<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/NCT03019640</url>
  </required_header>
  <id_info>
    <org_study_id>2015-0751</org_study_id>
    <secondary_id>NCI-2018-01239</secondary_id>
    <secondary_id>2015-0751</secondary_id>
    <nct_id>NCT03019640</nct_id>
  </id_info>
  <brief_title>Umbilical Cord Blood NK Cells, Rituximab, High-Dose Chemotherapy, and Stem Cell Transplant in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma</brief_title>
  <official_title>Immunotherapy With Ex Vivo-Expanded Cord Blood-Derived NK Cells Combined With Rituximab High-Dose Chemotherapy and Autologous Stem Cell Transplant for B-Cell Non-Hodgkin's Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II trial studies the side effects of cord blood-derived expanded allogeneic&#xD;
      natural killer cells (umbilical cord blood natural killer [NK] cells), rituximab, high-dose&#xD;
      chemotherapy, and stem cell transplant in treating patients with B-cell non-Hodgkin's&#xD;
      lymphoma that has come back (recurrent) or that does not respond to treatment (refractory).&#xD;
      Immune system cells, such as cord blood-derived expanded allogeneic natural killer cells, are&#xD;
      made by the body to attack foreign or cancerous cells. Immunotherapy with rituximab, may&#xD;
      induce changes in body's immune system and may interfere with the ability of tumor cells to&#xD;
      grow and spread. Drugs used in chemotherapy, such as carmustine, cytarabine, etoposide,&#xD;
      lenalidomide, melphalan, and rituximab, work in different ways to stop the growth of cancer&#xD;
      cells, either by killing the cells, by stopping them from dividing, or by stopping them from&#xD;
      spreading. A stem cell transplant using stem cells from the patient or a donor may be able to&#xD;
      replace blood-forming cells that were destroyed by chemotherapy used to kill cancer cells.&#xD;
      The donated stem cells may also replace the patient's immune cells and help destroy any&#xD;
      remaining cancer cells. Giving cord blood-derived expanded allogeneic natural killer cells,&#xD;
      rituximab, high-dose chemotherapy, and stem cell transplant may work better in treating&#xD;
      patients with recurrent or refractory B-cell non-Hodgkin's lymphoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To establish the safety of this treatment by determining its treatment-related mortality&#xD;
      (TRM) within 30 days.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To estimate the relapse-free survival (RFS). II. To estimate the overall survival (OS).&#xD;
      III. To quantify duration of infused allogeneic umbilical cord blood (UCB)-derived natural&#xD;
      killer (NK) cells in the recipient.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      PREPARATIVE REGIMEN: Patients receive carmustine intravenously (IV) over 2 hours on day -12,&#xD;
      etoposide IV twice daily (BID) over 3 hours on days -11 to -8, cytarabine IV BID over 1 hour&#xD;
      on days -11 to -8, melphalan IV over 30 minutes on day -7, and lenalidomide orally (PO) once&#xD;
      daily (QD) on days -7 to -2 in the absence of disease progression or unacceptable toxicity.&#xD;
      Patients who are CD20+ also receive rituximab IV over 3 hours on days -13 and -7.&#xD;
&#xD;
      NK-CELL INFUSION: Patients receive cord blood-derived expanded allogeneic NK cells IV over 1&#xD;
      hour on day -5 in the absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      STEM CELL TRANSPLANT: Patients undergo stem cell transplant IV over 30-60 minutes on day 0 in&#xD;
      the absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      POST-TRANSPLANT: Patients receive filgrastim subcutaneously (SC) QD beginning on day +5.&#xD;
      Treatment continues until white blood cell count recovers in the absence of disease&#xD;
      progression or unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 30, 100, and 180 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 10, 2017</start_date>
  <completion_date type="Actual">August 16, 2021</completion_date>
  <primary_completion_date type="Actual">August 16, 2021</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>Treatment-related Mortality Within 30 Days (TRM30)</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Participants that had Treatment-related mortality within 30 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Survived</measure>
    <time_frame>From the time of transplant, assessed up to day 180</time_frame>
    <description>Number of Participants Who Survived at day 180.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Mantle Cell Lymphoma</condition>
  <condition>Recurrent Diffuse Large B-Cell Lymphoma</condition>
  <condition>Recurrent Follicular Lymphoma</condition>
  <condition>Recurrent Indolent Adult Non-Hodgkin Lymphoma</condition>
  <condition>Refractory Diffuse Large B-Cell Lymphoma</condition>
  <condition>Refractory Follicular Lymphoma</condition>
