<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/NCT03800706</url>
  </required_header>
  <id_info>
    <org_study_id>TQB2450-II-01</org_study_id>
    <nct_id>NCT03800706</nct_id>
  </id_info>
  <brief_title>A Phase II Study to Evaluate the Safety and Efficacy of TQB2450 Injection in Relapsed or Refractory Classical Hodgkin's Lymphoma</brief_title>
  <official_title>A Phase II Study to Evaluate the Safety and Efficacy of TQB2450 Injection in Relapsed or Refractory Classical Hodgkin's Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chia Tai Tianqing Pharmaceutical Group Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chia Tai Tianqing Pharmaceutical Group 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>
      Single-Arm, Open-Label, Multicenter Clinical Trial. To observe the efficacy and safety of&#xD;
      TQB2450 in patients of non-hodgkin lymphoma&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 25, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</primary_completion_date>
  <phase>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>Overall Response Rate(ORR)</measure>
    <time_frame>Up to 96 weeks</time_frame>
    <description>Overall Response Rate (ORR) defined as the proportion of subjects who achieves a best response of CR or PR, assessed by IRC per the Lugano Classification</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complete Response (CR)</measure>
    <time_frame>Up to 96 weeks</time_frame>
    <description>Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (&lt;10mm short axis).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">85</enrollment>
  <condition>Safety and Effectiveness</condition>
  <arm_group>
    <arm_group_label>TQB2450</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TQB2450</intervention_name>
    <description>TQB2450 is injectived (IV) every-3-weeks (Q3W) and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent, the longest use time of experimental drugs is 96 weeks.</description>
    <arm_group_label>TQB2450</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject has voluntarily agreed to participate by giving written informed consent.;&#xD;
&#xD;
          2. Histopathological confirmed classical Hodgkin's lymphoma;&#xD;
&#xD;
          3. Relapsed/refractory cHL include：a)subject with relapse and progression after salvage&#xD;
             chemotherapy followed by autologous stem cell transplantation(ASCT); b) subject with&#xD;
             no ASCT: The first-line chemotherapy must be systemic multi-drug combination&#xD;
             chemotherapy and subsequent chemotherapy requires at least one first-line chemotherapy&#xD;
             must be systemic multi-drug combination chemotherapy; subject which is refractory&#xD;
             didn't achieve PR after 2 cycles or didn't achieve CR after&#xD;
&#xD;
          4. Age ranged from 18 to 75 years;&#xD;
&#xD;
          5. At least one measurable disease ;&#xD;
&#xD;
          6. Patients must have ECOG performance status of 0-2;&#xD;
&#xD;
          7. Subject must have adequate organ functions ：Count of Blood Cells:hemoglobin&#xD;
             content(HB)≥80g/L; absolute neutrophil count (ANC) ≥ 1.0 × 10^9 / L; platelet count&#xD;
             (PLT) ≥ 75 × 10^9 / L;; Biochemical examination: serum total bilirubin (TBIL) ≤ 1.5 ×&#xD;
             normal upper limit (ULN), with the exception of patients with hepatic metastases and&#xD;
             Gilbert's syndrome(TBIL≤3×ULN） ; alanine aminotransferase (ALT) and aspartate&#xD;
             aminotransferase (AST) ≤ 3 × ULN，with the exception of patients with hepatic&#xD;
             metastases (ALT and AST ≤ 5 × ULN) , serum creatinine (Cr) ≤ 1.5 × ULN or Creatinine&#xD;
             clearance rate（CCR）≥50 mL/min；Serum amylase and lipase ≤ 1.5 x ULN Blood coagulation&#xD;
             function:International standardized ratio(INR)≤1.5×ULN、Activation partial thrombin&#xD;
             time(APTT)≤1.5×ULN、Prothrombin time≤1.5×ULN；Doppler ultrasound evaluation：Left&#xD;
             ventricular ejection fraction（LVEF)≥50%×MLN;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1、Nodular lymphocyte-predominant Hodgkin lymphoma or gray zone lymphoma； 2、 Prior&#xD;
             exposure to any anti-PD-1, anti-PD-L1 ， anti-CTLA-4 antibody or CAR-T cell&#xD;
             treatment(Any other antibody that has been applied to a T cell synergistic stimulus or&#xD;
             checkpoint pathway); 3、Need to therapy with other anticancer during the study;&#xD;
             4、Received allogeneic organ transplantation or allogeneic hematopoietic stem cell&#xD;
             transplantation;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yuan Kai Shi</last_name>
    <phone>13701251865</phone>
    <email>syuankai@cicams.ac.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>No.17, panjiayuan nanli, chaoyang district, Beijing</name>
      <address>
        <city>Beijing</city>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>YuanKai Shi</last_name>
    </contact>
    <investigator>
      <last_name>YuanKai Shi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>October 8, 2020</last_update_submitted>
  <last_update_submitted_qc>October 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2020</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>Hodgkin Disease</mesh_term>
  </condition_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/NCT03800706
org study id: TQB2450-II-01
nct id: NCT03800706
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Single-Arm, Open-Label, Multicenter Clinical Trial. To observe the efficacy and safety of
      TQB2450 in patients of non-hodgkin lymphoma
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Response Rate(ORR)
time frame: Up to 96 weeks
description: Overall Response Rate (ORR) defined as the proportion of subjects who achieves a best response of CR or PR, assessed by IRC per the Lugano Classification
measure: Complete Response (CR)
time frame: Up to 96 weeks
description: Disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (<10mm short axis).
arm group label: TQB2450
arm group type: Experimental
intervention type: Drug
intervention name: TQB2450
description: TQB2450 is injectived (IV) every-3-weeks (Q3W) and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent, the longest use time of experimental drugs is 96 weeks.
arm group label: TQB2450
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yuan Kai Shi
phone: 13701251865
email: syuankai@cicams.ac.cn
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Hodgkin Disease