<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/NCT02190695</url>
  </required_header>
  <id_info>
    <org_study_id>21357</org_study_id>
    <nct_id>NCT02190695</nct_id>
    <nct_alias>NCT02188706</nct_alias>
  </id_info>
  <brief_title>Leukemia SPORE Phase II DAC Study for R/R and Elderly Acute AML and MDS</brief_title>
  <official_title>Leukemia SPORE Phase II Randomized Study of Decitabine Versus Decitabine and Carboplatin Versus Decitabine and Arsenic in Relapsed, Refractory, and Elderly Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fox Chase Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Teva Pharmaceuticals USA</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Fox Chase Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find a new way to treat Acute Myeloid Leukemia (AML),&#xD;
      Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML). All the drugs are&#xD;
      used to treat AML and MDS but are not usually combined together. The investigators are&#xD;
      looking at both the safety and Efficacy of each combination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Groups:&#xD;
&#xD;
      If the participant is found to be eligible to take part in this study and he/she is one of&#xD;
      the first 30 participants enrolled, the participant will have an equal chance of being in one&#xD;
      of 3 study groups. If the participant enrolls after the first 30 participants are enrolled,&#xD;
      he/she will have a higher chance of being assigned to the group is having better results.&#xD;
&#xD;
        -  If participant is in Group 1, he/she will receive decitabine alone.&#xD;
&#xD;
        -  If participant is in Group 2, he/she will receive decitabine and carboplatin.&#xD;
&#xD;
        -  If participant is in Group 3, he/she will receive decitabine and arsenic trioxide.&#xD;
&#xD;
      Study Drug Administration:&#xD;
&#xD;
      Every 4 weeks is a study cycle.&#xD;
&#xD;
      The participant will receive decitabine by vein over about 1 hours on Days 1-5 of each cycle.&#xD;
&#xD;
      If the participant is receiving carboplatin, he/she will receive it over 1 hour on Day 8&#xD;
      (+/-2 days) of each cycle.&#xD;
&#xD;
      If the participant is receiving arsenic trioxide, he/she will receive it over about 1 hour on&#xD;
      Days 1-5 of each cycle&#xD;
&#xD;
      Study Visits:&#xD;
&#xD;
      Blood (about 1-2 teaspoons) will be drawn 1-2 times a week during Cycle 1 and then every 2-4&#xD;
      weeks after that for routine tests. If you have stable disease, blood will only be drawn&#xD;
      every 4-6 weeks.&#xD;
&#xD;
      On Day 28 of Cycle 3 (+/- 3 days), the participant will have a bone marrow aspirate and&#xD;
      biopsy to check the status of the disease. After that, the participant will have bone marrow&#xD;
      biopsies/aspirations when the doctor thinks it is needed.&#xD;
&#xD;
      If the participant is in Group 3, he/she will have EKGs on Day 1 of each cycle before&#xD;
      receiving the study drugs. On Days 1 and 4 of each cycle, blood (about 1-2 teaspoons) will&#xD;
      also be drawn for routine tests before their dose of the study drugs.&#xD;
&#xD;
      If the participant is taken off study, blood (about 1-2 teaspoons) will be drawn for routine&#xD;
      tests.&#xD;
&#xD;
      Length of Study:&#xD;
&#xD;
      The participant may continue taking the study drugs for as long as the doctor thinks it is in&#xD;
      your best interest. The participant will no longer be able to take the study drug(s) if the&#xD;
      disease gets worse, if intolerable side effects occur, or if he/she is unable to follow study&#xD;
      directions.&#xD;
&#xD;
      This is an investigational study. Arsenic trioxide is FDA approved and commercially available&#xD;
      for the treatment of APL. Decitabine is FDA approved and commercially available for the&#xD;
      treatment of MDS. Carboplatin is FDA approved and commercially available for the treatment&#xD;
      solid tumors. The study drug or study drug combination the participant receives on this study&#xD;
      are considered investigational.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2013</start_date>
  <completion_date type="Actual">April 16, 2020</completion_date>
  <primary_completion_date type="Actual">June 26, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to complete or partial remission</measure>
    <time_frame>up to 16 weeks</time_frame>
    <description>evaluation of the complete and partial response rates (antileukemic effect) and the amount of time taken to achieve the response.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">92</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <condition>Myelodysplastic Syndrome</condition>
  <condition>Chronic Myelomonocytic Leukemia</condition>
  <arm_group>