  <condition>Refractory Indolent Adult Non-Hodgkin Lymphoma</condition>
  <arm_group>
    <arm_group_label>Treatment (chemotherapy, NK infusion, stem cell transplant)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>See Detailed Description.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Autologous Hematopoietic Stem Cell Transplantation</intervention_name>
    <description>Undergo stem cell transplant</description>
    <arm_group_label>Treatment (chemotherapy, NK infusion, stem cell transplant)</arm_group_label>
    <other_name>Autologous Hematopoietic Cell Transplantation</other_name>
    <other_name>autologous stem cell transplantation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carmustine</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (chemotherapy, NK infusion, stem cell transplant)</arm_group_label>
    <other_name>BCNU</other_name>
    <other_name>Becenum</other_name>
    <other_name>Becenun</other_name>
    <other_name>BiCNU</other_name>
    <other_name>Bis(chloroethyl) Nitrosourea</other_name>
    <other_name>Bis-Chloronitrosourea</other_name>
    <other_name>Carmubris</other_name>
    <other_name>Carmustin</other_name>
    <other_name>Carmustinum</other_name>
    <other_name>FDA 0345</other_name>
    <other_name>N,N''-Bis(2-chloroethyl)-N-nitrosourea</other_name>
    <other_name>Nitrourean</other_name>
    <other_name>Nitrumon</other_name>
    <other_name>SK 27702</other_name>
    <other_name>SRI 1720</other_name>
    <other_name>WR-139021</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Cord Blood-derived Expanded Allogeneic Natural Killer Cells</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (chemotherapy, NK infusion, stem cell transplant)</arm_group_label>
    <other_name>Allogeneic CB-derived Ex vivo-expanded NK Cells</other_name>
    <other_name>CB-derived Expanded Allogeneic NK Cells</other_name>
    <other_name>UCB-derived Expanded Allogeneic NK Cells</other_name>
    <other_name>Umbilical Cord Blood-derived Expanded Allogeneic Natural Killer Cells</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cytarabine</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (chemotherapy, NK infusion, stem cell transplant)</arm_group_label>
    <other_name>.beta.-Cytosine arabinoside</other_name>
    <other_name>1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone</other_name>
    <other_name>1-.beta.-D-Arabinofuranosylcytosine</other_name>
    <other_name>1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone</other_name>
    <other_name>1-Beta-D-arabinofuranosylcytosine</other_name>
    <other_name>1.beta.-D-Arabinofuranosylcytosine</other_name>
    <other_name>2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-</other_name>
    <other_name>2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-</other_name>
    <other_name>Alexan</other_name>
    <other_name>Ara-C</other_name>
    <other_name>ARA-cell</other_name>
    <other_name>Arabine</other_name>
    <other_name>Arabinofuranosylcytosine</other_name>
    <other_name>Arabinosylcytosine</other_name>
    <other_name>Aracytidine</other_name>
    <other_name>Aracytin</other_name>
    <other_name>Aracytine</other_name>
    <other_name>Beta-cytosine Arabinoside</other_name>
    <other_name>CHX-3311</other_name>
    <other_name>Cytarabinum</other_name>
    <other_name>Cytarbel</other_name>
    <other_name>Cytosar</other_name>
    <other_name>Cytosine Arabinoside</other_name>
    <other_name>Cytosine-.beta.-arabinoside</other_name>
    <other_name>Cytosine-beta-arabinoside</other_name>
    <other_name>Erpalfa</other_name>
    <other_name>Starasid</other_name>
    <other_name>Tarabine PFS</other_name>
    <other_name>U 19920</other_name>
    <other_name>U-19920</other_name>
    <other_name>Udicil</other_name>
    <other_name>WR-28453</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etoposide</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (chemotherapy, NK infusion, stem cell transplant)</arm_group_label>
    <other_name>Demethyl Epipodophyllotoxin Ethylidine Glucoside</other_name>
    <other_name>EPEG</other_name>
    <other_name>Lastet</other_name>
    <other_name>Toposar</other_name>
    <other_name>Vepesid</other_name>
    <other_name>VP 16</other_name>
    <other_name>VP 16-213</other_name>
    <other_name>VP-16</other_name>
    <other_name>VP-16-213</other_name>
    <other_name>VP16</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Filgrastim</intervention_name>
    <description>Given SC</description>
    <arm_group_label>Treatment (chemotherapy, NK infusion, stem cell transplant)</arm_group_label>
    <other_name>G-CSF</other_name>
    <other_name>Neupogen</other_name>
    <other_name>r-metHuG-CSF</other_name>
    <other_name>Recombinant Methionyl Human Granulocyte Colony Stimulating Factor</other_name>
    <other_name>rG-CSF</other_name>
    <other_name>Tevagrastim</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenalidomide</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (chemotherapy, NK infusion, stem cell transplant)</arm_group_label>
