<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/NCT03301597</url>
  </required_header>
  <id_info>
    <org_study_id>NLA-0101-CIN-01</org_study_id>
    <nct_id>NCT03301597</nct_id>
  </id_info>
  <brief_title>NLA101 in Adults Receiving High Dose Chemotherapy for AML</brief_title>
  <acronym>LAUNCH</acronym>
  <official_title>A Phase 2 Open-Label, Multi-Center, Randomized, Controlled, Dose-Finding Study of NLA101 in Adults Receiving High Dose Chemotherapy for Acute Myeloid Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nohla Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nohla Therapeutics, 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>
      Phase 2 open-label, multi-center, randomized, controlled, dose-finding study of safety and&#xD;
      efficacy of NLA101 to reduce the rate of infections associated with CIN in adult subjects&#xD;
      with AML.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase 2 open-label, multi-center, randomized, controlled, dose-finding study of safety and&#xD;
      efficacy of NLA101 to reduce the rate of infections associated with chemotherapy induced&#xD;
      neutropenia (CIN) in adult subjects with AML.&#xD;
&#xD;
      Eligible subjects with untreated de novo or secondary AML and per local institutional&#xD;
      standards planned to receive at least two cycles of chemotherapy with curative intent will be&#xD;
      enrolled into the study and randomized 1:1:1:1 to 1 of 3 Investigational Arms (Standard of&#xD;
      Care [SOC] chemotherapy + low, medium, or high dose NLA101) or a Control Arm (SOC&#xD;
      chemotherapy).&#xD;
&#xD;
      Subjects randomized to an Investigational Arm will be eligible to receive a single fixed&#xD;
      assigned dose of NLA101 after the first cycle of chemotherapy, and up to 2 additional&#xD;
      identical cell doses after subsequent chemotherapy cycles (one NLA101 infusion per cycle).&#xD;
      Subjects randomized to the Control Arm will be followed for up to 3 cycles of chemotherapy.&#xD;
&#xD;
      All subjects will be followed for 84 days following randomization, or 30 days post final&#xD;
      infusion of NLA101, or 30 days post the day after the last chemotherapy infusion for Control&#xD;
      Arm, whichever is longer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Development plan under review.&#xD;
  </why_stopped>
  <start_date type="Actual">January 24, 2018</start_date>
  <completion_date type="Actual">March 18, 2019</completion_date>
  <primary_completion_date type="Actual">March 18, 2019</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>
    <intervention_model_description>Subjects will be randomized to 1 of 3 Investigational Arms or a Control Arm in a 1:1:1:1 ratio.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>This is an open-label study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrent Event Rate of Grade 3 or Higher Bacterial or Fungal Infection</measure>
    <time_frame>From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Event rate of grade 3 or higher documented bacterial and fungal infections per cycle of chemotherapy</measure>
    <time_frame>From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and duration of filgrastim (or biosimilar) administration</measure>
    <time_frame>From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate</measure>
    <time_frame>From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and duration of complications due to infections</measure>
    <time_frame>From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and duration of febrile neutropenia</measure>
    <time_frame>From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">146</enrollment>
  <condition>Leukemia, Myeloid, Acute</condition>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The Control Arm will receive standard of care (SOC) chemotherapy without the infusion of NLA101. SOC chemotherapy will be determined by local PI and must be a standard regimen for untreated de novo or secondary AML that will result in moderate to severe myelosuppression and will be given with curative intent.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Dose Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Low Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of low-dose NLA101.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medium Dose Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Medium Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of medium-dose NLA101.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Dose Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The High Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of high-dose NLA101.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NLA101</intervention_name>
    <description>NLA101 is a universal donor &quot;off-the-shelf&quot; ex-vivo expanded hematopoietic stem and progenitor cell (HSPC) product that is cryopreserved and ready for immediate use.</description>
    <arm_group_label>High Dose Arm</arm_group_label>
    <arm_group_label>Low Dose Arm</arm_group_label>
    <arm_group_label>Medium Dose Arm</arm_group_label>
    <other_name>Dilanubicel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard of Care (SOC) chemotherapy</intervention_name>
    <description>The SOC chemotherapy regimen for each patient will be determined by local PI. Regimen must be a standard AML regimen that will result in moderate to severe myelosuppression and have curative intent.</description>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_label>High Dose Arm</arm_group_label>
    <arm_group_label>Low Dose Arm</arm_group_label>
    <arm_group_label>Medium Dose Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Criteria:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 (or legal age of majority for sites outside US).&#xD;
&#xD;
          -  Untreated de novo or secondary acute myeloid leukemia (AML), including AML that has&#xD;
             progressed from myelodysplastic syndrome (MDS), and histologically documented&#xD;
             diagnosis&#xD;
&#xD;
          -  Eligible for at least 2 cycles of standard of care AML chemotherapy that will result&#xD;
             in moderate to severe myelosuppression and have curative intent&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 or&#xD;
             Karnofsky Status of 50 to 100.&#xD;
&#xD;
          -  Adequate cardiac, renal, and hepatic functions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Extramedullary disease in the absence of bone marrow or blood involvement&#xD;
&#xD;
          -  Acute promyelocytic leukemia (APL) with PML-RARA&#xD;
&#xD;
          -  Prior AML therapy, with the exception of intrathecal chemotherapy or emergent&#xD;
             radiation for myeloid sarcoma.&#xD;
&#xD;
          -  Concurrent malignancy requiring active treatment with chemotherapy, immunotherapy, or&#xD;
             radiation&#xD;
&#xD;
          -  Prior allotransplant, including allogeneic hematopoietic cell transplant or solid&#xD;
             organ allogeneic transplant&#xD;
&#xD;
          -  Known hypersensitivity or history of hypersensitivity to dimethylsulfoxide (DMSO)&#xD;
&#xD;
          -  Active/chronic human immunodeficiency virus (HIV), hepatitis C virus (HCV), or&#xD;
             hepatitis B virus (HBV) 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>Martin S Tallman, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Naval G Daver, MD</last_name>
    <role>Study Chair</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UC San Diego Moores Cancer Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USC Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Davis Comprehensive Cancer Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Winship Cancer Institute, Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norton Cancer Institute, St. Matthews Campus</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center - Fred &amp; Pamela Buffett Cancer Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westchester Medical Center</name>
      <address>
        <city>Hawthorne</city>
        <state>New York</state>
        <zip>10532</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College - NewYork-Presbyterian Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai and Mount Sinai Health System</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stony Brook University</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Heath System, Duke Cancer Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Health</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Medical Center</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Penn Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Cancer Institute</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Froedtert Hospital and The Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent's Hospital Sydney</name>
      <address>
        <city>Darlinghurst</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. George Hospital</name>
      <address>
        <city>Kogarah</city>
        <state>New South Wales</state>
        <zip>2217</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Calvary Mater Newcastle</name>
      <address>
        <city>Waratah</city>
        <state>New South Wales</state>
        <zip>2298</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Health</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Epworth HealthCare</name>
      <address>
        <city>Richmond</city>
        <state>Victoria</state>
        <zip>3121</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Perth Hospital</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center</name>
      <address>
        <city>Incheon</city>
        <zip>21565</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea's Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Korea, Republic of</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>March 25, 2021</last_update_submitted>
  <last_update_submitted_qc>March 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chemotherapy-induced Neutropenia</keyword>
  <keyword>Bacterial Infections</keyword>
  <keyword>Fungal Infections</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>
  <!-- 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/NCT03301597
org study id: NLA-0101-CIN-01
nct id: NCT03301597
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Phase 2 open-label, multi-center, randomized, controlled, dose-finding study of safety and
      efficacy of NLA101 to reduce the rate of infections associated with CIN in adult subjects
      with AML.
Phase 2 open-label, multi-center, randomized, controlled, dose-finding study of safety and
      efficacy of NLA101 to reduce the rate of infections associated with chemotherapy induced
      neutropenia (CIN) in adult subjects with AML.

