<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/NCT02257242</url>
  </required_header>
  <id_info>
    <org_study_id>BrUOG 326</org_study_id>
    <nct_id>NCT02257242</nct_id>
  </id_info>
  <brief_title>Vincristine Sulfate Liposome Injection (Marqibo®), Bendamustine and Rituximab-Phase I Trial in Indolent B-cell Lymphoma</brief_title>
  <acronym>BRiM</acronym>
  <official_title>BrUOG 326: A Phase I Dose-Escalation Study of Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With Bendamustine and Rituximab (BRiM) in Indolent Non-Hodgkin Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Spectrum Pharmaceuticals, Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rhode Island Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Miriam Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Brown University</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 study evaluates addition of Vincristine Sulfate Liposome Injection (Marqibo®) to the&#xD;
      standard regimen of Bendamustine and Rituximab in adult patients with indolent B-cell&#xD;
      lymphoma. This is a dose-escalation study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bendamustine-rituximab is a standard chemotherapy regimen for treatment of many indolent&#xD;
      B-cell lymphomas, but most patients experience a recurrence of the lymphoma. Vincristine&#xD;
      sulfate has been a traditional component of chemotherapy regimens in non-Hodgkin lymphoma and&#xD;
      it is possible that adding it to the bendamustine-rituximab regimen might provide a better&#xD;
      quality of remissions or longer duration of remissions with acceptable toxicity.&#xD;
&#xD;
      This is a phase 1, single-center, open-label, single-arm trial in patients with indolent&#xD;
      B-cell non-Hodgkin lymphoma otherwise appropriate for bendamustine-rituximab as initial or&#xD;
      subsequent line of therapy. Patients will receive the of rituximab and bendamustine in&#xD;
      combination with escalating doses of vincristine sulfate liposome injection (Marqibo®). The&#xD;
      objective of this study is to assess safety of this combination by establishing the maximum&#xD;
      tolerated dose of vincristine sulfate liposome injection (Marqibo®) in the combination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 10, 2017</start_date>
  <completion_date type="Actual">November 18, 2020</completion_date>
  <primary_completion_date type="Actual">August 22, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Tolerated Dose</measure>
    <time_frame>Up to 6 cycles of treatment (approximately 6 months)</time_frame>
    <description>Determined as the median of the marginal posterior distribution using data from all available patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Completed Six Cycles of Study Treatment</measure>
    <time_frame>Up to 6 cycles of treatment (approximately 6 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response Rate</measure>
    <time_frame>Up to 6 cycles of treatment (approximately 6 months)</time_frame>
    <description>Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: 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>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Response Rate</measure>
    <time_frame>Up to 6 cycles of treatment (approximately 6 months)</time_frame>
    <description>The number of patients achieving complete response during treatment on study</description>
  </secondary_outcome>
  <number_of_arms>9</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Lymphoma, Non-Hodgkin</condition>
  <condition>Lymphoma, Follicular</condition>
  <condition>Lymphoma, Mantle-Cell</condition>
  <condition>Lymphoma, Small-Cell</condition>
  <condition>Waldenstrom Macroglobulinemia</condition>
  <condition>Lymphoma, B-Cell, Marginal Zone</condition>
  <arm_group>
    <arm_group_label>Vincristine sulfate liposome injection 1.8 mg/m^2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vincristine sulfate liposome injection 1.95 mg/m^2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vincristine sulfate liposome injection 1.98 mg/m^2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vincristine sulfate liposome injection 2.04 mg/m^2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vincristine sulfate liposome injection 2.10 mg/m^2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vincristine sulfate liposome injection 2.14 mg/m^2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vincristine sulfate liposome injection 2.19 mg/m^2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vincristine sulfate liposome injection 2.22 mg/m^2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vincristine sulfate liposome injection 2.24 mg/m^2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>375 mg/m2 I.V. on Day 1 of each cycle</description>
    <arm_group_label>Vincristine sulfate liposome injection 1.8 mg/m^2</arm_group_label>
    <arm_group_label>Vincristine sulfate liposome injection 1.95 mg/m^2</arm_group_label>
    <arm_group_label>Vincristine sulfate liposome injection 1.98 mg/m^2</arm_group_label>
    <arm_group_label>Vincristine sulfate liposome injection 2.04 mg/m^2</arm_group_label>
    <arm_group_label>Vincristine sulfate liposome injection 2.10 mg/m^2</arm_group_label>
    <arm_group_label>Vincristine sulfate liposome injection 2.14 mg/m^2</arm_group_label>
