<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/NCT01662102</url>
  </required_header>
  <id_info>
    <org_study_id>SPI-ZEV-12-302</org_study_id>
    <nct_id>NCT01662102</nct_id>
  </id_info>
  <brief_title>Rituximab or Zevalin - Efficacy Trial of Therapeutic Alternatives (RoZetta)</brief_title>
  <official_title>An Open-Label, Multicenter, Randomized Study in Previously Untreated Follicular Lymphoma Patients to Evaluate the Efficacy of Consolidation With Zevalin® Versus Maintenance Treatment With Rituximab After Initial Therapeutic Response to Rituximab Plus Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spectrum Pharmaceuticals, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Spectrum Pharmaceuticals, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of consolidation treatment Zevalin®&#xD;
      versus maintenance treatment with Rituxan® on progression-free survival (PFS) following&#xD;
      response induction with chemotherapy plus rituximab in previously untreated participants with&#xD;
      follicular lymphoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, multicenter and randomized study. Participants registered after&#xD;
      response induction (PR/CR) to R-chemotherapy. Participants achieving either a partial&#xD;
      response (PR) or complete response (CR) following R-chemotherapy eligible for randomization&#xD;
      to either consolidation with 90Y-ibritumumab tiuxetan followed by observation for 24 months,&#xD;
      or rituximab maintenance for 24 months. After the observation/maintenance period, patients&#xD;
      follow up for 5 years.&#xD;
&#xD;
      This study was terminated early for business reasons. (Maximum duration of study was up to&#xD;
      approximately 2.7 months).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor decision&#xD;
  </why_stopped>
  <start_date type="Actual">December 11, 2012</start_date>
  <completion_date type="Actual">March 5, 2013</completion_date>
  <primary_completion_date type="Actual">March 5, 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>Up to approximately 2.7 months</time_frame>
    <description>Progression-free survival (PFS) is defined as the time from randomization until progression, relapse, death from any cause, or introduction of a new anti-lymphoma treatment (chemotherapy, radiation therapy or immunotherapy).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complete Response Rate</measure>
    <time_frame>Up to approximately 2.7 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event Free Survival</measure>
    <time_frame>Up to approximately 2.7 months</time_frame>
    <description>EFS time is defined as the time from randomization to first documented progression, death from any cause, or introduction of a new anti-lymphoma treatment (chemotherapy, radiotherapy or immunotherapy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Progression (TTP)</measure>
    <time_frame>Up to approximately 2.7 months</time_frame>
    <description>TTP is defined as the time from randomization to the first disease progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Next Anti-Lymphoma Treatment (TTNLT)</measure>
    <time_frame>Up to approximately 2.7 months</time_frame>
    <description>TTNLT is defined as the time from randomization to the first introduction of any new anti lymphoma regimen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Next Chemotherapy (TTNCT)</measure>
    <time_frame>Up to approximately 2.7 months</time_frame>
    <description>TTNCT is defined as the time from randomization to the first introduction of any new chemotherapy (cytotoxic or radioimmunotherapy). The TTNCT may be the same as the TTNLT. Participants who respond to treatment and Participants who are lost to follow-up censored at the visit on which the dosing of a new medication was evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR)</measure>
    <time_frame>Up to approximately 2.7 months</time_frame>
    <description>Tumor response evaluated according to Cheson criteria at the time of randomization and at the end of the maintenance/observation, post randomization. ORR is defined as the percentage of Participants with a complete response (CR) or a partial response (PR), and compared between treatment groups. Participants with no response evaluation (for any reason) considered as not evaluable (NE).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to approximately 2.7 months</time_frame>
    <description>OS is defined as the time from randomization to death from any cause. In living patients, survival time was censored on the last date participants were known to be alive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transformation at First Progression</measure>
    <time_frame>Up to approximately 2.7 months</time_frame>
    <description>Transformation rate at first progression, defined as the appearance of diffuse areas of large lymphoma cells within a tumor site.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Toxicity</measure>
    <time_frame>Up to approximately 2.7 months</time_frame>
    <description>Toxicity graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Secondary Malignancies</measure>
    <time_frame>Up to approximately 2.7 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Assessment of Cancer - General (FACT-G)</measure>
    <time_frame>Up to approximately 2.7 months</time_frame>
