<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/NCT01702961</url>
  </required_header>
  <id_info>
    <org_study_id>H-11892</org_study_id>
    <secondary_id>Rituxan+BEAM</secondary_id>
    <nct_id>NCT01702961</nct_id>
  </id_info>
  <brief_title>Rituxan + BEAM and Auto Stem Cell Transplant for High Risk Lymphoma or Hodgkin's Disease</brief_title>
  <acronym>Rituxan+BEAM</acronym>
  <official_title>A Current Practice Study of Rituxan in Patient Receiving BEAM Chemotherapy and Autologous Blood Stem Cell Transplantation for High Risk Lymphoma or Hodgkin's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Methodist Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Center for Cell and Gene Therapy, Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      High-dose chemotherapy followed by autologous (the patient's own) peripheral blood&#xD;
      (circulating blood) stem cell (cells that divide to form white cells, red cells and cells&#xD;
      that help clot) transplantation is a conventional treatment for patients with lymphoma&#xD;
      (cancer of lymph glands) and Hodgkin's disease (cancer of lymph glands) after first relapse&#xD;
      (recurrence of disease). For patients who did not have a complete response after traditional&#xD;
      chemotherapy, the chance is high that the tumor will return even after high-dose&#xD;
      chemotherapy. To improve the response and decrease the chance of relapse, doctors have used&#xD;
      rituximab, an antibody that kills lymphoma cells, both before and after transplantation.&#xD;
      These doctors have reported that more patients had control of the tumor for an extended&#xD;
      period of time using rituximab with high-dose chemotherapy with autologous stem cell&#xD;
      transplantation. How widely this is applicable is not known.&#xD;
&#xD;
      The purpose of this clinical research trial is to confirm that there is a good control of&#xD;
      tumor in patients with lymphoma or Hodgkin's disease treated with rituximab and conventional&#xD;
      stem cell transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will receive the chemotherapy through a plastic tube (catheter) placed into a vein&#xD;
      under the collarbone. The antibody rituximab is given on the day of admission. The subject&#xD;
      will also start a six-day course of chemotherapy at that time. The chemotherapy will consist&#xD;
      of the following drugs: BCNU, etoposide also called VP-16, Ara-C also called cytosine&#xD;
      arabinoside, and melphalan. BCNU is given on the first day, Ara-C and VP-16 on the second,&#xD;
      third, fourth and fifth days, and melphalan on the sixth day. The infusion of blood stem&#xD;
      cells is given through the catheter the day after the last dose of chemotherapy. This is&#xD;
      called Day 0. A week later the subject will receive shots under the skin of Neupogen to help&#xD;
      the stem cells grow quickly. Three additional doses of rituximab are given weekly starting 2&#xD;
      weeks later. If the subject recovers and is discharged from the hospital before getting all&#xD;
      the doses of rituximab, they can receive the remainder in clinic.&#xD;
&#xD;
      Patients will remain in the hospital for approximately 3-4 weeks, and in the Houston area for&#xD;
      about 30 days from the infusion of the donor cells. The patient will have blood, urine, bone&#xD;
      marrow, and x-ray examinations performed as necessary to monitor the results of treatment.&#xD;
      They will have blood tests daily while hospitalized.&#xD;
&#xD;
      As an outpatient, the patient will be monitored to make sure their immune system (system in&#xD;
      the body that helps protect the body and fights bacterial, viral and fungal infections) is&#xD;
      recovering, and the patient may require additional infusions of immunoglobulins&#xD;
      (infection-fighting blood proteins) until the blood protein levels are safe. The patient will&#xD;
      also be taking antibiotic pills for about 6 months to prevent infections. They will have&#xD;
      x-rays and other diagnostic tests (PET scans) every 6-12 months during the next 5 years to&#xD;
      make sure the tumor stays under control.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2002</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>N/A</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>Disease-free Survival</measure>
    <time_frame>12 months post-transplant</time_frame>
    <description>Disease-free survival at 12 months post-transplant in patients with Hodgkin's disease or non-Hodgkin's lymphomas</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Median Days to Neutrophil Engraftment</measure>
    <time_frame>30 days post-transplant</time_frame>
    <description>Neutrophil engraftment was recorded as the first day that absolute neutrophil counts (ANC) exceeds 0.5 X 10^9/L for three consecutive readings.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Overall Best Response Achieved After Transplantation</measure>
    <time_frame>3 months post-transplant</time_frame>
