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/NCT05978739</url>
    </required_header>
    <id_info>
      <org_study_id>ICP-CL-00127</org_study_id>
      <nct_id>NCT05978739</nct_id>
    </id_info>
    <brief_title>Evaluating Different Doses of Orelabrutinib in MCL</brief_title>
    <official_title>A Randomized,Open-label, Multicenter, Phase II Trial Evaluating Two Different Doses of Orelabrutinib in Mantle Cell Lymphoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>InnoCare Pharma Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Beijing InnoCare Pharma Tech Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>InnoCare Pharma Inc.</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is A Randomized,Open-label, Multicenter, Phase II Trial Evaluating Two Different Doses&#xD;
        of Orelabrutinib in Mantle Cell Lymphoma to Evaluate the Efficacy and Safety in Mantle Cell&#xD;
        Lymphoma.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 18, 2023</start_date>
    <completion_date type="Anticipated">May 25, 2025</completion_date>
    <primary_completion_date type="Anticipated">February 25, 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Objective response rate（ORR）</measure>
      <time_frame>Through study completion, an average of 2 year</time_frame>
      <description>Proportion of subjects with tumor response of Complete Response（CR） or Partial Response（PR） after treatment in total subjects.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Complete Response Rate （CRR）</measure>
      <time_frame>Through study completion, an average of 2 year</time_frame>
      <description>The proportion of subjects with tumor response of Complete Response（CR） after treatment in total subjects.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-Free Survival (PFS)</measure>
      <time_frame>Through study completion, an average of 2 year</time_frame>
      <description>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DoR)</measure>
      <time_frame>Through study completion, an average of 2 year</time_frame>
      <description>The time from documentation of objective response to the first occurrence of tumor progression or death due to any cause, whichever occurs first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum concentration (Cmax,ss)</measure>
      <time_frame>Predose up to 24 hours postdose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to maximum concentration (Tmax)</measure>
      <time_frame>Predose up to 24 hours postdose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the plasma concentration-time curve (AUC)</measure>
      <time_frame>Predose up to 24 hours postdose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Half-life (T1/2)</measure>
      <time_frame>Predose up to 24 hours postdose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent clearance (CL/F)</measure>
      <time_frame>Predose up to 24 hours postdose</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events（AEs）</measure>
      <time_frame>Through study completion, an average of 2 year</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serious adverse events （SAEs）</measure>
      <time_frame>Through study completion, an average of 2 year</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Mantle Cell Lymphoma</condition>
    <arm_group>
      <arm_group_label>Orelabrutinib high dose</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Orelabrutinib low dose</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Orelabrutinib High dose</intervention_name>
      <description>Orelabrutinib will be administered as 3 tablets once per day</description>
      <arm_group_label>Orelabrutinib high dose</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Orelabrutinib Low dose</intervention_name>
      <description>Orelabrutinib will be administered as 1 tablet once per day</description>
      <arm_group_label>Orelabrutinib low dose</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male and female subjects between 18 and 85 years of age (inclusive).&#xD;
  &#xD;
            2. Mantle cell lymphoma (MCL) confirmed by histopathology.&#xD;
  &#xD;
            3. Subjects who have not previously received standard systemic care and&#xD;
               relapsing/refractory subjects who have previously received standard systemic care.&#xD;
  &#xD;
            4. At least one measurable lesion.&#xD;
  &#xD;
            5. ECOG Physical fitness score 0-2 points.&#xD;
  &#xD;
            6. Expected survival time ≥ 4 months.&#xD;
  &#xD;
            7. Full hematology function.&#xD;
  &#xD;
            8. Blood clotting function is basically normal.&#xD;
  &#xD;
            9. Subjects with basically normal liver, kidney and heart function.&#xD;
  &#xD;
           10. Subject voluntarily signs a written ICF.&#xD;
  &#xD;
           11. The serum pregnancy test of female subjects with fertility potential was negative&#xD;
               within 7 days before the first dosing.&#xD;
  &#xD;
           12. Female subjects with reproductive potential or male subjects and their partners must&#xD;
               agree to use effective contraception for at least 6 months from signing the ICF until&#xD;
