<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/NCT04432402</url>
  </required_header>
  <id_info>
    <org_study_id>2019-SR-443</org_study_id>
    <nct_id>NCT04432402</nct_id>
  </id_info>
  <brief_title>Lenalidomide in Combination With R-GemOx in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma</brief_title>
  <official_title>Efficacy and Safety of Lenalidomide in Combination With R-GemOx in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital with Nanjing Medical 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>
      The purpose of this study is to investigate efficacy and safety of Lenalidomide in&#xD;
      combination with R-GemOx as first-line treatment of elderly patients with Diffuse large B&#xD;
      cell lymphoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gemcitabine and Oxaliplatin(GemOx) shows effective activity in patients with relapsed diffuse&#xD;
      large-cell lymphoma and other solid tumors. The purpose of this study is to investigate&#xD;
      efficacy and safety of Lenalidomide in combination with R-GemOx as first-line treatment of&#xD;
      elderly patients with Diffuse large B cell lymphoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">June 14, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Maximum tolerated dose</measure>
    <time_frame>at the end of the first cycle of R2-GemOx (each cycle is 14 days)</time_frame>
    <description>Maximum tolerated dose</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dose limiting toxicity</measure>
    <time_frame>28 days</time_frame>
    <description>Dose limiting toxicity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dose limiting toxicity</measure>
    <time_frame>2 years</time_frame>
    <description>Dose limiting toxicity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>progression-free survival</measure>
    <time_frame>2 years</time_frame>
    <description>progression-free survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>2 years</time_frame>
    <description>overall survival</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">124</enrollment>
  <condition>Diffuse Large B Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>Lenalidomide in Combination With R-GemOx</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lenalidomide 10mg、15mg、20mg、25mg qd PO d1-7 Rituximab 375mg/m2 ivd d0 Gemcitabine 1g/m2 ivd d1 Oxaliplatin 100mg/m2 ivd d1 every14 days as a cycle</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenalidomide</intervention_name>
    <description>Lenalidomide: 10mg、15mg、20mg、25mg qd PO day 1-7, Rituximab: 375 mg/m2 IV day0, Gemcitabine :1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1 (every 14 days as a cycle)</description>
    <arm_group_label>Lenalidomide in Combination With R-GemOx</arm_group_label>
    <other_name>Rituximab, Gemcitabine, oxaliplatin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The histopathologic diagnosis was DLBCL (except primary mediastinal large B cell&#xD;
             lymphoma, primary central lymphoma, HIV related lymphoma).&#xD;
&#xD;
          2. Age older than 70 years or older than 60 years with Eastern Cooperative Oncology&#xD;
             Group(ECOG) performance status(PS) ≥ 2;&#xD;
&#xD;
          3. Expected survival ≥ 12 weeks;&#xD;
&#xD;
          4. At least a measurable or evaluable disease at the time of enrolment (diameter ≥1.5cm);&#xD;
&#xD;
          5. Understand and voluntarily sign an informed consent form, able to adhere to the study&#xD;
             visit schedule and other protocol requirements;&#xD;
&#xD;
          6. All patients must agree to take effective contraceptive measures during the trial&#xD;
             measures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital&#xD;
             immune deficiency diseases, including but not limited to HIV infected persons&#xD;
&#xD;
          2. Patients known to have varicella or herpes zoster virus infection&#xD;
&#xD;
          3. Previous exposure to any anti-tumor therapy&#xD;
&#xD;
          4. Poor hepatic and/or renal function, unless these abnormalities were related to the&#xD;
             lymphoma&#xD;
&#xD;
          5. Poor bone-marrow reserve, defined as neutrophil count less than 1.5×109/L or platelet&#xD;
             count less than 75×109/L, unless caused by bone marrow infiltration&#xD;
&#xD;
          6. History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within past 12 months&#xD;
&#xD;
          7. New York Heart Association class III or IV cardiac failure; or Ejection fraction less&#xD;