    <other_name>CC-5013</other_name>
    <other_name>CC5013</other_name>
    <other_name>CDC 501</other_name>
    <other_name>Revlimid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Melphalan</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (chemotherapy, NK infusion, stem cell transplant)</arm_group_label>
    <other_name>Alanine Nitrogen Mustard</other_name>
    <other_name>CB-3025</other_name>
    <other_name>L-PAM</other_name>
    <other_name>L-Phenylalanine Mustard</other_name>
    <other_name>L-sarcolysin</other_name>
    <other_name>L-Sarcolysin Phenylalanine mustard</other_name>
    <other_name>L-Sarcolysine</other_name>
    <other_name>Melphalanum</other_name>
    <other_name>Phenylalanine Mustard</other_name>
    <other_name>Phenylalanine nitrogen mustard</other_name>
    <other_name>Sarcoclorin</other_name>
    <other_name>Sarkolysin</other_name>
    <other_name>WR-19813</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (chemotherapy, NK infusion, stem cell transplant)</arm_group_label>
    <other_name>ABP 798</other_name>
    <other_name>BI 695500</other_name>
    <other_name>C2B8 Monoclonal Antibody</other_name>
    <other_name>Chimeric Anti-CD20 Antibody</other_name>
    <other_name>CT-P10</other_name>
    <other_name>IDEC-102</other_name>
    <other_name>IDEC-C2B8</other_name>
    <other_name>IDEC-C2B8 Monoclonal Antibody</other_name>
    <other_name>MabThera</other_name>
    <other_name>Monoclonal Antibody IDEC-C2B8</other_name>
    <other_name>PF-05280586</other_name>
    <other_name>Rituxan</other_name>
    <other_name>Rituximab ABBS</other_name>
    <other_name>Rituximab Biosimilar ABP 798</other_name>
    <other_name>Rituximab Biosimilar BI 695500</other_name>
    <other_name>Rituximab Biosimilar CT-P10</other_name>
    <other_name>Rituximab Biosimilar GB241</other_name>
    <other_name>Rituximab Biosimilar IBI301</other_name>
    <other_name>Rituximab Biosimilar JHL1101</other_name>
    <other_name>Rituximab Biosimilar PF-05280586</other_name>
    <other_name>Rituximab Biosimilar RTXM83</other_name>
    <other_name>Rituximab Biosimilar SAIT101</other_name>
    <other_name>rituximab biosimilar TQB2303</other_name>
    <other_name>rituximab-abbs</other_name>
    <other_name>RTXM83</other_name>
    <other_name>Truxima</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with B-cell lymphoma who are candidates to autologous stem-cell&#xD;
             transplantation:&#xD;
&#xD;
               -  Primary refractory or relapsed diffuse large B-cell lymphoma in response to&#xD;
                  salvage treatment&#xD;
&#xD;
               -  Primary refractory or relapsed follicular lymphoma or other indolent B-cell&#xD;
                  histology in response to salvage treatment&#xD;
&#xD;
               -  Chemosensitive mantle-cell lymphoma in first or later line of treatment&#xD;
&#xD;
          -  Estimated serum creatinine clearance &gt;= 60 ml/min and a normal serum creatinine for&#xD;
             age&#xD;
&#xD;
          -  Serum glutamic-oxaloacetic transaminase (SGOT) and/or serum glutamate pyruvate&#xD;
             transaminase (SGPT) =&lt; 3 x upper limit of normal (ULN)&#xD;
&#xD;
          -  Total bilirubin and alkaline phosphatase (ALP) =&lt; 2 x ULN or =&lt; 3 x ULN for Gilbert's&#xD;
             disease&#xD;
&#xD;
          -  Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and&#xD;
             diffusion lung capacity (DLCO) (corrected for hemoglobin [Hgb]) &gt;= 50% of the&#xD;
             predicted value&#xD;
&#xD;
          -  Left ventricular ejection fraction &gt;= 40%. No uncontrolled arrhythmias or symptomatic&#xD;
             cardiac disease&#xD;
&#xD;
          -  Performance status &lt; 2 (Eastern Cooperative Oncology Group [ECOG])&#xD;
&#xD;
          -  Negative beta human chorionic gonadotropin (HCG) in woman with child-bearing potential&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary central nervous system (CNS) lymphoma&#xD;
&#xD;
          -  Grade &gt;= 3 non-hematologic toxicity from prior therapy that has not resolved to =&lt;&#xD;
             grade (G) 1&#xD;
&#xD;
          -  Prior whole brain irradiation&#xD;
&#xD;
          -  Active hepatitis B, either active carrier (hepatitis B surface antigen positive [HBsAg&#xD;
             +]) or viremic (hepatitis B virus [HBV] deoxyribonucleic acid [DNA] &gt;= 10,000&#xD;
             copies/mL, or &gt;= 2,000 IU/mL)&#xD;
&#xD;
          -  Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic&#xD;
             hepatitis C or positive hepatitis C serology&#xD;
&#xD;
          -  Active infection requiring parenteral antibiotics&#xD;
&#xD;
          -  Human immunodeficiency virus (HIV) infection&#xD;
&#xD;
          -  Radiation therapy in the month prior to enroll&#xD;
&#xD;
          -  Breastfeeding females&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yago L Nieto</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <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>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <results_first_submitted>August 24, 2022</results_first_submitted>