    <description>The FACT-G is a participant rated, 27-item compilation of general questions divided into 4 primary Quality of Life (QOL) sub-scales: physical well-being (PWB; 7-items, score range 0-28), social/family well-being (SWB; 7-items, score range 0-28), emotional well-being (EWB; 6-items, score range 0-24), and functional well-being (FWB; 7-items, score range 0-28). This tool represents the generic core questionnaire that are utilized in combination with cancer site-specific questionnaires, (FBrain, in this study) Overall score and four subscale scores with ranges and distributions that are sample-specific can be calculated.FACT-G is scored by summing the individual scale scores; higher scores indicate better quality of life. FACT-G uses 5-point rating scale ranging from (0) = Not at all; (1) = A little bit; (2) = Somewhat; (3) = Quite a bit; to (4) = Very much.The FACT-G total score is the sum of the four subscale scores (if least 80% completed) and has a possible range of 0-108 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)</measure>
    <time_frame>Up to approximately 2.7 months</time_frame>
    <description>EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) &amp; other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health &amp; quality of life, coded on 7-point scale (1=very poor to 7=excellent).EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 &amp; 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. High score represented a favourable outcome with a best quality of life for participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacoeconomics (Cost Effectiveness Analysis)</measure>
    <time_frame>Up to approximately 2.7 months</time_frame>
    <description>A cost-effectiveness analysis done that compares the efficiency (cost/effectiveness unit) of consolidation treatment with 90Y-ibritumomab tiuxetan compared to maintenance treatment with rituximab. The analysis conducted according to a health economic analysis plan independent from this clinical study protocol.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Follicular Lymphoma</condition>
  <arm_group>
    <arm_group_label>Zevalin Regimen Consolidation (Group A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>90Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight &gt;80 kg: 1,184 MBq [32 mCi] maximum dose).&#xD;
The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rituximab Maintenance (Group B)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants were to receive 375 mg/m^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zevalin</intervention_name>
    <description>Zevalin administered intravenously.</description>
    <arm_group_label>Zevalin Regimen Consolidation (Group A)</arm_group_label>
    <other_name>90Y-ibritumomab tiuxetan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>Rituximab administered intravenously.</description>
    <arm_group_label>Rituximab Maintenance (Group B)</arm_group_label>
    <arm_group_label>Zevalin Regimen Consolidation (Group A)</arm_group_label>
    <other_name>Rituxan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 75 years of age.&#xD;
&#xD;
          -  Previously untreated with histologically confirmed grade 1, 2 or 3a cluster of&#xD;
             differentiation-20 (CD20)-positive follicular lymphoma, with any of the GELF (Groupe&#xD;
             d'Etude de Lymphomes Folliculaires) treatment criteria prior to induction.&#xD;
&#xD;
          -  Achieved a response to induction treatment with either rituximab-cyclophosphamide,&#xD;
             doxorubicin, vincristine, and prednisone (R-CHOP) (6 cycles of R-CHOP21 or R-CHOP14),&#xD;
             rituximab-cyclophosphamide, vincristine and prednisone (R-CVP) (6 cycles), or&#xD;
             rituximab-bendamustine (R-B) (4 to 6 cycles).&#xD;
&#xD;
          -  Must have completed all doses of the induction treatment, except for the modifications&#xD;
             allowed in the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Transformation to high grade lymphoma (secondary to &quot;low grade&quot; follicular lymphoma&#xD;
             [FL]).&#xD;
&#xD;
          -  Grade 3b follicular lymphoma.&#xD;
&#xD;
          -  Primary follicular lymphoma of the skin or gastrointestinal tract.&#xD;
&#xD;
          -  Previous treatment of follicular lymphoma.&#xD;
&#xD;
          -  Altered renal and hepatic function.&#xD;
&#xD;
          -  Known human immunodeficiency virus (HIV) infection and/or active hepatitis B virus&#xD;
             (HBV) and/or hepatitis C virus (HCV) infection&#xD;
&#xD;
          -  Serious co-morbid conditions (for example, ongoing infection, uncontrolled diabetes&#xD;
             mellitus, gastric ulcers, active autoimmune disease).&#xD;
&#xD;
          -  Life expectancy &lt; 6.&#xD;
&#xD;
          -  Must have:&#xD;
&#xD;
               -  Platelet count ≥ 100x10^9/L.&#xD;
&#xD;
               -  Bone marrow infiltration &lt;25%.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fernando Cabanillas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thomas Witzig, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Mayo Clinic &amp; Foundation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Steven E Finkelstein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>GenesisCare USA</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Leonard Klein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Illinois Cancer Specialists - US Oncology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Steven Jubelirer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>West Virginia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Petros Nikolinakos, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northeast Georgia Cancer Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>21st Century Oncology</name>
