<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/NCT02186860</url>
  </required_header>
  <id_info>
    <org_study_id>307-CTC-CAR T</org_study_id>
    <nct_id>NCT02186860</nct_id>
  </id_info>
  <brief_title>Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With Acute Lymphoblastic Leukemia</brief_title>
  <official_title>Treatment of Chemotherapy Resistant or Refractory Acute Lymphoblastic Leukemia by Chimeric Antigen Receptor (CAR)-Modified T Cells</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Affiliated Hospital to Academy of Military Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Affiliated Hospital to Academy of Military Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Traditional standard treatments of B cell acute lymphoblastic leukemia is not perfect for&#xD;
      fighting cancer. Many people do not respond to the standard treatments of ALL. One possible&#xD;
      treatment is chimeric antigen receptor (CAR) modified T cell infusions. This study aims to&#xD;
      evaluate the safety and efficacy of novel CARTs (targeting CD19) in the treatment of&#xD;
      refractory or recurrent ALL.The investigators start Phase I study aimed to chemotherapy&#xD;
      resistant or refractory acute lymphoblastic leukemia patients. The purpose of this study is&#xD;
      to assess the safety and effectiveness of CAR-T cells in patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CAR-T has stronger effect of anti-tumor capacity. While people have been able to control the&#xD;
      clinical complications now, so conducting CAR-T clinical trials has a strong demand and&#xD;
      value. This study aims to evaluate the safety and efficacy of CD19-CART in treating&#xD;
      refractory or recurrent ALL.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 2016</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">October 2021</primary_completion_date>
  <phase>Phase 1</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>Number of Adverse Events</measure>
    <time_frame>8 weeks</time_frame>
    <description>To evaluate the safety of CAR-T cells in adult patients with B-acute lymphoblastic leukemia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical responses to third generation CAR-T cells</measure>
    <time_frame>2 years</time_frame>
    <description>To assess the anti-leukemic effect of CAR-T cells in adult patients with B cell-acute lymphoblastic leukemia</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">5</enrollment>
  <condition>Acute Lymphoblastic Leukemia</condition>
  <arm_group>
    <arm_group_label>CAR-T cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Targeting CD19</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CAR-T cells</intervention_name>
    <description>Given IV</description>
    <arm_group_label>CAR-T cells</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18-65 years&#xD;
&#xD;
          -  Patients with Cluster of Differentiation 19 (CD19) positive B cell malignancies as&#xD;
             confirmed by flow cytometry&#xD;
&#xD;
          -  Refractory or relapsed B cell-acute lymphoblastic leukemia&#xD;
&#xD;
          -  No available curative treatment options (such as hematopoietic stem cell&#xD;
             transplantation)&#xD;
&#xD;
          -  Stage III-IV disease&#xD;
&#xD;
          -  Creatinine &lt; 2.5 mg/dl&#xD;
&#xD;
          -  Aspartate transaminase-alanine transaminase ratio &lt; 3x normal&#xD;
&#xD;
          -  Bilirubin &lt; 2.0 mg/dl&#xD;
&#xD;
          -  Karnofsky performance status &gt;= 60&#xD;
&#xD;
          -  Expected survival time &gt; 3 months&#xD;
&#xD;
          -  Adequate venous access for apheresis&#xD;
&#xD;
          -  Ability to understand and provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Patients requiring T cell immunosuppressive therapy&#xD;
&#xD;
          -  Active central nervous system leukemia&#xD;
&#xD;
          -  Any concurrent active malignancies&#xD;
&#xD;
          -  Patients with a history of a seizure disorder or cardiac disorder&#xD;
&#xD;
          -  Patients with human immunodeficiency virus, hepatitis B or C infection&#xD;
&#xD;
          -  Uncontrolled active infection&#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>Liangding Hu, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Affiliated Hospital to Academy of Military Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yao Sun, M.D., Ph.D.</last_name>
    <phone>+86-010-6694-7402</phone>
    <email>suny320@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Liangding Hu, M.D.</last_name>
    <phone>+86-010-6694-7107</phone>
    <email>huliangding@sohu.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Hematopoietic Stem Cell Transplantation</name>
      <address>
        <city>Beijing</city>
        <zip>100071</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sun Yao, M.D., Ph.D.</last_name>
      <phone>+86-010-6694-7402</phone>
      <email>suny320@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>February 6, 2021</last_update_submitted>
  <last_update_submitted_qc>February 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2021</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>Leukemia</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Leukemia, Lymphoid</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/NCT02186860
org study id: 307-CTC-CAR T
nct id: NCT02186860
lead sponsor: 
has dmc: Yes
Traditional standard treatments of B cell acute lymphoblastic leukemia is not perfect for
      fighting cancer. Many people do not respond to the standard treatments of ALL. One possible
      treatment is chimeric antigen receptor (CAR) modified T cell infusions. This study aims to
      evaluate the safety and efficacy of novel CARTs (targeting CD19) in the treatment of
      refractory or recurrent ALL.The investigators start Phase I study aimed to chemotherapy
      resistant or refractory acute lymphoblastic leukemia patients. The purpose of this study is
      to assess the safety and effectiveness of CAR-T cells in patients.
CAR-T has stronger effect of anti-tumor capacity. While people have been able to control the
      clinical complications now, so conducting CAR-T clinical trials has a strong demand and
      value. This study aims to evaluate the safety and efficacy of CD19-CART in treating
      refractory or recurrent ALL.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Adverse Events
time frame: 8 weeks
description: To evaluate the safety of CAR-T cells in adult patients with B-acute lymphoblastic leukemia
measure: Clinical responses to third generation CAR-T cells
time frame: 2 years
description: To assess the anti-leukemic effect of CAR-T cells in adult patients with B cell-acute lymphoblastic leukemia
arm group label: CAR-T cells
arm group type: Experimental
description: Targeting CD19
intervention type: Biological
intervention name: CAR-T cells
description: Given IV
arm group label: CAR-T cells
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Liangding Hu, M.D.
role: Principal Investigator
affiliation: Affiliated Hospital to Academy of Military Medical Sciences
last name: Yao Sun, M.D., Ph.D.
phone: +86-010-6694-7402
email: suny320@126.com
last name: Liangding Hu, M.D.
phone: +86-010-6694-7107
email: huliangding@sohu.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphoid