<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/NCT04435743</url>
  </required_header>
  <id_info>
    <org_study_id>LEN-NHL</org_study_id>
    <nct_id>NCT04435743</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Lenalidomide With or Without Rituximab and Other Drugs in B-cell Non-Hodgkin's Lymphomas</brief_title>
  <official_title>The Efficacy and Safety of Lenalidomide With or Without Rituximab and Other Drugs in B-cell Non-Hodgkin Lymphomas: a Real-world Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ruijin Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Describe the treatment of B-cell non-Hodgkin lymphoma patients who receive lenalidomide&#xD;
      single drug or lenalidomide combined with rituximab (with or without other drugs), and&#xD;
      evaluate the efficacy and safety of lenalidomide single drug or lenalidomide combined with&#xD;
      rituximab (with or without other drugs) in the real-world setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center prospective, observational real-world study, targeting patients with&#xD;
      B-cell non-Hodgkin's lymphomas. This study is designed to evaluate the efficacy and safety of&#xD;
      lenalidomide single drug or lenalidomide combined with rituximab (with or without other&#xD;
      drugs) in the real-world setting.&#xD;
&#xD;
      This study will mainly focus on the following three cohorts:&#xD;
&#xD;
      Cohort 1: patients diagnosed with CD20-positive diffuse large B-cell lymphoma; Cohort 2:&#xD;
      patients diagnosed with CD20-positive follicle lymphoma; Cohort 3: patients on maintenance&#xD;
      treatment who have achieved complete remission or partial remission after induction therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>Objective response rate</measure>
    <time_frame>At the end of Cycle 6 (each cycle is 21-28 days)</time_frame>
    <description>Rate of objective response, defined according to Lugano 2014 criterion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complete response rate</measure>
    <time_frame>At the end of Cycle 6 (each cycle is 21-28 days)</time_frame>
    <description>Rate of complete response, defined according to Lugano 2014 criterion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Partial response rate</measure>
    <time_frame>At the end of Cycle 6 (each cycle is 21-28 days)</time_frame>
    <description>Rate of partial response, defined according to Lugano 2014 criterion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>From response evaluation to study completion, an average of 2 years.</time_frame>
    <description>Time to relapse or progression, measured from documentation of response, in CR or PR patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2-year progression-free survival</measure>
    <time_frame>2 years after entry onto study</time_frame>
    <description>The rate of patients who are free of disease progression or death as a result of any cause, measured from entry onto study, in all patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From entry onto study to study completion, an average of 2 years.</time_frame>
    <description>Death as a result of any cause, measured from entry onto study, in all patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse event</measure>
    <time_frame>From entry onto study to study completion, an average of 2 years.</time_frame>
    <description>any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe adverse event</measure>
    <time_frame>From entry onto study to study completion, an average of 2 years.</time_frame>
    <description>An adverse event when the patient outcome is death, life-threatening, required intervention to prevent permanent impairment or damage, hospitalization, disability or permanent damage, congenital anomaly or birth defect, or other important medical events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dosage adjustment</measure>
    <time_frame>From entry onto study to study completion, an average of 2 years.</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Non-hodgkin Lymphoma,B Cell</condition>
  <arm_group>
    <arm_group_label>DLBCL</arm_group_label>
    <description>Treatment-naive or relapsed/refractory CD20+ diffuse large B-cell lymphoma patients who receive induction therapy containing lenalidomide.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FL/MCL/MZL</arm_group_label>
    <description>Treatment-naive or relapsed/refractory CD20+ follicular lymphoma, mantle cell lymphoma and marginal zone lymphoma patients who receive induction therapy containing lenalidomide.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maintenance</arm_group_label>
    <description>B-cell non-Hodgkin lymphoma patients who achieve complete or partial remission after induction therapy and receive maintenance therapy containing lenalidomide.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenalidomide</intervention_name>
    <description>Lenalidomide is given as any following dosage:&#xD;
25mg, PO QD, Day 1-10 in every 21 days for 6 cycles;&#xD;
15mg, PO QD, Day 1-14 in every 21 days for 6 cycles;&#xD;
25mg, PO QD, Day 1-10 in every 21 days for 1 year;&#xD;
25mg, PO QD, Day 1-21 in every 28 days for 1 year;&#xD;
25mg, PO QD, Day 1-10 in every 28 days for 12 cycles;&#xD;
20mg, PO QD, Day 1-21 in every 28 days for 12 cycles.</description>
    <arm_group_label>DLBCL</arm_group_label>
    <arm_group_label>FL/MCL/MZL</arm_group_label>
    <arm_group_label>Maintenance</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study focus on patients diagnosed with B-cell non-Hodgkin's lymphoma and treated with&#xD;
        lenalidomide single drug or lenalidomide combined with rituximab (with or without other&#xD;
        drugs) in the real-world setting.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed as B-cell non-Hodgkin's lymphoma&#xD;
&#xD;
          -  Voluntary participation in this study and the signing of an informed consent form&#xD;
&#xD;
          -  The researchers assessed that the patient will benefit from the treatment of&#xD;
             lenalidomide single drug or lenalidomide combined with rituximab (with or without&#xD;
             other drugs)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contradictions to any drug in the treatment regimen&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Patients who were not considered suitable for the study by the researchers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Weili Zhao, M.D. and Ph.D</last_name>
    <phone>+8613512112076</phone>
    <email>zhao.weili@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai Ruijin Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weili Zhao, M.D. and Ph.D</last_name>
      <phone>13512112076</phone>
      <email>zhao.weili@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>July 6, 2020</last_update_submitted>
  <last_update_submitted_qc>July 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ruijin Hospital</investigator_affiliation>
    <investigator_full_name>Zhao Weili</investigator_full_name>
    <investigator_title>First Deputy Director of Shanghai Institute of Hematology</investigator_title>
  </responsible_party>
  <keyword>lenalidomide</keyword>
  <keyword>Non-hodgkin Lymphoma,B Cell</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lenalidomide</mesh_term>
  </intervention_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/NCT04435743
org study id: LEN-NHL
nct id: NCT04435743
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Describe the treatment of B-cell non-Hodgkin lymphoma patients who receive lenalidomide
      single drug or lenalidomide combined with rituximab (with or without other drugs), and
      evaluate the efficacy and safety of lenalidomide single drug or lenalidomide combined with
      rituximab (with or without other drugs) in the real-world setting.
