<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/NCT02260804</url>
  </required_header>
  <id_info>
    <org_study_id>CT-P10 3.4</org_study_id>
    <nct_id>NCT02260804</nct_id>
  </id_info>
  <brief_title>To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma</brief_title>
  <official_title>A Phase 3, Randomised, Parallel-group, Active-controlled, Double-blind Study to Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Celltrion</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Celltrion</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by&#xD;
      overall response rate at 7 months&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 9, 2015</start_date>
  <completion_date type="Actual">September 4, 2019</completion_date>
  <primary_completion_date type="Actual">January 4, 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Efficacy Endpoint - Overall Response Rate by 7 Months</measure>
    <time_frame>During the Month 7 (up to Maintenance Cycle 3; Week 28)</time_frame>
    <description>ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed CR (CRu), or partial response (PR) by central review.&#xD;
Per 1999 IWG criteria, the disease status was assessed by using contrasted CT and/or MRI, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: &gt;75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: ≥50% decrease in SPD of target lesions and no evidence of disease progression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Endpoint - ORR Over the Study Period</measure>
    <time_frame>up to 27 months</time_frame>
    <description>ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed CR (CRu), or partial response (PR).&#xD;
Per 1999 IWG criteria, the disease status was assessed by using contrasted CT and/or MRI, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: &gt;75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: ≥50% decrease in SPD of target lesions and no evidence of disease progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary PD Endpoint - B-cell Kinetics (B-cell Depletion and Recovery)</measure>
    <time_frame>Baseline, Induction Cycle 1 (predose, 1 hr postdose), Induction Cycle 2 to 4 (predose), EOT1/EOT2 (anytime), Maintenance Cycle 1 to 2 (predose, 1hr postdose) and Maintenance Cycle 3 (predose).</time_frame>
    <description>B-cell kinetics were demonstrated by median values of B-cell counts. Any values below the LLoQ were set as LLoQ which was 20 cells/μL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary PK Endpoints - Cmax</measure>
    <time_frame>1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary PK Endpoints - Ctrough</measure>
    <time_frame>1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Endpoint - Progression-free Survival (PFS)</measure>
    <time_frame>Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).</time_frame>
    <description>PFS was defined as the interval between randomization and disease progression/relapse by IWG 1999 (at least a 50% increase of any single nodal after smallest decrease) or death from any cause, whichever occurred first. Locally reviewed data was used for the secondary efficacy analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Endpoint - Overall Survival (OS)</measure>
    <time_frame>Overall study period (median follow-up of 29.2 months)</time_frame>
    <description>Overall survival was defined as the interval between randomization and death from any cause. Locally reviewed data was used for the secondary efficacy analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Endpoint - Time-to Progression (TTP)</measure>
    <time_frame>Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).</time_frame>
    <description>Time to progression was defined as the interval between randomization and disease progression/relapse by IWG 1999 (at least a 50% increase of any single nodal after smallest decrease) or death as a result of lymphoma, whichever occurred first. Locally reviewed data was used for the secondary efficacy analyses.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">258</enrollment>
  <condition>Follicular Lymphoma</condition>
  <arm_group>
    <arm_group_label>CT-P10</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CT-P10, intervention 375mg/m2, intravenous, 4 cycles in induction period and additional 12 cycles in maintenance period</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rituxan</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rituxan, 375mg/m2 intravenous, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CT-P10</intervention_name>
    <description>375mg/m2, IV on day1 of 4 cycles in induction period, and 12 cycles in maintenance period.</description>
    <arm_group_label>CT-P10</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Rituxan</intervention_name>
    <description>375mg/m2, IV on day1 of 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.</description>
    <arm_group_label>Rituxan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed diagnosis of low tumour burden, CD20+ follicular lymphoma&#xD;
&#xD;
          -  Ann Arbor Stage II, III or IV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has receive rituximab&#xD;
&#xD;
          -  Allergies or hypersensitivity to murine, chimeric, human or humanised proteins&#xD;
&#xD;
          -  Previous treatment for NHL&#xD;
&#xD;
          -  Any malignancy&#xD;
&#xD;
          -  Current or recent treatment with any other investigational medicinal product or device&#xD;
&#xD;
          -  pregnant or lactating&#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>SungHyun Kim</last_name>
    <role>Study Director</role>
    <affiliation>Celltrion</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <link>
    <url>http://www.celltrion.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>October 5, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <results_first_submitted>January 21, 2021</results_first_submitted>
  <results_first_submitted_qc>March 16, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 8, 2021</results_first_posted>
  <last_update_submitted>March 16, 2021</last_update_submitted>
  <last_update_submitted_qc>March 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 28, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT02260804/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 17, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT02260804/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 402 participants were screened for the study. Of those, 144 participants failed screening and 258 participants were enrolled in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>CT-P10</title>
          <description>CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period</description>
        </group>
        <group group_id="P2">
          <title>Rituxan</title>
          <description>Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Induction Study Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="130"/>
                <participants group_id="P2" count="128"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="128"/>
                <participants group_id="P2" count="128"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>1st Year of the Maintenance Period (MP1)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="123">Five subjects completed the induction period but did not initiate this period in the CT-P10 group.</participants>
                <participants group_id="P2" count="120">Eight subjects completed the induction period but did not initiate this period in the Rituxan group.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="111"/>
                <participants group_id="P2" count="105"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>2nd Year of the Maintenance Period (MP2)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="110">One subject completed the MP1 but did not initiate this period in the CT-P10 group.</participants>
                <participants group_id="P2" count="103">Two subjects completed the MP1 but did not initiate this period in the Rituxan group.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
                <participants group_id="P2" count="97"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CT-P10</title>
          <description>CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period</description>
        </group>
        <group group_id="B2">
          <title>Rituxan</title>
          <description>Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.</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="130"/>
            <count group_id="B2" value="128"/>
            <count group_id="B3" value="258"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.7" spread="12.68"/>
                    <measurement group_id="B2" value="57.7" spread="11.53"/>
                    <measurement group_id="B3" value="57.7" spread="12.10"/>
                  </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="64"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="135"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="123"/>
                  </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="12"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="110"/>
                    <measurement group_id="B2" value="116"/>
                    <measurement group_id="B3" value="226"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Primary Efficacy Endpoint - Overall Response Rate by 7 Months</title>
        <description>ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed CR (CRu), or partial response (PR) by central review.&#xD;
Per 1999 IWG criteria, the disease status was assessed by using contrasted CT and/or MRI, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: &gt;75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: ≥50% decrease in SPD of target lesions and no evidence of disease progression.</description>
        <time_frame>During the Month 7 (up to Maintenance Cycle 3; Week 28)</time_frame>
        <population>The ITT population consisted of all patients enrolled and randomly assigned to receive a study drug, regardless of whether or not any study drug dosing was completed.</population>
        <group_list>
          <group group_id="O1">
            <title>CT-P10</title>
            <description>CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period</description>
          </group>
          <group group_id="O2">
            <title>Rituxan</title>
            <description>Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Efficacy Endpoint - Overall Response Rate by 7 Months</title>
          <description>ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed CR (CRu), or partial response (PR) by central review.&#xD;
Per 1999 IWG criteria, the disease status was assessed by using contrasted CT and/or MRI, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: &gt;75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: ≥50% decrease in SPD of target lesions and no evidence of disease progression.</description>
          <population>The ITT population consisted of all patients enrolled and randomly assigned to receive a study drug, regardless of whether or not any study drug dosing was completed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
                <count group_id="O2" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108"/>
                    <measurement group_id="O2" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>The equivalence margin of ±17% was predefined.</non_inferiority_desc>
            <param_type>Difference in proportion</param_type>
            <param_value>1.8</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.43</ci_lower_limit>
            <ci_upper_limit>10.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Efficacy Endpoint - ORR Over the Study Period</title>
        <description>ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed CR (CRu), or partial response (PR).&#xD;
Per 1999 IWG criteria, the disease status was assessed by using contrasted CT and/or MRI, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: &gt;75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: ≥50% decrease in SPD of target lesions and no evidence of disease progression.</description>
        <time_frame>up to 27 months</time_frame>
        <population>The ITT population consisted of all patients enrolled and randomly assigned to receive a study drug, regardless of whether or not any study drug dosing was completed.</population>
        <group_list>
          <group group_id="O1">
            <title>CT-P10</title>
            <description>CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period</description>
          </group>
          <group group_id="O2">
            <title>Rituxan</title>
            <description>Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Efficacy Endpoint - ORR Over the Study Period</title>
          <description>ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed CR (CRu), or partial response (PR).&#xD;
Per 1999 IWG criteria, the disease status was assessed by using contrasted CT and/or MRI, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: &gt;75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: ≥50% decrease in SPD of target lesions and no evidence of disease progression.</description>