  <results_first_submitted_qc>February 15, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 16, 2023</results_first_posted>
  <last_update_submitted>February 15, 2023</last_update_submitted>
  <last_update_submitted_qc>February 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 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>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Follicular</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
    <mesh_term>Lymphoma, Mantle-Cell</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cytarabine</mesh_term>
    <mesh_term>Rituximab</mesh_term>
    <mesh_term>Antineoplastic Agents, Immunological</mesh_term>
    <mesh_term>Etoposide</mesh_term>
    <mesh_term>Lenalidomide</mesh_term>
    <mesh_term>Etoposide phosphate</mesh_term>
    <mesh_term>Melphalan</mesh_term>
    <mesh_term>Mechlorethamine</mesh_term>
    <mesh_term>Carmustine</mesh_term>
    <mesh_term>Podophyllotoxin</mesh_term>
    <mesh_term>Nitrogen Mustard Compounds</mesh_term>
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Immunoglobulins</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
    <mesh_term>Lenograstim</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 5, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT03019640/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants recruitment from October 2017 to August 2021 at MD Anderson Cancer Center.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)</title>
          <description>Patients receive carmustine intravenously (IV) over 2 hours on day -12, etoposide IV twice daily (BID) over 3 hours on days -11 to -8, cytarabine IV BID over 1 hour on days -11 to -8, melphalan IV over 30 minutes on day -7, and lenalidomide orally (PO) once daily (QD) on days -7 to -2 in the absence of disease progression or unacceptable toxicity. Patients who are CD20+ also receive rituximab IV over 3 hours on days -13 and -7.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Screen Failures</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant Relapsed</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)</title>
          <description>Patients receive carmustine intravenously (IV) over 2 hours on day -12, etoposide IV twice daily (BID) over 3 hours on days -11 to -8, cytarabine IV BID over 1 hour on days -11 to -8, melphalan IV over 30 minutes on day -7, and lenalidomide orally (PO) once daily (QD) on days -7 to -2 in the absence of disease progression or unacceptable toxicity. Patients who are CD20+ also receive rituximab IV over 3 hours on days -13 and -7.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="22"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Treatment-related Mortality Within 30 Days (TRM30)</title>
        <description>Participants that had Treatment-related mortality within 30 days.</description>
        <time_frame>Up to 30 days</time_frame>
        <population>Four participants did not received treatment due to screen failures.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)</title>
            <description>See Detailed Description.&#xD;
Autologous Hematopoietic Stem Cell Transplantation: Undergo stem cell transplant&#xD;
Carmustine: Given IV&#xD;
Cord Blood-derived Expanded Allogeneic Natural Killer Cells: Given IV&#xD;
Cytarabine: Given IV&#xD;
Etoposide: Given IV&#xD;
Filgrastim: Given SC&#xD;
Lenalidomide: Given PO&#xD;
Melphalan: Given IV&#xD;
Rituximab: Given IV</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment-related Mortality Within 30 Days (TRM30)</title>
          <description>Participants that had Treatment-related mortality within 30 days.</description>
          <population>Four participants did not received treatment due to screen failures.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Survived</title>
        <description>Number of Participants Who Survived at day 180.</description>
        <time_frame>From the time of transplant, assessed up to day 180</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)</title>
            <description>See Detailed Description.&#xD;
Autologous Hematopoietic Stem Cell Transplantation: Undergo stem cell transplant&#xD;
Carmustine: Given IV&#xD;
Cord Blood-derived Expanded Allogeneic Natural Killer Cells: Given IV&#xD;
Cytarabine: Given IV&#xD;
Etoposide: Given IV&#xD;
Filgrastim: Given SC&#xD;
Lenalidomide: Given PO&#xD;
Melphalan: Given IV&#xD;
Rituximab: Given IV</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Survived</title>
          <description>Number of Participants Who Survived at day 180.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All-Cause Mortality monitored/assessed up to 180 days.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)</title>