      Eligible subjects with untreated de novo or secondary AML and per local institutional
      standards planned to receive at least two cycles of chemotherapy with curative intent will be
      enrolled into the study and randomized 1:1:1:1 to 1 of 3 Investigational Arms (Standard of
      Care [SOC] chemotherapy + low, medium, or high dose NLA101) or a Control Arm (SOC
      chemotherapy).

      Subjects randomized to an Investigational Arm will be eligible to receive a single fixed
      assigned dose of NLA101 after the first cycle of chemotherapy, and up to 2 additional
      identical cell doses after subsequent chemotherapy cycles (one NLA101 infusion per cycle).
      Subjects randomized to the Control Arm will be followed for up to 3 cycles of chemotherapy.

      All subjects will be followed for 84 days following randomization, or 30 days post final
      infusion of NLA101, or 30 days post the day after the last chemotherapy infusion for Control
      Arm, whichever is longer.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects will be randomized to 1 of 3 Investigational Arms or a Control Arm in a 1:1:1:1 ratio.
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: This is an open-label study.
measure: Recurrent Event Rate of Grade 3 or Higher Bacterial or Fungal Infection
time frame: From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later
measure: Event rate of grade 3 or higher documented bacterial and fungal infections per cycle of chemotherapy
time frame: From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later
measure: Incidence and duration of filgrastim (or biosimilar) administration
time frame: From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later
measure: Overall Response Rate
time frame: From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later
measure: Incidence and duration of complications due to infections
time frame: From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later
measure: Incidence and duration of febrile neutropenia
time frame: From randomization through follow-up of 84 days post randomization, 30 days post last infusion of NLA101, or 30 days post last infusion of chemotherapy for Control Arm, whichever is later
arm group label: Control Arm
arm group type: Other
description: The Control Arm will receive standard of care (SOC) chemotherapy without the infusion of NLA101. SOC chemotherapy will be determined by local PI and must be a standard regimen for untreated de novo or secondary AML that will result in moderate to severe myelosuppression and will be given with curative intent.
arm group label: Low Dose Arm
arm group type: Experimental
description: The Low Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of low-dose NLA101.
arm group label: Medium Dose Arm
arm group type: Experimental
description: The Medium Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of medium-dose NLA101.
arm group label: High Dose Arm
arm group type: Experimental
description: The High Dose Arm will receive standard of care (SOC) chemotherapy with the infusion of high-dose NLA101.
intervention type: Biological
intervention name: NLA101
description: NLA101 is a universal donor "off-the-shelf" ex-vivo expanded hematopoietic stem and progenitor cell (HSPC) product that is cryopreserved and ready for immediate use.
arm group label: High Dose Arm
arm group label: Low Dose Arm
arm group label: Medium Dose Arm
other name: Dilanubicel
intervention type: Drug
intervention name: Standard of Care (SOC) chemotherapy
description: The SOC chemotherapy regimen for each patient will be determined by local PI. Regimen must be a standard AML regimen that will result in moderate to severe myelosuppression and have curative intent.
arm group label: Control Arm
arm group label: High Dose Arm
arm group label: Low Dose Arm
arm group label: Medium Dose Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martin S Tallman, MD
role: Study Chair
affiliation: Memorial Sloan Kettering Cancer Center
last name: Naval G Daver, MD
role: Study Chair
affiliation: M.D. Anderson Cancer Center
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country: Australia
country: Korea, Republic of
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute