<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/NCT04442022</url>
  </required_header>
  <id_info>
    <org_study_id>XPORT-DLBCL-030</org_study_id>
    <secondary_id>2020-000605-84</secondary_id>
    <nct_id>NCT04442022</nct_id>
  </id_info>
  <brief_title>A Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma</brief_title>
  <official_title>A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) With or Without Selinexor in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR 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>
      The purpose of this Phase 2/3 study is to evaluate efficacy and safety of the combination of&#xD;
      selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive&#xD;
      hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T)&#xD;
      therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study&#xD;
      will assess the two doses of selinexor (40 milligram [mg] or 60 mg) in combination with&#xD;
      R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent&#xD;
      continuous therapy for those who have reached a partial or complete response. Phase 3 portion&#xD;
      of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus&#xD;
      standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo&#xD;
      or 60 mg selinexor single agent continuous therapy for those who have reached partial or&#xD;
      complete response.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 3, 2020</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Phase 2 Portion of the Study: open label; Phase 3 Portion of the Study: double blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Phase 2: Overall Response Rate (ORR): Based on Lugano Criteria 2014</measure>
    <time_frame>From date of initial randomization to the date of disease progression or initiating a new DLBCL treatment (maximum of 5 years from randomization)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 3: Progression-free Survival (PFS): Based on Lugano Criteria 2014</measure>
    <time_frame>From date of initial randomization to the date of disease progression or death (maximum of 5 years from randomization)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Progression-free Survival: Based on Lugano Criteria 2014</measure>
    <time_frame>From date of initial randomization to the date of disease progression or death (maximum of 5 years from randomization)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Overall Survival (OS)</measure>
    <time_frame>From date of initial randomization until death (maximum of 5 years from randomization)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3: Overall Response Rate: Based on Lugano Criteria 2014</measure>
    <time_frame>From date of initial randomization to the date of disease progression or initiating a new DLBCL treatment (maximum of 5 years from randomization)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3: Overall Survival</measure>
    <time_frame>From date of initial randomization until death (maximum of 5 years from randomization)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Overall Response Rate at the End of Combination Therapy (ORR-EoC): Based on Lugano Criteria 2014</measure>
    <time_frame>From C1D1 (Cycles 1 up to 6; 21 days per cycle) up to 28 days after EoC therapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Overall Response Rate at the End of Combination Therapy: Based on Modified Lugano Criteria</measure>
    <time_frame>From C1D1 (Cycles 1 up to 6; 21 days per cycle) up to 28 days after EoC therapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Duration of Response (DOR): Based on Lugano Criteria 2014</measure>
    <time_frame>From time of first response until disease progression or death (maximum of 5 years from randomization)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Number of Patients with Adverse Events (AEs)</measure>
    <time_frame>Up to 30 days after last dose of study drug (maximum of 5 years from randomization)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3: Overall Response Rate at the End of Combination Therapy: Based on Lugano Criteria 2014</measure>
    <time_frame>From C1D1 (Cycles 1 up to 6; 21 days per cycle) up to 28 days after EoC therapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3: Overall Response Rate at the End of Combination Therapy: Based on Modified Lugano Criteria</measure>
    <time_frame>From C1D1 (Cycles 1 up to 6; 21 days per cycle) up to 28 days after EoC therapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3: Duration of Response: Based on Lugano Criteria 2014</measure>
    <time_frame>From time of first response until disease progression or death (maximum of 5 years from randomization)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3: Progression-free Survival: Based on Modified Lugano Criteria</measure>
    <time_frame>From date of initial randomization to the date of disease progression or death (maximum of 5 years from randomization)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3: Number of Patients with Adverse Events</measure>
    <time_frame>Up to 30 days after last dose of study drug (maximum of 5 years from randomization)</time_frame>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">501</enrollment>
