<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/NCT02227251</url>
  </required_header>
  <id_info>
    <org_study_id>KCP-330-009</org_study_id>
    <secondary_id>2014-001977-15</secondary_id>
    <nct_id>NCT02227251</nct_id>
  </id_info>
  <brief_title>Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)</brief_title>
  <official_title>A Phase 2b Open-label Study of Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karyopharm Therapeutics Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karyopharm Therapeutics Inc</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>
      A multicenter, open-label Phase 2b study of selinexor (KPT-330) in participants with&#xD;
      relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have no therapeutic&#xD;
      options of demonstrated clinical benefit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, open label, Phase 2b study of the selective inhibitor of nuclear&#xD;
      export (SINE) selinexor (40 or 60 milligrams [mg]) given orally (PO) to participants with R/R&#xD;
      DLBCL). The study is being conducted in 2 parts (Part 1 and Part 2). For Part 1, a fixed 60&#xD;
      mg dose of selinexor is given orally to 130 participants with R/R DLBCL who have no&#xD;
      therapeutic options of demonstrated clinical benefit and who meet eligibility criteria and&#xD;
      have none of the exclusion criteria will be enrolled to receive selinexor until either&#xD;
      disease progression or intolerance has occurred. For Part 2, approximately 110 participants&#xD;
      (55 in each arm) are planned to be enrolled. Participants will be randomized (open label) in&#xD;
      a 1:1 ratio to either Arm A (40 mg) or Arm B (60 mg) and will be stratified based on history&#xD;
      of prior autologous stem cell transplantation (ASCT) versus no prior ASCT. All the&#xD;
      participants will be followed until disease progression and/or death.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Anticipated">November 2027</completion_date>
  <primary_completion_date type="Anticipated">April 2027</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Part 1: Overall Response Rate (ORR)</measure>
    <time_frame>One year</time_frame>
    <description>Assessed according to the revised response criteria based on the Guidelines of the International Working Group (IWG).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Overall Response Rate (ORR) Based on Lugano Criteria</measure>
    <time_frame>From initial randomization until date of disease progression or death (maximum of 1 year from Part 2 randomization)</time_frame>
    <description>Assessed according to the response assessment of lymphoma based on Lugano classification.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part 1: Duration of Response (DOR)</measure>
    <time_frame>From time of first response until disease progression or death (maximum of 1 year from Part 1 randomization)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Disease Control Rate (DCR)</measure>
    <time_frame>From initial response until disease progression or death (maximum of 1 year from Part 1 randomization)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs)</measure>
    <time_frame>From Baseline up to 30 days after last dose (maximum of 1 year from Part 1 randomization)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Number of Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status</measure>
    <time_frame>From Baseline up to 30 days after last dose (maximum of 1 year from Part 1 randomization)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Duration of response (DOR)</measure>
    <time_frame>From time of first response (Part 2) until disease progression or death (maximum of 1 year from Part 2 randomization)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Disease control rate (DCR)</measure>
    <time_frame>From initial response (Part 2) until disease progression or death (maximum of 1 year from Part 2 randomization)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Overall Response Rate (ORR) Based on Modified Lugano Criteria</measure>
    <time_frame>From initial randomization until date of disease progression or death (maximum of 1 year from Part 2 randomization)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Number of Participants with Treatment-emergent Adverse Events</measure>
    <time_frame>From Baseline up to 30 days after last dose (maximum of 1 year from Part 2 randomization)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Number of Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status</measure>
    <time_frame>From Baseline up to 30 days after last dose (maximum of 1 year from Part 2 randomization)</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">244</enrollment>
  <condition>Diffuse Large B-cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>Part 1: Selinexor 60 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received fixed dose of 60 mg selinexor orally, twice weekly (BIW) on Days 1 and 3 (e.g., Monday and Wednesday or Tuesday and Thursday, etc.) of Weeks 1-4 of each four week (each cycle of 28 days) cycle (total of 8 doses per cycle).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Arm A-Selinexor 40 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received selinexor 40 mg orally BIW on Days 1 and 3 of each week of 4-week treatment cycles (28 days) until disease progression (total of 8 doses per cycle).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Arm B-Selinexor 60 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received selinexor 60 mg orally BIW on Days 1 and 3 of each week of 4-week treatment cycles) for 2 cycles (each cycle of 28 days) followed by 60 mg once weekly (QW) in the subsequent cycles until disease progression (total of 8 doses per cycle).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Selinexor</intervention_name>
    <description>Dose: 60 mg (BIW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral</description>
    <arm_group_label>Part 1: Selinexor 60 mg</arm_group_label>
    <other_name>KPT-330</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Selinexor</intervention_name>
    <description>Dose: 40 mg (BIW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral</description>
    <arm_group_label>Part 2: Arm A-Selinexor 40 mg</arm_group_label>
    <other_name>KPT-330</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Selinexor</intervention_name>
    <description>Dose: 60 mg (BIW) and 60 mg (QW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral</description>
    <arm_group_label>Part 2: Arm B-Selinexor 60 mg</arm_group_label>
    <other_name>KPT-330</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (Parts 1 and 2):&#xD;
&#xD;
          -  Written informed consent in accordance with federal, local, and institutional&#xD;
             guidelines. The participant must provide informed consent prior to the first screening&#xD;
             procedure.&#xD;
&#xD;
          -  Age greater than or equal to (≥) 18 years.&#xD;
&#xD;
          -  ECOG performance status of less than or equal to (≤) 2.&#xD;
&#xD;
          -  Participants should have estimated life expectancy of greater than (&gt;) 3 months at&#xD;
             study entry.&#xD;
&#xD;
          -  Previously treated, pathologically confirmed de novo DLBCL, or DLBCL transformed from&#xD;
             previously diagnosed indolent lymphoma (e.g., follicular lymphoma).&#xD;
&#xD;
          -  Participants must have received at least 2 but no more than 5 previous systemic&#xD;
             regimens for the treatment of their de novo or transformed DLBCL including (i) at&#xD;
             least 1 course of anthracycline-based chemotherapy (unless absolutely contraindicated&#xD;
             due to cardiac dysfunction, in which case other active agents such as etoposide,&#xD;
             bendamustine, or gemcitabine must have been given) and (ii) at least 1 course of&#xD;
             anti-CD20 immunotherapy (e.g., rituximab), unless contraindicated due to severe&#xD;
             toxicity. Participants who were considered ineligible for standard multi-agent&#xD;
             immunochemotherapy must have received at least 2 and no more than 5 prior treatment&#xD;
             regimens including at least 1 course of anti-CD20 antibodies and must be approved by&#xD;
             the Medical Monitor. Prior stem cell transplantation is allowed; induction,&#xD;
             consolidation, stem cell collection, preparative regimen and transplantation ±&#xD;
             maintenance are considered a single line of therapy.&#xD;
&#xD;
          -  Female participants of child-bearing potential must have a negative serum pregnancy&#xD;
             test at screening and agree to use reliable methods of contraception for 3 months&#xD;
             after their last dose of medication. Male participants must use a reliable method of&#xD;
             contraception if sexually active with a female of child-bearing potential. For both&#xD;
             male and female participants, effective methods of contraception must be used&#xD;
             throughout the study and for 3 months following the last dose.&#xD;
&#xD;
        Part 1 additional inclusion criteria:&#xD;
&#xD;
          -  For participants whose most recent systemic anti-DLBCL therapy induced a PR or CR, at&#xD;
             least 60 days must have elapsed since the end of that therapy. For all other&#xD;
             participants, at least 14 weeks (98 days) must have elapsed since the end of their&#xD;
             most recent systemic anti-DLBCL therapy. . Palliative localized radiation within the&#xD;
             therapy-free interval is allowed. Non-chemotherapy maintenance will not be considered&#xD;
             anti DLBCL therapy, and therefore is allowed during the therapy-free interval.&#xD;
&#xD;
          -  Documented clinical or radiographic evidence of progressive DLBCL prior to dosing.&#xD;
&#xD;
          -  Participants must have measurable disease per the revised criteria for response&#xD;
             assessment of lymphoma. Lymph nodes should be considered abnormal if the long axis is&#xD;
             &gt;1.5 centimeter (cm), regardless of the short axis. If a lymph node has a long axis of&#xD;
             1.1 to 1.5 cm, it should only be considered abnormal if its short axis is &gt;1.0. Lymph&#xD;
             nodes ≤1.0 by ≤1.0 will not be considered abnormal for relapse or PD.&#xD;
&#xD;
        Part 2 additional inclusion criteria:&#xD;
&#xD;
        • At least 3 weeks (21 days) must have elapsed since the end of participant's most recent&#xD;
        systemic anti-DLBCL therapy (prior to Cycle 1 Day 1). Palliative localized radiation within&#xD;
        the therapy-free interval is allowed.Non-chemotherapy maintenance will not be considered&#xD;
        anti-DLBCL therapy, and therefore is allowed during the therapy-free interval.&#xD;
&#xD;
        • Adequate hematopoietic function: (i) Hemoglobin ≥10.0 grams per deciliters (g/dL) within&#xD;
        14 days of starting therapy (participant may receive red blood cell [RBC] transfusion&#xD;
        within 14 days).&#xD;
&#xD;
        (ii) Absolute neutrophil count ≥1000 cells/millimeter (mm^3) (use of granulocyte growth&#xD;
        factors prior to and during the study is acceptable).&#xD;
&#xD;
        (iii) Platelet count ≥100,000/mm^3 within 14 days of starting therapy (use of platelet&#xD;
        growth factors prior to and during the study is acceptable).&#xD;
&#xD;
          -  Participants must have measurable disease per the revised criteria for response&#xD;
             assessment of lymphoma. Lymph nodes should be considered abnormal if the long axis is&#xD;
             &gt;1.5 cm, regardless of the short axis. Extranodal lesion should be considered abnormal&#xD;
             if the long axis is &gt;1.0 cm.&#xD;
&#xD;
        Exclusion Criteria (Parts 1 and 2):&#xD;
&#xD;
          -  Participants who are pregnant or lactating.&#xD;
&#xD;
          -  Primary mediastinal (thymic) large B-cell lymphoma (PMBL)&#xD;
&#xD;
          -  Participants must not be eligible for high-dose chemotherapy with autologous stem cell&#xD;
             transplantation rescue (Investigator must provide detailed documentation for&#xD;
             ineligibility).&#xD;
&#xD;
          -  Participants who have not recovered to Grade ≤1 clinically significant adverse events,&#xD;
             or to their baseline, from their most recent systemic anti-DLBCL therapy.&#xD;
&#xD;
          -  Major surgery within 2 weeks of first dose of study treatment.&#xD;
&#xD;
          -  Participants with active hepatitis B virus (HBV), hepatitis C virus (HCV), or human&#xD;
             immunodeficiency virus (HIV) infections.&#xD;
&#xD;
          -  Psychiatric illness or substance use that would prevent the participant from giving&#xD;
             informed consent or being compliant with the study procedures.&#xD;
&#xD;
          -  Any of the following laboratory abnormalities:&#xD;
&#xD;
             (i) A circulating lymphocyte count of &gt;50,000/L. (ii) Hepatic dysfunction: bilirubin&#xD;
             &gt;2.0 times the upper limit of normal (ULN) (except participants with Gilbert's&#xD;
             syndrome: total bilirubin of &gt;3*ULN) and alanine aminotransferase (ALT) and aspartate&#xD;
             aminotransferase (AST) &gt;2.5 times ULN. In participants with known liver involvement of&#xD;
             their DLBCL, AST and ALT &gt;5*ULN.&#xD;
&#xD;
        (iii) Severe renal dysfunction: estimated creatinine clearance of &lt;30 mL/min, measured in&#xD;
        24-hour urine or calculated using the formula of Cockroft and Gault [(140-Age)*Mass&#xD;
        (kg)/(72*creatinine mg/dL); multiply by 0.85 if female].&#xD;
&#xD;
          -  Any life-threatening illness, medical condition, or organ system dysfunction which, in&#xD;
             the Investigator's opinion, could compromise the participant's safety.&#xD;
&#xD;
          -  Participants with active graft-versus-host disease after allogeneic stem cell&#xD;
             transplantation. At least 4 months must have elapsed since completion of allogeneic&#xD;
             stem cell transplantation.&#xD;
&#xD;
          -  Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics,&#xD;
             antivirals, or antifungals on Cycle 1 Day 1; however, prophylactic use of these agents&#xD;
             is acceptable even if parenteral.&#xD;
&#xD;
          -  Participants unable to swallow tablets, participants with malabsorption syndrome, or&#xD;
             any other gastrointestinal disease or gastrointestinal dysfunction that could&#xD;
             interfere with absorption of study treatment.&#xD;
&#xD;
        Part 1 additional exclusion criteria:&#xD;
&#xD;
          -  For participants whose most recent systemic anti-DLBCL therapy induced a PR or CR:&#xD;
             Radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer&#xD;
             therapy other than glucocorticoids &lt;60 days or &lt;14 weeks prior to Cycle 1 Day 1.&#xD;
&#xD;
          -  Known central nervous system lymphoma or meningeal involvement.&#xD;
&#xD;
          -  DLBCL with mucosa-associated lymphoid tissue [MALT] lymphoma, composite lymphoma&#xD;
             (Hodgkin's lymphoma+NHL), or DLBCL transformed from diseases other than indolent NHL.&#xD;
&#xD;
          -  Unstable cardiovascular function:&#xD;
&#xD;
             (i) Symptomatic ischemia, or (ii) Uncontrolled clinically significant conduction&#xD;
             abnormalities (i.e., ventricular tachycardia on anti-arrhythmia are excluded; 1st&#xD;
             degree atrioventricular block or asymptomatic left anterior fascicular block /right&#xD;
             bundle branch block will not be excluded), or (iii) Congestive heart failure of New&#xD;
             York Heart Association Class ≥3, or (iv) Myocardial infarction within 3 months.&#xD;
&#xD;
          -  Participants with a BSA &lt;1.4 m^2 as calculated per Dubois 1916 or Mosteller 1987.&#xD;
&#xD;
          -  Any of the following laboratory abnormalities:&#xD;
&#xD;
             (i) Absolute neutrophil count (ANC) &lt;1000 cells/mm^3 or platelet count &lt;75,000/mm^3&#xD;
             during screening and on Cycle 1 Day 1. Use of granulocyte-stimulating factors and&#xD;
             platelet growth factors prior to and during the study is acceptable.&#xD;
&#xD;
        (ii) Hematopoietic dysfunction: hemoglobin &lt; 10.0 g/dL within 14 days of and including&#xD;
        Cycle 1 Day 1 and/or patients receiving red blood cell (RBC) transfusion within 14 days of&#xD;
        and including Cycle 1 Day 1.&#xD;
&#xD;
          -  Participants who have been committed to an institution by official or judicial order.&#xD;
&#xD;
          -  Participants with dependency on the Sponsor, Investigator or study site.&#xD;
&#xD;
        Part 2 additional exclusion criteria:&#xD;
&#xD;
          -  Participants with active HBV, HVC, or HIV infections. Participants with active HBV are&#xD;
             allowed if antiviral therapy for hepatitis B has been given for &gt;8 weeks and viral&#xD;
             load is &lt;100 International units per milliliters (IU/mL) prior to first dose of study&#xD;
             treatment. Participants with known history of HCV or found to be HCV antibody positive&#xD;
             on screening, are allowed if there is documentation of negative viral load per&#xD;
             institutional standard. Participants with HIV who have CD4+T-cell counts ≥350&#xD;
             cells/microliter (mcL), negative viral load per institutional standard, and no history&#xD;
             of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections in the&#xD;
             last year are allowed.&#xD;
&#xD;
          -  Known active central nervous system lymphoma or meningeal involvement. Participants&#xD;
             with a history of CNS disease treated into remission may be enrolled.&#xD;
&#xD;
          -  DLBCL with MALT lymphoma, composite lymphoma (Hodgkin's lymphoma + NHL), DLBCL arising&#xD;
             from CLL (Richter's transformation), or high-grade B-cell lymphoma.&#xD;
&#xD;
          -  Received strong cytochrome P450 3A (CYP3A) inhibitors ≤7 days prior to Day 1 dosing or&#xD;
             strong CYP3A inducers ≤14 days prior to Day 1 dosing.&#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>Karyopharm Medical Information</last_name>
    <phone>(888) 209-9326</phone>
    <email>clinicaltrials@karyopharm.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>UACC Arizona</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85704</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of California Los Angeles (UCLA)</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Boca Raton Cancer Research Medical Center</name>
      <address>
        <city>Plantation</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Robert H. Lurie Comprehensive Cancer Center/Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Norton Cancer Institute</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40241</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Lahey Clinic</name>
      <address>