    <description>Response was summarized as complete remission (CR): disappearance of all evidence of disease; partial remission (PR): regression of measurable disease (&gt;=50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses) and no new sites; stable disease (SD): failure to attain CR/PR/PD; relapsed disease or progressive disease (PD): any new lesion or increase by &gt;= 50% of previously involved sites from nadir.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Lymphoma</condition>
  <condition>Hodgkin's Disease</condition>
  <arm_group>
    <arm_group_label>BEAM+R: Autologous Stem Cell Transplant</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Melphalan</intervention_name>
    <description>Given on Day -1&#xD;
Melphalan is administered according to the current SOP.</description>
    <arm_group_label>BEAM+R: Autologous Stem Cell Transplant</arm_group_label>
    <other_name>Alkeran</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ara-C</intervention_name>
    <description>200 mg/m2 IB BID given on Days -5, -4, -3, -2</description>
    <arm_group_label>BEAM+R: Autologous Stem Cell Transplant</arm_group_label>
    <other_name>Cytarabine</other_name>
    <other_name>Cytosar-u</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VP-16</intervention_name>
    <description>200 mg/m2 IV BID given on Days -5, -4, -3, -2</description>
    <arm_group_label>BEAM+R: Autologous Stem Cell Transplant</arm_group_label>
    <other_name>Etoposide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BCNU</intervention_name>
    <description>BCNU 300 mg/m2 IV given on Day -6</description>
    <arm_group_label>BEAM+R: Autologous Stem Cell Transplant</arm_group_label>
    <other_name>Carmustine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituxan</intervention_name>
    <description>375 mg/m2 IB given on Days -6, +14, +21, +28</description>
    <arm_group_label>BEAM+R: Autologous Stem Cell Transplant</arm_group_label>
    <other_name>Rituxamib</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Stem Cells</intervention_name>
    <description>Stem cells given on Day 0</description>
    <arm_group_label>BEAM+R: Autologous Stem Cell Transplant</arm_group_label>
    <other_name>Autologous Blood Stem Cells</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with biopsy-proven, relapsed, or refractory CD20+ lymphoma, or HD.&#xD;
&#xD;
          -  At least 2e6 CD34+/kg autologous PBSC stored. If patients are non-mobilizers, then at&#xD;
             least 2e8 TNC/kg autologous marrow should be stored.&#xD;
&#xD;
          -  Patient is not pregnant.&#xD;
&#xD;
          -  Zubrod performance status less than or equal to 2.&#xD;
&#xD;
          -  Life expectancy is not severely limited by concomitant illness.&#xD;
&#xD;
          -  Left ventricular ejection fraction greater than or equal to 50%.&#xD;
&#xD;
          -  No uncontrolled arrhythmias or symptomatic cardiac disease.&#xD;
&#xD;
          -  FEV1, FVC and DLCO greater than or equal to 50%.&#xD;
&#xD;
          -  No symptomatic pulmonary disease.&#xD;
&#xD;
          -  Serum creatinine less than or equal to 1.5 mg/dL.&#xD;
&#xD;
          -  Serum bilirubin less than or equal to 2X upper limit of normal, SGPT less than or&#xD;
             equal to 3X upper limit of normal.&#xD;
&#xD;
          -  No evidence of chronic active hepatitis or cirrhosis.&#xD;
&#xD;
          -  No effusion or ascites greater than or equal to 1L prior to drainage.&#xD;
&#xD;
          -  HIV negative.&#xD;
&#xD;
          -  Patient or guardian able to sign informed consent.&#xD;
&#xD;
          -  Patients of any age may be enrolled on this protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anyone not meeting the above criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>George Carrum, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor; Director-Adult Outpatient Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Texas Children's Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Methodist Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <results_first_submitted>August 27, 2015</results_first_submitted>
  <results_first_submitted_qc>August 27, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 28, 2015</results_first_posted>
  <last_update_submitted>November 29, 2018</last_update_submitted>
  <last_update_submitted_qc>November 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>George Carrum</investigator_full_name>
    <investigator_title>Associate Professor; Director-Adult Outpatient Clinic</investigator_title>
  </responsible_party>
  <keyword>Lymphoma</keyword>
  <keyword>Hodgkin's Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Hodgkin Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cytarabine</mesh_term>
    <mesh_term>Etoposide</mesh_term>
    <mesh_term>Rituximab</mesh_term>
    <mesh_term>Melphalan</mesh_term>
    <mesh_term>Carmustine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Rituxan+BEAM: Autologous Stem Cell Transplant</title>
          <description>Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.&#xD;
Melphalan: Given on Day -1&#xD;
Melphalan is administered according to the current SOP.&#xD;
Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2&#xD;
VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2&#xD;
BCNU: BCNU 300 mg/m2 IV given on Day -6&#xD;
Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28&#xD;
Stem Cells: Stem cells given on Day 0</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Additional treatment</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive disease</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Relapse</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Ongoing</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Rituxan+BEAM: Autologous Stem Cell Transplant</title>
          <description>Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells&#xD;
BEAM Conditioning.&#xD;
Melphalan: Given on Day -1&#xD;
Melphalan is administered according to the current SOP.&#xD;
Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2&#xD;
VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2&#xD;
BCNU: BCNU 300 mg/m2 IV given on Day -6&#xD;
Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28&#xD;
Stem Cells: Stem cells given on Day 0</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="75"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53" lower_limit="14" upper_limit="69"/>
                  </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="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disease at diagnosis</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Hodgkin's Disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Hodgkin's Lymphoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Disease-free Survival</title>
        <description>Disease-free survival at 12 months post-transplant in patients with Hodgkin's disease or non-Hodgkin's lymphomas</description>
        <time_frame>12 months post-transplant</time_frame>
        <group_list>
          <group group_id="O1">
            <title>BEAM + R: Autologous Stem Cell Transplant</title>
            <description>Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.&#xD;
Melphalan: Given on Day -1&#xD;
Melphalan is administered according to the current SOP.&#xD;
Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2&#xD;
VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2&#xD;
BCNU: BCNU 300 mg/m2 IV given on Day -6&#xD;
Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28&#xD;
Stem Cells: Stem cells given on Day 0</description>
          </group>
        </group_list>
        <measure>
          <title>Disease-free Survival</title>
          <description>Disease-free survival at 12 months post-transplant in patients with Hodgkin's disease or non-Hodgkin's lymphomas</description>
          <units>percentage of participant</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All patients</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76" lower_limit="65" upper_limit="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hodgkin's Disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88" lower_limit="67" upper_limit="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Hodgkin's Lymphomas</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70" lower_limit="55" upper_limit="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Days to Neutrophil Engraftment</title>
        <description>Neutrophil engraftment was recorded as the first day that absolute neutrophil counts (ANC) exceeds 0.5 X 10^9/L for three consecutive readings.</description>
        <time_frame>30 days post-transplant</time_frame>
        <population>All of the participants enrolled in the study engrafted.</population>
        <group_list>
          <group group_id="O1">
            <title>BEAM + R: Autologous Stem Cell Transplant</title>
            <description>Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.&#xD;
Melphalan: Given on Day -1&#xD;
Melphalan is administered according to the current SOP.&#xD;
Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2&#xD;
VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2&#xD;
BCNU: BCNU 300 mg/m2 IV given on Day -6&#xD;
Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28&#xD;
Stem Cells: Stem cells given on Day 0</description>
          </group>
        </group_list>
        <measure>
          <title>Median Days to Neutrophil Engraftment</title>
          <description>Neutrophil engraftment was recorded as the first day that absolute neutrophil counts (ANC) exceeds 0.5 X 10^9/L for three consecutive readings.</description>
          <population>All of the participants enrolled in the study engrafted.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" lower_limit="9" upper_limit="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Overall Best Response Achieved After Transplantation</title>
        <description>Response was summarized as complete remission (CR): disappearance of all evidence of disease; partial remission (PR): regression of measurable disease (&gt;=50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses) and no new sites; stable disease (SD): failure to attain CR/PR/PD; relapsed disease or progressive disease (PD): any new lesion or increase by &gt;= 50% of previously involved sites from nadir.</description>
        <time_frame>3 months post-transplant</time_frame>
        <population>Analysis comprised of all participants who received standard BEAM chemotherapy and adjuvant rituximab while undergoing autologous blood stem cell transplantation for high-risk lymphoma or Hodgkin's disease.</population>
        <group_list>
          <group group_id="O1">
            <title>BEAM + R: Autologous Stem Cell Transplant</title>
            <description>Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.&#xD;
Melphalan: Given on Day -1&#xD;
Melphalan is administered according to the current SOP.&#xD;
Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2&#xD;
VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2&#xD;
BCNU: BCNU 300 mg/m2 IV given on Day -6&#xD;
Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28&#xD;
Stem Cells: Stem cells given on Day 0</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Overall Best Response Achieved After Transplantation</title>
          <description>Response was summarized as complete remission (CR): disappearance of all evidence of disease; partial remission (PR): regression of measurable disease (&gt;=50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses) and no new sites; stable disease (SD): failure to attain CR/PR/PD; relapsed disease or progressive disease (PD): any new lesion or increase by &gt;= 50% of previously involved sites from nadir.</description>
          <population>Analysis comprised of all participants who received standard BEAM chemotherapy and adjuvant rituximab while undergoing autologous blood stem cell transplantation for high-risk lymphoma or Hodgkin's disease.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Complete Remission (CR)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial Remission (PR)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stable Disease (SD)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relapsed Disease or Progressive Disease (PD)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events related to the study drug, rituximab, are reported during the period of 30 days after transplant.</time_frame>
      <desc>Only related adverse events were collected for this study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Rituxan+BEAM: Autologous Stem Cell Transplant</title>
          <description>Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.&#xD;
BEAM Conditioning.&#xD;
Melphalan: Given on Day -1&#xD;
Melphalan is administered according to the current SOP.&#xD;
Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2&#xD;
VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2&#xD;
BCNU: BCNU 300 mg/m2 IV given on Day -6&#xD;
Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28&#xD;
Stem Cells: Stem cells given on Day 0</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (2.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia</sub_title>
                <description>Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia (ANC &lt;1.0 x 10e9/L)</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (2.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiovascular/ General - Other</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Stomatitis/pharyngitis (oral/pharyngeal mucositis)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain - Other</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection without neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="75"/>
              </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>George Carrum, MD</name_or_title>
      <organization>Baylor College of Medicine</organization>
      <email>GCarrum@houstonmethodist.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01702961
org study id: H-11892
secondary id: Rituxan+BEAM
nct id: NCT01702961
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
High-dose chemotherapy followed by autologous (the patient's own) peripheral blood
      (circulating blood) stem cell (cells that divide to form white cells, red cells and cells
      that help clot) transplantation is a conventional treatment for patients with lymphoma
      (cancer of lymph glands) and Hodgkin's disease (cancer of lymph glands) after first relapse
      (recurrence of disease). For patients who did not have a complete response after traditional
      chemotherapy, the chance is high that the tumor will return even after high-dose
      chemotherapy. To improve the response and decrease the chance of relapse, doctors have used
      rituximab, an antibody that kills lymphoma cells, both before and after transplantation.
      These doctors have reported that more patients had control of the tumor for an extended
      period of time using rituximab with high-dose chemotherapy with autologous stem cell
      transplantation. How widely this is applicable is not known.

      The purpose of this clinical research trial is to confirm that there is a good control of
      tumor in patients with lymphoma or Hodgkin's disease treated with rituximab and conventional
      stem cell transplantation.