               the last dose of the study drug.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Adequate treatment with BTK inhibitors.&#xD;
  &#xD;
            2. Have a history of severe allergic disease and a history of severe drug allergy.&#xD;
  &#xD;
            3. Subjects who have received the treatment or drug restricted in the protocol within the&#xD;
               time specified for the first use of the investigational drug.&#xD;
  &#xD;
            4. The last use of a potent CYP3A inhibitor or potent CYP3A inducer (including food,&#xD;
               western medicine, and Chinese medicine) was less than 2 weeks (or less than 5&#xD;
               half-lives, depending on the time) from the first trial, or plan to take a potent&#xD;
               CYP3A inhibitor or potent CYP3A inducer drug or food during the study period.&#xD;
  &#xD;
            5. History of other active malignant diseases within 2 years prior to screening.&#xD;
  &#xD;
            6. Subjects with systemic bacterial, viral, fungal (other than nail fungal infections) or&#xD;
               parasitic infections with poorly controlled activity.&#xD;
  &#xD;
            7. Indicates active hepatitis B or C virus infection.&#xD;
  &#xD;
            8. There are diseases that are excluded from the criteria in the programme.&#xD;
  &#xD;
            9. Toxicity of previous anticancer therapy was still ≥ grade 2 at the start of study&#xD;
               therapy (according to CTCAE V5.0).&#xD;
  &#xD;
           10. History of severe bleeding disorder.&#xD;
  &#xD;
           11. People with a known history of alcohol or drug abuse.&#xD;
  &#xD;
           12. Subjects with mental disorders or poor compliance.&#xD;
  &#xD;
           13. Pregnant or lactating female subjects.&#xD;
  &#xD;
           14. Other conditions deemed unsuitable for participation in this study by the&#xD;
               investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Alexia Lu</last_name>
      <phone>010-66609745</phone>
      <email>CO_HGRAC@innocarepharma.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Bengbu Medical College</name>
        <address>
          <city>Bengbu</city>
          <state>Anhui</state>
          <zip>233040</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Yanli Yang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Anhui Medical University</name>
        <address>
          <city>Hefei</city>
          <state>Anhui</state>
          <zip>230022</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Qingshu Zeng</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Peking University Third Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100191</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Hongmei Jing</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Chongqing Cancer Hospital</name>
        <address>
          <city>Chongqing</city>
          <state>Chongqing</state>
          <zip>400030</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Jieping Li</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Fujian Medical University Union Hospital</name>
        <address>
          <city>Fuzhou</city>
          <state>Fuzhou</state>
          <zip>350001</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Jianzhen Shen</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Sun Yat-sen University Cancer Center</name>
        <address>
          <city>Guangdong</city>
          <state>Guangzhou</state>
          <zip>510055</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zhiming Li</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Henan Cancer Hospital</name>
        <address>
          <city>Zhengzhou</city>
          <state>Henan</state>
          <zip>450003</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Zhihua Yao</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Zhengzhou University</name>
        <address>
          <city>Zhengzhou</city>
          <state>Henan</state>
          <zip>450052</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Lei Zhang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Union Hospital Tongji Medical College, Huazhong University of Science and Technology</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430022</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Guohui Cui</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hubei Cancer Hospital</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430079</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Huijing Wu</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hunan Cancer Hospital</name>
        <address>
          <city>Changsha</city>
          <state>Hunan</state>
          <zip>410031</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Hui Zhou</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Chenzhou First People's Hospital</name>
        <address>
          <city>Chenzhou</city>
          <state>Hunan</state>
          <zip>423003</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Xinquan Liang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Nanchang University</name>
