<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/NCT03283111</url>
  </required_header>
  <id_info>
    <org_study_id>CSCO-LWP</org_study_id>
    <nct_id>NCT03283111</nct_id>
  </id_info>
  <brief_title>Correlation Analysis of T-lymphocyte Subsets and Prognosis in Autologous Stem Cell Transplantation (ASCT) for Lymphoma</brief_title>
  <official_title>Correlation Analysis of T-lymphocyte Subsets and Prognosis in Autologous Stem Cell Transplantation (ASCT) for Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University</source>
  <oversight_info>
    <has_dmc>No</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 retrospective, single-center, non-randomized, non-controlled study. This study aims&#xD;
      to explore the effect of T-lymphocyte subsets changes in immunologic reconstitution and&#xD;
      prognosis in lymphoma patients who were treated by autologous stem cell transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      High dose chemotherapy combined with autologous peripheral blood stem cell transplantation is&#xD;
      the consolidation treatment for advanced lymphoma patients and approved for treating&#xD;
      recurrent and refractory lymphoma by prolonging progression-free survival significantly while&#xD;
      also improving quality of life. Evidences to date, have validated that changes of&#xD;
      T-lymphocyte subsets after autologous stem cell transplantation associated closely with&#xD;
      immunologic reconstitution, and have produced amazing effects in prognosis. Whether&#xD;
      T-lymphocyte subsets changes could serve as an effective index for prognosis has been a&#xD;
      serious question for lymphoma patients treated by autologous stem cell transplantation. In&#xD;
      this study, the investigators explore the changes of T-lymphocyte subsets in lymphoma&#xD;
      patients before and after autologous stem cell transplantation, and evaluate the significant&#xD;
      effect of T-lymphocyte subsets changes in immunologic reconstitution and prognosis in these&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">July 2018</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</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>Progression-free survival</measure>
    <time_frame>2 years</time_frame>
    <description>Progression-free survival serves as an effective index to analysis the correlation of T-lymphocyte subsets and prognosis. And it would be measured within 2 years.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>2 years</time_frame>
    <description>The investigators would measure the overall survival of participants within 2 years. Overall survival serves as an effective index to analysis the correlation of T-lymphocyte subsets and prognosis.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Lymphoma</condition>
  <arm_group>
    <arm_group_label>autologous stem cell transplantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lymphoma patients received autologous stem cell transplantation for the first time</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>autologous stem cell transplantation</intervention_name>
    <description>autologous stem cell transplantation</description>
    <arm_group_label>autologous stem cell transplantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women≥18 years, &lt;65 years;&#xD;
&#xD;
          2. Lymphoma patients treated by autologous stem cell transplantation for the first time;&#xD;
&#xD;
          3. ECOG ≤ 2;&#xD;
&#xD;
          4. Ccr ≥ 50 ml/min;&#xD;
&#xD;
          5. ALT, AST and TBIL≤2.5-fold upper normal range;&#xD;
&#xD;
          6. Satisfactory heart and lung function;&#xD;
&#xD;
          7. Women of reproductive potential must have a negative pregnancy test. Male and female&#xD;
             of reproductive potential must agree to practice birth control during the study and&#xD;
             one year post study;&#xD;
&#xD;
          8. Good compliance and sighed informed consent voluntarily.&#xD;
&#xD;
        Patients should be conformed to all inclusion criteria above.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior autologous/ allogeneic hematopoietic stem cell transplantation for lymphoma;&#xD;
&#xD;
          2. Senior or uncontrolled virus injection: HIV, TP, hepatitis virus;&#xD;
&#xD;
          3. Serious complications;&#xD;
&#xD;
          4. LVEF&lt;55%;&#xD;
&#xD;
          5. Atopy or allergy to biological product derived from colibacillus;&#xD;
&#xD;
          6. Women who are breastfeeding, pregnant or refused to practice contraception;&#xD;
&#xD;
          7. Severe mental or nervous system diseases;&#xD;
&#xD;
          8. Severe abnormalities of heart, lung and central nervous system symptoms;&#xD;
&#xD;
          9. Patients with sickle cell disease, erythronoclastic anemia or other hematological&#xD;
             disease which has an impact on medullary hematopoiesis;&#xD;
&#xD;
         10. Enrolled in other study currently or 30 days before screen;&#xD;
&#xD;
         11. Patients, in the opinion of investigators, may not be eligible or are not able to&#xD;
             comply with the study.&#xD;
&#xD;
        Patients conformed to any of above criteria should be excluded from this study.&#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_contact>
    <last_name>Weiping Liu, MD</last_name>
    <phone>8613522796323</phone>
    <email>dreaming2217@126.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>Jun Zhu, MD</last_name>
      <phone>+86-10-88196596</phone>
      <email>zj@bjcancer.org</email>
    </contact>
    <contact_backup>
      <last_name>Weiping Liu, MD</last_name>
      <phone>+86-10-88196109</phone>
      <email>dreaming2217@126.com</email>
    </contact_backup>
    <investigator>
      <last_name>Jun Zhu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>July 24, 2018</last_update_submitted>
  <last_update_submitted_qc>July 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2018</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>Principal Investigator, Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</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/NCT03283111
org study id: CSCO-LWP
nct id: NCT03283111
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a retrospective, single-center, non-randomized, non-controlled study. This study aims
      to explore the effect of T-lymphocyte subsets changes in immunologic reconstitution and
      prognosis in lymphoma patients who were treated by autologous stem cell transplantation.
High dose chemotherapy combined with autologous peripheral blood stem cell transplantation is
      the consolidation treatment for advanced lymphoma patients and approved for treating
      recurrent and refractory lymphoma by prolonging progression-free survival significantly while
      also improving quality of life. Evidences to date, have validated that changes of
      T-lymphocyte subsets after autologous stem cell transplantation associated closely with
      immunologic reconstitution, and have produced amazing effects in prognosis. Whether
      T-lymphocyte subsets changes could serve as an effective index for prognosis has been a
      serious question for lymphoma patients treated by autologous stem cell transplantation. In
      this study, the investigators explore the changes of T-lymphocyte subsets in lymphoma
      patients before and after autologous stem cell transplantation, and evaluate the significant
      effect of T-lymphocyte subsets changes in immunologic reconstitution and prognosis in these
      patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival
time frame: 2 years
description: Progression-free survival serves as an effective index to analysis the correlation of T-lymphocyte subsets and prognosis. And it would be measured within 2 years.
measure: Overall survival
time frame: 2 years
description: The investigators would measure the overall survival of participants within 2 years. Overall survival serves as an effective index to analysis the correlation of T-lymphocyte subsets and prognosis.
arm group label: autologous stem cell transplantation
arm group type: Experimental
description: Lymphoma patients received autologous stem cell transplantation for the first time
intervention type: Biological
intervention name: autologous stem cell transplantation
description: autologous stem cell transplantation
arm group label: autologous stem cell transplantation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Weiping Liu, MD
phone: 8613522796323
email: dreaming2217@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Jun Zhu
investigator title: Principal Investigator, Clinical Professor
mesh term: Lymphoma