             than 50%;or history of following disease in past 6 months: acute coronary&#xD;
             syndrome#acute heart failure#severe ventricular arrhythmia&#xD;
&#xD;
          8. Central nervous system (CNS) or meningeal involvement&#xD;
&#xD;
          9. Known sensitivity or allergy to investigational product&#xD;
&#xD;
         10. Major surgery within three weeks&#xD;
&#xD;
         11. Patients receiving organ transplantation&#xD;
&#xD;
         12. Patients with secondary tumour, excluding cured (5 years without relapse) in situ&#xD;
             Non-melanoma skin cancer. superficial bladder cancer, in situ cervical cancer,&#xD;
             Gastrointestinal intramucous carcinoma and breast cancer&#xD;
&#xD;
         13. Presence of Grade III nervous toxicity within past two weeks&#xD;
&#xD;
         14. Active and severe infectious diseases&#xD;
&#xD;
         15. Any potential drug abuse, medical, psychological or social conditions which may&#xD;
             disturb this investigation and assessment&#xD;
&#xD;
         16. In any conditions which investigator considered ineligible for this study.&#xD;
&#xD;
         17. Histologic transformation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wei Xu, M.D., Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Li Wang, M.D</last_name>
    <phone>+862568136034</phone>
    <email>lilyw7878@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wei Xu, M.D., Ph.D</last_name>
    <phone>+862568136034</phone>
    <email>xuwei0484@jsph.org.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Li Wang, M.D., Ph.D</last_name>
      <phone>86 25 68306034</phone>
      <email>lilyw7878@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Wei Xu, M.D., Ph.D</last_name>
      <phone>86 25 68306034</phone>
      <email>xuwei10000@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 13, 2020</last_update_submitted>
  <last_update_submitted_qc>June 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital with Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>WEI XU</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>R-Gemox</keyword>
  <keyword>Lenalidomide</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Lenalidomide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT04432402
org study id: 2019-SR-443
nct id: NCT04432402
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate efficacy and safety of Lenalidomide in
      combination with R-GemOx as first-line treatment of elderly patients with Diffuse large B
      cell lymphoma.
Gemcitabine and Oxaliplatin(GemOx) shows effective activity in patients with relapsed diffuse
      large-cell lymphoma and other solid tumors. The purpose of this study is to investigate
      efficacy and safety of Lenalidomide in combination with R-GemOx as first-line treatment of
      elderly patients with Diffuse large B cell lymphoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum tolerated dose
time frame: at the end of the first cycle of R2-GemOx (each cycle is 14 days)
description: Maximum tolerated dose
measure: Dose limiting toxicity
time frame: 28 days
description: Dose limiting toxicity
measure: Dose limiting toxicity
time frame: 2 years
description: Dose limiting toxicity
measure: progression-free survival
time frame: 2 years
description: progression-free survival
measure: overall survival
time frame: 2 years
description: overall survival
arm group label: Lenalidomide in Combination With R-GemOx
arm group type: Experimental
description: Lenalidomide 10mg、15mg、20mg、25mg qd PO d1-7 Rituximab 375mg/m2 ivd d0 Gemcitabine 1g/m2 ivd d1 Oxaliplatin 100mg/m2 ivd d1 every14 days as a cycle
intervention type: Drug
intervention name: Lenalidomide
description: Lenalidomide: 10mg、15mg、20mg、25mg qd PO day 1-7, Rituximab: 375 mg/m2 IV day0, Gemcitabine :1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1 (every 14 days as a cycle)
arm group label: Lenalidomide in Combination With R-GemOx
other name: Rituximab, Gemcitabine, oxaliplatin
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Wei Xu, M.D., Ph.D
role: Principal Investigator
affiliation: The First Affiliated Hospital with Nanjing Medical University
last name: Li Wang, M.D
phone: +862568136034
email: lilyw7878@163.com
last name: Wei Xu, M.D., Ph.D
phone: +862568136034
email: xuwei0484@jsph.org.cn
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The First Affiliated Hospital with Nanjing Medical University
investigator full name: WEI XU
investigator title: Professor
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Gemcitabine
mesh term: Oxaliplatin
mesh term: Lenalidomide
sharing ipd: Yes