Subjects will receive the chemotherapy through a plastic tube (catheter) placed into a vein
      under the collarbone. The antibody rituximab is given on the day of admission. The subject
      will also start a six-day course of chemotherapy at that time. The chemotherapy will consist
      of the following drugs: BCNU, etoposide also called VP-16, Ara-C also called cytosine
      arabinoside, and melphalan. BCNU is given on the first day, Ara-C and VP-16 on the second,
      third, fourth and fifth days, and melphalan on the sixth day. The infusion of blood stem
      cells is given through the catheter the day after the last dose of chemotherapy. This is
      called Day 0. A week later the subject will receive shots under the skin of Neupogen to help
      the stem cells grow quickly. Three additional doses of rituximab are given weekly starting 2
      weeks later. If the subject recovers and is discharged from the hospital before getting all
      the doses of rituximab, they can receive the remainder in clinic.

      Patients will remain in the hospital for approximately 3-4 weeks, and in the Houston area for
      about 30 days from the infusion of the donor cells. The patient will have blood, urine, bone
      marrow, and x-ray examinations performed as necessary to monitor the results of treatment.
      They will have blood tests daily while hospitalized.

      As an outpatient, the patient will be monitored to make sure their immune system (system in
      the body that helps protect the body and fights bacterial, viral and fungal infections) is
      recovering, and the patient may require additional infusions of immunoglobulins
      (infection-fighting blood proteins) until the blood protein levels are safe. The patient will
      also be taking antibiotic pills for about 6 months to prevent infections. They will have
      x-rays and other diagnostic tests (PET scans) every 6-12 months during the next 5 years to
      make sure the tumor stays under control.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease-free Survival
time frame: 12 months post-transplant
description: Disease-free survival at 12 months post-transplant in patients with Hodgkin's disease or non-Hodgkin's lymphomas
measure: Median Days to Neutrophil Engraftment
time frame: 30 days post-transplant
description: Neutrophil engraftment was recorded as the first day that absolute neutrophil counts (ANC) exceeds 0.5 X 10^9/L for three consecutive readings.
measure: Number of Participants With Overall Best Response Achieved After Transplantation
time frame: 3 months post-transplant
description: Response was summarized as complete remission (CR): disappearance of all evidence of disease; partial remission (PR): regression of measurable disease (>=50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses) and no new sites; stable disease (SD): failure to attain CR/PR/PD; relapsed disease or progressive disease (PD): any new lesion or increase by >= 50% of previously involved sites from nadir.
arm group label: BEAM+R: Autologous Stem Cell Transplant
arm group type: Other
description: Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells
intervention type: Drug
intervention name: Melphalan
description: Given on Day -1
Melphalan is administered according to the current SOP.
arm group label: BEAM+R: Autologous Stem Cell Transplant
other name: Alkeran
intervention type: Drug
intervention name: Ara-C
description: 200 mg/m2 IB BID given on Days -5, -4, -3, -2
arm group label: BEAM+R: Autologous Stem Cell Transplant
other name: Cytarabine
other name: Cytosar-u
intervention type: Drug
intervention name: VP-16
description: 200 mg/m2 IV BID given on Days -5, -4, -3, -2
arm group label: BEAM+R: Autologous Stem Cell Transplant
other name: Etoposide
intervention type: Drug
intervention name: BCNU
description: BCNU 300 mg/m2 IV given on Day -6
arm group label: BEAM+R: Autologous Stem Cell Transplant
other name: Carmustine
intervention type: Drug
intervention name: Rituxan
description: 375 mg/m2 IB given on Days -6, +14, +21, +28
arm group label: BEAM+R: Autologous Stem Cell Transplant
other name: Rituxamib
intervention type: Drug
intervention name: Stem Cells
description: Stem cells given on Day 0
arm group label: BEAM+R: Autologous Stem Cell Transplant
other name: Autologous Blood Stem Cells
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: George Carrum, MD
role: Principal Investigator
affiliation: Associate Professor; Director-Adult Outpatient Clinic
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: George Carrum
investigator title: Associate Professor; Director-Adult Outpatient Clinic
mesh term: Lymphoma
mesh term: Hodgkin Disease
mesh term: Cytarabine
mesh term: Etoposide
mesh term: Rituximab
mesh term: Melphalan
mesh term: Carmustine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 