xml: <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/NCT05968001</url>
    </required_header>
    <id_info>
      <org_study_id>JCLG-23-04</org_study_id>
      <nct_id>NCT05968001</nct_id>
    </id_info>
    <brief_title>Obinutuzumab in Chinese Real-world Patients With iNHL</brief_title>
    <official_title>Efficacy and Safety of Obinutuzumab in Chinese Patients With Indolent Non-Hodgkin's B-cell Lymphoma in the Real-World.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Affiliated Hospital of Nantong University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Affiliated Hospital of Nantong University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</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>
        This study aims to assess the clinical efficacy and safety of obinutuzumab in Chinese&#xD;
        patients with indolent non-Hodgkin B-cell Lymphoma (predominantly Follicular lymphoma and&#xD;
        Marginal zone lymphoma) in a real-world setting.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study was a prospective, multicenter, non-interventional, real-world study. The study&#xD;
        will be divided into two cohorts: Cohort 1 is the younger cohort (aged ≥ 18 and &lt; 60 years at&#xD;
        the start of treatment); Cohort 2 is the older cohort (aged ≥ 60 years at the start of&#xD;
        treatment). Patients in this study will receive obinutuzumab-contained regimens according to&#xD;
        the investigators' clinical opinion.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 20, 2023</start_date>
    <completion_date type="Anticipated">July 20, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2024</primary_completion_date>
    <study_type>Observational</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>
    <primary_outcome>
      <measure>Efficacy Endpoints</measure>
      <time_frame>12 months</time_frame>
      <description>The best objective response rate (ORR), and CR rate; ORR and CR rate at the end of treatment; DCR, DoR, TTNT, PFS, DFS, and OS.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Safety Endpoints</measure>
      <time_frame>12 months</time_frame>
      <description>All AEs, SAEs, Grade 3 AEs, and all other safety variables, including vital signs, Physical examination results, and laboratory parameters.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Exploratory Endpoints</measure>
      <time_frame>12 months</time_frame>
      <description>Subgroup analyses will be performed for some special populations, such as in high-risk patients</description>
    </other_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Lymphomas Non-Hodgkin's B-Cell</condition>
    <arm_group>
      <arm_group_label>Cohort 1</arm_group_label>
      <description>the younger cohort (aged ≥ 18 and &lt; 60 years at the start of treatment)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2</arm_group_label>
      <description>the older cohort (aged ≥ 60 years at the start of treatment)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Obinutuzumab</intervention_name>
      <description>obinutuzumab (G)-contained regimens, including GB, G-CHOP, and G-CVP.</description>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_label>Cohort 2</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          patients with FL and MZL who started treatment with otuzumab between June 2021 and April&#xD;
          2023.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age: Age ≥ 18 years at the start of treatment;&#xD;
  &#xD;
            -  Be diagnosed with grade 1-3a follicular Lymphoma, Marginal zone lymphoma;&#xD;
  &#xD;
            -  Previously untreated or relapsed or refractory patients;&#xD;
  &#xD;
            -  Patients who started treatment with otuzumab between June 2021 and April 2023.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients currently participating or planning to participate in any interventional&#xD;
               clinical trial;&#xD;
  &#xD;
            -  Patients who, in the opinion of the investigator, are Discomfort for any other reason&#xD;
               to participate in this study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Wenyu Shi, PhD</last_name>
      <phone>+86 13515203737</phone>
      <email>shiwenyu@hotmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Changzhou No.2 People's Hospital</name>
        <address>
          <city>Changzhou</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xuzhang Lu, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First People's hospital of Changzhou</name>
        <address>
          <city>Changzhou</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Weiying Gu, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Huai'an First People's hospital</name>
        <address>
          <city>Huai'an</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Liang Yu, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Jiangyin People's Hospital</name>
        <address>
          <city>Jiangyin</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Maozhong Xu, PhD</last_name>
      </contact>
      <investigator>
        <last_name>Maozhong Xu, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Xi Xu, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Jingjiang People's Hospital</name>
        <address>
          <city>Jingjiang</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Miao Sun, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The first people's hospital of Lianyungang</name>
        <address>
          <city>Lianyungang</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Tao Jia, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The second people's hospital of Lianyungang</name>
        <address>
          <city>Lianyungang</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Wanchuan Zhuang, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Jiangsu Province Hospital of Chinese Medicine</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Haiwen Ni, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Jiangsu Province Hospital</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Jianyong Li, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Nanjing Drum Tower Hospital</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Nanjing Jiangning Hospital</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Jinning Shi, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Nantong Tumor Hospital</name>
        <address>
          <city>Nantong</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xiaohong Xu, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Affiliated Hospital of Nantong University</name>
        <address>
          <city>Nanyang</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Wenyu Shi, PhD</last_name>
        <phone>+86 13515203737</phone>
        <email>shiwenyu@hotmail.com</email>
      </contact>
      <investigator>
        <last_name>Wenyu Shi, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Yihong Cai, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Soochow University</name>
        <address>
          <city>Suzhou</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Bingzong Li, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Jiangsu Taizhou People's Hospital</name>
        <address>
          <city>Taizhou</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Jianfeng Zhu, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Affiliated Hospital of Jiangnan University</name>
        <address>
          <city>Wuxi</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Haiying Hua, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Wuxi People's Hospital</name>
        <address>
          <city>Wuxi</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yun Zhuang, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Wuxi Second People's Hospital</name>
        <address>
          <city>Wuxi</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Zhi Wang, PhD</last_name>
      </contact>
      <investigator>
        <last_name>Zhi Wang, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ping Liu, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Yancheng No.1 People's Hospital</name>
        <address>
          <city>Yancheng</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yuexin Cheng, PhD</last_name>
      </contact>
      <investigator>
        <last_name>Yuexin Cheng, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Yuqing Miao, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Yancheng Third People's Hospital</name>
        <address>
          <city>Yancheng</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Naitong Sun, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Subei People's Hospital</name>
        <address>
          <city>Yangzhou</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xiaoyan Xie, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Yixing People's Hospital</name>
        <address>
          <city>Yixing</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yunping Zhang, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Zhangjiagang First People's Hospital</name>
        <address>
          <city>Zhangjiagang</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Min Xu, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Affiliated Hospital of Jiangsu University</name>
        <address>
          <city>Zhenjiang</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xiaoming Fei, PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Zhenjiang First People's Hospital</name>
        <address>
          <city>Zhenjiang</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Jun Qian, PhD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Affiliated Hospital of Nantong University</investigator_affiliation>
      <investigator_full_name>Wenyu Shi</investigator_full_name>
      <investigator_title>Director, Department of Oncology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphoma</mesh_term>
      <mesh_term>Lymphoma, B-Cell</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obinutuzumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>all IPD that underlie results in a publication</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>starting 6 months after publication</ipd_time_frame>
      <ipd_access_criteria>IPD could be shared by contacting the corresponding author via email after publication.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05968001
  org study id: JCLG-23-04
  nct id: NCT05968001
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  This study aims to assess the clinical efficacy and safety of obinutuzumab in Chinese
        patients with indolent non-Hodgkin B-cell Lymphoma (predominantly Follicular lymphoma and
        Marginal zone lymphoma) in a real-world setting.
  This study was a prospective, multicenter, non-interventional, real-world study. The study
        will be divided into two cohorts: Cohort 1 is the younger cohort (aged ≥ 18 and < 60 years at
        the start of treatment); Cohort 2 is the older cohort (aged ≥ 60 years at the start of
        treatment). Patients in this study will receive obinutuzumab-contained regimens according to
        the investigators' clinical opinion.
  observational model: Cohort
  time perspective: Prospective
  measure: Efficacy Endpoints
  time frame: 12 months
  description: The best objective response rate (ORR), and CR rate; ORR and CR rate at the end of treatment; DCR, DoR, TTNT, PFS, DFS, and OS.
  measure: Safety Endpoints
  time frame: 12 months
  description: All AEs, SAEs, Grade 3 AEs, and all other safety variables, including vital signs, Physical examination results, and laboratory parameters.
  measure: Exploratory Endpoints
  time frame: 12 months
  description: Subgroup analyses will be performed for some special populations, such as in high-risk patients
  arm group label: Cohort 1
  description: the younger cohort (aged ≥ 18 and < 60 years at the start of treatment)
  arm group label: Cohort 2
  description: the older cohort (aged ≥ 60 years at the start of treatment)
  intervention type: Drug
  intervention name: Obinutuzumab
  description: obinutuzumab (G)-contained regimens, including GB, G-CHOP, and G-CVP.
  arm group label: Cohort 1
  arm group label: Cohort 2
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Wenyu Shi, PhD
  phone: +86 13515203737
  email: shiwenyu@hotmail.com
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  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Affiliated Hospital of Nantong University
  investigator full name: Wenyu Shi
  investigator title: Director, Department of Oncology
  mesh term: Lymphoma
  mesh term: Lymphoma, B-Cell
  mesh term: Obinutuzumab
  sharing ipd: Yes
  ipd description: all IPD that underlie results in a publication
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: starting 6 months after publication
  ipd access criteria: IPD could be shared by contacting the corresponding author via email after publication.