This is a multi-center prospective, observational real-world study, targeting patients with
      B-cell non-Hodgkin's lymphomas. This study is designed to evaluate the efficacy and safety of
      lenalidomide single drug or lenalidomide combined with rituximab (with or without other
      drugs) in the real-world setting.

      This study will mainly focus on the following three cohorts:

      Cohort 1: patients diagnosed with CD20-positive diffuse large B-cell lymphoma; Cohort 2:
      patients diagnosed with CD20-positive follicle lymphoma; Cohort 3: patients on maintenance
      treatment who have achieved complete remission or partial remission after induction therapy.
observational model: Cohort
time perspective: Prospective
measure: Objective response rate
time frame: At the end of Cycle 6 (each cycle is 21-28 days)
description: Rate of objective response, defined according to Lugano 2014 criterion.
measure: Complete response rate
time frame: At the end of Cycle 6 (each cycle is 21-28 days)
description: Rate of complete response, defined according to Lugano 2014 criterion
measure: Partial response rate
time frame: At the end of Cycle 6 (each cycle is 21-28 days)
description: Rate of partial response, defined according to Lugano 2014 criterion
measure: Duration of response
time frame: From response evaluation to study completion, an average of 2 years.
description: Time to relapse or progression, measured from documentation of response, in CR or PR patients
measure: 2-year progression-free survival
time frame: 2 years after entry onto study
description: The rate of patients who are free of disease progression or death as a result of any cause, measured from entry onto study, in all patients
measure: Overall survival
time frame: From entry onto study to study completion, an average of 2 years.
description: Death as a result of any cause, measured from entry onto study, in all patients
measure: Adverse event
time frame: From entry onto study to study completion, an average of 2 years.
description: any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
measure: Severe adverse event
time frame: From entry onto study to study completion, an average of 2 years.
description: An adverse event when the patient outcome is death, life-threatening, required intervention to prevent permanent impairment or damage, hospitalization, disability or permanent damage, congenital anomaly or birth defect, or other important medical events
measure: Dosage adjustment
time frame: From entry onto study to study completion, an average of 2 years.
arm group label: DLBCL
description: Treatment-naive or relapsed/refractory CD20+ diffuse large B-cell lymphoma patients who receive induction therapy containing lenalidomide.
arm group label: FL/MCL/MZL
description: Treatment-naive or relapsed/refractory CD20+ follicular lymphoma, mantle cell lymphoma and marginal zone lymphoma patients who receive induction therapy containing lenalidomide.
arm group label: Maintenance
description: B-cell non-Hodgkin lymphoma patients who achieve complete or partial remission after induction therapy and receive maintenance therapy containing lenalidomide.
intervention type: Drug
intervention name: Lenalidomide
description: Lenalidomide is given as any following dosage:
25mg, PO QD, Day 1-10 in every 21 days for 6 cycles;
15mg, PO QD, Day 1-14 in every 21 days for 6 cycles;
25mg, PO QD, Day 1-10 in every 21 days for 1 year;
25mg, PO QD, Day 1-21 in every 28 days for 1 year;
25mg, PO QD, Day 1-10 in every 28 days for 12 cycles;
20mg, PO QD, Day 1-21 in every 28 days for 12 cycles.
arm group label: DLBCL
arm group label: FL/MCL/MZL
arm group label: Maintenance
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Weili Zhao, M.D. and Ph.D
phone: +8613512112076
email: zhao.weili@yahoo.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Ruijin Hospital
investigator full name: Zhao Weili
investigator title: First Deputy Director of Shanghai Institute of Hematology
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Lymphoma, B-Cell
mesh term: Lenalidomide