    <arm_group_label>Decitabine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Decitabine 20mg/m2 IV over 1hour daily times 5 days every 28 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Decitabine and Carboplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Decitabine 20mg/m2 IV over 1hour daily times 5 days, plus Carboplatin AUC 5 IV over 1hour on day 8. repeat every 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Decitabine and Arsenic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Decitabine 20mg/m2 IV over 1 hour daily for 5 days plus Arsenic Trioxide 0.15mg/kg IV daily for 5 days. repeat every 28 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Decitabine</intervention_name>
    <description>20 mg/m2 by vein daily over 1 hour on Days 1-5 of each 28 day cycle.</description>
    <arm_group_label>Decitabine</arm_group_label>
    <arm_group_label>Decitabine and Arsenic</arm_group_label>
    <arm_group_label>Decitabine and Carboplatin</arm_group_label>
    <other_name>Dacogen</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>AUC 5 by vein over 1 hour on Day 8 of each 28 day cycle.</description>
    <arm_group_label>Decitabine and Carboplatin</arm_group_label>
    <other_name>cis-Diammine</other_name>
    <other_name>Paraplatin</other_name>
    <other_name>Paraplatin-AQ</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Arsenic trioxide</intervention_name>
    <description>0.15 mg/kg by vein over 1 hour on Days 1-5 of each 28 day cycle.</description>
    <arm_group_label>Decitabine and Arsenic</arm_group_label>
    <other_name>ATO</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with AML, relapsed or refractory to standard therapy or elderly patients with&#xD;
             AML (age 65 or over). Patients who have AML and are younger than age 65 but considered&#xD;
             unfit for conventional chemotherapy are eligible. Patients with de novo or treated MDS&#xD;
             or CMML INT-1 or above are eligible. Patients may have had prior exposure to&#xD;
             azacitidine but no more than one cycle of decitabine. Patients must have been off&#xD;
             chemotherapy for 2 weeks prior to entering this study and have recovered from the&#xD;
             toxicities of that therapy; A caveat to this is in the case of rapidly progressive&#xD;
             disease. Hydroxyurea is permitted for control of elevated WBC prior to treatment and&#xD;
             can be continued for the first 4 weeks of therapy. Erythropoiesis stimulating agents&#xD;
             (ESAs) and GCSF are allowed before therapy. ESAs, GCSF or other growth factors are&#xD;
             permitted on therapy.&#xD;
&#xD;
          2. Performance 0-2 (ECOG).&#xD;
&#xD;
          3. Adequate cardiac functions assessed by 2D ECHO (NYHA cardiac III-IV excluded).&#xD;
&#xD;
          4. Pre-treatment EKG&#xD;
&#xD;
          5. Adequate end organ function with creatinine &lt;/= 2mg/dL and total bilirubin &lt;/= 2mg/dL,&#xD;
             AST and ALT &lt;/= or = 2.5 X institutional ULN.&#xD;
&#xD;
          6. Absence of significant intercurrent illness such as uncontrolled heart failure,&#xD;
             unstable angina, cardiac arrhythmia and psychiatric illness which precludes the giving&#xD;
             of informed consent.&#xD;
&#xD;
          7. Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Nursing and pregnant females. Patients of childbearing potential should practice&#xD;
             effective methods of contraception. Should a woman become preg-nant or suspect she is&#xD;
             pregnant while participating in this study, she should inform her treating physician&#xD;
             immediately.&#xD;
&#xD;
          2. Current uncontrolled infections.&#xD;
&#xD;
          3. Uncontrolled intercurrent illness including, but not limited to, symptomatic&#xD;
             congestive heart failure, unstable angina pectoris, or psychiatric illness/social&#xD;
             situations that would limit compliance with study requirements.&#xD;
&#xD;
          4. Chronic kidney disease &gt; stage 3.&#xD;
&#xD;
          5. HIV 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>Patricia Kropf, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Temple University Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Temple BMT Program at Jeanes Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M.D. Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>May 18, 2021</last_update_submitted>
  <last_update_submitted_qc>May 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
    <mesh_term>Preleukemia</mesh_term>
    <mesh_term>Leukemia, Myelomonocytic, Chronic</mesh_term>
    <mesh_term>Leukemia, Myelomonocytic, Juvenile</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Decitabine</mesh_term>
    <mesh_term>Arsenic Trioxide</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/NCT02190695
org study id: 21357
nct id: NCT02190695
nct alias: NCT02188706
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated device: No
The purpose of this study is to find a new way to treat Acute Myeloid Leukemia (AML),
      Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML). All the drugs are
      used to treat AML and MDS but are not usually combined together. The investigators are
      looking at both the safety and Efficacy of each combination.
Study Groups:

      If the participant is found to be eligible to take part in this study and he/she is one of
      the first 30 participants enrolled, the participant will have an equal chance of being in one
      of 3 study groups. If the participant enrolls after the first 30 participants are enrolled,
      he/she will have a higher chance of being assigned to the group is having better results.

        -  If participant is in Group 1, he/she will receive decitabine alone.

        -  If participant is in Group 2, he/she will receive decitabine and carboplatin.

        -  If participant is in Group 3, he/she will receive decitabine and arsenic trioxide.

      Study Drug Administration:

      Every 4 weeks is a study cycle.

      The participant will receive decitabine by vein over about 1 hours on Days 1-5 of each cycle.

      If the participant is receiving carboplatin, he/she will receive it over 1 hour on Day 8
      (+/-2 days) of each cycle.

      If the participant is receiving arsenic trioxide, he/she will receive it over about 1 hour on
      Days 1-5 of each cycle

      Study Visits:

      Blood (about 1-2 teaspoons) will be drawn 1-2 times a week during Cycle 1 and then every 2-4
      weeks after that for routine tests. If you have stable disease, blood will only be drawn
      every 4-6 weeks.

      On Day 28 of Cycle 3 (+/- 3 days), the participant will have a bone marrow aspirate and
      biopsy to check the status of the disease. After that, the participant will have bone marrow
      biopsies/aspirations when the doctor thinks it is needed.

      If the participant is in Group 3, he/she will have EKGs on Day 1 of each cycle before
      receiving the study drugs. On Days 1 and 4 of each cycle, blood (about 1-2 teaspoons) will
      also be drawn for routine tests before their dose of the study drugs.

      If the participant is taken off study, blood (about 1-2 teaspoons) will be drawn for routine
      tests.

      Length of Study:

      The participant may continue taking the study drugs for as long as the doctor thinks it is in
      your best interest. The participant will no longer be able to take the study drug(s) if the
      disease gets worse, if intolerable side effects occur, or if he/she is unable to follow study
      directions.

      This is an investigational study. Arsenic trioxide is FDA approved and commercially available
      for the treatment of APL. Decitabine is FDA approved and commercially available for the
      treatment of MDS. Carboplatin is FDA approved and commercially available for the treatment
      solid tumors. The study drug or study drug combination the participant receives on this study
      are considered investigational.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Time to complete or partial remission
time frame: up to 16 weeks
description: evaluation of the complete and partial response rates (antileukemic effect) and the amount of time taken to achieve the response.
arm group label: Decitabine
arm group type: Active Comparator
description: Decitabine 20mg/m2 IV over 1hour daily times 5 days every 28 days
arm group label: Decitabine and Carboplatin
arm group type: Experimental
description: Decitabine 20mg/m2 IV over 1hour daily times 5 days, plus Carboplatin AUC 5 IV over 1hour on day 8. repeat every 28 days.
arm group label: Decitabine and Arsenic
arm group type: Experimental
description: Decitabine 20mg/m2 IV over 1 hour daily for 5 days plus Arsenic Trioxide 0.15mg/kg IV daily for 5 days. repeat every 28 days
intervention type: Drug
intervention name: Decitabine
description: 20 mg/m2 by vein daily over 1 hour on Days 1-5 of each 28 day cycle.
arm group label: Decitabine
arm group label: Decitabine and Arsenic
arm group label: Decitabine and Carboplatin
other name: Dacogen
intervention type: Drug
intervention name: Carboplatin
description: AUC 5 by vein over 1 hour on Day 8 of each 28 day cycle.
arm group label: Decitabine and Carboplatin
other name: cis-Diammine
other name: Paraplatin
other name: Paraplatin-AQ
intervention type: Drug
intervention name: Arsenic trioxide
description: 0.15 mg/kg by vein over 1 hour on Days 1-5 of each 28 day cycle.
arm group label: Decitabine and Arsenic
other name: ATO
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Patricia Kropf, MD
role: Principal Investigator
affiliation: Temple University Health System
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Preleukemia
mesh term: Leukemia, Myelomonocytic, Chronic
mesh term: Leukemia, Myelomonocytic, Juvenile
mesh term: Myelodysplastic Syndromes
mesh term: Carboplatin
mesh term: Decitabine
mesh term: Arsenic Trioxide