<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/NCT02189824</url>
  </required_header>
  <id_info>
    <org_study_id>SCTL141501</org_study_id>
    <secondary_id>PG1061252</secondary_id>
    <nct_id>NCT02189824</nct_id>
  </id_info>
  <brief_title>Chemotherapy Followed by Infusion of Partially HLA Matched Unrelated Donor Cells for Patients With AML Who Are Ineligible for Stem Cell Transplantation</brief_title>
  <acronym>SCRAMBLE</acronym>
  <official_title>Chemotherapy Followed by Infusion of Partially HLA Matched Unrelated Donor Cells for Patients With AML Who Are Ineligible for Stem Cell Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sydney</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Melbourne Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Royal Brisbane and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sydney</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A phase 1 study of infusion of partially HLA matched unrelated donor blood or marrow cells&#xD;
      (microtransplantation) following consolidation chemotherapy in patients with AML that are not&#xD;
      suitable for allogenic stem cell transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To determine the safety and tolerability of co-administration of partially HLA antigen&#xD;
      matched unrelated donor cryopreserved donor lymphocytes (microtransplantation) with&#xD;
      chemotherapy for patients with high risk acute myeloid leukaemia ineligible or unsuitable for&#xD;
      high dose chemotherapy and stem cell transplantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of acute graft versus host disease within 60 days of completion of final infusion of donor lymphocytes</measure>
    <time_frame>60 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of post chemotherapy cytopenias</measure>
    <time_frame>60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission rate</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of complete remission</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Acute Myeloid Leukaemia</condition>
  <arm_group>
    <arm_group_label>Infusion of partially matched unrelated donor cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Partially HLA-matched unrelated donor cells</intervention_name>
    <arm_group_label>Infusion of partially matched unrelated donor cells</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Newly diagnosed AML not considered suitable for allogenic stem cell transplant on the&#xD;
             basis of age or co-morbidities&#xD;
&#xD;
          2. Complete morphological remission following 1-2 cycles of induction chemotherapy&#xD;
             consisting of an anthracycline/cytosine arabinoside combination&#xD;
&#xD;
          3. Availability of cryopreserved donor stem cells or bone marrow with appropriate HLA&#xD;
             matching&#xD;
&#xD;
          4. Adequate hepatic and renal function&#xD;
&#xD;
          5. Estimated life expectancy of at least 6 months&#xD;
&#xD;
          6. Patient has given informed consent or in the event of a patient not able to give&#xD;
             informed consent, consent has been given according to hospital procedures in force at&#xD;
             the time of trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient not in morphological remission following 2 cycles of induction chemotherapy&#xD;
&#xD;
          2. Use of fludarabine or other purine analogue during remission induction or use of any&#xD;
             major immunosuppressive medication or any other immunomodulatory agent including&#xD;
             thalidomide, lenalidomide, or azacitidine immediately prior to concurrent with&#xD;
             administration of chemotherapy for AML or during or in the 3 months after&#xD;
             administration of partially HLA matched 3rd party cells&#xD;
&#xD;
          3. Absence of a cryopreserved donor stem cell or bone marrow product with appropriate&#xD;
             matching&#xD;
&#xD;
          4. Presence of significant hepatic, renal or other major organ dysfunction&#xD;
&#xD;
          5. Uncontrolled infection or bleeding prior to commencement of consolidation chemotherapy&#xD;
&#xD;
          6. Privately insured in or outpatient on the day the consent is signed and the days that&#xD;
             cryopreserved partially HLA matched donor cells are infused&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Emily Blyth</last_name>
    <email>emily.blyth@sydney.edu.au</email>
  </overall_contact>
  <location>
    <facility>
      <name>Westmead Hospital Department of Haematology</name>
      <address>
        <city>Westmead, Sydney</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emily Blyth</last_name>
      <phone>+61 2 9845 6274</phone>
      <email>emily.blyth@sydney.edu.au</email>
    </contact>
    <investigator>
      <last_name>David Gottlieb</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Emily Blyth</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>October 29, 2015</last_update_submitted>
  <last_update_submitted_qc>October 29, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02189824
org study id: SCTL141501
secondary id: PG1061252
nct id: NCT02189824
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
A phase 1 study of infusion of partially HLA matched unrelated donor blood or marrow cells
      (microtransplantation) following consolidation chemotherapy in patients with AML that are not
      suitable for allogenic stem cell transplantation.
To determine the safety and tolerability of co-administration of partially HLA antigen
      matched unrelated donor cryopreserved donor lymphocytes (microtransplantation) with
      chemotherapy for patients with high risk acute myeloid leukaemia ineligible or unsuitable for
      high dose chemotherapy and stem cell transplantation.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of acute graft versus host disease within 60 days of completion of final infusion of donor lymphocytes
time frame: 60 days
measure: Duration of post chemotherapy cytopenias
time frame: 60 days
measure: Remission rate
time frame: 12 months
measure: Duration of complete remission
time frame: 12 months
arm group label: Infusion of partially matched unrelated donor cells
arm group type: Experimental
intervention type: Biological
intervention name: Partially HLA-matched unrelated donor cells
arm group label: Infusion of partially matched unrelated donor cells
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Emily Blyth
email: emily.blyth@sydney.edu.au
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Australia
responsible party type: Sponsor