          <population>The ITT population consisted of all patients enrolled and randomly assigned to receive a study drug, regardless of whether or not any study drug dosing was completed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
                <count group_id="O2" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109"/>
                    <measurement group_id="O2" value="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary PD Endpoint - B-cell Kinetics (B-cell Depletion and Recovery)</title>
        <description>B-cell kinetics were demonstrated by median values of B-cell counts. Any values below the LLoQ were set as LLoQ which was 20 cells/μL.</description>
        <time_frame>Baseline, Induction Cycle 1 (predose, 1 hr postdose), Induction Cycle 2 to 4 (predose), EOT1/EOT2 (anytime), Maintenance Cycle 1 to 2 (predose, 1hr postdose) and Maintenance Cycle 3 (predose).</time_frame>
        <population>The PD population consisted of all patients who received at least 1 dose (full) of study drug and had at least 1 posttreatment PD result.</population>
        <group_list>
          <group group_id="O1">
            <title>CT-P10</title>
            <description>CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period</description>
          </group>
          <group group_id="O2">
            <title>Rituxan</title>
            <description>Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary PD Endpoint - B-cell Kinetics (B-cell Depletion and Recovery)</title>
          <description>B-cell kinetics were demonstrated by median values of B-cell counts. Any values below the LLoQ were set as LLoQ which was 20 cells/μL.</description>
          <population>The PD population consisted of all patients who received at least 1 dose (full) of study drug and had at least 1 posttreatment PD result.</population>
          <units>cells/uL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="128"/>
                <count group_id="O2" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.0" lower_limit="56.0" upper_limit="171.5"/>
                    <measurement group_id="O2" value="120.0" lower_limit="64.0" upper_limit="182.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induction Cycle 1 (1hr after end of infusion)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                    <count group_id="O2" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                    <measurement group_id="O2" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induction Cycle 2 (predose)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="122"/>
                    <count group_id="O2" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                    <measurement group_id="O2" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induction Cycle 3 (predose)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="122"/>
                    <count group_id="O2" value="124"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                    <measurement group_id="O2" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induction Cycle 4 (predose)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="121"/>
                    <count group_id="O2" value="122"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                    <measurement group_id="O2" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EOT1 (anytime)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                    <measurement group_id="O2" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maintenance Cycle 1 (predose)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="113"/>
                    <count group_id="O2" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                    <measurement group_id="O2" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maintenance Cycle 1 (1hr after end of infusion)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="108"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                    <measurement group_id="O2" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maintenance Cycle 2 (predose)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                    <measurement group_id="O2" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maintenance Cycle 2 (1hr after end of infusion)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="108"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                    <measurement group_id="O2" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maintenance Cycle 3 (predose)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="109"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                    <measurement group_id="O2" value="20.0" lower_limit="20.0" upper_limit="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary PK Endpoints - Cmax</title>
        <time_frame>1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose)</time_frame>
        <population>The PK population consisted of all patients who received at least 1 dose (full) of study drug and had at least 1 posttreatment PK result.</population>
        <group_list>
          <group group_id="O1">
            <title>CT-P10</title>
            <description>CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period</description>
          </group>
          <group group_id="O2">
            <title>Rituxan</title>
            <description>Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary PK Endpoints - Cmax</title>
          <population>The PK population consisted of all patients who received at least 1 dose (full) of study drug and had at least 1 posttreatment PK result.</population>
          <units>μg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="128"/>
                <count group_id="O2" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Induction Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="212.86" spread="50.64"/>
                    <measurement group_id="O2" value="217.38" spread="56.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induction Cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="283.35" spread="53.84"/>
                    <measurement group_id="O2" value="285.98" spread="62.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induction Cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="125"/>
                    <count group_id="O2" value="126"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="327.32" spread="71.05"/>
                    <measurement group_id="O2" value="341.59" spread="77.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induction Cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="125"/>
                    <count group_id="O2" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="373.46" spread="70.50"/>
