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/NCT05990985</url>
    </required_header>
    <id_info>
      <org_study_id>CSPC-DED-DLBCL-K10</org_study_id>
      <nct_id>NCT05990985</nct_id>
    </id_info>
    <brief_title>The Efficacy and Safety of the RCMOP Sequential Therapy as a First-line Treatment for Patients With Intermediate-to-high Risk Diffuse Large B-cell Lymphoma Who Had Incomplete Remission.</brief_title>
    <official_title>A Clinical Study Was Conducted to Evaluate the Efficacy and Safety of the RCMOP Regimen Sequential Therapy as a First-line Treatment for Patients With Intermediate-to-high Risk Diffuse Large B-cell Lymphoma Who Had Incomplete Remission.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The First Hospital of Jilin University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>CSPC Ouyi Pharmaceutical Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>The First Hospital of Jilin University</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        A clinical study was conducted to evaluate the efficacy and safety of the RCMOP regimen&#xD;
        sequential therapy as a first-line treatment for patients with intermediate-to-high risk&#xD;
        diffuse large B-cell lymphoma who had incomplete remission.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group 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>At the end of cycle 2, At the end of cycle 4, (each cycle is 21 days)</time_frame>
      <description>To evaluate the efficacy of anti-tumor</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Complete response rate (CRR)</measure>
      <time_frame>At the end of cycle 2, At the end of cycle 4; (each cycle is 21 days)</time_frame>
      <description>To evaluate the efficacy of anti-tumor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DOR)</measure>
      <time_frame>CR or PR up to data cut-off (up to approximately 2 years)</time_frame>
      <description>To evaluate the efficacy of anti-tumor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS)</measure>
      <time_frame>Baseline up to data cut-off (up to approximately 2 years)</time_frame>
      <description>To evaluate the efficacy of anti-tumor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>Baseline up to data cut-off (up to approximately 2 years)</time_frame>
      <description>To evaluate the efficacy of anti-tumor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment emergent adverse events (TEAEs)</measure>
      <time_frame>The first dose up to 21 or 28 days after the last dose</time_frame>
      <description>The incidence and severity of adverse events assessed by CTCAE v5.0</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Diffuse Large B-cell Lymphoma</condition>
    <arm_group>
      <arm_group_label>RCMOP</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>RiTUXimab Injection+Cyclophosphamid+Mitoxantrone hydrochloride liposome injection+Vincristine+Prednisolone, 4 cycles of treatment</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Mitoxantrone hydrochloride liposome injection</intervention_name>
      <description>Mitoxantrone hydrochloride liposome injection (18 mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.</description>
      <arm_group_label>RCMOP</arm_group_label>
      <other_name>duoenda</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>RiTUXimab Injection</intervention_name>
      <description>RiTUXimab Injection (375 mg/m^2) will be administered by intravenous infusion on day 0 in a 3-week treatment cycle.</description>
      <arm_group_label>RCMOP</arm_group_label>
      <other_name>lituoxidankang</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cyclophosphamid</intervention_name>
      <description>Cyclophosphamid (750 mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.</description>
      <arm_group_label>RCMOP</arm_group_label>
      <other_name>huanlinxianan</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Vincristine</intervention_name>
      <description>Vincristine (1.4 mg/m^2，maximum dose 2mg ) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.</description>
      <arm_group_label>RCMOP</arm_group_label>
      <other_name>changchunxinjian</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Prednisolone</intervention_name>
      <description>Prednisolone (100mg/d) will be administered by intravenous infusion on day 1-5 in a 3-week treatment cycle.</description>
      <arm_group_label>RCMOP</arm_group_label>
      <other_name>ponisong</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subjects fully understand and voluntarily participate in this study and sign informed&#xD;
               consent&#xD;
  &#xD;
            2. Age≥18 years old&#xD;
  &#xD;
            3. International Prognostic Index (IPI)&gt;2&#xD;
  &#xD;
            4. Expected survival ≥ 3 months&#xD;
  &#xD;
            5. DLBCL initially diagnosed by histopathology meets the following subtypes according to&#xD;
               the 2016 WHO classification: (1) Germinal center B-cell-like (GCB) subtype; (2)&#xD;
               Non-germinal center B-cell-like (non-GCB) subtype&#xD;
  &#xD;
            6. Patients who were evaluated as incomplete remission after 2 cycles of RCHOP/RCDOP for&#xD;
               initial treatment&#xD;
  &#xD;
            7. At least 1 evaluable or measurable lesion meeting Lugano 2014 criteria: Nodal lesion:&#xD;
               Greatest transverse diameter&gt;1.5cm; Extra-nodal lesion: Greatest transverse&#xD;
               diameter&gt;1.0cm&#xD;
  &#xD;
            8. ECOG Performance Status: 0-1&#xD;
  &#xD;
            9. Bone marrow function: Absolute neutrophil count ≥1.5×10^9/L, Platelet count&#xD;
               ≥75×10^9/L, Hemoglobin ≥ 80g/L (Patients with bone marrow involvement were judged by&#xD;
               the investigator to enter the group)&#xD;
  &#xD;
           10. Liver and kidney function: serum creatinine ≤ 1.5×ULN (upper limit of normal); AST and&#xD;
               ALT ≤ 2.5×ULN (≤ 5×ULN for subjects with liver metastases); total bilirubin ≤ 1.5×ULN&#xD;
               (≤ 3×ULN for subjects with liver metastases).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Hypersensitivity to any study drug or its components&#xD;
