<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/NCT03003039</url>
  </required_header>
  <id_info>
    <org_study_id>GB241NHL1</org_study_id>
    <nct_id>NCT03003039</nct_id>
  </id_info>
  <brief_title>A Study Comparing GB241 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma</brief_title>
  <official_title>A Study Comparing GB241 And Rituximab in Patients With B-cell Non-Hodgkin's Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing Yoko Biomedical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing Yoko Biomedical Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is the area under the curve (AUC) for GB241 and rituximab&#xD;
      concentrations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 5, 2017</start_date>
  <completion_date type="Actual">May 20, 2019</completion_date>
  <primary_completion_date type="Actual">May 20, 2019</primary_completion_date>
  <phase>Phase 1</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>Area under the curve (AUC) for GB241 and rituximab concentrations</measure>
    <time_frame>85 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC for GB241 and rituximab concentrations</measure>
    <time_frame>1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed concentration of the GB241 and rituximab</measure>
    <time_frame>85 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of clearance from baseline of CD19+ , CD20+ B-cells between the two study arms</measure>
    <time_frame>85 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of AEs between the two study arms</measure>
    <time_frame>85 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the incidence rate of HACA（host anti-chimeric antibody） between the two study arms</measure>
    <time_frame>85 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>B-Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>GB241</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GB241:375 mg/m2, iv, one infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rituximab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Rituximab: 375 mg/m2, iv, one infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>GB241</intervention_name>
    <description>Single intravenous infusion (IV) 375 mg/m2</description>
    <arm_group_label>GB241</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>Single intravenous infusion (IV) 375 mg/m2</description>
    <arm_group_label>Rituximab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  having histologically confirmed NHL expressing CD20 antigen&#xD;
&#xD;
          -  having obtained CR (complete remission) or CRu (uncertain complete remission) after&#xD;
             the prior therapy&#xD;
&#xD;
          -  signed an informed consent form which was approved by the institutional review board&#xD;
             of the respective medical center&#xD;
&#xD;
          -  aged from 18 to 75 years&#xD;
&#xD;
          -  ECOG performance status of 0 to 1&#xD;
&#xD;
          -  expected survival of at least ≥ 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1&#xD;
             year before enrollment&#xD;
&#xD;
          -  having to be at least 4 weeks beyond prior anticancer therapy including&#xD;
             corticosteroid, or have not recovered from significant toxicities of prior therapy&#xD;
&#xD;
          -  participating in other clinical trial within 30 days before enrolment&#xD;
&#xD;
          -  with serious hematologic dysfunction (white blood cell count of &lt;3.0×103/uL; absolute&#xD;
             neutrophil count of &lt;1.5×103/ uL; platelet count of &lt; 75×103/uL; hemoglobin level of &lt;&#xD;
             8.0 g/dL); hepatic dysfunction (total bilirubin level of &gt; 1.5×ULN; aspartate amino&#xD;
             transferase (AST) and alanine amino transferase (ALT) levels of &gt;2.5 × ULN; renal&#xD;
             dysfunction (serum creatinine level of &gt; 1.5×ULN ); and International normalized ratio&#xD;
             (INR) and partial thromboplastin time or activated partial thromboplastin time (aPTT)&#xD;
             &gt; 1.5 × ULN (unless on therapeutic coagulation)&#xD;
&#xD;
          -  had received live vaccine within 4 weeks prior to study entry&#xD;
&#xD;
          -  with other malignancies ; or central nervous system (CNS) lymphoma, AIDS-related&#xD;
             lymphoma; or active opportunistic infection, a serious nonmalignant disease&#xD;
&#xD;
          -  seropositive for HCV antibody, or HIV antibody, or hepatitis B virus surface antigen&#xD;
             (HBsAg). HBc antibody seropositive, but HBV DNA and HBsAg negative patients may&#xD;
             participle following consultation with a hepatitis expert regarding monitoring and use&#xD;
             of HBV antiviral therapy, and provided they agree to receive treatment as indicated&#xD;
&#xD;
          -  recent major surgery (within 28 days prior to study entry )&#xD;
&#xD;
          -  with a history of allergic reaction or protein product allergy including murine&#xD;
             proteins&#xD;
&#xD;
          -  pregnant or lactating or not accepted birth control methods including male patients&#xD;
&#xD;
          -  patients considered unsuitable by PI&#xD;
&#xD;
          -  previous malignant tumor except cured cervical cancer,basal cell carcinoma and&#xD;
             squamous cell skin cancer&#xD;
&#xD;
          -  active opportunistic infections and other serious non neoplastic diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cancer Hospital Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100076</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>March 19, 2021</last_update_submitted>
  <last_update_submitted_qc>March 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>GB241</keyword>
  <keyword>Rituximab</keyword>
  <keyword>B-cell Lymphoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</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>Rituximab</mesh_term>
  </intervention_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/NCT03003039
org study id: GB241NHL1
nct id: NCT03003039
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is the area under the curve (AUC) for GB241 and rituximab
      concentrations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the curve (AUC) for GB241 and rituximab concentrations
time frame: 85 days
measure: AUC for GB241 and rituximab concentrations
time frame: 1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks
measure: Maximum observed concentration of the GB241 and rituximab
time frame: 85 days
measure: Degree of clearance from baseline of CD19+ , CD20+ B-cells between the two study arms
time frame: 85 days
measure: Comparison of AEs between the two study arms
time frame: 85 days
measure: Comparison of the incidence rate of HACA（host anti-chimeric antibody） between the two study arms
time frame: 85 days
arm group label: GB241
arm group type: Experimental
description: GB241:375 mg/m2, iv, one infusion
arm group label: Rituximab
arm group type: Active Comparator
description: Rituximab: 375 mg/m2, iv, one infusion
intervention type: Biological
intervention name: GB241
description: Single intravenous infusion (IV) 375 mg/m2
arm group label: GB241
intervention type: Biological
intervention name: Rituximab
description: Single intravenous infusion (IV) 375 mg/m2
arm group label: Rituximab
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Lymphoma, B-Cell
mesh term: Rituximab