        <city>Burlington</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Massachusetts Medical School</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>John Theurer Cancer Center at Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Clinical Research Alliance</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>New York Presbyterian Hospital/ Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Stony Brook University Hospital</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Gabrail Cancer Center</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University Hospitals Seidman Cancer Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Greenville Hospital System</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>MD Anderson</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Swedish Cancer Institute</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Virginia Mason Hospital &amp; Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>St. Vincent's Hospital Sydney</name>
      <address>
        <city>Darlinghurst</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Liverpool Hospital, Ingham Institute of Medical Research</name>
      <address>
        <city>Liverpool</city>
        <state>New South Wales</state>
        <zip>2170</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Calvary Mater Newcastle Hospital</name>
      <address>
        <city>Waratah</city>
        <state>New South Wales</state>
        <zip>2298</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Icon Cancer Care</name>
      <address>
        <city>South Brisbane</city>
        <state>Queensland</state>
        <zip>4101</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Ashford Cancer Centre</name>
      <address>
        <city>Kurralta Park</city>
        <state>South Australia</state>
        <zip>5037</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Monash Medical Centre</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Epworth Hospital</name>
      <address>
        <city>East Melbourne</city>
        <state>Victoria</state>
        <zip>3001</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>St. Vincent's Melbourne</name>
      <address>
        <city>Fitzroy</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Alfred Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Fiona Stanley Hospital</name>
      <address>
        <city>Murdoch</city>
        <state>Western Australia</state>
        <zip>6150</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Medical University of Graz</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Medizinische Universität Innsbruck für Innere Medizin</name>
      <address>
        <city>Innsbruck</city>
        <country>Austria</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>LKH Leoben Department for Haemato-Oncology</name>
      <address>
        <city>Leoben</city>
        <zip>8700</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Akh Linz Innere Med III - Zentrum für Hämatologie und med. Onkologie</name>
      <address>
        <city>Linz</city>
        <country>Austria</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Barmherzigen Schwestern Linz</name>
      <address>
        <city>Linz</city>
        <country>Austria</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Krankenhaus der Elisabethinen Linz GmbH</name>
      <address>
        <city>Linz</city>
        <country>Austria</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Uni. Klinik für Innere Medizin III Universitätsklinikum der PMU LKH Salzburg</name>
      <address>
        <city>Salzburg</city>
        <zip>A-5020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Medical University of Vienna (MUW) Department of Medicine I</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Univ. General Hospital Hietzing</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Netwerk Antwerpen</name>
      <address>
        <city>Antwerpen</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>AZ Sint-Jan</name>
      <address>
        <city>Bruges</city>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Institut Jules Bordet</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires Saint-Luc</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>CH Jolimont</name>
      <address>
        <city>La Louviere</city>
        <zip>7100</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>AZ Delta</name>
      <address>
        <city>Roeselare</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>H-Hartziekenhuis Roeselare-Menen</name>
      <address>
        <city>Roeselare</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University Hospital for Active Treatment Dr. Georgi Stranski</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Specialized Hospital for Active Treatment of Haematological Diseases EAD</name>
      <address>
        <city>Sofia</city>
        <zip>1756</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Sir Mortimer B Davis Jewish General Hospital/McGill University</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>CHU Lyon Sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <state>Lyon</state>
        <country>France</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <country>France</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Unite Hemopathies Lymphoides Chu Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <country>France</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Chu Dijon-Bourgogne - Hematologie Clinique</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Hospitalier de la Rochelle-Ré-Aunis</name>
      <address>
        <city>La Rochelle</city>
        <country>France</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>CHRU de Lille - Hopital Claude-Huriez</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>CHU Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hostpial Saint Louis - CIRCO (Centre d'Investigations et de Recherche Clinique en Oncologie)</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hôpital Necker Service d'Hématologie Adult</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Pitié-Salpêtrière Hospital</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Centre Henri Becquerel</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Uniklinik Aachen Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation</name>
      <address>
        <city>Aachen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>HELIOS Klinikum Bad Saarow</name>
      <address>
        <city>Bad Saarow</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Charite Universitatsmedizin Berlin (Benjamin Franklin Campus)</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Charite Universitatsmedizin Berlin (Virchow Campus)</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Ev. Diakonie-Krankenhaus gGmbH</name>
      <address>
        <city>Bremen</city>
        <zip>28239</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis Haematologie and Onkologie-Dresden</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Martin-Luther-University Halle-Wittenberg Department of Oncology</name>
      <address>
        <city>Halle</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule</name>
      <address>
        <city>Hannover</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Universität Heidelberg Medizinische Klinik V Hämatologie, Onkologie und Rheumatologie</name>
      <address>
        <city>Heidelberg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Klinikum Kempten Klinik für Innere Medizin III - Hämatologie, Onkologie und Palliativmedizin</name>
      <address>
        <city>Koln</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Klinikum Leverkusen</name>
      <address>
        <city>Leverkusen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Klinikum Ludwigshafen</name>
      <address>
        <city>Ludwigshafen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Rotkreuzklinikum München</name>
      <address>
        <city>Muenchen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Klinikum Nürnberg Nord</name>
      <address>
        <city>Nuernberg</city>
        <zip>90419</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Haematology Department and HCT Unit G.Papanicolaou Hospital</name>
      <address>
        <city>Exochi</city>
        <state>Thessaloniki</state>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Niki Stavroyianni</last_name>
      <phone>+302313307533</phone>
      <email>niki.stavroyianni@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Niki Stavroyianni</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hematology Clinic,General Hospital of Athens,G. Gennimatos</name>
      <address>
        <city>Athens</city>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Theodoros Marinakis</last_name>
      <phone>00306932704780</phone>
      <email>tpmarin1@otenet.gr</email>
    </contact>
    <investigator>
      <last_name>Theodoros Marinakis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>National &amp; Kapodistrian University of Athens, Laiko General Hospital</name>
      <address>
        <city>Athens</city>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hematology Department Laiko General Hospital</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Theodoros Vassilakopoulos</last_name>
      <phone>+30 6945472338</phone>
      <email>theopvass@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Theodoros Vassilakopoulos</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Second Depth of Internal Medicine, Attiko University Hospital</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Panagiotis Tsirigotis</last_name>
      <phone>+306944618814</phone>
      <email>panagtsirigotis@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Panagiotis Tsirigotis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>National &amp; Kapodistrian University of Athens, Attiko University Hospital</name>
      <address>
        <city>Chaidari</city>
        <zip>12462</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Department of clinical hematology ,university hospital Ioannina</name>
      <address>
        <city>Ioánnina</city>
        <zip>45110</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eleni Kapsali</last_name>
      <phone>0032651099650</phone>
      <email>elkapsali@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Eleni Kapsali</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Patras Medical School</name>
      <address>
        <city>Patras</city>
        <zip>26504</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Semmelweis Egyetem Általános Orvosi Kar</name>
      <address>
        <city>Budapest</city>
        <zip>1083</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Országos Onkológiai Intézet &quot;A&quot; Belgyógyászati Onkológiai Osztály</name>
      <address>
        <city>Budapest</city>
        <zip>1122</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Semmelweis University Department of Medicine and Oncology</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Somogy Megyei Kaposi Mór Oktató Kórház</name>
      <address>
        <city>Kaposvár</city>
        <zip>7400</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Pécsi Tudományegyetem, ÁOK, I. számú Belgyógyászati Klinika</name>
      <address>
        <city>Pécs</city>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Veszprém Megyei Csolnoky Ferenc Kórház</name>
      <address>
        <city>Veszprém</city>
        <zip>8200</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>CSolnoky ferenc Hospital</name>
      <address>
        <city>Veszprém</city>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Regional Cancer Centre, IGIMS</name>
      <address>
        <city>Patna</city>
        <state>Bihar</state>
        <zip>800014</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>SRM Institutes for Medical Science</name>
      <address>
        <city>Vadapalani</city>
        <state>Chennai</state>
        <zip>600026</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Rajiv Gandhi Cancer Hospital</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110085</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Regional Cancer Centre</name>
      <address>
        <city>Thiruvananthapuram</city>
        <state>Kerala</state>
        <zip>695011</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Prince Aly Khan Hospital</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400010</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Jaslok Hospital and Research Centre</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400026</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Deenanath Mangeshkar Hospital</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411004</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Institute of Medical Sciences &amp; SUM Hospital</name>
