<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/NCT03027739</url>
  </required_header>
  <id_info>
    <org_study_id>CART-19-02</org_study_id>
    <nct_id>NCT03027739</nct_id>
  </id_info>
  <brief_title>CART-19 Cells For MRD Positive CD19+ ALL</brief_title>
  <acronym>CCFMPCA</acronym>
  <official_title>CART-19 Cells For Patients With Minimal Residual Disease (MRD) Positive CD19+ Acute Lymphoblastic Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fujian Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fujian Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      CART-19 cells has emerged as a powerful targeted immunotherapy, showing striking responses in&#xD;
      highly refractory CD19+ acute lymphoblastic leukemia (ALL). This study aims to assess the&#xD;
      safety and toxicity of CART-19 cells to patients who are refractory or at highest risk of&#xD;
      relapse as defined by MRD+ status.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Leukemia free survival</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events that are related to treatment</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Acute Lymphoblastic Leukemia</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CART-19 cells treated</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CART-19</intervention_name>
    <description>CART-19 cells treated</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed written informed consent&#xD;
&#xD;
          -  Aged between 1-60 years&#xD;
&#xD;
          -  Patients with MRD positive CD19+ ALL&#xD;
&#xD;
          -  Cardiac: Left ventricular ejection fraction ≥ 50%&#xD;
&#xD;
          -  Adequate renal and hepatic function&#xD;
&#xD;
          -  Performance status: Karnofsky ≥ 70%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating females.&#xD;
&#xD;
          -  Any co-morbidity precluding the administration of CART-19 cells.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jianda Hu, 86-13959169016</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fujian Medical University Union Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jianda Hu, Prof.M.D.Ph.D</last_name>
    <phone>86-13959169016</phone>
    <email>drjiandahu@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fujian Medical University Union Hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianda Hu, Prof.M.D.Ph.D</last_name>
      <phone>+86-13959169016</phone>
      <email>drjiandahu@163.com</email>
    </contact>
    <investigator>
      <last_name>Jianda Hu, Prof.M.D.Ph.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fujian Medical University</investigator_affiliation>
    <investigator_full_name>Jianda Hu</investigator_full_name>
    <investigator_title>Director of the department of Hematology</investigator_title>
  </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>
  <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/NCT03027739
org study id: CART-19-02
nct id: NCT03027739
lead sponsor: 
has dmc: No
CART-19 cells has emerged as a powerful targeted immunotherapy, showing striking responses in
      highly refractory CD19+ acute lymphoblastic leukemia (ALL). This study aims to assess the
      safety and toxicity of CART-19 cells to patients who are refractory or at highest risk of
      relapse as defined by MRD+ status.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Leukemia free survival
time frame: 1 year
measure: Adverse events that are related to treatment
time frame: 1 year
arm group label: Arm 1
arm group type: Experimental
description: CART-19 cells treated
intervention type: Biological
intervention name: CART-19
description: CART-19 cells treated
arm group label: Arm 1
criteria: 
gender: All
minimum age: 1 Year
maximum age: 60 Years
healthy volunteers: No
last name: Jianda Hu, 86-13959169016
role: Principal Investigator
affiliation: Fujian Medical University Union Hospital
last name: Jianda Hu, Prof.M.D.Ph.D
phone: 86-13959169016
email: drjiandahu@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fujian Medical University
investigator full name: Jianda Hu
investigator title: Director of the department of Hematology
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphoid
sharing ipd: No