          <description>Patients receive carmustine intravenously (IV) over 2 hours on day -12, etoposide IV twice daily (BID) over 3 hours on days -11 to -8, cytarabine IV BID over 1 hour on days -11 to -8, melphalan IV over 30 minutes on day -7, and lenalidomide orally (PO) once daily (QD) on days -7 to -2 in the absence of disease progression or unacceptable toxicity. Patients who are CD20+ also receive rituximab IV over 3 hours on days -13 and -7.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>White blood cell decreased</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infections and infestations</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Lung</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Lymph node pain</sub_title>
                <description>Lymph node pain</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <description>Sinus bradycardia</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <description>Sinus tachycardia</description>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <description>Ear pain</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Endocrine disorders</sub_title>
                <description>Endocrine disorders</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <description>Hypothyroidism</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye disorders</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bloating</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <description>Constipation</description>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <description>Diarrhea</description>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <description>Dyspepsia</description>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Esophagitis</sub_title>
                <description>Esophagitis</description>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Gastroesophageal reflux disease</sub_title>
                <description>Gastroesophageal reflux disease</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Gastrointestinal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hemorrhoidal hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <description>Ileus</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Mucositis oral</sub_title>
                <description>Mucositis oral</description>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <description>Nausea</description>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Rectal pain</sub_title>
                <description>Rectal pain</description>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <description>Chills</description>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <description>Cough</description>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Edema face</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Edema limbs</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>General disorders and administration site conditions</sub_title>
                <description>General disorders and administration site conditions</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <description>Pain</description>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <description>Dizziness</description>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Immune system disorders</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bladder infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Infections and infestations</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Mucosal infection</sub_title>
                <description>Mucosal infection</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Papulopustular rash</sub_title>
                <description>Papulopustular rash</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <description>Sinusitis</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Upper respiratory infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <description>Back pain</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Cholesterol high</sub_title>
                <description>Cholesterol high</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <description>Creatinine increased</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <description>Hypoxia</description>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>INR increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Investigations</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Lymphocyte count increased</sub_title>
                <description>Lymphocyte count increased</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <description>Platelet count decreased</description>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Weight gain</sub_title>
                <description>Weight gain</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>White blood cell decreased</sub_title>
                <description>White blood cell decreased</description>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <description>Anorexia</description>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <description>Dehydration</description>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hypercalcemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hypermagnesemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hypernatremia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hyperuricemia</sub_title>