        <address>
          <city>Nanchang</city>
          <state>Jiangxi</state>
          <zip>330006</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Li Yu</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Jiangxi Cancer Hospital</name>
        <address>
          <city>Nanchang</city>
          <state>Jiangxi</state>
          <zip>330029</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Wuping Li</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Hospital of Dalian Medical University</name>
        <address>
          <city>Dalian</city>
          <state>Liaoning</state>
          <zip>116023</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xiuhua Sun</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of China Medical University</name>
        <address>
          <city>Shenyang</city>
          <state>Liaoning</state>
          <zip>110001</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Xiaojing Yan</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Linyi People's Hospital</name>
        <address>
          <city>Linyi</city>
          <state>Shandong</state>
          <zip>276034</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Haiyan Zhang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shanxi Provincial Cancer Hospital</name>
        <address>
          <city>Taiyuan</city>
          <state>Shanxi</state>
          <zip>030013</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Liping Su</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Xi'an Jiaotong University</name>
        <address>
          <city>Xi'an</city>
          <state>Shanxi</state>
          <zip>710004</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Jianli Wang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Affiliated Cancer Hospital of Xinjiang Medical University</name>
        <address>
          <city>Urumqi</city>
          <state>Uygur Autonomous Region</state>
          <zip>830000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Shujuan Wen</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Zhejiang University School of Medicine</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310003</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Wenjuan Yu</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</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, Mantle-Cell</mesh_term>
    </condition_browse>
    <!-- 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/NCT05978739
  org study id: ICP-CL-00127
  nct id: NCT05978739
  lead sponsor: 
  collaborator: 
  is fda regulated drug: Yes
  is fda regulated device: No
  This is A Randomized,Open-label, Multicenter, Phase II Trial Evaluating Two Different Doses
        of Orelabrutinib in Mantle Cell Lymphoma to Evaluate the Efficacy and Safety in Mantle Cell
        Lymphoma.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective response rate（ORR）
  time frame: Through study completion, an average of 2 year
  description: Proportion of subjects with tumor response of Complete Response（CR） or Partial Response（PR） after treatment in total subjects.
  measure: Complete Response Rate （CRR）
  time frame: Through study completion, an average of 2 year
  description: The proportion of subjects with tumor response of Complete Response（CR） after treatment in total subjects.
  measure: Progression-Free Survival (PFS)
  time frame: Through study completion, an average of 2 year
  description: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.
  measure: Duration of Response (DoR)
  time frame: Through study completion, an average of 2 year
  description: The time from documentation of objective response to the first occurrence of tumor progression or death due to any cause, whichever occurs first.
  measure: Maximum concentration (Cmax,ss)
  time frame: Predose up to 24 hours postdose
  measure: Time to maximum concentration (Tmax)
  time frame: Predose up to 24 hours postdose
  measure: Area under the plasma concentration-time curve (AUC)
  time frame: Predose up to 24 hours postdose
  measure: Half-life (T1/2)
  time frame: Predose up to 24 hours postdose
  measure: Apparent clearance (CL/F)
  time frame: Predose up to 24 hours postdose
  measure: Adverse events（AEs）
  time frame: Through study completion, an average of 2 year
  measure: Serious adverse events （SAEs）
  time frame: Through study completion, an average of 2 year
  arm group label: Orelabrutinib high dose
  arm group type: Experimental
  arm group label: Orelabrutinib low dose
  arm group type: Experimental
  intervention type: Drug
  intervention name: Orelabrutinib High dose
  description: Orelabrutinib will be administered as 3 tablets once per day
  arm group label: Orelabrutinib high dose
  intervention type: Drug
  intervention name: Orelabrutinib Low dose
  description: Orelabrutinib will be administered as 1 tablet once per day
  arm group label: Orelabrutinib low dose
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Alexia Lu
  phone: 010-66609745
  email: CO_HGRAC@innocarepharma.com
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Lymphoma
  mesh term: Lymphoma, Mantle-Cell