    <arm_group_label>Vincristine sulfate liposome injection 2.19 mg/m^2</arm_group_label>
    <arm_group_label>Vincristine sulfate liposome injection 2.22 mg/m^2</arm_group_label>
    <arm_group_label>Vincristine sulfate liposome injection 2.24 mg/m^2</arm_group_label>
    <other_name>Rituxan, anti-CD20 antibody</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bendamustine</intervention_name>
    <description>90 mg/m2 I.V. on Day 1 and 2 of each cycle</description>
    <arm_group_label>Vincristine sulfate liposome injection 1.8 mg/m^2</arm_group_label>
    <arm_group_label>Vincristine sulfate liposome injection 1.95 mg/m^2</arm_group_label>
    <arm_group_label>Vincristine sulfate liposome injection 1.98 mg/m^2</arm_group_label>
    <arm_group_label>Vincristine sulfate liposome injection 2.04 mg/m^2</arm_group_label>
    <arm_group_label>Vincristine sulfate liposome injection 2.10 mg/m^2</arm_group_label>
    <arm_group_label>Vincristine sulfate liposome injection 2.14 mg/m^2</arm_group_label>
    <arm_group_label>Vincristine sulfate liposome injection 2.19 mg/m^2</arm_group_label>
    <arm_group_label>Vincristine sulfate liposome injection 2.22 mg/m^2</arm_group_label>
    <arm_group_label>Vincristine sulfate liposome injection 2.24 mg/m^2</arm_group_label>
    <other_name>Treanda</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vincristine sulfate liposome injection</intervention_name>
    <description>Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
    <arm_group_label>Vincristine sulfate liposome injection 1.8 mg/m^2</arm_group_label>
    <arm_group_label>Vincristine sulfate liposome injection 1.95 mg/m^2</arm_group_label>
    <arm_group_label>Vincristine sulfate liposome injection 1.98 mg/m^2</arm_group_label>
    <arm_group_label>Vincristine sulfate liposome injection 2.04 mg/m^2</arm_group_label>
    <arm_group_label>Vincristine sulfate liposome injection 2.10 mg/m^2</arm_group_label>
    <arm_group_label>Vincristine sulfate liposome injection 2.14 mg/m^2</arm_group_label>
    <arm_group_label>Vincristine sulfate liposome injection 2.19 mg/m^2</arm_group_label>
    <arm_group_label>Vincristine sulfate liposome injection 2.22 mg/m^2</arm_group_label>
    <arm_group_label>Vincristine sulfate liposome injection 2.24 mg/m^2</arm_group_label>
    <other_name>Marqibo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed indolent B-cell non-Hodgkin lymphoma.&#xD;
&#xD;
          -  Radiological measurable disease.&#xD;
&#xD;
          -  Previous treatment for lymphoma is allowed, with the exception of use of bendamustine&#xD;
             within 6 months or any prior use of vincristine sulfate liposome injection&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status 0 or 1;&#xD;
&#xD;
          -  Life expectancy of at least 6 months;&#xD;
&#xD;
          -  Adequate organ and marrow function;&#xD;
&#xD;
          -  Women of child-bearing potential and men must agree to use adequate contraception.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of allergic reactions attributed to any drug used in the study.&#xD;
&#xD;
          -  Any lymphoma-directed therapy within 4 weeks.&#xD;
&#xD;
          -  Any prior treatment with vincristine sulfate liposome injection.&#xD;
&#xD;
          -  Prior treatment with bendamustine or vincristine sulfate within 180 days of&#xD;
             enrollment.&#xD;
&#xD;
          -  Patients who are receiving any other investigational agents with the exception of&#xD;
             endocrine therapy for breast or prostate cancer.&#xD;
&#xD;
          -  Central nervous system involvement.&#xD;
&#xD;
          -  Peripheral sensory or motor neuropathy.&#xD;
&#xD;
          -  History of a demyelinating condition.&#xD;
&#xD;
          -  Positive test for the Human Anti-Chimeric Antibody (HACA).&#xD;
&#xD;
          -  Patients receiving any medications or substances that are strong inhibitors or&#xD;
             inducers of Cytochrome P450, family 3, subfamily A (CYP3A) enzyme are ineligible.&#xD;
&#xD;
          -  Uncontrolled intercurrent illness.&#xD;
&#xD;
          -  Prisoners.&#xD;
&#xD;
          -  Pregnant or breast-feeding women.&#xD;
&#xD;
          -  Known Human Immunodeficiency Virus (HIV) or active Hepatitis B infection&#xD;
&#xD;
          -  Any prior or active cancer, which in the opinion of the investigator would preclude&#xD;
             safe participation in this study.&#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>Adam J Olszewski, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rhode Island Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rhode Island Hospital and The Miriam Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <results_first_submitted>November 4, 2021</results_first_submitted>
  <results_first_submitted_qc>May 12, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 9, 2023</results_first_posted>
  <last_update_submitted>May 12, 2022</last_update_submitted>
  <last_update_submitted_qc>May 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bendamustine</keyword>
  <keyword>Rituximab</keyword>
  <keyword>Vincristine sulfate</keyword>
  <keyword>Vincristine sulfate liposome injection</keyword>
  <keyword>Phase I</keyword>
  <keyword>Escalation With Overdose Control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Waldenstrom Macroglobulinemia</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