                <description>Hyperuricemia</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hypoglycemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hypomagnesemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hypophosphatemia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Metabolism and nutrition disorders</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Generalized muscle weakness</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <description>Myalgia</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <description>Neck pain</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <description>Pain in extremity</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Nervous system disorders</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <description>Paresthesia</description>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Peripheral motor neuropathy</sub_title>
                <description>Peripheral motor neuropathy</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <description>Restlessness</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <description>Insomnia</description>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hematuria</sub_title>
                <description>Hematuria</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Renal and urinary disorders</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Urinary frequency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Urinary tract pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Prostatic obstruction</sub_title>
                <description>Prostatic obstruction</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <description>Dyspnea</description>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <description>Nasal congestion</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <description>Pleural effusion</description>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Pulmonary edema</sub_title>
                <description>Pulmonary edema</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <description>Respiratory failure</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Sore throat</sub_title>
                <description>Sore throat</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Rash acneiform</sub_title>
                <description>Rash acneiform</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <description>Rash maculo-papular</description>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Skin and subcutaneous tissue disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Skin hyperpigmentation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Skin ulceration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <description>Hypotension</description>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Vascular disorders</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>UT MD Anderson Cancer Center</name_or_title>
      <organization>Yago Nieto, PhD / Stem Cell Transplantation Department</organization>
      <phone>713-792-8750</phone>
      <email>ynieto@mdanderson.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03019640
org study id: 2015-0751
secondary id: NCI-2018-01239
secondary id: 2015-0751
nct id: NCT03019640
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: Yes
This phase II trial studies the side effects of cord blood-derived expanded allogeneic
      natural killer cells (umbilical cord blood natural killer [NK] cells), rituximab, high-dose
      chemotherapy, and stem cell transplant in treating patients with B-cell non-Hodgkin's
      lymphoma that has come back (recurrent) or that does not respond to treatment (refractory).
      Immune system cells, such as cord blood-derived expanded allogeneic natural killer cells, are
      made by the body to attack foreign or cancerous cells. Immunotherapy with rituximab, may
      induce changes in body's immune system and may interfere with the ability of tumor cells to
      grow and spread. Drugs used in chemotherapy, such as carmustine, cytarabine, etoposide,
      lenalidomide, melphalan, and rituximab, work in different ways to stop the growth of cancer
      cells, either by killing the cells, by stopping them from dividing, or by stopping them from
      spreading. A stem cell transplant using stem cells from the patient or a donor may be able to
      replace blood-forming cells that were destroyed by chemotherapy used to kill cancer cells.
      The donated stem cells may also replace the patient's immune cells and help destroy any
      remaining cancer cells. Giving cord blood-derived expanded allogeneic natural killer cells,
      rituximab, high-dose chemotherapy, and stem cell transplant may work better in treating
      patients with recurrent or refractory B-cell non-Hodgkin's lymphoma.