  &#xD;
            2. Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension,&#xD;
               diabetes, etc.)&#xD;
  &#xD;
            3. Heart function and disease meet one of the following conditions: (1) Long QTc syndrome&#xD;
               or QTc interval &gt; 480 ms; (2) Serious and uncontrolled arrhythmias requiring drug&#xD;
               treatment, uncontrolled angina with poor drug control and myocardial infarction within&#xD;
               6 months before enrollment; (3) New York Heart Association grade III~IV; (4) Cardiac&#xD;
               ejection fraction (LVEF)&lt; 45%&#xD;
  &#xD;
            4. Hepatitis B and hepatitis C active infection (HBV DNA above upper limit of normal; HCV&#xD;
               antibody positive and HCV RNA above upper limit of normal)&#xD;
  &#xD;
            5. Human immunodeficiency virus (HIV) infection (HIV antibody positive)&#xD;
  &#xD;
            6. Subjects with other malignant tumors past or present (except for non-melanoma skin&#xD;
               basal cell carcinoma, breast/cervical carcinoma in control, and other malignant tumors&#xD;
               that have been effectively controlled without treatment within the past five years)&#xD;
  &#xD;
            7. Subjects suffering from primary or secondary central nervous system (CNS) lymphoma&#xD;
  &#xD;
            8. pregnancy, lactation and patients of childbearing age who are unwilling to take&#xD;
               contraceptive measures&#xD;
  &#xD;
            9. Mental patients or those who cannot obtain informed consent&#xD;
  &#xD;
           10. Unsuitable subjects for this study determined by the investigator.&#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>Ou Bai, PHD</last_name>
      <phone>13039046656</phone>
      <email>oubai16@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>The First Bethune Hospital of Jilin University</name>
        <address>
          <city>Changchun</city>
          <state>Jilin</state>
          <zip>130021</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Ou Bai, PHD</last_name>
        <phone>13039046656</phone>
        <email>oubai16@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The First Hospital of Jilin University</investigator_affiliation>
      <investigator_full_name>Ou Bai, MD/PHD</investigator_full_name>
      <investigator_title>Director</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>
      <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prednisolone</mesh_term>
      <mesh_term>Cyclophosphamide</mesh_term>
      <mesh_term>Rituximab</mesh_term>
      <mesh_term>Vincristine</mesh_term>
      <mesh_term>Mitoxantrone</mesh_term>
    </intervention_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/NCT05990985
  org study id: CSPC-DED-DLBCL-K10
  nct id: NCT05990985
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A clinical study was conducted to evaluate the efficacy and safety of the RCMOP regimen
        sequential therapy as a first-line treatment for patients with intermediate-to-high risk
        diffuse large B-cell lymphoma who had incomplete remission.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective response rate (ORR)
  time frame: At the end of cycle 2, At the end of cycle 4, (each cycle is 21 days)
  description: To evaluate the efficacy of anti-tumor
  measure: Complete response rate (CRR)
  time frame: At the end of cycle 2, At the end of cycle 4; (each cycle is 21 days)
  description: To evaluate the efficacy of anti-tumor
  measure: Duration of Response (DOR)
  time frame: CR or PR up to data cut-off (up to approximately 2 years)
  description: To evaluate the efficacy of anti-tumor
  measure: Progression-free survival (PFS)
  time frame: Baseline up to data cut-off (up to approximately 2 years)
  description: To evaluate the efficacy of anti-tumor
  measure: Overall survival (OS)
  time frame: Baseline up to data cut-off (up to approximately 2 years)
  description: To evaluate the efficacy of anti-tumor
  measure: Treatment emergent adverse events (TEAEs)
  time frame: The first dose up to 21 or 28 days after the last dose
  description: The incidence and severity of adverse events assessed by CTCAE v5.0
  arm group label: RCMOP
  arm group type: Experimental
  description: RiTUXimab Injection+Cyclophosphamid+Mitoxantrone hydrochloride liposome injection+Vincristine+Prednisolone, 4 cycles of treatment
  intervention type: Drug
  intervention name: Mitoxantrone hydrochloride liposome injection
  description: Mitoxantrone hydrochloride liposome injection (18 mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
  arm group label: RCMOP
  other name: duoenda
  intervention type: Drug
  intervention name: RiTUXimab Injection
  description: RiTUXimab Injection (375 mg/m^2) will be administered by intravenous infusion on day 0 in a 3-week treatment cycle.
  arm group label: RCMOP
  other name: lituoxidankang
  intervention type: Drug
  intervention name: Cyclophosphamid
  description: Cyclophosphamid (750 mg/m^2) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
  arm group label: RCMOP
  other name: huanlinxianan
  intervention type: Drug
  intervention name: Vincristine
  description: Vincristine (1.4 mg/m^2，maximum dose 2mg ) will be administered by intravenous infusion on day 1 in a 3-week treatment cycle.
  arm group label: RCMOP
  other name: changchunxinjian
  intervention type: Drug
  intervention name: Prednisolone
  description: Prednisolone (100mg/d) will be administered by intravenous infusion on day 1-5 in a 3-week treatment cycle.
  arm group label: RCMOP
  other name: ponisong
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ou Bai, PHD
  phone: 13039046656
  email: oubai16@163.com
  facility: 
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: The First Hospital of Jilin University
  investigator full name: Ou Bai, MD/PHD
  investigator title: Director
  mesh term: Lymphoma
  mesh term: Lymphoma, B-Cell
  mesh term: Lymphoma, Large B-Cell, Diffuse
  mesh term: Prednisolone
  mesh term: Cyclophosphamide
  mesh term: Rituximab
  mesh term: Vincristine
  mesh term: Mitoxantrone