    <mesh_term>Lymphoma, Follicular</mesh_term>
    <mesh_term>Lymphoma, Mantle-Cell</mesh_term>
    <mesh_term>Lymphoma, B-Cell, Marginal Zone</mesh_term>
    <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rituximab</mesh_term>
    <mesh_term>Vincristine</mesh_term>
    <mesh_term>Bendamustine Hydrochloride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT02257242/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Vincristine Sulfate Liposome Injection: 1.8 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
        </group>
        <group group_id="P2">
          <title>Vincristine Sulfate Liposome Injection: 1.95 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
        </group>
        <group group_id="P3">
          <title>Vincristine Sulfate Liposome Injection: 1.98 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
        </group>
        <group group_id="P4">
          <title>Vincristine Sulfate Liposome Injection: 2.04 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
        </group>
        <group group_id="P5">
          <title>Vincristine Sulfate Liposome Injection: 2.10 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
        </group>
        <group group_id="P6">
          <title>Vincristine Sulfate Liposome Injection: 2.14 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
        </group>
        <group group_id="P7">
          <title>Vincristine Sulfate Liposome Injection: 2.19 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
        </group>
        <group group_id="P8">
          <title>Vincristine Sulfate Liposome Injection: 2.22 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
        </group>
        <group group_id="P9">
          <title>Vincristine Sulfate Liposome Injection: 2.24 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</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 group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>1 subject removed from study before any treatment due to temporary unavailability of study drug</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Vincristine Sulfate Liposome Injection: 1.8 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
        </group>
        <group group_id="B2">
          <title>Vincristine Sulfate Liposome Injection: 1.95 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.</description>
        </group>
        <group group_id="B3">
          <title>Vincristine Sulfate Liposome Injection: 1.98 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.</description>
        </group>
        <group group_id="B4">
          <title>Vincristine Sulfate Liposome Injection: 2.04 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.</description>
        </group>
        <group group_id="B5">
          <title>Vincristine Sulfate Liposome Injection: 2.10 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.</description>
        </group>
        <group group_id="B6">
          <title>Vincristine Sulfate Liposome Injection: 2.14 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.</description>
        </group>
        <group group_id="B7">
          <title>Vincristine Sulfate Liposome Injection: 2.19 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.</description>
        </group>
        <group group_id="B8">
          <title>Vincristine Sulfate Liposome Injection: 2.22 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.</description>
        </group>
        <group group_id="B9">
          <title>Vincristine Sulfate Liposome Injection: 2.24 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.</description>
        </group>
        <group group_id="B10">
          <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="2"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="1"/>
            <count group_id="B4" value="2"/>
            <count group_id="B5" value="1"/>
            <count group_id="B6" value="1"/>
            <count group_id="B7" value="1"/>
            <count group_id="B8" value="1"/>
            <count group_id="B9" value="1"/>
            <count group_id="B10" value="11"/>
          </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" 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="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70" lower_limit="66" upper_limit="74"/>
                    <measurement group_id="B2" value="40" lower_limit="40" upper_limit="40"/>
                    <measurement group_id="B3" value="75" lower_limit="75" upper_limit="75"/>
                    <measurement group_id="B4" value="69" lower_limit="62" upper_limit="76"/>
                    <measurement group_id="B5" value="58" lower_limit="58" upper_limit="58"/>
                    <measurement group_id="B6" value="61" lower_limit="61" upper_limit="61"/>
                    <measurement group_id="B7" value="54" lower_limit="54" upper_limit="54"/>
                    <measurement group_id="B8" value="57" lower_limit="57" upper_limit="57"/>
                    <measurement group_id="B9" value="39" lower_limit="39" upper_limit="39"/>
                    <measurement group_id="B10" value="60" lower_limit="39" upper_limit="76"/>
