<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/NCT02989844</url>
  </required_header>
  <id_info>
    <org_study_id>2016LS058</org_study_id>
    <secondary_id>MT2016-07</secondary_id>
    <nct_id>NCT02989844</nct_id>
  </id_info>
  <brief_title>Relapse Prophylaxis With N-803 for AML and MDS Pts Following Allo HSCT</brief_title>
  <official_title>Relapse Prophylaxis With IL-15 Super Agonist N-803 in Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome Following Reduced Intensity Conditioning (RIC) Allogeneic Stem Cell Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Masonic Cancer Center, University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Masonic Cancer Center, University of Minnesota</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>
      This is a single-arm, multi-center Phase II trial using IL-15 super-agonist complex (N-803&#xD;
      formerly known as Alt-803) maintenance after allogeneic hematopoietic cell transplant&#xD;
      (alloHCT) for acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 12, 2017</start_date>
  <completion_date type="Actual">August 31, 2022</completion_date>
  <primary_completion_date type="Actual">March 19, 2022</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Relapse</measure>
    <time_frame>24 months</time_frame>
    <description>Efficacy of N-803 as measured by the cumulative incidence of relapse between the 1st dose of N-803 and 2 years after a reduced intensity conditioning (RIC) allogeneic hematopoietic cell transplant (alloHCT)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Adverse Events</measure>
    <time_frame>12 months</time_frame>
    <description>Frequency of adverse and serious adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of acute graft-versus-host disease</measure>
    <time_frame>Day 100</time_frame>
    <description>Incidence of grade 2-4 and grade 3-4 acute graft-versus-host-disease (GVHD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of acute graft-versus-host disease</measure>
    <time_frame>Day 180</time_frame>
    <description>Incidence of grade 2-4 and grade 3-4 acute graft-versus-host-disease (GVHD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chronic GVHD</measure>
    <time_frame>1 year</time_frame>
    <description>Incidence of acute graft-versus-host disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimal residual disease (MRD)</measure>
    <time_frame>Day 100, 1 year</time_frame>
    <description>Incidence of minimal residual disease (MRD) post-transplant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>1 year post transplant</time_frame>
    <description>Incidence of overall survival at one year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-Relapse mortality</measure>
    <time_frame>1 year</time_frame>
    <description>Incidence of non-relapse mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse</measure>
    <time_frame>2 Years</time_frame>
    <description>Incidence of relapse at 2 years after alloHCT stratified by number of doses of N-803 (1-3 or 4-10)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Acute Myelogenous Leukemia (AML)</condition>
  <condition>Myelodysplastic Syndrome (MDS)</condition>
  <arm_group>
    <arm_group_label>N-803</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>N-803</intervention_name>
    <description>N-803 at 6 mcg/kg SQ Day 1 of a 4 week (28 day) cycle with ± 1 week window Continue N-803 every 4 weeks for 10 doses or until relapse, unacceptable toxicity, or patient refusal, whichever comes earlier.</description>
    <arm_group_label>N-803</arm_group_label>
    <other_name>Nant-803</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) for&#xD;
             whom an allogeneic hematopoietic stem cell transplant using a reduced intensity&#xD;
             conditioning is planned or has been performed and patient is prior to day 60&#xD;
             post-transplant.&#xD;
&#xD;
          2. Able to begin study treatment between day +42 and day +60 after the transplant and&#xD;
             meets the following transplant related requirements:&#xD;
&#xD;
               -  Sustained neutrophil (ANC &gt; 1000/mcL) and platelet (&gt; 30,000/mcL) engraftment&#xD;
&#xD;
               -  &gt;50% donor myeloid and lymphoid chimerism blood or bone marrow on most recent&#xD;
                  bone marrow (BM) evaluation&#xD;
&#xD;
               -  No evidence of recurrent disease on most recent bone marrow evaluation (day 21 or&#xD;
                  28 post-transplant is acceptable)&#xD;
&#xD;
               -  No morphologic evidence of relapse (&lt; 5% bone marrow blasts) on most recent BM&#xD;
                  evaluation (Day 21 or 28 post-transplant is acceptable)&#xD;
&#xD;
               -  Being followed in the outpatient setting (not an inpatient)&#xD;
&#xD;
               -  No plan of giving other anti-cancer treatment directed at diseases under study&#xD;
                  (i.e. maintenance therapy [e.g. sorafenib for FLT3m+ AML or hypomethylating&#xD;
                  therapy], additional therapy for MRD)&#xD;
&#xD;
          3. If acute GVHD is present it must be clinically improving on topical steroids and/or on&#xD;
             low dose systemic steroids (≤ 0.3 mg/kg/day prednisone) and with clinical stability&#xD;
             for at least 1 week prior to determination of eligibility. GVHD prophylaxis will be&#xD;
             continued per individual institutional standard practice&#xD;
&#xD;
          4. One of the following donor graft sources used for the transplant:&#xD;
&#xD;
               -  Group 1: sibling donor&#xD;
&#xD;
