<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/NCT01678443</url>
  </required_header>
  <id_info>
    <org_study_id>2361.00</org_study_id>
    <secondary_id>NCI-2012-01505</secondary_id>
    <secondary_id>2361.00</secondary_id>
    <secondary_id>P01CA044991</secondary_id>
    <secondary_id>P30CA015704</secondary_id>
    <nct_id>NCT01678443</nct_id>
  </id_info>
  <brief_title>Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies</brief_title>
  <official_title>A Phase I Study Evaluating Escalating Doses of 90Y-BC8-DOTA (Anti-CD45) Antibody Followed by Autologous Stem Cell Transplantation for Relapsed or Refractory Lymphoid Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fred Hutchinson 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>Fred Hutchinson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase I trial studies the side effects and best dose of monoclonal antibody therapy&#xD;
      before stem cell transplant in treating patients with relapsed or refractory lymphoid&#xD;
      malignancies. Radiolabeled monoclonal antibodies, such as yttrium-90 anti-CD45 monoclonal&#xD;
      antibody BC8, can find cancer cells and carry cancer-killing substances to them without&#xD;
      harming normal cells. When the healthy stem cells from a donor are infused into the patient&#xD;
      they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,&#xD;
      and platelets. Giving radiolabeled monoclonal antibody before a stem cell transplant may be&#xD;
      an effective treatment for relapsed or refractory lymphoid malignancies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To estimate the maximally tolerated dose (MTD) of 90Y-BC8-DOTA (anti-cluster of&#xD;
      differentiation [CD]45) (yttrium-90 anti-CD45 monoclonal antibody BC8) that can be delivered&#xD;
      prior to autologous stem cell transplantation for patients with relapsed/refractory B-cell&#xD;
      non-Hodgkin lymphoma (B-NHL), T-cell NHL (T-NHL), and Hodgkin lymphoma (HL).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To optimize the protein dose (antibody [Ab]) to deliver a favorable biodistribution in the&#xD;
      majority of patients.&#xD;
&#xD;
      II. To describe the impact of rituximab concentrations, B-cell depletion, and disease burden&#xD;
      on CD20 and CD45 targeting.&#xD;
&#xD;
      III. To describe response rates and remission durations in relapsed B-NHL, T-NHL, and HL&#xD;
      following administration of myeloablative doses of 90Y-BC8-DOTA prior to autologous stem cell&#xD;
      transplant (ASCT).&#xD;
&#xD;
      IV. To assess the correlation of lymphoma biomarkers with outcomes.&#xD;
&#xD;
      OUTLINE: This is a dose-escalation study of yttrium-90 anti-CD45 monoclonal antibody BC8.&#xD;
&#xD;
      Patients receive indium-111 anti-CD45 monoclonal antibody BC8 intravenously (IV) on day -28&#xD;
      and (if necessary) day -21 to evaluate the antibody's biodistribution. Patients then receive&#xD;
      yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -14. Patients then undergo autologous&#xD;
      peripheral blood stem cell transplantation on day 0.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 3, 6, and 12 months and then&#xD;
      annually thereafter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Terminated due to low accrual.&#xD;
  </why_stopped>
  <start_date type="Actual">September 1, 1999</start_date>
  <completion_date type="Actual">September 27, 2018</completion_date>
  <primary_completion_date type="Actual">September 21, 2013</primary_completion_date>
  <phase>Phase 1</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>Percentage of Participants With Dose Limiting Toxicities (DLT) of Yttrium-90 Anti-CD45</measure>
    <time_frame>Up to 30 days after receiving study drug</time_frame>
    <description>A DLT (dose limiting toxicity) is defined as a therapy-related grade III or IV Bearman (transplant) toxicity within 30 days of transplant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate</measure>
    <time_frame>Up to 6 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Up to 6 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival</measure>
    <time_frame>Up to 6 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor to Normal Organ Ratios</measure>
    <time_frame>Up to 6 years</time_frame>
    <description>Derived from dosimetry estimates coupled with the absorbed dose to normal organs based on the administered activity of 90Y.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Adult Nasal Type Extranodal NK/T-cell Lymphoma</condition>
  <condition>Anaplastic Large Cell Lymphoma</condition>
  <condition>Angioimmunoblastic T-cell Lymphoma</condition>
  <condition>Cutaneous B-cell Non-Hodgkin Lymphoma</condition>
  <condition>Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue</condition>
  <condition>Hepatosplenic T-cell Lymphoma</condition>
  <condition>Intraocular Lymphoma</condition>
  <condition>Nodal Marginal Zone B-cell Lymphoma</condition>
  <condition>Noncutaneous Extranodal Lymphoma</condition>
  <condition>Peripheral T-cell Lymphoma</condition>
  <condition>Recurrent Adult Burkitt Lymphoma</condition>
  <condition>Recurrent Adult Diffuse Large Cell Lymphoma</condition>
  <condition>Recurrent Adult Diffuse Mixed Cell Lymphoma</condition>
  <condition>Recurrent Adult Diffuse Small Cleaved Cell Lymphoma</condition>
  <condition>Recurrent Adult Grade III Lymphomatoid Granulomatosis</condition>
  <condition>Recurrent Adult Hodgkin Lymphoma</condition>
  <condition>Recurrent Adult Immunoblastic Large Cell Lymphoma</condition>
  <condition>Recurrent Adult Lymphoblastic Lymphoma</condition>
  <condition>Recurrent Adult T-cell Leukemia/Lymphoma</condition>
  <condition>Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma</condition>
  <condition>Recurrent Grade 1 Follicular Lymphoma</condition>
  <condition>Recurrent Grade 2 Follicular Lymphoma</condition>
  <condition>Recurrent Grade 3 Follicular Lymphoma</condition>
  <condition>Recurrent Mantle Cell Lymphoma</condition>
  <condition>Recurrent Marginal Zone Lymphoma</condition>
  <condition>Recurrent Mycosis Fungoides/Sezary Syndrome</condition>
  <condition>Recurrent Small Lymphocytic Lymphoma</condition>
  <condition>Refractory Hairy Cell Leukemia</condition>
  <condition>Small Intestine Lymphoma</condition>
  <condition>Splenic Marginal Zone Lymphoma</condition>
  <condition>T-cell Large Granular Lymphocyte Leukemia</condition>
  <condition>Testicular Lymphoma</condition>
  <condition>Waldenström Macroglobulinemia</condition>
  <arm_group>
    <arm_group_label>Treatment (yttrium-90 anti-CD45 monoclonal antibody BC8)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>indium In 111 anti-CD45 monoclonal antibody BC8</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (yttrium-90 anti-CD45 monoclonal antibody BC8)</arm_group_label>
    <other_name>In 111 MOAB BC8</other_name>
    <other_name>In 111 monoclonal antibody BC8</other_name>
    <other_name>In111 MOAB BC8</other_name>
    <other_name>indium In 111 MOAB BC8</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>yttrium Y 90 anti-CD45 monoclonal antibody BC8</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (yttrium-90 anti-CD45 monoclonal antibody BC8)</arm_group_label>
    <other_name>90Y anti-CD45 MAb BC8</other_name>
    <other_name>90Y anti-CD45 MoAb BC8</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>peripheral blood stem cell transplantation</intervention_name>
    <description>Undergo autologous peripheral blood stem cell transplant</description>
    <arm_group_label>Treatment (yttrium-90 anti-CD45 monoclonal antibody BC8)</arm_group_label>
    <other_name>PBPC transplantation</other_name>
    <other_name>PBSC transplantation</other_name>
    <other_name>peripheral blood progenitor cell transplantation</other_name>
    <other_name>transplantation, peripheral blood stem cell</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have a histologically confirmed diagnosis of B-NHL, T-NHL, or HL; only&#xD;
             patients with classical HL must have documented histologic demonstration of CD45+&#xD;
             cells adjacent to the Reed Sternberg cells; patients must have received at least one&#xD;
             prior standard systemic therapy with documented recurrent or refractory disease;&#xD;
             patients with mantle cell lymphoma (MCL), T-NHL, or other high-risk malignancies may&#xD;
             be enrolled/transplanted in complete remission (CR)/first partial remission (PR1)&#xD;
&#xD;
          -  Creatinine &lt; 2.0&#xD;
&#xD;
          -  Bilirubin &lt; 1.5 mg/dL&#xD;
&#xD;
          -  All patients eligible for therapeutic study must have a minimum of &gt;= 2 x 10^6 CD34/kg&#xD;
             autologous hematopoietic stem cells harvested and cryopreserved&#xD;
&#xD;
          -  Patients must have an expected survival of &gt; 60 days and must be free of major&#xD;
             infection&#xD;
&#xD;
          -  Patients are preferred to have either a tumor mass amenable to core needle biopsy&#xD;
             during the dosimetry phase, or a measurable tumor mass with at least one site of&#xD;
             involvement measuring 2.5 cm in largest dimension on computed tomography (CT) imaging&#xD;
             for purposes of planar and/or single-photon emission computed tomography (SPECT)/CT&#xD;
             tumor dosimetry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Circulating human anti-mouse antibody (HAMA), to be determined before each infusion&#xD;
&#xD;
          -  Systemic anti-lymphoma therapy given in the previous 30 days before the scheduled&#xD;
             therapy dose with the exception of rituximab&#xD;
&#xD;
          -  Inability to understand or give an informed consent&#xD;
&#xD;
          -  Lymphoma involving the central nervous system&#xD;
&#xD;
          -  Other serious medical conditions considered to represent contraindications to ASCT&#xD;
             (e.g., abnormally decreased cardiac ejection fraction, diffusion capacity of the lung&#xD;
             for carbon monoxide [DLCO] &lt; 50% predicted, acquired immune deficiency syndrome&#xD;
             [AIDS], etc.)&#xD;
&#xD;
          -  Known human immunodeficiency virus (HIV) seropositivity&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Prior allogeneic bone marrow or stem cell transplant&#xD;
&#xD;
          -  Prior autologous bone marrow or stem cell transplant within 1 year of enrollment&#xD;
&#xD;
          -  Prior radiation therapy (RT) &gt; 20 Gray (Gy) to a critical organ within 1 year of&#xD;
             enrollment&#xD;
&#xD;
          -  Southwest Oncology Group (SWOG) performance status &gt;= 2.0&#xD;
&#xD;
          -  Patients with relapsed diffuse large B-cell lymphoma (DLBCL) or HL that have achieved&#xD;
             a positron emission tomography (PET)-negative CR following first salvage chemotherapy&#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>Ajay Gopal</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <results_first_submitted>October 7, 2016</results_first_submitted>
  <results_first_submitted_qc>October 10, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">November 9, 2017</results_first_posted>
  <last_update_submitted>March 7, 2021</last_update_submitted>
  <last_update_submitted_qc>March 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fred Hutchinson Cancer Center</investigator_affiliation>
    <investigator_full_name>Ajay Gopal</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burkitt Lymphoma</mesh_term>
    <mesh_term>Mycoses</mesh_term>
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Lymphoma, Follicular</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
    <mesh_term>Hodgkin Disease</mesh_term>
    <mesh_term>Lymphoma, Mantle-Cell</mesh_term>
    <mesh_term>Lymphoma, T-Cell</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Peripheral</mesh_term>
    <mesh_term>Lymphoma, B-Cell, Marginal Zone</mesh_term>
    <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
    <mesh_term>Lymphoma, Large-Cell, Immunoblastic</mesh_term>
    <mesh_term>Plasmablastic Lymphoma</mesh_term>
    <mesh_term>Mycosis Fungoides</mesh_term>
    <mesh_term>Sezary Syndrome</mesh_term>
    <mesh_term>Leukemia, T-Cell</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Cutaneous</mesh_term>
    <mesh_term>Waldenstrom Macroglobulinemia</mesh_term>
    <mesh_term>Leukemia-Lymphoma, Adult T-Cell</mesh_term>
    <mesh_term>Lymphoma, Large-Cell, Anaplastic</mesh_term>
    <mesh_term>Leukemia, Hairy Cell</mesh_term>
    <mesh_term>Lymphomatoid Granulomatosis</mesh_term>
    <mesh_term>Lymphoma, Extranodal NK-T-Cell</mesh_term>
    <mesh_term>Intraocular Lymphoma</mesh_term>
    <mesh_term>Leukemia, Large Granular Lymphocytic</mesh_term>
    <mesh_term>Immunoblastic Lymphadenopathy</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antineoplastic Agents, Immunological</mesh_term>
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Immunoglobulins</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)</title>
          <description>Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.&#xD;
indium In 111 anti-CD45 monoclonal antibody BC8: Given IV&#xD;
yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV&#xD;
peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)</title>
          <description>Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.&#xD;
indium In 111 anti-CD45 monoclonal antibody BC8: Given IV&#xD;
yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV&#xD;
peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52" spread="0"/>
                  </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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </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>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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Dose Limiting Toxicities (DLT) of Yttrium-90 Anti-CD45</title>
        <description>A DLT (dose limiting toxicity) is defined as a therapy-related grade III or IV Bearman (transplant) toxicity within 30 days of transplant.</description>
        <time_frame>Up to 30 days after receiving study drug</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)</title>
            <description>Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.&#xD;
indium In 111 anti-CD45 monoclonal antibody BC8: Given IV&#xD;
yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV&#xD;
peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Dose Limiting Toxicities (DLT) of Yttrium-90 Anti-CD45</title>
          <description>A DLT (dose limiting toxicity) is defined as a therapy-related grade III or IV Bearman (transplant) toxicity within 30 days of transplant.</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="2"/>
              </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>Overall Response Rate</title>
        <time_frame>Up to 6 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)</title>
            <description>Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.&#xD;
indium In 111 anti-CD45 monoclonal antibody BC8: Given IV&#xD;
yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV&#xD;
peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </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>Overall Survival</title>
        <time_frame>Up to 6 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)</title>
            <description>Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.&#xD;
indium In 111 anti-CD45 monoclonal antibody BC8: Given IV&#xD;
yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV&#xD;
peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="750.5" lower_limit="243" upper_limit="1258"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-free Survival</title>
        <time_frame>Up to 6 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)</title>
            <description>Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.&#xD;
indium In 111 anti-CD45 monoclonal antibody BC8: Given IV&#xD;
yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV&#xD;
peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </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>Tumor to Normal Organ Ratios</title>
        <description>Derived from dosimetry estimates coupled with the absorbed dose to normal organs based on the administered activity of 90Y.</description>
        <time_frame>Up to 6 years</time_frame>
        <population>This outcome measure was not done. Only two patients were enrolled before the study was closed early. Tumor to normal organ ratios was not determined due to small sample size.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)</title>
            <description>Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.&#xD;
indium In 111 anti-CD45 monoclonal antibody BC8: Given IV&#xD;
yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV&#xD;
peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant</description>
          </group>
        </group_list>
        <measure>
          <title>Tumor to Normal Organ Ratios</title>
          <description>Derived from dosimetry estimates coupled with the absorbed dose to normal organs based on the administered activity of 90Y.</description>
          <population>This outcome measure was not done. Only two patients were enrolled before the study was closed early. Tumor to normal organ ratios was not determined due to small sample size.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to the investigational product in this study (i.e., the start of the first dosimetry infusion) through day +30 post transplant or through discharge prior to that date from the SCCA system to care of the patient's primary physician</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)</title>
          <description>Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.&#xD;
indium In 111 anti-CD45 monoclonal antibody BC8: Given IV&#xD;
yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV&#xD;
peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE</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="2" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title vocab="CTCAE (Unspecified)">Hyperglycemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" 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>
    <limitations_and_caveats>This study was closed when replaced by a new study adding chemotherapy to this regimen</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Ajay K. Gopal, MD</name_or_title>
      <organization>Fred Hutchinson Cancer Research Center</organization>
      <phone>206-288-2037</phone>
      <email>agopal@u.washington.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/NCT01678443
org study id: 2361.00
secondary id: NCI-2012-01505
secondary id: 2361.00
secondary id: P01CA044991
secondary id: P30CA015704
nct id: NCT01678443
lead sponsor: 
collaborator: 
has dmc: No
This phase I trial studies the side effects and best dose of monoclonal antibody therapy
      before stem cell transplant in treating patients with relapsed or refractory lymphoid
      malignancies. Radiolabeled monoclonal antibodies, such as yttrium-90 anti-CD45 monoclonal
      antibody BC8, can find cancer cells and carry cancer-killing substances to them without
      harming normal cells. When the healthy stem cells from a donor are infused into the patient
      they may help the patient's bone marrow make stem cells, red blood cells, white blood cells,
      and platelets. Giving radiolabeled monoclonal antibody before a stem cell transplant may be
      an effective treatment for relapsed or refractory lymphoid malignancies.
PRIMARY OBJECTIVES:

      I. To estimate the maximally tolerated dose (MTD) of 90Y-BC8-DOTA (anti-cluster of
      differentiation [CD]45) (yttrium-90 anti-CD45 monoclonal antibody BC8) that can be delivered
      prior to autologous stem cell transplantation for patients with relapsed/refractory B-cell
      non-Hodgkin lymphoma (B-NHL), T-cell NHL (T-NHL), and Hodgkin lymphoma (HL).

      SECONDARY OBJECTIVES:

      I. To optimize the protein dose (antibody [Ab]) to deliver a favorable biodistribution in the
      majority of patients.

      II. To describe the impact of rituximab concentrations, B-cell depletion, and disease burden
      on CD20 and CD45 targeting.

      III. To describe response rates and remission durations in relapsed B-NHL, T-NHL, and HL
      following administration of myeloablative doses of 90Y-BC8-DOTA prior to autologous stem cell
      transplant (ASCT).

      IV. To assess the correlation of lymphoma biomarkers with outcomes.

      OUTLINE: This is a dose-escalation study of yttrium-90 anti-CD45 monoclonal antibody BC8.

      Patients receive indium-111 anti-CD45 monoclonal antibody BC8 intravenously (IV) on day -28
      and (if necessary) day -21 to evaluate the antibody's biodistribution. Patients then receive
      yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -14. Patients then undergo autologous
      peripheral blood stem cell transplantation on day 0.

      After completion of study treatment, patients are followed up at 3, 6, and 12 months and then
      annually thereafter.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Dose Limiting Toxicities (DLT) of Yttrium-90 Anti-CD45
time frame: Up to 30 days after receiving study drug
description: A DLT (dose limiting toxicity) is defined as a therapy-related grade III or IV Bearman (transplant) toxicity within 30 days of transplant.
measure: Overall Response Rate
time frame: Up to 6 years
measure: Overall Survival
time frame: Up to 6 years
measure: Progression-free Survival
time frame: Up to 6 years
measure: Tumor to Normal Organ Ratios
time frame: Up to 6 years
description: Derived from dosimetry estimates coupled with the absorbed dose to normal organs based on the administered activity of 90Y.
arm group label: Treatment (yttrium-90 anti-CD45 monoclonal antibody BC8)
arm group type: Experimental
description: Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.
intervention type: Biological
intervention name: indium In 111 anti-CD45 monoclonal antibody BC8
description: Given IV
arm group label: Treatment (yttrium-90 anti-CD45 monoclonal antibody BC8)
other name: In 111 MOAB BC8
other name: In 111 monoclonal antibody BC8
other name: In111 MOAB BC8
other name: indium In 111 MOAB BC8
intervention type: Radiation
intervention name: yttrium Y 90 anti-CD45 monoclonal antibody BC8
description: Given IV
arm group label: Treatment (yttrium-90 anti-CD45 monoclonal antibody BC8)
other name: 90Y anti-CD45 MAb BC8
other name: 90Y anti-CD45 MoAb BC8
intervention type: Procedure
intervention name: peripheral blood stem cell transplantation
description: Undergo autologous peripheral blood stem cell transplant
arm group label: Treatment (yttrium-90 anti-CD45 monoclonal antibody BC8)
other name: PBPC transplantation
other name: PBSC transplantation
other name: peripheral blood progenitor cell transplantation
other name: transplantation, peripheral blood stem cell
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ajay Gopal
role: Principal Investigator
affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Fred Hutchinson Cancer Center
investigator full name: Ajay Gopal
investigator title: Principal Investigator
mesh term: Burkitt Lymphoma
mesh term: Mycoses
mesh term: Lymphoma
mesh term: Leukemia
mesh term: Lymphoma, Follicular
mesh term: Lymphoma, Non-Hodgkin
mesh term: Lymphoma, B-Cell
mesh term: Hodgkin Disease
mesh term: Lymphoma, Mantle-Cell
mesh term: Lymphoma, T-Cell
mesh term: Lymphoma, T-Cell, Peripheral
mesh term: Lymphoma, B-Cell, Marginal Zone
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Lymphoma, Large-Cell, Immunoblastic
mesh term: Plasmablastic Lymphoma
mesh term: Mycosis Fungoides
mesh term: Sezary Syndrome
mesh term: Leukemia, T-Cell
mesh term: Lymphoma, T-Cell, Cutaneous
mesh term: Waldenstrom Macroglobulinemia
mesh term: Leukemia-Lymphoma, Adult T-Cell
mesh term: Lymphoma, Large-Cell, Anaplastic
mesh term: Leukemia, Hairy Cell
mesh term: Lymphomatoid Granulomatosis
mesh term: Lymphoma, Extranodal NK-T-Cell
mesh term: Intraocular Lymphoma
mesh term: Leukemia, Large Granular Lymphocytic
mesh term: Immunoblastic Lymphadenopathy
mesh term: Recurrence
mesh term: Antineoplastic Agents, Immunological
mesh term: Antibodies
mesh term: Immunoglobulins
mesh term: Antibodies, Monoclonal
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study was closed when replaced by a new study adding chemotherapy to this regimen
point of contact: 