                  </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="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="5"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="9"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" 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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" 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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" 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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" 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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="8"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" 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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="2"/>
                  </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 group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Maximum Tolerated Dose</title>
        <description>Determined as the median of the marginal posterior distribution using data from all available patients</description>
        <time_frame>Up to 6 cycles of treatment (approximately 6 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dose-escalation Cohort</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Tolerated Dose</title>
          <description>Determined as the median of the marginal posterior distribution using data from all available patients</description>
          <units>mg/m^2</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Completed Six Cycles of Study Treatment</title>
        <time_frame>Up to 6 cycles of treatment (approximately 6 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vincristine Sulfate Liposome Injection: 1.8 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
          <group group_id="O2">
            <title>Vincristine Sulfate Liposome Injection: 1.95 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
          <group group_id="O3">
            <title>Vincristine Sulfate Liposome Injection: 1.98 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
          <group group_id="O4">
            <title>Vincristine Sulfate Liposome Injection: 2.04 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
          <group group_id="O5">
            <title>Vincristine Sulfate Liposome Injection: 2.10 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
          <group group_id="O6">
            <title>Vincristine Sulfate Liposome Injection: 2.14 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
          <group group_id="O7">
            <title>Vincristine Sulfate Liposome Injection: 2.19 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
          <group group_id="O8">
            <title>Vincristine Sulfate Liposome Injection: 2.22 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
          <group group_id="O9">
            <title>Vincristine Sulfate Liposome Injection: 2.24 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Completed Six Cycles of Study Treatment</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="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="1"/>
                <count group_id="O7" value="1"/>
                <count group_id="O8" value="1"/>
                <count group_id="O9" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Response Rate</title>
        <description>Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: 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 6 cycles of treatment (approximately 6 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vincristine Sulfate Liposome Injection: 1.8 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
          <group group_id="O2">
            <title>Vincristine Sulfate Liposome Injection: 1.95 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
          <group group_id="O3">
            <title>Vincristine Sulfate Liposome Injection: 1.98 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
          <group group_id="O4">
            <title>Vincristine Sulfate Liposome Injection: 2.04 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
          <group group_id="O5">
            <title>Vincristine Sulfate Liposome Injection: 2.10 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
          <group group_id="O6">
            <title>Vincristine Sulfate Liposome Injection: 2.14 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
          <group group_id="O7">
            <title>Vincristine Sulfate Liposome Injection: 2.19 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
          <group group_id="O8">
            <title>Vincristine Sulfate Liposome Injection: 2.22 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
          <group group_id="O9">
            <title>Vincristine Sulfate Liposome Injection: 2.24 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
        </group_list>
        <measure>
          <title>Response Rate</title>
          <description>Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: 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>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="1"/>
                <count group_id="O7" value="1"/>
                <count group_id="O8" value="1"/>
                <count group_id="O9" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Complete Response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Partial Response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Stable Disease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complete Response Rate</title>
        <description>The number of patients achieving complete response during treatment on study</description>
        <time_frame>Up to 6 cycles of treatment (approximately 6 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Vincristine Sulfate Liposome Injection 1.8 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
          <group group_id="O2">
            <title>Vincristine Sulfate Liposome Injection 1.95 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
          <group group_id="O3">
            <title>Vincristine Sulfate Liposome Injection 1.98 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
          <group group_id="O4">
            <title>Vincristine Sulfate Liposome Injection 2.04 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
          <group group_id="O5">
            <title>Vincristine Sulfate Liposome Injection 2.10 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
          <group group_id="O6">
            <title>Vincristine Sulfate Liposome Injection 2.14 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
          <group group_id="O7">
            <title>Vincristine Sulfate Liposome Injection 2.19 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
          <group group_id="O8">
            <title>Vincristine Sulfate Liposome Injection 2.22 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
          <group group_id="O9">
            <title>Vincristine Sulfate Liposome Injection 2.24 mg/m^2</title>
            <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Response Rate</title>
          <description>The number of patients achieving complete response during treatment on study</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="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="1"/>
                <count group_id="O7" value="1"/>
                <count group_id="O8" value="1"/>
                <count group_id="O9" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Vincristine Sulfate Liposome Injection: 1.8 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
        </group>
        <group group_id="E2">
          <title>Vincristine Sulfate Liposome Injection: 1.95 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
        </group>
        <group group_id="E3">
          <title>Vincristine Sulfate Liposome Injection: 1.98 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
        </group>
        <group group_id="E4">
          <title>Vincristine Sulfate Liposome Injection: 2.04 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
        </group>
        <group group_id="E5">
          <title>Vincristine Sulfate Liposome Injection: 2.1 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
        </group>
        <group group_id="E6">
          <title>Vincristine Sulfate Liposome Injection: 2.14 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
        </group>
        <group group_id="E7">
          <title>Vincristine Sulfate Liposome Injection: 2.19 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
        </group>
        <group group_id="E8">
          <title>Vincristine Sulfate Liposome Injection: 2.22 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
        </group>
        <group group_id="E9">
          <title>Vincristine Sulfate Liposome Injection: 2.24 mg/m^2</title>
          <description>Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.&#xD;
Rituximab: 375 mg/m2 I.V. on Day 1 of each cycle&#xD;
Bendamustine: 90 mg/m2 I.V. on Day 1 and 2 of each cycle&#xD;
Vincristine sulfate liposome injection: Dose per dose escalation protocol, I.V. on Day 2 of each cycle</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Non-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="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Thromboembolic Event</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Non-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="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neck edema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Mucosal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>White blood cell decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypophosphatemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary frequency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hoarseness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>BrUOG</name_or_title>
      <organization>Brown University Oncology Research Group</organization>
      <phone>4018633000</phone>
      <email>BrUOG@BROWN.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/NCT02257242
org study id: BrUOG 326
nct id: NCT02257242
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study evaluates addition of Vincristine Sulfate Liposome Injection (Marqibo®) to the
      standard regimen of Bendamustine and Rituximab in adult patients with indolent B-cell
      lymphoma. This is a dose-escalation study.
Bendamustine-rituximab is a standard chemotherapy regimen for treatment of many indolent
      B-cell lymphomas, but most patients experience a recurrence of the lymphoma. Vincristine
      sulfate has been a traditional component of chemotherapy regimens in non-Hodgkin lymphoma and
      it is possible that adding it to the bendamustine-rituximab regimen might provide a better
      quality of remissions or longer duration of remissions with acceptable toxicity.

