<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/NCT02981745</url>
  </required_header>
  <id_info>
    <org_study_id>CT-1530-101</org_study_id>
    <nct_id>NCT02981745</nct_id>
  </id_info>
  <brief_title>Study of Safety,Efficacy and Pharmacokinetics of CT-1530 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia</brief_title>
  <official_title>Study of Safety, Efficacy and Pharmacokinetics of CT-1530 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centaurus Biopharma Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centaurus Biopharma Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a phase I study of BTK inhibitor CT-1530 in patients with relapsed or refractory B&#xD;
      cell non-Hodgkin lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's&#xD;
      macroglobulinemia (WM).&#xD;
&#xD;
      The purpose of the study is to determine the MTD/RP2D of CT-1530, and evaluate its safety and&#xD;
      tolerability as monotherapy in subjects with relapsed or refractory B cell non-Hodgkin&#xD;
      lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's macroglobulinemia (WM).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)</measure>
    <time_frame>28 days</time_frame>
    <description>Maximum Tolerated Dose(s) (MTD(s)) and/or recommended phase 2 dose (RP2D(s)) of CT-1530 in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Mental-cell lymphoma, Diffuse large B-cell lymphoma, FL and Waldenstrom's Macroglobulinemia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR) - Phase I</measure>
    <time_frame>Up to 24 month</time_frame>
    <description>Preliminary measure of anti-tumor activity of CT-1530</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS) per RECIST v1.1 - Phase I</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Preliminary measures of anti-tumor activity of CT-1530</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DOR)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Preliminary measure of anti-tumor activity of CT-707</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Relapsed or Refractory B Cell Non-Hodgkin Lymphoma</condition>
  <condition>Chronic Lymphocytic Leukemia</condition>
  <condition>Waldenstrom's Macroglobulinemia</condition>
  <condition>Mantle Zone Lymphoma Refractory/Recurrent</condition>
  <condition>Follicle Centre Lymphoma Diffuse</condition>
  <condition>Diffuse Large B Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>CT-1530</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CT-1530</intervention_name>
    <description>Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Waldenstrom's Macroglobulinemia, FL, Diffuse B-cell lymphoma, Mental-cell lymphoma</description>
    <arm_group_label>CT-1530</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed diagnosis of B cell Non-Hodgkin Lymphoma(according to World Health&#xD;
             Organization [WHO] classification)including Chronic Lymphocytic Leukemia/Small cell&#xD;
             Lymphocytic Leukemia (International Workshop),or Waldenstrom's&#xD;
             Macroglobulinemia(Second International Workshop).&#xD;
&#xD;
          -  Have failed ≥1 previous treatment for B-NHL/CLL/WM, and have relapsed or refractory&#xD;
             disease following last prior treatment.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status of ≤ 1 and a life expectancy of&#xD;
             at least 3 months.&#xD;
&#xD;
          -  Measurable disease as per RECIST v1.1&#xD;
&#xD;
          -  Availability of tumor sample&#xD;
&#xD;
          -  Adequate hematologic function, as defined by neutrophils ≥ 1.0 x 10^9/L and platelets&#xD;
             ≥ 50 x 10^9/L; patients with neutrophils &lt; 1.0 x 10^9/L due to marrow infiltration are&#xD;
             allowed to receive growth factors to bring pre-treatment neutrophils to ≥ 1.0 x&#xD;
             10^9/L.&#xD;
&#xD;
          -  Adequate renal function, as defined by creatinine clearance of ≥ 50 ml/min (as&#xD;
             estimated by the Cockcroft-Gault equation or as measured by nuclear medicine scan or&#xD;
             24 hour urine collection).&#xD;
&#xD;
          -  Adequate liver function, as defined by AST and ALT ≤ 3 x ULN, and bilirubin ≤ 1.5 x&#xD;
             ULN (unless documented Gilbert's syndrome).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior allogeneic bone marrow transplant&#xD;
&#xD;
          -  Autologous stem cell transplant within 3 months of screening&#xD;
&#xD;