      <address>
        <city>Bhubaneswar</city>
        <state>Odisha</state>
        <zip>751003</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Dayanand Medical College and Hospital</name>
      <address>
        <city>Ludhiāna</city>
        <state>Punjab</state>
        <zip>160012</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Cancer Institute (WIA)</name>
      <address>
        <city>Chennai</city>
        <state>Tamil Nadu</state>
        <zip>600020</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Saveetha Medical College Hospital</name>
      <address>
        <city>Chennai</city>
        <state>Tamil Nadu</state>
        <zip>602105</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>G. Kuppu Swamy Naidu Hospital</name>
      <address>
        <city>Coimbatore</city>
        <state>Tamil Nadu</state>
        <zip>641037</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Meenakshi Mission Hospital &amp; Research Centre</name>
      <address>
        <city>Madurai</city>
        <state>Tamil Nadu</state>
        <zip>625107</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>King George's Medical University (KGMU)</name>
      <address>
        <city>Lucknow</city>
        <state>Uttar Pradesh</state>
        <zip>226003</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Nil Ratan Sircar Medical College and Hospital</name>
      <address>
        <city>Kolkata</city>
        <state>West Bengal</state>
        <zip>700014</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Netaji Subhas Chandra Bose Cancer Research Hospital</name>
      <address>
        <city>Kolkata</city>
        <state>West Bengal</state>
        <zip>700094</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>TATA Memorial Centre</name>
      <address>
        <city>Kolkata</city>
        <state>West Bengal</state>
        <zip>700156</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Netaji Subhas Chandra Bose Cancer Research Institute</name>
      <address>
        <city>Kolkata</city>
        <state>West Bengal</state>
        <zip>70016</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>IRCH, All India Institute of Medical Sciences</name>
      <address>
        <city>Delhi</city>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Dr. B.R.A. Institute Rotary Cancer Hospital All India Institute of Medical Sciences</name>
      <address>
        <city>New Delhi</city>
        <zip>110029</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hematology-Soroka</name>
      <address>
        <city>Beer Sheva</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Rambam Healthcare Campus</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Wolfson MC</name>
      <address>
        <city>Holon</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petach Tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Assuta Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>69710</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>TLV Sorasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Tel Hashomer</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Instituto di Ematologia Seragnoli Pad 8 Universita di Bologna</name>
      <address>
        <city>Bologna</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>SODc Ematologica ,AOU Careggi</name>
      <address>
        <city>Florence</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luca Nassi</last_name>
      <phone>00390557947358</phone>
      <email>nassil@aou-careggi.toscana.it</email>
    </contact>
    <investigator>
      <last_name>Luca Nassi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>AOU Maggiore della Carità SCDU Ematologia</name>
      <address>
        <city>Florence</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clara Deambrogi (SC)</last_name>
      <phone>003903213732094</phone>
      <email>clara.deambrogi@med.uniupo.it</email>
    </contact>
    <investigator>
      <last_name>Riccardo Bruna</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hematology-Oncology &amp; Stem Cell Transplantation Unit, National Cancer Institute, Fondazione 'G. Pascale', IRCCS</name>
      <address>
        <city>Naples</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antonio Pinto</last_name>
      <phone>+39 (0) 81 5903 1816</phone>
      <email>a.pinto@istitutotumori.na.it</email>
    </contact>
    <investigator>
      <last_name>Antonio Pinto</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>SCDU Ematologia, Division of Hematology, Dept. of Translational Medicine, Universita del Piemonte Orientale</name>
      <address>
        <city>Novara</city>
        <zip>28100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario A. Gemelli</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefan Hohaus</last_name>
      <phone>+39-0630154180</phone>
      <email>stefan.hohaus@unicatt.it</email>
    </contact>
    <investigator>
      <last_name>Stefan Hohaus</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Senese</name>
      <address>
        <city>Siena</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ALBERTO FABBRI</last_name>
      <phone>+390577585618</phone>
      <email>fabbri7@unisi.it</email>
    </contact>
    <investigator>
      <last_name>ALBERTO FABBRI</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Città della Salute e della Scienza di Torino</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>VUMc (Vrije Universiteit Amsterdam)</name>
      <address>
        <city>Amsterdam</city>
        <zip>1081 HV</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>LUMC (leidse universitair medisch centrum)</name>
      <address>
        <city>Leiden</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>North Shore Hospital</name>
      <address>
        <city>Auckland</city>
        <zip>0622</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Christchurch Hospital</name>
      <address>
        <city>Christchurch</city>
        <zip>8001</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Kliniczny im. Jana Mikulicza</name>
      <address>
        <city>Wrocław</city>
        <state>Radeckiego</state>
        <zip>50-367</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tomasz Wrobel</last_name>
      <phone>+48 533 193 182</phone>
      <email>tomasz_wrobel@wp.pl</email>
    </contact>
    <investigator>