PRIMARY OBJECTIVE:

      I. To establish the safety of this treatment by determining its treatment-related mortality
      (TRM) within 30 days.

      SECONDARY OBJECTIVES:

      I. To estimate the relapse-free survival (RFS). II. To estimate the overall survival (OS).
      III. To quantify duration of infused allogeneic umbilical cord blood (UCB)-derived natural
      killer (NK) cells in the recipient.

      OUTLINE:

      PREPARATIVE REGIMEN: Patients receive carmustine intravenously (IV) over 2 hours on day -12,
      etoposide IV twice daily (BID) over 3 hours on days -11 to -8, cytarabine IV BID over 1 hour
      on days -11 to -8, melphalan IV over 30 minutes on day -7, and lenalidomide orally (PO) once
      daily (QD) on days -7 to -2 in the absence of disease progression or unacceptable toxicity.
      Patients who are CD20+ also receive rituximab IV over 3 hours on days -13 and -7.

      NK-CELL INFUSION: Patients receive cord blood-derived expanded allogeneic NK cells IV over 1
      hour on day -5 in the absence of disease progression or unacceptable toxicity.

      STEM CELL TRANSPLANT: Patients undergo stem cell transplant IV over 30-60 minutes on day 0 in
      the absence of disease progression or unacceptable toxicity.

      POST-TRANSPLANT: Patients receive filgrastim subcutaneously (SC) QD beginning on day +5.
      Treatment continues until white blood cell count recovers in the absence of disease
      progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up at 30, 100, and 180 days.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Treatment-related Mortality Within 30 Days (TRM30)
time frame: Up to 30 days
description: Participants that had Treatment-related mortality within 30 days.
measure: Number of Participants Who Survived
time frame: From the time of transplant, assessed up to day 180
description: Number of Participants Who Survived at day 180.
arm group label: Treatment (chemotherapy, NK infusion, stem cell transplant)
arm group type: Experimental
description: See Detailed Description.
intervention type: Procedure
intervention name: Autologous Hematopoietic Stem Cell Transplantation
description: Undergo stem cell transplant
arm group label: Treatment (chemotherapy, NK infusion, stem cell transplant)
other name: Autologous Hematopoietic Cell Transplantation
other name: autologous stem cell transplantation
intervention type: Drug
intervention name: Carmustine
description: Given IV
arm group label: Treatment (chemotherapy, NK infusion, stem cell transplant)
other name: BCNU
other name: Becenum
other name: Becenun
other name: BiCNU
other name: Bis(chloroethyl) Nitrosourea
other name: Bis-Chloronitrosourea
other name: Carmubris
other name: Carmustin
other name: Carmustinum
other name: FDA 0345
other name: N,N''-Bis(2-chloroethyl)-N-nitrosourea
other name: Nitrourean
other name: Nitrumon
other name: SK 27702
other name: SRI 1720
other name: WR-139021
intervention type: Biological
intervention name: Cord Blood-derived Expanded Allogeneic Natural Killer Cells
description: Given IV
arm group label: Treatment (chemotherapy, NK infusion, stem cell transplant)
other name: Allogeneic CB-derived Ex vivo-expanded NK Cells
other name: CB-derived Expanded Allogeneic NK Cells
other name: UCB-derived Expanded Allogeneic NK Cells
other name: Umbilical Cord Blood-derived Expanded Allogeneic Natural Killer Cells
intervention type: Drug
intervention name: Cytarabine
description: Given IV
arm group label: Treatment (chemotherapy, NK infusion, stem cell transplant)
other name: .beta.-Cytosine arabinoside
other name: 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
other name: 1-.beta.-D-Arabinofuranosylcytosine
other name: 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
other name: 1-Beta-D-arabinofuranosylcytosine
other name: 1.beta.-D-Arabinofuranosylcytosine
other name: 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
