<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/NCT04489264</url>
  </required_header>
  <id_info>
    <org_study_id>ASCT for PTCL</org_study_id>
    <nct_id>NCT04489264</nct_id>
  </id_info>
  <brief_title>The Role of Consolidative Autologous Stem Cell Transplantation After First-line Therapy in Peripheral T Cell Lymphoma</brief_title>
  <official_title>A Prospective Study of Consolidative Autologous Stem Cell Transplantation After First-line Therapy in Peripheral T Cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University</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 role of autologous stem cell transplantation (ASCT) in the first remission (CR1 &amp; PR1) of&#xD;
      peripheral T-cell lymphomas (PTCLs) is not well defined. This study analyzed the impact of&#xD;
      ASCT on the clinical outcomes of patients with newly diagnosed PTCL in CR1 and PR1.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">November 30, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>PFS</measure>
    <time_frame>2-year PFS</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Peripheral T Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>ASCT group</arm_group_label>
    <description>patients who achieved CR or PR after 6-8 cycles first-line therapy receive ASCT as consolidation therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observation group</arm_group_label>
    <description>patients who achieved CR or PR after 6-8 cycles first-line therapy finish their therapy and go into follow-up</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Transplant, Autologous</intervention_name>
    <description>high dose chemotherapy followed by autologous stem cell transplantation</description>
    <arm_group_label>ASCT group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        lymphoma patients in several hospitals in China&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with confirmed pathological diagnosis of aggressive PTCL&#xD;
&#xD;
          -  Age 18-65 years old&#xD;
&#xD;
          -  Achieving CR or PR after first-line therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subtypes with a more indolent course, including precursor T/natural killer neoplasms,&#xD;
             T-cell large granular lymphocytic leukemia, mycosis fungoides other than transformed&#xD;
             mycosis fungoides, Sézary syndrome, and primary cutaneous CD30-positive disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Jun Zhu, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Cancer Hospital &amp; Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jun Zhu, Dr.</last_name>
    <phone>+86-13910333346</phone>
    <email>zhu-jun2017@outlook.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Meng Wu</last_name>
      <phone>+861088196109</phone>
      <email>lxywumeng@foxmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>December 2, 2020</last_update_submitted>
  <last_update_submitted_qc>December 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Jun Zhu</investigator_full_name>
    <investigator_title>Party secretary of Cancer Hospital of Peking University, Director of Internal Medicine</investigator_title>
  </responsible_party>
  <keyword>Autologous Stem Cell Transplantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, T-Cell</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Peripheral</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/NCT04489264
org study id: ASCT for PTCL
nct id: NCT04489264
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The role of autologous stem cell transplantation (ASCT) in the first remission (CR1 & PR1) of
      peripheral T-cell lymphomas (PTCLs) is not well defined. This study analyzed the impact of
      ASCT on the clinical outcomes of patients with newly diagnosed PTCL in CR1 and PR1.
observational model: Cohort
time perspective: Prospective
measure: PFS
time frame: 2-year PFS
arm group label: ASCT group
description: patients who achieved CR or PR after 6-8 cycles first-line therapy receive ASCT as consolidation therapy
arm group label: Observation group
description: patients who achieved CR or PR after 6-8 cycles first-line therapy finish their therapy and go into follow-up
intervention type: Drug
intervention name: Transplant, Autologous
description: high dose chemotherapy followed by autologous stem cell transplantation
arm group label: ASCT group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
last name: Jun Zhu, Dr.
role: Principal Investigator
affiliation: Peking University Cancer Hospital & Institute
last name: Jun Zhu, Dr.
phone: +86-13910333346
email: zhu-jun2017@outlook.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Jun Zhu
investigator title: Party secretary of Cancer Hospital of Peking University, Director of Internal Medicine
mesh term: Lymphoma
mesh term: Lymphoma, T-Cell
mesh term: Lymphoma, T-Cell, Peripheral
sharing ipd: No