      <address>
        <city>Sun City</city>
        <state>Arizona</state>
        <zip>85351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Georgia Cancer Care</name>
      <address>
        <city>Athens</city>
        <state>Georgia</state>
        <zip>30607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois Cancer Specialists</name>
      <address>
        <city>Niles</city>
        <state>Illinois</state>
        <zip>60714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Park Nicollet Institute</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charleston Area Medical Center</name>
      <address>
        <city>Charleston</city>
        <state>West Virginia</state>
        <zip>25304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 3, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <results_first_submitted>October 16, 2015</results_first_submitted>
  <results_first_submitted_qc>December 4, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 11, 2016</results_first_posted>
  <last_update_submitted>September 6, 2021</last_update_submitted>
  <last_update_submitted_qc>September 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Follicular</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rituximab</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Zevalin Regimen Consolidation (Group A)</title>
          <description>90Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 megabecquerel/kilogram (MBq/kg) (0.4 millicurie/kg [mCi/kg] of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight &gt;80 kg: 1,184 MBq [32 mCi] maximum dose).&#xD;
The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 milligram/meter^2 [mg/m^2]); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)</description>
        </group>
        <group group_id="P2">
          <title>Rituximab Maintenance (Group B)</title>
          <description>Participants were to receive 375 mg/m^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Sponsor's decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>1 participant was enrolled in the Zevalin Regimen Consolidation (Group A) arm. Due to confidentiality considerations, baseline data is not being provided to protect participant privacy.</population>
      <group_list>
        <group group_id="B1">
          <title>Zevalin Regimen Consolidation (Group A)</title>
          <description>990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight &gt;80 kg: 1,184 MBq [32 mCi] maximum dose).&#xD;
The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)</description>
        </group>
        <group group_id="B2">
          <title>Rituximab Maintenance (Group B)</title>
          <description>Participants were to receive 375 mg/m^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="0"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="0"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                </category>
                <category>
                  <title>Male</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                </category>
                <category>
                  <title>Asian</title>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                </category>
                <category>
                  <title>Black or African American</title>
                </category>
                <category>
                  <title>White</title>
                </category>
                <category>
                  <title>More than one race</title>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression Free Survival</title>
        <description>Progression-free survival (PFS) is defined as the time from randomization until progression, relapse, death from any cause, or introduction of a new anti-lymphoma treatment (chemotherapy, radiation therapy or immunotherapy).</description>
        <time_frame>Up to approximately 2.7 months</time_frame>
        <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
        <group_list>
          <group group_id="O1">
            <title>Zevalin Regimen Consolidation (Group A)</title>
            <description>90Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight &gt;80 kg: 1,184 MBq [32 mCi] maximum dose).&#xD;
The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months).</description>
          </group>
          <group group_id="O2">
            <title>Rituximab Maintenance (Group B)</title>
            <description>Participants were to receive 375 mg/m^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival</title>
          <description>Progression-free survival (PFS) is defined as the time from randomization until progression, relapse, death from any cause, or introduction of a new anti-lymphoma treatment (chemotherapy, radiation therapy or immunotherapy).</description>
          <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complete Response Rate</title>
        <time_frame>Up to approximately 2.7 months</time_frame>
        <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
        <group_list>
