<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/NCT04491721</url>
  </required_header>
  <id_info>
    <org_study_id>NCC2288</org_study_id>
    <nct_id>NCT04491721</nct_id>
  </id_info>
  <brief_title>Follow-up the OS and PFS of Rituximab Biosimilar HLX01 and MabThera, in Untreated Subjects With CD20+ DLBCL</brief_title>
  <official_title>Long-term Follow-up the OS and PFS of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in Previously Untreated Subjects With CD20+ DLBCL</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this study is to observe the overall survival of Rituximab Biosimilar&#xD;
      HLX01 and MabThera in Combination With CHOP, in previously untreated subjects with CD20+&#xD;
      DLBCL. The secondary objective of this study is to observe the progression-free survival of&#xD;
      Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in previously untreated&#xD;
      subjects with CD20+ DLBCL.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Enrollment:407 subjects.&#xD;
&#xD;
        2. The inclusion criteria of this study: subjects who have participated in Phase III&#xD;
           clinical trials.Phase III clinical trial（NCT02787239） has ended.&#xD;
&#xD;
        3. The exclusion criteria: ①Subjects died; ②Subjects are unwilling to participate in&#xD;
           follow-up study; ③ the investigator judges that the subject is not suitable for&#xD;
           participating the study.&#xD;
&#xD;
        4. Duration and method of follow-up: 2-10 years (2020-2027)after the end of the Phase III&#xD;
           trial and follow up the subjects by the phone.&#xD;
&#xD;
        5. Statistical analysis method: For progression-free survival and overall survival (OS),&#xD;
           the median time and its 95% confidence intervals will be calculated by the Kaplan-Meier&#xD;
           method.The Log-Rank test will be used for finding the difference between groups. The&#xD;
           efficacy will be analyzed by SAS9.4 , and all hypothesis tests are two-sided. The&#xD;
           confidence level of all confidence intervals is 95%. P value less than 0.05 was regarded&#xD;
           as statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">July 2027</completion_date>
  <primary_completion_date type="Anticipated">June 2027</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>overall survival</measure>
    <time_frame>up to 8 years</time_frame>
    <description>The main objective of this study is to observe the overall survival of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in previously untreated subjects with CD20+ DLBCL.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>progression-free survival</measure>
    <time_frame>up to 8 years</time_frame>
    <description>The secondary objective of this study is to observe the progression-free survival of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in previously untreated subjects with CD20+ DLBCL.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">407</enrollment>
  <condition>Diffuse Large B Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>Rituximab Biosimilar HLX01 in Combination With CHOP</arm_group_label>
    <description>Rituximab Biosimilar HLX01 in Combination With CHOP,in Previously Untreated Subjects With CD20+ DLBCL.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MabThera in Combination With CHOP</arm_group_label>
    <description>MabThera in Combination With CHOP，in Previously Untreated Subjects With CD20+ DLBCL.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects who have participated in Phase III study. Phase III study（NCT02787239）was&#xD;
        rituximab biosimilar HLX01 and MabThera in patients with diffuse large B-cell lymphoma.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who have participated in Phase III study（NCT02787239）.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ①Subjects died; ②Subjects are unwilling to participate in follow-up study; ③ the&#xD;
             investigator judges that the subject is not suitable for participating the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuankai Shi, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cancer Institute/Hospital, Chinese Academy of Medical Sciences &amp; Peking Union Medical College</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 25, 2020</last_update_submitted>
  <last_update_submitted_qc>July 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Shi Yuankai</investigator_full_name>
    <investigator_title>chief physician</investigator_title>
  </responsible_party>
  <keyword>rituximab</keyword>
  <keyword>overall survival</keyword>
  <keyword>progression-free survival</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04491721
org study id: NCC2288
nct id: NCT04491721
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The main objective of this study is to observe the overall survival of Rituximab Biosimilar
      HLX01 and MabThera in Combination With CHOP, in previously untreated subjects with CD20+
      DLBCL. The secondary objective of this study is to observe the progression-free survival of
      Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in previously untreated
      subjects with CD20+ DLBCL.
1. Enrollment:407 subjects.

        2. The inclusion criteria of this study: subjects who have participated in Phase III
           clinical trials.Phase III clinical trial（NCT02787239） has ended.

        3. The exclusion criteria: ①Subjects died; ②Subjects are unwilling to participate in
           follow-up study; ③ the investigator judges that the subject is not suitable for
           participating the study.

        4. Duration and method of follow-up: 2-10 years (2020-2027)after the end of the Phase III
           trial and follow up the subjects by the phone.

        5. Statistical analysis method: For progression-free survival and overall survival (OS),
           the median time and its 95% confidence intervals will be calculated by the Kaplan-Meier
           method.The Log-Rank test will be used for finding the difference between groups. The
           efficacy will be analyzed by SAS9.4 , and all hypothesis tests are two-sided. The
           confidence level of all confidence intervals is 95%. P value less than 0.05 was regarded
           as statistically significant.
observational model: Cohort
time perspective: Prospective
measure: overall survival
time frame: up to 8 years
description: The main objective of this study is to observe the overall survival of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in previously untreated subjects with CD20+ DLBCL.
measure: progression-free survival
time frame: up to 8 years
description: The secondary objective of this study is to observe the progression-free survival of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in previously untreated subjects with CD20+ DLBCL.
arm group label: Rituximab Biosimilar HLX01 in Combination With CHOP
description: Rituximab Biosimilar HLX01 in Combination With CHOP,in Previously Untreated Subjects With CD20+ DLBCL.
arm group label: MabThera in Combination With CHOP
description: MabThera in Combination With CHOP，in Previously Untreated Subjects With CD20+ DLBCL.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yuankai Shi, Doctor
role: Principal Investigator
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Shi Yuankai
investigator title: chief physician
mesh term: Lymphoma, Large B-Cell, Diffuse