      <last_name>Tomasz Wrobel</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Szpitale Wojewódzkie w Gdyni, Gdyńskie Centrum onkologii</name>
      <address>
        <city>Gdynia</city>
        <zip>81-519</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>MCM (Małopolskie Centrum Medyczne)</name>
      <address>
        <city>Krakow</city>
        <zip>30-510</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Wojewodzki Szpital Specjalistyczny w Legnicy</name>
      <address>
        <city>Legnica</city>
        <zip>59-220</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jadwiga Holojda</last_name>
      <phone>+48 767211621</phone>
      <email>j.holojda@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Jadwiga Holojda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie</name>
      <address>
        <city>Lublin</city>
        <zip>20-081</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Hematology Department St John's Cancer Centre</name>
      <address>
        <city>Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marta Morawska, MD, PhD</last_name>
      <phone>+ 48 814541231</phone>
      <email>mmorawska79@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Marta Morawska, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Samodzielny Publiczny Zakład Opieki Zdrowotnej Ministerstwa</name>
      <address>
        <city>Olsztyn</city>
        <zip>10-228</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Instytut Hematologii i Transfuzjologii</name>
      <address>
        <city>Warszawa</city>
        <zip>02-776</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Centrum Onkologii- Insytut Im. Marii Skłodowskiej-Curie Klinika Nowotworow Ukladu Chlonnego</name>
      <address>
        <city>Warszawa</city>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Maria Sklodowska Curie National Research Institute</name>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joanna Romejko-Jarosinska</last_name>
      <phone>48225462448</phone>
      <email>joanna.romejko-jarosinska@pib-nio.pl</email>
    </contact>
    <investigator>
      <last_name>Joanna Romejko-Jarosinska</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Provincial Specialist Hospital in Lodz</name>
      <address>
        <city>Łódź</city>
        <zip>62-1010</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Institut za onkologiju i radiologiju Srbije</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Klinicko Bolnick Centar Zemun Odeljenje hematologije</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Klinički centar Srbije Klinika za hematologiju</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Kliničko bolnički centar Zvezdara</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Klinički centar Niš Klinika za hematologiju</name>
      <address>
        <city>Nis</city>
        <zip>18000</zip>
        <country>Serbia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Institut za onkologiju Vojvodine</name>
      <address>
        <city>Sremska Kamenica</city>
        <zip>21204</zip>
        <country>Serbia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hospitla Universitari Germans Trias i Pujol - ICO</name>
      <address>
        <city>Badalona</city>
        <zip>8916</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hospital University Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic i Provincial de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hospital de Son Llàtzer</name>
      <address>
        <city>Palma de Mallorca</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Clínica Universidad De Navarra</name>
      <address>
        <city>Pamplona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocio</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Gloucestershire Royal Hospital</name>
      <address>
        <city>Gloucester</city>
        <state>Gloucestershire</state>
        <zip>GL1 3NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Southampton University Hospital</name>
      <address>
        <city>Southampton</city>
        <state>Hampshire</state>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital</name>
      <address>
        <city>Sutton</city>
        <state>London</state>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Northwick Park Hospital</name>
      <address>
        <city>Harrow</city>
        <state>Middlesex</state>
        <zip>HA1 3UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Leeds Teaching Hospitals NHS Trust</name>
      <address>
        <city>Leeds</city>
        <state>Yorkshire</state>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Addenbrooke's Hospital Cambridge</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Royal Liverpool University Hospital</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Clatterbridge Cancer Centre NHS Foundation Trust</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>King's College Hospital</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Princess Royal University Hospital (PRUH)</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Guy's and St Thomas' NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Christie NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Oxford University Hospitals NHS Trust Oxford Cancer and Haematology Centre, Churchill Hospital</name>
      <address>
        <city>Oxford</city>
        <zip>OX3 7LE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Derriford Hospital</name>
      <address>
        <city>Plymouth</city>
        <zip>PL6 8DH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>India</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>New Zealand</country>
    <country>Poland</country>
    <country>Serbia</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>August 3, 2023</last_update_submitted>
  <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diffuse large B-cell Lymphoma</keyword>
  <keyword>DLBCL</keyword>
  <keyword>Karyopharm</keyword>
  <keyword>KPT-330</keyword>
  <keyword>selinexor</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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02227251
org study id: KCP-330-009
secondary id: 2014-001977-15
nct id: NCT02227251
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
A multicenter, open-label Phase 2b study of selinexor (KPT-330) in participants with
      relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have no therapeutic
      options of demonstrated clinical benefit.