          -  Active central nervous system involvement&#xD;
&#xD;
          -  Subjects with autoimmune hemolytic anemia or immune thrombocytopenia&#xD;
&#xD;
          -  Prior treatment with a Btk inhibitor&#xD;
&#xD;
          -  Active uncontrolled infection&#xD;
&#xD;
          -  History of malabsorption&#xD;
&#xD;
          -  Uncontrolled illness, i.e cardiac, endocrine, respiratory, etc.&#xD;
&#xD;
          -  History of myocardial infarction, acute coronary syndromes, coronary angioplasty&#xD;
             and/or stenting with in the previous 6 months&#xD;
&#xD;
          -  History of another currently active cancer&#xD;
&#xD;
          -  History of major surgery within 4 weeks or minor surgery within 1 week&#xD;
&#xD;
          -  Other medical or psychiatric illness or organ dysfunction&#xD;
&#xD;
          -  HIV positive&#xD;
&#xD;
          -  Positive for Hepatitis B surface antigen or Hepatitis C-virus&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuankai Shi, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Hospital of Chines Academy of Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yong Peng, M.D. &amp; Ph.D</last_name>
    <phone>86(10)-88858866</phone>
    <email>ypeng@centaurusbio.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Deng Hou, BS</last_name>
    <phone>86(10)-88858866</phone>
    <email>dhou@centaurusbio.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cancer Hospital of Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuankai Shi, MD</last_name>
      <phone>86(10)67781331</phone>
      <email>syuankaipumc@126.com</email>
    </contact>
    <investigator>
      <last_name>Yuankai Shi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>July 18, 2017</last_update_submitted>
  <last_update_submitted_qc>July 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2017</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>Leukemia</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
    <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
    <mesh_term>Waldenstrom Macroglobulinemia</mesh_term>
    <mesh_term>Lymphoma, Follicular</mesh_term>
    <mesh_term>Lymphoma, Mantle-Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02981745
org study id: CT-1530-101
nct id: NCT02981745
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a phase I study of BTK inhibitor CT-1530 in patients with relapsed or refractory B
      cell non-Hodgkin lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's
      macroglobulinemia (WM).

      The purpose of the study is to determine the MTD/RP2D of CT-1530, and evaluate its safety and
      tolerability as monotherapy in subjects with relapsed or refractory B cell non-Hodgkin
      lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's macroglobulinemia (WM).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)
time frame: 28 days
description: Maximum Tolerated Dose(s) (MTD(s)) and/or recommended phase 2 dose (RP2D(s)) of CT-1530 in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Mental-cell lymphoma, Diffuse large B-cell lymphoma, FL and Waldenstrom's Macroglobulinemia
measure: Overall Response Rate (ORR) - Phase I
time frame: Up to 24 month
description: Preliminary measure of anti-tumor activity of CT-1530
measure: Progression free survival (PFS) per RECIST v1.1 - Phase I
time frame: Up to 24 months
description: Preliminary measures of anti-tumor activity of CT-1530
measure: Duration of response (DOR)
time frame: Up to 24 months
description: Preliminary measure of anti-tumor activity of CT-707
arm group label: CT-1530
arm group type: Experimental
intervention type: Drug
intervention name: CT-1530
description: Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Waldenstrom's Macroglobulinemia, FL, Diffuse B-cell lymphoma, Mental-cell lymphoma
arm group label: CT-1530
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yuankai Shi, M.D.
role: Principal Investigator
affiliation: Cancer Hospital of Chines Academy of Medical Sciences
last name: Yong Peng, M.D. & Ph.D
phone: 86(10)-88858866
email: ypeng@centaurusbio.com
last name: Deng Hou, BS
phone: 86(10)-88858866
email: dhou@centaurusbio.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Leukemia
mesh term: Lymphoma, Non-Hodgkin
mesh term: Leukemia, Lymphoid
mesh term: Lymphoma, B-Cell
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Waldenstrom Macroglobulinemia
mesh term: Lymphoma, Follicular
mesh term: Lymphoma, Mantle-Cell
sharing ipd: No