                    <measurement group_id="O2" value="383.05" spread="83.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maintenance Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="256.97" spread="65.61"/>
                    <measurement group_id="O2" value="265.03" spread="53.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maintenance Cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="119"/>
                    <count group_id="O2" value="116"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="239.70" spread="65.72"/>
                    <measurement group_id="O2" value="249.86" spread="69.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary PK Endpoints - Ctrough</title>
        <time_frame>1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose)</time_frame>
        <population>The PK population consisted of all patients who received at least 1 dose (full) of study drug and had at least 1 posttreatment PK result.</population>
        <group_list>
          <group group_id="O1">
            <title>CT-P10</title>
            <description>CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period</description>
          </group>
          <group group_id="O2">
            <title>Rituxan</title>
            <description>Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary PK Endpoints - Ctrough</title>
          <population>The PK population consisted of all patients who received at least 1 dose (full) of study drug and had at least 1 posttreatment PK result.</population>
          <units>μg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="128"/>
                <count group_id="O2" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Induction Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="126"/>
                    <count group_id="O2" value="127"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.66" spread="24.88"/>
                    <measurement group_id="O2" value="72.94" spread="40.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induction Cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="126"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113.23" spread="34.60"/>
                    <measurement group_id="O2" value="120.92" spread="36.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induction Cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="125"/>
                    <count group_id="O2" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="149.53" spread="43.65"/>
                    <measurement group_id="O2" value="161.80" spread="43.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induction Cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="122"/>
                    <count group_id="O2" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.78" spread="33.58"/>
                    <measurement group_id="O2" value="31.38" spread="19.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maintenance Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.68" spread="37.22"/>
                    <measurement group_id="O2" value="21.35" spread="20.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maintenance Cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="118"/>
                    <count group_id="O2" value="110"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.96" spread="9.61"/>
                    <measurement group_id="O2" value="18.37" spread="10.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Efficacy Endpoint - Progression-free Survival (PFS)</title>
        <description>PFS was defined as the interval between randomization and disease progression/relapse by IWG 1999 (at least a 50% increase of any single nodal after smallest decrease) or death from any cause, whichever occurred first. Locally reviewed data was used for the secondary efficacy analyses.</description>
        <time_frame>Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).</time_frame>
        <population>The ITT population consisted of all patients enrolled and randomly assigned to receive a study drug, regardless of whether or not any study drug dosing was completed.</population>
        <group_list>
          <group group_id="O1">
            <title>CT-P10</title>
            <description>CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period</description>
          </group>
          <group group_id="O2">
            <title>Rituxan</title>
            <description>Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Efficacy Endpoint - Progression-free Survival (PFS)</title>
          <description>PFS was defined as the interval between randomization and disease progression/relapse by IWG 1999 (at least a 50% increase of any single nodal after smallest decrease) or death from any cause, whichever occurred first. Locally reviewed data was used for the secondary efficacy analyses.</description>
          <population>The ITT population consisted of all patients enrolled and randomly assigned to receive a study drug, regardless of whether or not any study drug dosing was completed.</population>
          <units>Proportion of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
                <count group_id="O2" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.93" lower_limit="0.87" upper_limit="0.96"/>
                    <measurement group_id="O2" value="0.89" lower_limit="0.82" upper_limit="0.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.88" lower_limit="0.81" upper_limit="0.92"/>
                    <measurement group_id="O2" value="0.83" lower_limit="0.75" upper_limit="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.80" lower_limit="0.70" upper_limit="0.87"/>
                    <measurement group_id="O2" value="0.68" lower_limit="0.54" upper_limit="0.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Efficacy Endpoint - Overall Survival (OS)</title>
        <description>Overall survival was defined as the interval between randomization and death from any cause. Locally reviewed data was used for the secondary efficacy analyses.</description>
        <time_frame>Overall study period (median follow-up of 29.2 months)</time_frame>
        <population>The ITT population consisted of all patients enrolled and randomly assigned to receive a study drug, regardless of whether or not any study drug dosing was completed.</population>
        <group_list>
          <group group_id="O1">
            <title>CT-P10</title>
            <description>CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period</description>
          </group>
          <group group_id="O2">
            <title>Rituxan</title>
            <description>Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Efficacy Endpoint - Overall Survival (OS)</title>
          <description>Overall survival was defined as the interval between randomization and death from any cause. Locally reviewed data was used for the secondary efficacy analyses.</description>
          <population>The ITT population consisted of all patients enrolled and randomly assigned to receive a study drug, regardless of whether or not any study drug dosing was completed.</population>
          <units>Proportion of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
                <count group_id="O2" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" lower_limit="0.93" upper_limit="0.99"/>
                    <measurement group_id="O2" value="0.98" lower_limit="0.94" upper_limit="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" lower_limit="0.93" upper_limit="0.99"/>
                    <measurement group_id="O2" value="0.98" lower_limit="0.94" upper_limit="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" lower_limit="0.93" upper_limit="0.99"/>
                    <measurement group_id="O2" value="0.97" lower_limit="0.89" upper_limit="0.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>42 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.98" lower_limit="0.93" upper_limit="0.99"/>
                    <measurement group_id="O2" value="0.97" lower_limit="0.89" upper_limit="0.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Efficacy Endpoint - Time-to Progression (TTP)</title>
        <description>Time to progression was defined as the interval between randomization and disease progression/relapse by IWG 1999 (at least a 50% increase of any single nodal after smallest decrease) or death as a result of lymphoma, whichever occurred first. Locally reviewed data was used for the secondary efficacy analyses.</description>
        <time_frame>Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).</time_frame>
        <population>The ITT population consisted of all patients enrolled and randomly assigned to receive a study drug, regardless of whether or not any study drug dosing was completed.</population>
        <group_list>
          <group group_id="O1">
            <title>CT-P10</title>
            <description>CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period</description>
          </group>
          <group group_id="O2">
            <title>Rituxan</title>
            <description>Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Efficacy Endpoint - Time-to Progression (TTP)</title>
          <description>Time to progression was defined as the interval between randomization and disease progression/relapse by IWG 1999 (at least a 50% increase of any single nodal after smallest decrease) or death as a result of lymphoma, whichever occurred first. Locally reviewed data was used for the secondary efficacy analyses.</description>
          <population>The ITT population consisted of all patients enrolled and randomly assigned to receive a study drug, regardless of whether or not any study drug dosing was completed.</population>
          <units>Proportion of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
                <count group_id="O2" value="128"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.94" lower_limit="0.88" upper_limit="0.97"/>
                    <measurement group_id="O2" value="0.89" lower_limit="0.83" upper_limit="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.89" lower_limit="0.82" upper_limit="0.94"/>
                    <measurement group_id="O2" value="0.84" lower_limit="0.76" upper_limit="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.82" lower_limit="0.72" upper_limit="0.88"/>
                    <measurement group_id="O2" value="0.68" lower_limit="0.54" upper_limit="0.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from the last dose of the study drug, regardless of the relationship to the study drug. data from the overall study period (median follow-up of 29.2 months) are presented.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>CT-P10</title>
          <description>CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period</description>
        </group>
        <group group_id="E2">
          <title>Rituxan</title>
          <description>Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperparathyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Crohn's disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Intestinal polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Peptic ulcer perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Nasal neoplasm benign</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of lung</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Genital prolapse</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal surgery</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 18.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="93" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="86" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Herpes virus infection</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="128"/>
              </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="42" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="39" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="130"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="128"/>
              </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>A confidentiality and non-disclosure agreement (CDA) was executed between Celltrion, Inc. and some PIs who have participated in publications funded by the sponsor for academic purposes for a period that is more than 180 days from the time submitted to the sponsor for review.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>In this study, TTE endpoints were secondary endpoints and were not powered. As medians of PFS, TTP, and OS were not reached in both treatment groups, longer follow-up is needed to ascertain the median time for TTE parameters of PFS, TTP, and OS.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Sung Hyun Kim</name_or_title>
      <organization>CELLTRION, Inc.</organization>
      <phone>+82-32-850-5000</phone>
      <email>contact@celltrion.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/NCT02260804
org study id: CT-P10 3.4
nct id: NCT02260804
lead sponsor: 
has dmc: Yes
To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by
      overall response rate at 7 months
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Primary Efficacy Endpoint - Overall Response Rate by 7 Months
time frame: During the Month 7 (up to Maintenance Cycle 3; Week 28)
description: ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed CR (CRu), or partial response (PR) by central review.