This is a multicenter, open label, Phase 2b study of the selective inhibitor of nuclear
      export (SINE) selinexor (40 or 60 milligrams [mg]) given orally (PO) to participants with R/R
      DLBCL). The study is being conducted in 2 parts (Part 1 and Part 2). For Part 1, a fixed 60
      mg dose of selinexor is given orally to 130 participants with R/R DLBCL who have no
      therapeutic options of demonstrated clinical benefit and who meet eligibility criteria and
      have none of the exclusion criteria will be enrolled to receive selinexor until either
      disease progression or intolerance has occurred. For Part 2, approximately 110 participants
      (55 in each arm) are planned to be enrolled. Participants will be randomized (open label) in
      a 1:1 ratio to either Arm A (40 mg) or Arm B (60 mg) and will be stratified based on history
      of prior autologous stem cell transplantation (ASCT) versus no prior ASCT. All the
      participants will be followed until disease progression and/or death.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Part 1: Overall Response Rate (ORR)
time frame: One year
description: Assessed according to the revised response criteria based on the Guidelines of the International Working Group (IWG).
measure: Part 2: Overall Response Rate (ORR) Based on Lugano Criteria
time frame: From initial randomization until date of disease progression or death (maximum of 1 year from Part 2 randomization)
description: Assessed according to the response assessment of lymphoma based on Lugano classification.
measure: Part 1: Duration of Response (DOR)
time frame: From time of first response until disease progression or death (maximum of 1 year from Part 1 randomization)
measure: Part 1: Disease Control Rate (DCR)
time frame: From initial response until disease progression or death (maximum of 1 year from Part 1 randomization)
measure: Part 1: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
time frame: From Baseline up to 30 days after last dose (maximum of 1 year from Part 1 randomization)
measure: Part 1: Number of Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status
time frame: From Baseline up to 30 days after last dose (maximum of 1 year from Part 1 randomization)
measure: Part 2: Duration of response (DOR)
time frame: From time of first response (Part 2) until disease progression or death (maximum of 1 year from Part 2 randomization)
measure: Part 2: Disease control rate (DCR)
time frame: From initial response (Part 2) until disease progression or death (maximum of 1 year from Part 2 randomization)
measure: Part 2: Overall Response Rate (ORR) Based on Modified Lugano Criteria
time frame: From initial randomization until date of disease progression or death (maximum of 1 year from Part 2 randomization)
measure: Part 2: Number of Participants with Treatment-emergent Adverse Events
time frame: From Baseline up to 30 days after last dose (maximum of 1 year from Part 2 randomization)
measure: Part 2: Number of Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status
time frame: From Baseline up to 30 days after last dose (maximum of 1 year from Part 2 randomization)
arm group label: Part 1: Selinexor 60 mg
arm group type: Experimental
description: Participants received fixed dose of 60 mg selinexor orally, twice weekly (BIW) on Days 1 and 3 (e.g., Monday and Wednesday or Tuesday and Thursday, etc.) of Weeks 1-4 of each four week (each cycle of 28 days) cycle (total of 8 doses per cycle).
arm group label: Part 2: Arm A-Selinexor 40 mg
arm group type: Experimental
description: Participants received selinexor 40 mg orally BIW on Days 1 and 3 of each week of 4-week treatment cycles (28 days) until disease progression (total of 8 doses per cycle).
arm group label: Part 2: Arm B-Selinexor 60 mg
arm group type: Experimental
description: Participants received selinexor 60 mg orally BIW on Days 1 and 3 of each week of 4-week treatment cycles) for 2 cycles (each cycle of 28 days) followed by 60 mg once weekly (QW) in the subsequent cycles until disease progression (total of 8 doses per cycle).
intervention type: Drug
intervention name: Selinexor
description: Dose: 60 mg (BIW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral
arm group label: Part 1: Selinexor 60 mg
other name: KPT-330
intervention type: Drug
intervention name: Selinexor
description: Dose: 40 mg (BIW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral
arm group label: Part 2: Arm A-Selinexor 40 mg
other name: KPT-330
intervention type: Drug
intervention name: Selinexor
description: Dose: 60 mg (BIW) and 60 mg (QW); Dosage form: film-coated (20 mg each) immediate release tablets; Route of administration: Oral
arm group label: Part 2: Arm B-Selinexor 60 mg
other name: KPT-330
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karyopharm Medical Information
phone: (888) 209-9326
email: clinicaltrials@karyopharm.com
facility: 
status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Suspended
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status: Suspended
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Suspended
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status: Suspended
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
facility: 
status: Recruiting
contact: 
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facility: 
status: Recruiting
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investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
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status: Completed
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status: Completed
facility: 
status: Suspended
facility: 
status: Completed
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status: Suspended
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status: Completed
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status: Suspended
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
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investigator: 
facility: 
status: Recruiting
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investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
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status: Recruiting
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facility: 
status: Completed
facility: 
status: Completed
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status: Completed
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status: Completed
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status: Completed
facility: 
status: Recruiting
contact: 
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facility: 
status: Completed
facility: 
status: Completed
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status: Recruiting
contact: 
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facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
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facility: 
status: Completed
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status: Completed
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status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
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status: Completed
country: Australia
country: Austria
country: Belgium
country: Bulgaria
country: Canada
country: France
country: Germany
country: Greece
country: Hungary
country: India
country: Israel
country: Italy
country: Netherlands
country: New Zealand
country: Poland
country: Serbia
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse
sharing ipd: Undecided