          <group group_id="O1">
            <title>Zevalin Regimen Consolidation (Group A)</title>
            <description>990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight &gt;80 kg: 1,184 MBq [32 mCi] maximum dose).&#xD;
The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)</description>
          </group>
          <group group_id="O2">
            <title>Rituximab Maintenance (Group B)</title>
            <description>Participants were to receive 375 mg/m^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Response Rate</title>
          <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Event Free Survival</title>
        <description>EFS time is defined as the time from randomization to first documented progression, death from any cause, or introduction of a new anti-lymphoma treatment (chemotherapy, radiotherapy or immunotherapy).</description>
        <time_frame>Up to approximately 2.7 months</time_frame>
        <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
        <group_list>
          <group group_id="O1">
            <title>Zevalin Regimen Consolidation (Group A)</title>
            <description>990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight &gt;80 kg: 1,184 MBq [32 mCi] maximum dose).&#xD;
The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)</description>
          </group>
          <group group_id="O2">
            <title>Rituximab Maintenance (Group B)</title>
            <description>Participants were to receive 375 mg/m^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Event Free Survival</title>
          <description>EFS time is defined as the time from randomization to first documented progression, death from any cause, or introduction of a new anti-lymphoma treatment (chemotherapy, radiotherapy or immunotherapy).</description>
          <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Progression (TTP)</title>
        <description>TTP is defined as the time from randomization to the first disease progression.</description>
        <time_frame>Up to approximately 2.7 months</time_frame>
        <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
        <group_list>
          <group group_id="O1">
            <title>Zevalin Regimen Consolidation (Group A)</title>
            <description>990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight &gt;80 kg: 1,184 MBq [32 mCi] maximum dose).&#xD;
The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)</description>
          </group>
          <group group_id="O2">
            <title>Rituximab Maintenance (Group B)</title>
            <description>Participants were to receive 375 mg/m^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Progression (TTP)</title>
          <description>TTP is defined as the time from randomization to the first disease progression.</description>
          <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Next Anti-Lymphoma Treatment (TTNLT)</title>
        <description>TTNLT is defined as the time from randomization to the first introduction of any new anti lymphoma regimen.</description>
        <time_frame>Up to approximately 2.7 months</time_frame>
        <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
        <group_list>
          <group group_id="O1">
            <title>Zevalin Regimen Consolidation (Group A)</title>
            <description>990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight &gt;80 kg: 1,184 MBq [32 mCi] maximum dose).&#xD;
The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)</description>
          </group>
          <group group_id="O2">
            <title>Rituximab Maintenance (Group B)</title>
            <description>Participants were to receive 375 mg/m^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Next Anti-Lymphoma Treatment (TTNLT)</title>
          <description>TTNLT is defined as the time from randomization to the first introduction of any new anti lymphoma regimen.</description>
          <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Next Chemotherapy (TTNCT)</title>
        <description>TTNCT is defined as the time from randomization to the first introduction of any new chemotherapy (cytotoxic or radioimmunotherapy). The TTNCT may be the same as the TTNLT. Participants who respond to treatment and Participants who are lost to follow-up censored at the visit on which the dosing of a new medication was evaluated.</description>
        <time_frame>Up to approximately 2.7 months</time_frame>
        <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
        <group_list>
          <group group_id="O1">
            <title>Zevalin Regimen Consolidation (Group A)</title>
            <description>990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight &gt;80 kg: 1,184 MBq [32 mCi] maximum dose).&#xD;
The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)</description>
          </group>
          <group group_id="O2">
            <title>Rituximab Maintenance (Group B)</title>
            <description>Participants were to receive 375 mg/m^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Next Chemotherapy (TTNCT)</title>
          <description>TTNCT is defined as the time from randomization to the first introduction of any new chemotherapy (cytotoxic or radioimmunotherapy). The TTNCT may be the same as the TTNLT. Participants who respond to treatment and Participants who are lost to follow-up censored at the visit on which the dosing of a new medication was evaluated.</description>