Per 1999 IWG criteria, the disease status was assessed by using contrasted CT and/or MRI, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: >75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: ≥50% decrease in SPD of target lesions and no evidence of disease progression.
measure: Secondary Efficacy Endpoint - ORR Over the Study Period
time frame: up to 27 months
description: ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed CR (CRu), or partial response (PR).
Per 1999 IWG criteria, the disease status was assessed by using contrasted CT and/or MRI, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: >75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: ≥50% decrease in SPD of target lesions and no evidence of disease progression.
measure: Secondary PD Endpoint - B-cell Kinetics (B-cell Depletion and Recovery)
time frame: Baseline, Induction Cycle 1 (predose, 1 hr postdose), Induction Cycle 2 to 4 (predose), EOT1/EOT2 (anytime), Maintenance Cycle 1 to 2 (predose, 1hr postdose) and Maintenance Cycle 3 (predose).
description: B-cell kinetics were demonstrated by median values of B-cell counts. Any values below the LLoQ were set as LLoQ which was 20 cells/μL.
measure: Secondary PK Endpoints - Cmax
time frame: 1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose)
measure: Secondary PK Endpoints - Ctrough
time frame: 1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose)
measure: Secondary Efficacy Endpoint - Progression-free Survival (PFS)
time frame: Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).
description: PFS was defined as the interval between randomization and disease progression/relapse by IWG 1999 (at least a 50% increase of any single nodal after smallest decrease) or death from any cause, whichever occurred first. Locally reviewed data was used for the secondary efficacy analyses.
measure: Secondary Efficacy Endpoint - Overall Survival (OS)
time frame: Overall study period (median follow-up of 29.2 months)
description: Overall survival was defined as the interval between randomization and death from any cause. Locally reviewed data was used for the secondary efficacy analyses.
measure: Secondary Efficacy Endpoint - Time-to Progression (TTP)
time frame: Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).
description: Time to progression was defined as the interval between randomization and disease progression/relapse by IWG 1999 (at least a 50% increase of any single nodal after smallest decrease) or death as a result of lymphoma, whichever occurred first. Locally reviewed data was used for the secondary efficacy analyses.
arm group label: CT-P10
arm group type: Experimental
description: CT-P10, intervention 375mg/m2, intravenous, 4 cycles in induction period and additional 12 cycles in maintenance period
arm group label: Rituxan
arm group type: Active Comparator
description: Rituxan, 375mg/m2 intravenous, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.
intervention type: Biological
intervention name: CT-P10
description: 375mg/m2, IV on day1 of 4 cycles in induction period, and 12 cycles in maintenance period.
arm group label: CT-P10
intervention type: Biological
intervention name: Rituxan
description: 375mg/m2, IV on day1 of 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.
arm group label: Rituxan
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: SungHyun Kim
role: Study Director
affiliation: Celltrion
facility: 
country: Korea, Republic of
url: http://www.celltrion.com
description: Related Info
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Follicular
mesh term: Rituximab
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: In this study, TTE endpoints were secondary endpoints and were not powered. As medians of PFS, TTP, and OS were not reached in both treatment groups, longer follow-up is needed to ascertain the median time for TTE parameters of PFS, TTP, and OS.
point of contact: 