<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/NCT03272633</url>
  </required_header>
  <id_info>
    <org_study_id>011702</org_study_id>
    <secondary_id>NCI-2017-01537</secondary_id>
    <secondary_id>Pro20170000537</secondary_id>
    <secondary_id>011702</secondary_id>
    <secondary_id>P30CA072720</secondary_id>
    <nct_id>NCT03272633</nct_id>
  </id_info>
  <brief_title>Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies</brief_title>
  <official_title>Post-Transplant Use of Irradiated Haplo-Allogeneic Cells</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rutgers, The State University of New Jersey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Rutgers, The State University of New Jersey</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot clinical trial studies the side effects of irradiated donor cells following stem&#xD;
      cell transplant in controlling cancer in patients with hematologic malignancies. Transfusion&#xD;
      of irradiated donor cells (immune cells) from relatives may cause the patient's cancer to&#xD;
      decrease in size and may help control cancer in patients receiving a stem cell transplant.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the toxicity associated with the administration of irradiated haploidentical&#xD;
      cells (IHC) to patients with high-risk hematologic malignancies.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine if there is evidence of disease response associated with IHC.&#xD;
&#xD;
      TERTIARY OBJECTIVES:&#xD;
&#xD;
      I. To determine if treatment with the irradiated cells induces an immune response targeting&#xD;
      tumor associated epitopes.&#xD;
&#xD;
      OUTLINE: Patients are assigned to 1 of 2 cohorts.&#xD;
&#xD;
      COHORT I: Within 42 days after hematopoietic engraftment (both neutrophils and platelets)&#xD;
      after autologous hematopoietic stem cell transplantation (HSCT), patients receive initial&#xD;
      treatment with IHC. Patients that do not have evidence of relapse or progressive disease may&#xD;
      be treated every 8-12 weeks for up to 3 doses.&#xD;
&#xD;
      COHORT II: Patients with high-risk disease receive initial treatment with IHC within 70 days&#xD;
      after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT.&#xD;
      Patients being treated for relapsed disease may receive initial treatment with IHC any time&#xD;
      after relapse is documented. Patients that do not have evidence of relapse or progressive&#xD;
      disease may be treated every 8-12 weeks for up to 3 doses.&#xD;
&#xD;
      After completion of study treatment, patients will be followed up within 8 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">October 26, 2020</start_date>
  <completion_date type="Actual">September 22, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Received Irradiated Haploidentical Cells (IHC) With Disease Response</measure>
    <time_frame>Up to 8 weeks after last protocol treatment</time_frame>
    <description>Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the Number of Participants With Toxicities Associated With Administration of Irradiated Haploidentical Cells (IHC) Evaluated According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0</measure>
    <time_frame>Up to 12 weeks of completion of therapy</time_frame>
    <description>The anticipated/projected IHC-associated toxicities of greatest concern include: short-term toxicities- constitutional/systemic adverse events including fevers, hypotension, pulmonary infiltrates; long-term toxicities: autoimmune effects, graft-versus-host disease (GVHD), graft rejection. Toxicity will be measured by occurrence of any experimental treatment-related adverse events (AE) up to 12 weeks of completion of therapy. The CTCAE version 4.0 will be utilized for the description and grading of the AE. All symptoms, signs, or diseases assessed as experimental treatment-related will be captu</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Induction of Host T Cells Reactive With Tumor Associated Epitopes</measure>
    <time_frame>Up to 8 weeks after last protocol treatment</time_frame>
    <description>It will be determined if treatment with the irradiated cells induces an immune response targeting tumor associated epitopes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Acute Lymphoblastic Leukemia</condition>
  <condition>Acute Myeloid Leukemia in Remission</condition>
  <condition>Hematopoietic Cell Transplantation Recipient</condition>
  <condition>JAK2 Gene Mutation</condition>
  <condition>Loss of Chromosome 17p</condition>
  <condition>Mantle Cell Lymphoma</condition>
  <condition>Minimal Residual Disease</condition>
  <condition>Myelodysplastic Syndrome</condition>
  <condition>Non-Hodgkin Lymphoma</condition>
  <condition>Plasma Cell Myeloma</condition>
  <condition>RAS Family Gene Mutation</condition>
  <condition>Recurrent Diffuse Large B-Cell Lymphoma</condition>
  <condition>Recurrent Hematologic Malignancy</condition>
  <condition>Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma</condition>
  <condition>Refractory Diffuse Large B-Cell Lymphoma</condition>
  <condition>Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma</condition>
  <condition>Therapy-Related Acute Myeloid Leukemia</condition>
  <condition>Therapy-Related Myelodysplastic Syndrome</condition>
  <condition>TP53 Gene Mutation</condition>
  <arm_group>
    <arm_group_label>Cohort I (initial IHC within 42 days)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort II (initial IHC within 70 days or after relapse)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Allogeneic Hematopoietic Stem Cell Transplantation</intervention_name>
    <description>Receive IHC</description>
    <arm_group_label>Cohort I (initial IHC within 42 days)</arm_group_label>
    <arm_group_label>Cohort II (initial IHC within 70 days or after relapse)</arm_group_label>
    <other_name>Allogeneic Hematopoietic Cell Transplantation</other_name>
    <other_name>allogeneic stem cell transplantation</other_name>
    <other_name>HSC</other_name>
    <other_name>HSCT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Irradiated Allogeneic Cells</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Cohort I (initial IHC within 42 days)</arm_group_label>
    <arm_group_label>Cohort II (initial IHC within 70 days or after relapse)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with disease (stage) eligible per cohort&#xD;
&#xD;
          -  COHORT 1: patients undergoing high dose chemotherapy with autologous stem cell rescue&#xD;
             and ?high-risk? disease as defined below:&#xD;
&#xD;
               -  Diffuse large cell lymphoma or peripheral T cell lymphoma (including specified&#xD;
                  World Health Organization [WHO] subtypes) not in computed tomography&#xD;
                  (CT)-positron emission tomography (PET) complete remission at time of high dose&#xD;
                  therapy&#xD;
&#xD;
               -  Diffuse large cell lymphoma with ?double hit? or ?double expressor? features&#xD;
&#xD;
               -  Diffuse large cell lymphoma or peripheral T cell lymphoma (including WHO&#xD;
                  specified subtypes) refractory to standard induction therapy OR relapsing within&#xD;
                  1 year of treatment OR in greater that second complete remission (CR)&#xD;
&#xD;
               -  Mantle cell lymphoma not in CR1&#xD;
&#xD;
               -  Multiple myeloma with ONE (or more) of the following high risk features:&#xD;
&#xD;
                    -  Less than very good partial remission at time of high dose therapy&#xD;
&#xD;
                    -  High Revised-International Staging System (R-ISS) (stage III ? 2&#xD;
                       microglobulin &gt;= 5.5 plus lactate dehydrogenase [LDH] &gt; upper limit of&#xD;
                       normal [ULN] and/or del17p, t(4;14), t(14;16)) at time of diagnosis&#xD;
&#xD;
                    -  Cytogenetics or fluorescent in situ hybridization (FISH) del17p&#xD;
&#xD;
          -  COHORT 2: patients with high risk disease having undergone an allogeneic hematopoietic&#xD;
             stem cell transplant from a 10/10 human leukocyte antigen (HLA) matched donor with one&#xD;
             of the following disease subtypes:&#xD;
&#xD;
               -  Acute myeloid leukemia (AML) in CR1 with high risk features (European Leukemia&#xD;
                  Network [ELN]) at presentation&#xD;
&#xD;
                    -  Diagnostic sample with either t(6;9), t(9;22), 11q23, inv 3, -5, -7, del17p,&#xD;
                       complex cytogenetics, NPMwt-flt3ITD+, OR p53 mutation (mut); patients whose&#xD;
                       samples have mutations in RUNX1 or ASXL1 are also eligible (unless the&#xD;
                       patient has favorable cytogenetics)&#xD;
&#xD;
               -  AML in CR1 with measurable minimal residual disease (MRD) by molecular (e.g.,&#xD;
                  myeloid mutation profile, polymerase chain reaction [PCR] for NPM1, core-binding&#xD;
                  factor [CBF], mixed lineage leukemia [MLL]) or flow cytometry&#xD;
&#xD;
               -  AML not in CR1 (including patients with morphologic CR but with incomplete&#xD;
                  recovery, CRi)&#xD;
&#xD;
               -  Myelodysplastic syndrome (MDS) with complex cytogenetics, 17p deletion or p53&#xD;
                  mutation, or JAK2 or RAS mutation&#xD;
&#xD;
               -  Treatment-related MDS or AML&#xD;
&#xD;
               -  Acute lymphoblastic leukemia (ALL) not in CR1&#xD;
&#xD;
               -  ALL with MRD&#xD;
&#xD;
               -  Any hematologic malignancy relapsed or with persistent disease after allogeneic&#xD;
                  hematopoietic stem cell transplant&#xD;
&#xD;
               -  Multiple myeloma&#xD;
&#xD;
               -  Non-Hodgkin lymphoma (NHL) with chemoresistant disease at time of transplant&#xD;
&#xD;
               -  Any patient undergoing allogeneic hematopoietic stem cell transplant and an&#xD;
                  anticipated rate of relapse &gt; 80% based upon published data and for which there&#xD;
                  is consensus amongst the Hematologic Malignancies Tumor Study Group that&#xD;
                  enrollment is appropriate&#xD;
&#xD;
          -  Availability of a genetic child, genetic parent or sibling as a potential HLA&#xD;
             haploidentical donor&#xD;
&#xD;
          -  Meets standard eligibility requirements for high dose chemotherapy with autologous&#xD;
             stem cell rescue (COHORT 1) or allogeneic hematopoietic stem cell transplant (COHORT&#xD;
             2) and has signed consent for those procedures&#xD;
&#xD;
          -  DONOR: Donor must be related to patient and be partially (&gt;= 3/6 antigen) HLA-matched&#xD;
&#xD;
          -  DONOR: Donor must meet all Robert Wood Johnson (RWJ) Blood Services requirements for&#xD;
             hematopoietic stem cell donation including:&#xD;
&#xD;
               -  Age &gt;= 18 years old;&#xD;
&#xD;
               -  Normal hemogram (white blood cells [WBC] 4.0-10.0 x 10^3/mm^3; platelet count&#xD;
                  150,000 to 440,000/mm^3 ; hemoglobin/hematocrit; 12.5-18 g/dl, 38 to 54%&#xD;
&#xD;
               -  Not pregnant or lactating;&#xD;
&#xD;
               -  Not human immunodeficiency virus (HIV)-1, HIV-2, hepatitis C virus (HCV),&#xD;
                  hepatitis B core or human T-cell lymphotropic virus (HTLV)-I/II seropositive;&#xD;
                  hepatitis B surface antigen (HB S ag) (-); meet other infectious disease&#xD;
                  screening criteria utilized by RWJ Blood Services;&#xD;
&#xD;
               -  No uncontrolled infections, other medical or psychological/social conditions, or&#xD;
                  medications that might increase the likelihood of patient or donor adverse&#xD;
                  effects or poor outcomes;&#xD;
&#xD;
               -  Meet other blood bank criteria for blood product donation (as determined by RWJ&#xD;
                  Blood Center screening history and laboratory studies)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking person&#xD;
&#xD;
          -  Patients undergoing haploidentical allogeneic hematopoietic stem cell transplants are&#xD;
             not eligible; patients undergoing &lt; 10/10 HLA allele matched allogeneic transplant are&#xD;
             not eligible&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  DONOR: Non-English speaking person&#xD;
&#xD;
          -  DONOR: Pregnant women&#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>Roger Strair</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rutgers Cancer Institute of New Jersey</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rutgers Cancer Institute of New Jersey</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <results_first_submitted>March 20, 2023</results_first_submitted>
  <results_first_submitted_qc>June 23, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 26, 2023</results_first_posted>
  <last_update_submitted>June 23, 2023</last_update_submitted>
  <last_update_submitted_qc>June 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rutgers Cancer Institute of New Jersey</investigator_affiliation>
    <investigator_full_name>Roger Strair, MD, PhD</investigator_full_name>
    <investigator_title>Professor of Medicine, RWJMS</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Preleukemia</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</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>Hematologic Neoplasms</mesh_term>
    <mesh_term>Neoplasm, Residual</mesh_term>
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Lymphoma, T-Cell</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_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>April 23, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT03272633/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 23, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT03272633/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cohort I (Initial IHC Within 42 Days)</title>
          <description>Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.&#xD;
Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC&#xD;
Irradiated Allogeneic Cells: Correlative studies</description>
        </group>
        <group group_id="P2">
          <title>Cohort II (Initial IHC Within 70 Days or After Relapse)</title>
          <description>Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.&#xD;
Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC&#xD;
Irradiated Allogeneic Cells: Correlative studies</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>No participants qualified for cohort I</population>
      <group_list>
        <group group_id="B1">
          <title>Cohort I (Initial IHC Within 42 Days)</title>
          <description>Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.&#xD;
Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC&#xD;
Irradiated Allogeneic Cells: Correlative studies</description>
        </group>
        <group group_id="B2">
          <title>Cohort II (Initial IHC Within 70 Days or After Relapse)</title>
          <description>Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.&#xD;
Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC&#xD;
Irradiated Allogeneic Cells: Correlative studies</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="0"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="2"/>
          </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" 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="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Received Irradiated Haploidentical Cells (IHC) With Disease Response</title>
        <description>Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR</description>
        <time_frame>Up to 8 weeks after last protocol treatment</time_frame>
        <population>no data was collected. Refers to the Cohort 1 Arm</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort I (Initial IHC Within 42 Days)</title>
            <description>Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.&#xD;
Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC&#xD;
Irradiated Allogeneic Cells: Correlative studies</description>
          </group>
          <group group_id="O2">
            <title>Cohort II (Initial IHC Within 70 Days or After Relapse)</title>
            <description>Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.&#xD;
Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC&#xD;
Irradiated Allogeneic Cells: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received Irradiated Haploidentical Cells (IHC) With Disease Response</title>
          <description>Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR</description>
          <population>no data was collected. Refers to the Cohort 1 Arm</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="0"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>the Number of Participants With Toxicities Associated With Administration of Irradiated Haploidentical Cells (IHC) Evaluated According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0</title>
        <description>The anticipated/projected IHC-associated toxicities of greatest concern include: short-term toxicities- constitutional/systemic adverse events including fevers, hypotension, pulmonary infiltrates; long-term toxicities: autoimmune effects, graft-versus-host disease (GVHD), graft rejection. Toxicity will be measured by occurrence of any experimental treatment-related adverse events (AE) up to 12 weeks of completion of therapy. The CTCAE version 4.0 will be utilized for the description and grading of the AE. All symptoms, signs, or diseases assessed as experimental treatment-related will be captu</description>
        <time_frame>Up to 12 weeks of completion of therapy</time_frame>
        <population>no data was collected. Refers to the Cohort 1 Arm</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort I (Initial IHC Within 42 Days)</title>
            <description>Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.&#xD;
Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC&#xD;
Irradiated Allogeneic Cells: Correlative studies</description>
          </group>
          <group group_id="O2">
            <title>Cohort II (Initial IHC Within 70 Days or After Relapse)</title>
            <description>Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.&#xD;
Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC&#xD;
Irradiated Allogeneic Cells: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>the Number of Participants With Toxicities Associated With Administration of Irradiated Haploidentical Cells (IHC) Evaluated According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0</title>
          <description>The anticipated/projected IHC-associated toxicities of greatest concern include: short-term toxicities- constitutional/systemic adverse events including fevers, hypotension, pulmonary infiltrates; long-term toxicities: autoimmune effects, graft-versus-host disease (GVHD), graft rejection. Toxicity will be measured by occurrence of any experimental treatment-related adverse events (AE) up to 12 weeks of completion of therapy. The CTCAE version 4.0 will be utilized for the description and grading of the AE. All symptoms, signs, or diseases assessed as experimental treatment-related will be captu</description>
          <population>no data was collected. Refers to the Cohort 1 Arm</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="0"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Induction of Host T Cells Reactive With Tumor Associated Epitopes</title>
        <description>It will be determined if treatment with the irradiated cells induces an immune response targeting tumor associated epitopes.</description>
        <time_frame>Up to 8 weeks after last protocol treatment</time_frame>
        <population>no data was collected</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort I (Initial IHC Within 42 Days)</title>
            <description>Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.&#xD;
Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC&#xD;
Irradiated Allogeneic Cells: Correlative studies</description>
          </group>
          <group group_id="O2">
            <title>Cohort II (Initial IHC Within 70 Days or After Relapse)</title>
            <description>Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.&#xD;
Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC&#xD;
Irradiated Allogeneic Cells: Correlative studies</description>
          </group>
        </group_list>
        <measure>
          <title>Induction of Host T Cells Reactive With Tumor Associated Epitopes</title>
          <description>It will be determined if treatment with the irradiated cells induces an immune response targeting tumor associated epitopes.</description>
          <population>no data was collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 8 weeks after last protocol treatment</time_frame>
      <desc>no data was collected. Adverse Events Description text only refers to the Cohort II No participants were enrolled in Cohort I, so no adverse events were monitored/assessed for Cohort I</desc>
      <group_list>
        <group group_id="E1">
          <title>Cohort I (Initial IHC Within 42 Days)</title>
          <description>Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.&#xD;
Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC&#xD;
Irradiated Allogeneic Cells: Correlative studies</description>
        </group>
        <group group_id="E2">
          <title>Cohort II (Initial IHC Within 70 Days or After Relapse)</title>
          <description>Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.&#xD;
Allogeneic Hematopoietic Stem Cell Transplantation: Receive IHC&#xD;
Irradiated Allogeneic Cells: Correlative studies</description>
        </group>
      </group_list>
      <serious_events>
        <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="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorders</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <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="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye disorders</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>General disorders and administration site conditions</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Investigations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" events="5" subjects_affected="2" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Metabolism and nutrition disorders</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Nervous system disorders</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </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>Roger K. Strair, MD</name_or_title>
      <organization>Cancer Institute of New Jersey Rutgers</organization>
      <phone>732-235-4523</phone>
      <email>strairrk@cinj.rutgers.edu</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/NCT03272633
org study id: 011702
secondary id: NCI-2017-01537
secondary id: Pro20170000537
secondary id: 011702
secondary id: P30CA072720
nct id: NCT03272633
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This pilot clinical trial studies the side effects of irradiated donor cells following stem
      cell transplant in controlling cancer in patients with hematologic malignancies. Transfusion
      of irradiated donor cells (immune cells) from relatives may cause the patient's cancer to
      decrease in size and may help control cancer in patients receiving a stem cell transplant.
PRIMARY OBJECTIVES:

      I. To determine the toxicity associated with the administration of irradiated haploidentical
      cells (IHC) to patients with high-risk hematologic malignancies.

      SECONDARY OBJECTIVES:

      I. To determine if there is evidence of disease response associated with IHC.

      TERTIARY OBJECTIVES:

      I. To determine if treatment with the irradiated cells induces an immune response targeting
      tumor associated epitopes.

