg/dl&#xD;
&#xD;
               8. ECOG-Performance status &gt; 2&#xD;
&#xD;
               9. CNS disease involvement&#xD;
&#xD;
              10. Severe pleural effusion and ascites. Concurrent Conditions&#xD;
&#xD;
               1. Pregnant or lactating females&#xD;
&#xD;
               2. Known human immunodeficiency virus infection&#xD;
&#xD;
               3. Active hepatitis B or C infection&#xD;
&#xD;
               4. Non hematologic malignancy within the past 3 years with the exception of a)&#xD;
                  adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid&#xD;
                  cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of&#xD;
                  Gleason Grade 6 or less with stable prostate-specific antigen levels; or d)&#xD;
                  cancer considered cured by surgical resection or unlikely to impact survival&#xD;
                  during the duration of the study, such as localized transitional cell carcinoma&#xD;
                  of the bladder or benign tumors of the adrenal or pancreas&#xD;
&#xD;
               5. Contraindication to any of the required concomitant drugs or supportive&#xD;
                  treatments, including hypersensitivity to all anticoagulation and antiplatelet&#xD;
                  options, antiviral drugs, or intolerance to hydration due to preexisting&#xD;
                  pulmonary or cardiac impairment&#xD;
&#xD;
               6. Any other clinically significant medical disease or condition that, in the&#xD;
                  Investigator's opinion, may interfere with protocol adherence or a subject's&#xD;
                  ability to give informed consent.&#xD;
&#xD;
               7. Patients with relapse or disease progression &gt;3 months post HSCT are allowed into&#xD;
                  the study unless they have severe (grade III-IV) GVHD.&#xD;
&#xD;
        Patients with grade III-IV GVHD will be excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chaim Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <zip>57261</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 27, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sheba Medical Center</investigator_affiliation>
    <investigator_full_name>Prof Arnon Nagler</investigator_full_name>
    <investigator_title>Arnon Nagler, M.D., M.Sc Professor of Medicine Tel Aviv University, Director Hematology Division BMT and Cord Blood Bank, Chair Israeli BMT Association, Chair of the ALWP of the EBMT, Co-Chair Scientific Council of the EBMT</investigator_title>
  </responsible_party>
  <keyword>relapsed AML</keyword>
  <keyword>refractory AML</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>Bisantrene</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03820908
org study id: 5792-18 - SMC
nct id: NCT03820908
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Induction of response in patients with AML that are either primary resistant (failed
      induction and or salvage therapy) or relapsed including post allogeneic stem cell
      transplantation and failed salvage therapy or cannot receive additional anthracycline .
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The patientswith Rel /Ref AML will receive bisantrene in conjunction with the conventional supportive care. In the event of a CR, patients will receive a 3-day consolidation course of bisantrene 250mg/m2/d (optional).
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival
time frame: 24 months
description: Overall survival will be calculated from the day of bisantrene administration until death or last follow-up.
measure: Leukemia-free survival
time frame: 24 months
description: Leukemia-free survival will be calculated from the day of bisantrene administration until relapse, death of any cause, or last follow-up.
arm group label: Bisantrene
arm group type: Experimental
description: patients will receive bisantrene 250mg/m2/d for 7 days
intervention type: Drug
intervention name: Bisantrene
description: The patients will receive bisantrene 250mg/m2/d for 7 days in conjunction with the conventional supportive care.
arm group label: Bisantrene
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Sheba Medical Center
investigator full name: Prof Arnon Nagler
investigator title: Arnon Nagler, M.D., M.Sc Professor of Medicine Tel Aviv University, Director Hematology Division BMT and Cord Blood Bank, Chair Israeli BMT Association, Chair of the ALWP of the EBMT, Co-Chair Scientific Council of the EBMT
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Bisantrene