other name: 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
other name: Alexan
other name: Ara-C
other name: ARA-cell
other name: Arabine
other name: Arabinofuranosylcytosine
other name: Arabinosylcytosine
other name: Aracytidine
other name: Aracytin
other name: Aracytine
other name: Beta-cytosine Arabinoside
other name: CHX-3311
other name: Cytarabinum
other name: Cytarbel
other name: Cytosar
other name: Cytosine Arabinoside
other name: Cytosine-.beta.-arabinoside
other name: Cytosine-beta-arabinoside
other name: Erpalfa
other name: Starasid
other name: Tarabine PFS
other name: U 19920
other name: U-19920
other name: Udicil
other name: WR-28453
intervention type: Drug
intervention name: Etoposide
description: Given IV
arm group label: Treatment (chemotherapy, NK infusion, stem cell transplant)
other name: Demethyl Epipodophyllotoxin Ethylidine Glucoside
other name: EPEG
other name: Lastet
other name: Toposar
other name: Vepesid
other name: VP 16
other name: VP 16-213
other name: VP-16
other name: VP-16-213
other name: VP16
intervention type: Biological
intervention name: Filgrastim
description: Given SC
arm group label: Treatment (chemotherapy, NK infusion, stem cell transplant)
other name: G-CSF
other name: Neupogen
other name: r-metHuG-CSF
other name: Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
other name: rG-CSF
other name: Tevagrastim
intervention type: Drug
intervention name: Lenalidomide
description: Given PO
arm group label: Treatment (chemotherapy, NK infusion, stem cell transplant)
other name: CC-5013
other name: CC5013
other name: CDC 501
other name: Revlimid
intervention type: Drug
intervention name: Melphalan
description: Given IV
arm group label: Treatment (chemotherapy, NK infusion, stem cell transplant)
other name: Alanine Nitrogen Mustard
other name: CB-3025
other name: L-PAM
other name: L-Phenylalanine Mustard
other name: L-sarcolysin
other name: L-Sarcolysin Phenylalanine mustard
other name: L-Sarcolysine
other name: Melphalanum
other name: Phenylalanine Mustard
other name: Phenylalanine nitrogen mustard
other name: Sarcoclorin
other name: Sarkolysin
other name: WR-19813
intervention type: Biological
intervention name: Rituximab
description: Given IV
arm group label: Treatment (chemotherapy, NK infusion, stem cell transplant)
other name: ABP 798
other name: BI 695500
other name: C2B8 Monoclonal Antibody
other name: Chimeric Anti-CD20 Antibody
other name: CT-P10
other name: IDEC-102
other name: IDEC-C2B8
other name: IDEC-C2B8 Monoclonal Antibody
other name: MabThera
other name: Monoclonal Antibody IDEC-C2B8
other name: PF-05280586
other name: Rituxan
other name: Rituximab ABBS
other name: Rituximab Biosimilar ABP 798
other name: Rituximab Biosimilar BI 695500
other name: Rituximab Biosimilar CT-P10
other name: Rituximab Biosimilar GB241
other name: Rituximab Biosimilar IBI301
other name: Rituximab Biosimilar JHL1101
other name: Rituximab Biosimilar PF-05280586
other name: Rituximab Biosimilar RTXM83
other name: Rituximab Biosimilar SAIT101
other name: rituximab biosimilar TQB2303
other name: rituximab-abbs
other name: RTXM83
other name: Truxima
criteria: 
gender: All
minimum age: 15 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yago L Nieto
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Follicular
mesh term: Lymphoma, Non-Hodgkin
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, Mantle-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Recurrence
mesh term: Cytarabine
mesh term: Rituximab
mesh term: Antineoplastic Agents, Immunological
mesh term: Etoposide
mesh term: Lenalidomide
mesh term: Etoposide phosphate
mesh term: Melphalan
mesh term: Mechlorethamine
mesh term: Carmustine
mesh term: Podophyllotoxin
mesh term: Nitrogen Mustard Compounds
mesh term: Antibodies
mesh term: Immunoglobulins
mesh term: Antibodies, Monoclonal
mesh term: Lenograstim
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 