          <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Response Rate (ORR)</title>
        <description>Tumor response evaluated according to Cheson criteria at the time of randomization and at the end of the maintenance/observation, post randomization. ORR is defined as the percentage of Participants with a complete response (CR) or a partial response (PR), and compared between treatment groups. Participants with no response evaluation (for any reason) considered as not evaluable (NE).</description>
        <time_frame>Up to approximately 2.7 months</time_frame>
        <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
        <group_list>
          <group group_id="O1">
            <title>Zevalin Regimen Consolidation (Group A)</title>
            <description>990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight &gt;80 kg: 1,184 MBq [32 mCi] maximum dose).&#xD;
The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)</description>
          </group>
          <group group_id="O2">
            <title>Rituximab Maintenance (Group B)</title>
            <description>Participants were to receive 375 mg/m^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate (ORR)</title>
          <description>Tumor response evaluated according to Cheson criteria at the time of randomization and at the end of the maintenance/observation, post randomization. ORR is defined as the percentage of Participants with a complete response (CR) or a partial response (PR), and compared between treatment groups. Participants with no response evaluation (for any reason) considered as not evaluable (NE).</description>
          <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>OS is defined as the time from randomization to death from any cause. In living patients, survival time was censored on the last date participants were known to be alive.</description>
        <time_frame>Up to approximately 2.7 months</time_frame>
        <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
        <group_list>
          <group group_id="O1">
            <title>Zevalin Regimen Consolidation (Group A)</title>
            <description>990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight &gt;80 kg: 1,184 MBq [32 mCi] maximum dose).&#xD;
The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)</description>
          </group>
          <group group_id="O2">
            <title>Rituximab Maintenance (Group B)</title>
            <description>Participants were to receive 375 mg/m^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>OS is defined as the time from randomization to death from any cause. In living patients, survival time was censored on the last date participants were known to be alive.</description>
          <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Transformation at First Progression</title>
        <description>Transformation rate at first progression, defined as the appearance of diffuse areas of large lymphoma cells within a tumor site.</description>
        <time_frame>Up to approximately 2.7 months</time_frame>
        <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
        <group_list>
          <group group_id="O1">
            <title>Zevalin Regimen Consolidation (Group A)</title>
            <description>990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight &gt;80 kg: 1,184 MBq [32 mCi] maximum dose).&#xD;
The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)</description>
          </group>
          <group group_id="O2">
            <title>Rituximab Maintenance (Group B)</title>
            <description>Participants were to receive 375 mg/m^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Transformation at First Progression</title>
          <description>Transformation rate at first progression, defined as the appearance of diffuse areas of large lymphoma cells within a tumor site.</description>
          <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Toxicity</title>
        <description>Toxicity graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0.</description>
        <time_frame>Up to approximately 2.7 months</time_frame>
        <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
        <group_list>
          <group group_id="O1">
            <title>Zevalin Regimen Consolidation (Group A)</title>
            <description>990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight &gt;80 kg: 1,184 MBq [32 mCi] maximum dose).&#xD;
The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)</description>
          </group>
          <group group_id="O2">
            <title>Rituximab Maintenance (Group B)</title>
            <description>Participants were to receive 375 mg/m^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Toxicity</title>
          <description>Toxicity graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0.</description>
          <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Secondary Malignancies</title>
        <time_frame>Up to approximately 2.7 months</time_frame>
        <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
        <group_list>
          <group group_id="O1">
            <title>Zevalin Regimen Consolidation (Group A)</title>
            <description>990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight &gt;80 kg: 1,184 MBq [32 mCi] maximum dose).&#xD;