      OUTLINE: Patients are assigned to 1 of 2 cohorts.

      COHORT I: Within 42 days after hematopoietic engraftment (both neutrophils and platelets)
      after autologous hematopoietic stem cell transplantation (HSCT), patients receive initial
      treatment with IHC. Patients that do not have evidence of relapse or progressive disease may
      be treated every 8-12 weeks for up to 3 doses.

      COHORT II: Patients with high-risk disease receive initial treatment with IHC within 70 days
      after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT.
      Patients being treated for relapsed disease may receive initial treatment with IHC any time
      after relapse is documented. Patients that do not have evidence of relapse or progressive
      disease may be treated every 8-12 weeks for up to 3 doses.

      After completion of study treatment, patients will be followed up within 8 weeks.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants Who Received Irradiated Haploidentical Cells (IHC) With Disease Response
time frame: Up to 8 weeks after last protocol treatment
description: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
measure: the Number of Participants With Toxicities Associated With Administration of Irradiated Haploidentical Cells (IHC) Evaluated According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
time frame: Up to 12 weeks of completion of therapy
description: The anticipated/projected IHC-associated toxicities of greatest concern include: short-term toxicities- constitutional/systemic adverse events including fevers, hypotension, pulmonary infiltrates; long-term toxicities: autoimmune effects, graft-versus-host disease (GVHD), graft rejection. Toxicity will be measured by occurrence of any experimental treatment-related adverse events (AE) up to 12 weeks of completion of therapy. The CTCAE version 4.0 will be utilized for the description and grading of the AE. All symptoms, signs, or diseases assessed as experimental treatment-related will be captu
measure: Induction of Host T Cells Reactive With Tumor Associated Epitopes
time frame: Up to 8 weeks after last protocol treatment
description: It will be determined if treatment with the irradiated cells induces an immune response targeting tumor associated epitopes.
arm group label: Cohort I (initial IHC within 42 days)
arm group type: Experimental
description: Within 42 days after hematopoietic engraftment (both neutrophils and platelets) after autologous HSCT, patients receive initial treatment with IHC. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.
arm group label: Cohort II (initial IHC within 70 days or after relapse)
arm group type: Experimental
description: Patients with high-risk disease receive initial treatment with IHC within 70 days after hematopoietic engraftment (both neutrophils and platelets) after allogeneic HSCT. Patients being treated for relapsed disease may receive initial treatment with IHC any time after relapse is documented. Patients that do not have evidence of relapse or progressive disease may be treated every 8-12 weeks for up to 3 doses.
intervention type: Procedure
intervention name: Allogeneic Hematopoietic Stem Cell Transplantation
description: Receive IHC
arm group label: Cohort I (initial IHC within 42 days)
arm group label: Cohort II (initial IHC within 70 days or after relapse)
other name: Allogeneic Hematopoietic Cell Transplantation
other name: allogeneic stem cell transplantation
other name: HSC
other name: HSCT
intervention type: Biological
intervention name: Irradiated Allogeneic Cells
description: Correlative studies
arm group label: Cohort I (initial IHC within 42 days)
arm group label: Cohort II (initial IHC within 70 days or after relapse)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roger Strair
role: Principal Investigator
affiliation: Rutgers Cancer Institute of New Jersey
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rutgers Cancer Institute of New Jersey
investigator full name: Roger Strair, MD, PhD
investigator title: Professor of Medicine, RWJMS
mesh term: Lymphoma
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Neoplasms
mesh term: Lymphoma, Non-Hodgkin
mesh term: Preleukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, Mantle-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Hematologic Neoplasms
mesh term: Neoplasm, Residual
mesh term: Multiple Myeloma
mesh term: Lymphoma, T-Cell
mesh term: Myelodysplastic Syndromes
mesh term: Syndrome
mesh term: Recurrence
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 