               -  Group 2: haploidentical donor [with post-transplant cyclophosphamide]&#xD;
&#xD;
               -  Group 3: unrelated donor&#xD;
&#xD;
               -  Group 4: unrelated umbilical cord blood&#xD;
&#xD;
          5. Karnofsky performance status ≥ 70%&#xD;
&#xD;
          6. Adequate organ function within 14 days of study enrollment defined as:&#xD;
&#xD;
               -  Renal: serum creatinine: ≤ 2.0 mg/dL&#xD;
&#xD;
               -  Hepatic: SGOT ≤ 3 x upper limit of institutional normal (ULN)&#xD;
&#xD;
          7. Sexually active females of child-bearing potential and males with partners of child&#xD;
             bearing potential must agree to use effective contraception during therapy and for 4&#xD;
             months after completion of therapy.&#xD;
&#xD;
          8. Voluntary written consent prior to the performance of any research related procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior N-803 (previously known as ALT-803)&#xD;
&#xD;
          2. Pregnant or breastfeeding - N-803 is an investigational agent. Women of child bearing&#xD;
             potential must have a negative pregnancy test at screening.&#xD;
&#xD;
          3. Class II or greater New York Heart Association Functional Classification criteria or&#xD;
             serious cardiac arrhythmias likely to increase the risk of cardiac complications of&#xD;
             cytokine therapy (e.g. ventricular tachycardia, frequent ventricular ectopy, or&#xD;
             supraventricular tachyarrhythmia requiring chronic therapy)&#xD;
&#xD;
          4. Marked baseline prolongation of QT/QTc interval (e.g. demonstration of a QTc interval&#xD;
             &gt; 500 milliseconds)&#xD;
&#xD;
          5. Active uncontrolled bacterial, fungal, or viral infections - all prior infections must&#xD;
             have resolved following optimal therapy and must be afebrile for at least 24 hours at&#xD;
             time of enrollment.&#xD;
&#xD;
          6. Active autoimmune disease requiring immunosuppressive therapy (GVHD prophylaxis is&#xD;
             permitted per institutional practice)&#xD;
&#xD;
          7. History of severe asthma and currently on chronic medications (mild asthma requiring&#xD;
             inhaled steroids only is eligible)&#xD;
&#xD;
          8. Received any investigational agent within the 14 days before the start of study&#xD;
             treatment (1st dose of N-803)&#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>Claudio Brunstein, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Masonic Cancer Center at University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>November 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>February 20, 2023</last_update_submitted>
  <last_update_submitted_qc>February 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</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>Preleukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>July 24, 2023</submitted>
    <returned>August 14, 2023</returned>
    <submitted>August 16, 2023</submitted>
    <returned>September 6, 2023</returned>
    <submitted>September 15, 2023</submitted>
  </pending_results>
  <!-- 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/NCT02989844
org study id: 2016LS058
secondary id: MT2016-07
nct id: NCT02989844
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a single-arm, multi-center Phase II trial using IL-15 super-agonist complex (N-803
      formerly known as Alt-803) maintenance after allogeneic hematopoietic cell transplant
      (alloHCT) for acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Relapse
time frame: 24 months
description: Efficacy of N-803 as measured by the cumulative incidence of relapse between the 1st dose of N-803 and 2 years after a reduced intensity conditioning (RIC) allogeneic hematopoietic cell transplant (alloHCT)
measure: Incidence of Adverse Events
time frame: 12 months
description: Frequency of adverse and serious adverse events
measure: Incidence of acute graft-versus-host disease
time frame: Day 100
description: Incidence of grade 2-4 and grade 3-4 acute graft-versus-host-disease (GVHD)
measure: Incidence of acute graft-versus-host disease
time frame: Day 180
description: Incidence of grade 2-4 and grade 3-4 acute graft-versus-host-disease (GVHD)
measure: Chronic GVHD
time frame: 1 year
description: Incidence of acute graft-versus-host disease
measure: Minimal residual disease (MRD)
time frame: Day 100, 1 year
description: Incidence of minimal residual disease (MRD) post-transplant
measure: Overall Survival
time frame: 1 year post transplant
description: Incidence of overall survival at one year
measure: Non-Relapse mortality
time frame: 1 year
description: Incidence of non-relapse mortality
measure: Relapse
time frame: 2 Years
description: Incidence of relapse at 2 years after alloHCT stratified by number of doses of N-803 (1-3 or 4-10)
arm group label: N-803
arm group type: Experimental
intervention type: Drug
intervention name: N-803
description: N-803 at 6 mcg/kg SQ Day 1 of a 4 week (28 day) cycle with ± 1 week window Continue N-803 every 4 weeks for 10 doses or until relapse, unacceptable toxicity, or patient refusal, whichever comes earlier.
arm group label: N-803
other name: Nant-803
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Claudio Brunstein, MD, PhD
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Preleukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Myelodysplastic Syndromes
submitted: July 24, 2023
returned: August 14, 2023
submitted: August 16, 2023
returned: September 6, 2023
submitted: September 15, 2023