The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)</description>
          </group>
          <group group_id="O2">
            <title>Rituximab Maintenance (Group B)</title>
            <description>Participants were to receive 375 mg/m^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Secondary Malignancies</title>
          <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Functional Assessment of Cancer - General (FACT-G)</title>
        <description>The FACT-G is a participant rated, 27-item compilation of general questions divided into 4 primary Quality of Life (QOL) sub-scales: physical well-being (PWB; 7-items, score range 0-28), social/family well-being (SWB; 7-items, score range 0-28), emotional well-being (EWB; 6-items, score range 0-24), and functional well-being (FWB; 7-items, score range 0-28). This tool represents the generic core questionnaire that are utilized in combination with cancer site-specific questionnaires, (FBrain, in this study) Overall score and four subscale scores with ranges and distributions that are sample-specific can be calculated.FACT-G is scored by summing the individual scale scores; higher scores indicate better quality of life. FACT-G uses 5-point rating scale ranging from (0) = Not at all; (1) = A little bit; (2) = Somewhat; (3) = Quite a bit; to (4) = Very much.The FACT-G total score is the sum of the four subscale scores (if least 80% completed) and has a possible range of 0-108 points.</description>
        <time_frame>Up to approximately 2.7 months</time_frame>
        <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
        <group_list>
          <group group_id="O1">
            <title>Zevalin Regimen Consolidation (Group A)</title>
            <description>990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight &gt;80 kg: 1,184 MBq [32 mCi] maximum dose).&#xD;
The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)</description>
          </group>
          <group group_id="O2">
            <title>Rituximab Maintenance (Group B)</title>
            <description>Participants were to receive 375 mg/m^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Functional Assessment of Cancer - General (FACT-G)</title>
          <description>The FACT-G is a participant rated, 27-item compilation of general questions divided into 4 primary Quality of Life (QOL) sub-scales: physical well-being (PWB; 7-items, score range 0-28), social/family well-being (SWB; 7-items, score range 0-28), emotional well-being (EWB; 6-items, score range 0-24), and functional well-being (FWB; 7-items, score range 0-28). This tool represents the generic core questionnaire that are utilized in combination with cancer site-specific questionnaires, (FBrain, in this study) Overall score and four subscale scores with ranges and distributions that are sample-specific can be calculated.FACT-G is scored by summing the individual scale scores; higher scores indicate better quality of life. FACT-G uses 5-point rating scale ranging from (0) = Not at all; (1) = A little bit; (2) = Somewhat; (3) = Quite a bit; to (4) = Very much.The FACT-G total score is the sum of the four subscale scores (if least 80% completed) and has a possible range of 0-108 points.</description>
          <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)</title>
        <description>EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) &amp; other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health &amp; quality of life, coded on 7-point scale (1=very poor to 7=excellent).EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 &amp; 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. High score represented a favourable outcome with a best quality of life for participant.</description>
        <time_frame>Up to approximately 2.7 months</time_frame>
        <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
        <group_list>
          <group group_id="O1">
            <title>Zevalin Regimen Consolidation (Group A)</title>
            <description>990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight &gt;80 kg: 1,184 MBq [32 mCi] maximum dose).&#xD;
The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)</description>
          </group>
          <group group_id="O2">
            <title>Rituximab Maintenance (Group B)</title>
            <description>Participants were to receive 375 mg/m^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).</description>
          </group>
        </group_list>
        <measure>
          <title>European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)</title>
          <description>EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) &amp; other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health &amp; quality of life, coded on 7-point scale (1=very poor to 7=excellent).EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 &amp; 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. High score represented a favourable outcome with a best quality of life for participant.</description>
          <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacoeconomics (Cost Effectiveness Analysis)</title>
        <description>A cost-effectiveness analysis done that compares the efficiency (cost/effectiveness unit) of consolidation treatment with 90Y-ibritumomab tiuxetan compared to maintenance treatment with rituximab. The analysis conducted according to a health economic analysis plan independent from this clinical study protocol.</description>