      This is a phase 1, single-center, open-label, single-arm trial in patients with indolent
      B-cell non-Hodgkin lymphoma otherwise appropriate for bendamustine-rituximab as initial or
      subsequent line of therapy. Patients will receive the of rituximab and bendamustine in
      combination with escalating doses of vincristine sulfate liposome injection (Marqibo®). The
      objective of this study is to assess safety of this combination by establishing the maximum
      tolerated dose of vincristine sulfate liposome injection (Marqibo®) in the combination.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Tolerated Dose
time frame: Up to 6 cycles of treatment (approximately 6 months)
description: Determined as the median of the marginal posterior distribution using data from all available patients
measure: Number of Participants Who Completed Six Cycles of Study Treatment
time frame: Up to 6 cycles of treatment (approximately 6 months)
measure: Response Rate
time frame: Up to 6 cycles of treatment (approximately 6 months)
description: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: 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: Complete Response Rate
time frame: Up to 6 cycles of treatment (approximately 6 months)
description: The number of patients achieving complete response during treatment on study
arm group label: Vincristine sulfate liposome injection 1.8 mg/m^2
arm group type: Experimental
description: Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
arm group label: Vincristine sulfate liposome injection 1.95 mg/m^2
arm group type: Experimental
description: Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
arm group label: Vincristine sulfate liposome injection 1.98 mg/m^2
arm group type: Experimental
description: Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
arm group label: Vincristine sulfate liposome injection 2.04 mg/m^2
arm group type: Experimental
description: Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
arm group label: Vincristine sulfate liposome injection 2.10 mg/m^2
arm group type: Experimental
description: Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
arm group label: Vincristine sulfate liposome injection 2.14 mg/m^2
arm group type: Experimental
description: Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
arm group label: Vincristine sulfate liposome injection 2.19 mg/m^2
arm group type: Experimental
description: Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
arm group label: Vincristine sulfate liposome injection 2.22 mg/m^2
arm group type: Experimental
description: Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
arm group label: Vincristine sulfate liposome injection 2.24 mg/m^2
arm group type: Experimental
description: Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
intervention type: Drug
intervention name: Rituximab
description: 375 mg/m2 I.V. on Day 1 of each cycle
arm group label: Vincristine sulfate liposome injection 1.8 mg/m^2
arm group label: Vincristine sulfate liposome injection 1.95 mg/m^2
arm group label: Vincristine sulfate liposome injection 1.98 mg/m^2
arm group label: Vincristine sulfate liposome injection 2.04 mg/m^2
arm group label: Vincristine sulfate liposome injection 2.10 mg/m^2
arm group label: Vincristine sulfate liposome injection 2.14 mg/m^2
arm group label: Vincristine sulfate liposome injection 2.19 mg/m^2
arm group label: Vincristine sulfate liposome injection 2.22 mg/m^2
arm group label: Vincristine sulfate liposome injection 2.24 mg/m^2
other name: Rituxan, anti-CD20 antibody
intervention type: Drug
intervention name: Bendamustine
description: 90 mg/m2 I.V. on Day 1 and 2 of each cycle
arm group label: Vincristine sulfate liposome injection 1.8 mg/m^2
arm group label: Vincristine sulfate liposome injection 1.95 mg/m^2
arm group label: Vincristine sulfate liposome injection 1.98 mg/m^2
arm group label: Vincristine sulfate liposome injection 2.04 mg/m^2
arm group label: Vincristine sulfate liposome injection 2.10 mg/m^2
arm group label: Vincristine sulfate liposome injection 2.14 mg/m^2
arm group label: Vincristine sulfate liposome injection 2.19 mg/m^2
arm group label: Vincristine sulfate liposome injection 2.22 mg/m^2
arm group label: Vincristine sulfate liposome injection 2.24 mg/m^2
other name: Treanda
intervention type: Drug
intervention name: Vincristine sulfate liposome injection
description: Dose per dose escalation protocol, I.V. on Day 2 of each cycle
arm group label: Vincristine sulfate liposome injection 1.8 mg/m^2
arm group label: Vincristine sulfate liposome injection 1.95 mg/m^2
arm group label: Vincristine sulfate liposome injection 1.98 mg/m^2
arm group label: Vincristine sulfate liposome injection 2.04 mg/m^2
arm group label: Vincristine sulfate liposome injection 2.10 mg/m^2
arm group label: Vincristine sulfate liposome injection 2.14 mg/m^2
arm group label: Vincristine sulfate liposome injection 2.19 mg/m^2
arm group label: Vincristine sulfate liposome injection 2.22 mg/m^2
arm group label: Vincristine sulfate liposome injection 2.24 mg/m^2
other name: Marqibo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Adam J Olszewski, MD
role: Principal Investigator
affiliation: Rhode Island Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Waldenstrom Macroglobulinemia
mesh term: Lymphoma, Non-Hodgkin
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, Follicular
mesh term: Lymphoma, Mantle-Cell
mesh term: Lymphoma, B-Cell, Marginal Zone
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
mesh term: Rituximab
mesh term: Vincristine
mesh term: Bendamustine Hydrochloride
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 