        <time_frame>Up to approximately 2.7 months</time_frame>
        <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
        <group_list>
          <group group_id="O1">
            <title>Zevalin Regimen Consolidation (Group A)</title>
            <description>990Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight &gt;80 kg: 1,184 MBq [32 mCi] maximum dose).&#xD;
The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months)</description>
          </group>
          <group group_id="O2">
            <title>Rituximab Maintenance (Group B)</title>
            <description>Participants were to receive 375 mg/m^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacoeconomics (Cost Effectiveness Analysis)</title>
          <description>A cost-effectiveness analysis done that compares the efficiency (cost/effectiveness unit) of consolidation treatment with 90Y-ibritumomab tiuxetan compared to maintenance treatment with rituximab. The analysis conducted according to a health economic analysis plan independent from this clinical study protocol.</description>
          <population>Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to approximately 2.7 months</time_frame>
      <desc>At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.</desc>
      <group_list>
        <group group_id="E1">
          <title>Zevalin Regimen Consolidation (Group A)</title>
          <description>90Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight &gt;80 kg: 1,184 MBq [32 mCi] maximum dose).&#xD;
The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months).</description>
        </group>
        <group group_id="E2">
          <title>Rituximab Maintenance (Group B)</title>
          <description>Participants were to receive 375 mg/m^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>Gajanan Bhat, PhD</name_or_title>
      <organization>Spectrum Pharmaceuticals</organization>
      <phone>949-743-9219</phone>
      <email>Gajanan.Bhat@sppirx.com</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/NCT01662102
org study id: SPI-ZEV-12-302
nct id: NCT01662102
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the effect of consolidation treatment Zevalin®
      versus maintenance treatment with Rituxan® on progression-free survival (PFS) following
      response induction with chemotherapy plus rituximab in previously untreated participants with
      follicular lymphoma.
This is an open-label, multicenter and randomized study. Participants registered after
      response induction (PR/CR) to R-chemotherapy. Participants achieving either a partial
      response (PR) or complete response (CR) following R-chemotherapy eligible for randomization
      to either consolidation with 90Y-ibritumumab tiuxetan followed by observation for 24 months,
      or rituximab maintenance for 24 months. After the observation/maintenance period, patients
      follow up for 5 years.

      This study was terminated early for business reasons. (Maximum duration of study was up to
      approximately 2.7 months).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival
time frame: Up to approximately 2.7 months
description: Progression-free survival (PFS) is defined as the time from randomization until progression, relapse, death from any cause, or introduction of a new anti-lymphoma treatment (chemotherapy, radiation therapy or immunotherapy).
measure: Complete Response Rate
time frame: Up to approximately 2.7 months
measure: Event Free Survival
time frame: Up to approximately 2.7 months
description: EFS time is defined as the time from randomization to first documented progression, death from any cause, or introduction of a new anti-lymphoma treatment (chemotherapy, radiotherapy or immunotherapy).
measure: Time to Progression (TTP)
time frame: Up to approximately 2.7 months
description: TTP is defined as the time from randomization to the first disease progression.
measure: Time to Next Anti-Lymphoma Treatment (TTNLT)
time frame: Up to approximately 2.7 months
description: TTNLT is defined as the time from randomization to the first introduction of any new anti lymphoma regimen.
measure: Time to Next Chemotherapy (TTNCT)
time frame: Up to approximately 2.7 months
description: TTNCT is defined as the time from randomization to the first introduction of any new chemotherapy (cytotoxic or radioimmunotherapy). The TTNCT may be the same as the TTNLT. Participants who respond to treatment and Participants who are lost to follow-up censored at the visit on which the dosing of a new medication was evaluated.
measure: Overall Response Rate (ORR)
time frame: Up to approximately 2.7 months
description: Tumor response evaluated according to Cheson criteria at the time of randomization and at the end of the maintenance/observation, post randomization. ORR is defined as the percentage of Participants with a complete response (CR) or a partial response (PR), and compared between treatment groups. Participants with no response evaluation (for any reason) considered as not evaluable (NE).
measure: Overall Survival (OS)
time frame: Up to approximately 2.7 months
description: OS is defined as the time from randomization to death from any cause. In living patients, survival time was censored on the last date participants were known to be alive.
measure: Transformation at First Progression
time frame: Up to approximately 2.7 months
description: Transformation rate at first progression, defined as the appearance of diffuse areas of large lymphoma cells within a tumor site.
measure: Number of Participants With Toxicity
time frame: Up to approximately 2.7 months
description: Toxicity graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0.
measure: Number of Participants With Secondary Malignancies
time frame: Up to approximately 2.7 months
measure: Functional Assessment of Cancer - General (FACT-G)
time frame: Up to approximately 2.7 months
description: The FACT-G is a participant rated, 27-item compilation of general questions divided into 4 primary Quality of Life (QOL) sub-scales: physical well-being (PWB; 7-items, score range 0-28), social/family well-being (SWB; 7-items, score range 0-28), emotional well-being (EWB; 6-items, score range 0-24), and functional well-being (FWB; 7-items, score range 0-28). This tool represents the generic core questionnaire that are utilized in combination with cancer site-specific questionnaires, (FBrain, in this study) Overall score and four subscale scores with ranges and distributions that are sample-specific can be calculated.FACT-G is scored by summing the individual scale scores; higher scores indicate better quality of life. FACT-G uses 5-point rating scale ranging from (0) = Not at all; (1) = A little bit; (2) = Somewhat; (3) = Quite a bit; to (4) = Very much.The FACT-G total score is the sum of the four subscale scores (if least 80% completed) and has a possible range of 0-108 points.
measure: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
time frame: Up to approximately 2.7 months
description: EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) & other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health & quality of life, coded on 7-point scale (1=very poor to 7=excellent).EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 & 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. High score represented a favourable outcome with a best quality of life for participant.
measure: Pharmacoeconomics (Cost Effectiveness Analysis)
time frame: Up to approximately 2.7 months
description: A cost-effectiveness analysis done that compares the efficiency (cost/effectiveness unit) of consolidation treatment with 90Y-ibritumomab tiuxetan compared to maintenance treatment with rituximab. The analysis conducted according to a health economic analysis plan independent from this clinical study protocol.
arm group label: Zevalin Regimen Consolidation (Group A)
arm group type: Experimental
description: 90Y-Ibritumomab tiuxetan administered 8 to 12 weeks after the last chemotherapy infusion. Each participant randomized to this treatment group was to receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Participants with a pre-treatment platelet count between 100 and 149 x10^9/L were to receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan. (Body weight ≤80 kg: 14.8 MBq [0.4 mCi] yttrium-90/kg and Body weight >80 kg: 1,184 MBq [32 mCi] maximum dose).
The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion. (Maximum duration of study was up to approximately 2.7 months).
arm group label: Rituximab Maintenance (Group B)
arm group type: Active Comparator
description: Participants were to receive 375 mg/m^2 of rituximab, administered by intravenous (I.V.) infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle. (Maximum duration of study was up to approximately 2.7 months).
intervention type: Drug
intervention name: Zevalin
description: Zevalin administered intravenously.
arm group label: Zevalin Regimen Consolidation (Group A)
other name: 90Y-ibritumomab tiuxetan
intervention type: Drug
intervention name: Rituximab
description: Rituximab administered intravenously.
arm group label: Rituximab Maintenance (Group B)
arm group label: Zevalin Regimen Consolidation (Group A)
other name: Rituxan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Fernando Cabanillas, MD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
last name: Thomas Witzig, MD
role: Principal Investigator
affiliation: The Mayo Clinic & Foundation
last name: Steven E Finkelstein, MD
role: Principal Investigator
affiliation: GenesisCare USA
last name: Leonard Klein, MD
role: Principal Investigator
affiliation: Illinois Cancer Specialists - US Oncology
last name: Steven Jubelirer, MD
role: Principal Investigator
affiliation: West Virginia University
last name: Petros Nikolinakos, MD
role: Principal Investigator
affiliation: Northeast Georgia Cancer Care
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Follicular
mesh term: Rituximab
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 