  <condition>Relapsed/Refractory Diffuse Large B-cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>Phase 2: Selinexor 40 mg + R-GDP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with RR DLBCL will receive combination therapy of selinexor 40 mg orally at Day 1, and Day 8 of each 21-day cycle for up to 6 cycles in combination with R-GDP followed by single-agent continuous therapy with selinexor 60 mg orally once weekly (QW) for each 28-day cycle until progressive disease (PD) or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2: Selinexor 60 mg + R-GDP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with RR DLBCL will receive combination therapy of selinexor 60 mg orally at Day 1 and Day 8 of each 21-day cycle for up to 6 cycles in combination with R-GDP followed by single-agent continuous therapy with selinexor 60 mg orally QW for each 28-day cycle until PD or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2: R-GDP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with RR DLBCL will receive R-GDP on specified days (Days 1, 2, 3, 4, and 8) for each 21-day cycle for up to 6 cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 3: Selinexor (Selected Dose) + R-GDP followed by Selinexor 60 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with RR DLBCL will receive combination therapy of selinexor (selected dose from Phase 2) at Day 1 and Day 8 of each 21-day cycle for up to 6 cycles in combination with R-GDP followed by selinexor 60 mg orally QW for each 28-day cycle until PD or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 3: Selinexor (Selected Dose) + R-GDP followed by Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with RR DLBCL will receive combination therapy of selinexor (selected dose from Phase 2) at Day 1 and Day 8 of each 21-day cycle for up to 6 cycles in combination with R-GDP followed by matching placebo for selinexor orally QW for each 28-day cycle until PD or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 3: Placebo + R-GDP followed by Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients with RR DLBCL will receive combination therapy of placebo matching for selinexor (selected dose from Phase 2) at Day 1 and Day 8 of each 21-day cycle for up to 6 cycles in combination with R-GDP followed by matching placebo for selinexor orally QW for each 28-day cycle until PD or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Selinexor (combination therapy)</intervention_name>
    <description>Dose: 40 mg on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral</description>
    <arm_group_label>Phase 2: Selinexor 40 mg + R-GDP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Selinexor (combination therapy)</intervention_name>
    <description>Dose: 60 mg on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral</description>
    <arm_group_label>Phase 2: Selinexor 60 mg + R-GDP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Selinexor (combination therapy)</intervention_name>
    <description>Dose: Selected dose of selinexor (from Phase 2) on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral</description>
    <arm_group_label>Phase 3: Selinexor (Selected Dose) + R-GDP followed by Placebo</arm_group_label>
    <arm_group_label>Phase 3: Selinexor (Selected Dose) + R-GDP followed by Selinexor 60 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo matching for Selinexor (combination therapy)</intervention_name>
    <description>Dose: Placebo matching for selected dose of selinexor (from Phase 2) on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral</description>
    <arm_group_label>Phase 3: Placebo + R-GDP followed by Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab (combination therapy)</intervention_name>
    <description>Dose: 375 milligram per meter square (mg/m^2) on Day 1; Route of administration: intravenous (IV)</description>
    <arm_group_label>Phase 2: Selinexor 40 mg + R-GDP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab (combination therapy)</intervention_name>
    <description>Dose: 375 mg/m^2 on Day 1; Route of administration: IV</description>
    <arm_group_label>Phase 2: R-GDP</arm_group_label>
    <arm_group_label>Phase 2: Selinexor 60 mg + R-GDP</arm_group_label>
    <arm_group_label>Phase 3: Placebo + R-GDP followed by Placebo</arm_group_label>
    <arm_group_label>Phase 3: Selinexor (Selected Dose) + R-GDP followed by Placebo</arm_group_label>
    <arm_group_label>Phase 3: Selinexor (Selected Dose) + R-GDP followed by Selinexor 60 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine (combination therapy)</intervention_name>
    <description>Dose: 1000 mg/m^2 on Days 1 and 8; Route of administration: IV</description>
    <arm_group_label>Phase 2: R-GDP</arm_group_label>
    <arm_group_label>Phase 2: Selinexor 40 mg + R-GDP</arm_group_label>
    <arm_group_label>Phase 2: Selinexor 60 mg + R-GDP</arm_group_label>
    <arm_group_label>Phase 3: Placebo + R-GDP followed by Placebo</arm_group_label>
    <arm_group_label>Phase 3: Selinexor (Selected Dose) + R-GDP followed by Placebo</arm_group_label>
    <arm_group_label>Phase 3: Selinexor (Selected Dose) + R-GDP followed by Selinexor 60 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone (combination therapy)</intervention_name>
    <description>Dose: 40 mg (20 mg if patient is more than 70 years old) on Days 1, 2, 3, and 4; Route of administration: oral or IV</description>
    <arm_group_label>Phase 2: R-GDP</arm_group_label>
    <arm_group_label>Phase 2: Selinexor 40 mg + R-GDP</arm_group_label>
    <arm_group_label>Phase 2: Selinexor 60 mg + R-GDP</arm_group_label>
    <arm_group_label>Phase 3: Placebo + R-GDP followed by Placebo</arm_group_label>
    <arm_group_label>Phase 3: Selinexor (Selected Dose) + R-GDP followed by Placebo</arm_group_label>
    <arm_group_label>Phase 3: Selinexor (Selected Dose) + R-GDP followed by Selinexor 60 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin (combination therapy)</intervention_name>
    <description>Dose: 75 mg/m^2 on Day 1; Route of administration: IV</description>
    <arm_group_label>Phase 2: R-GDP</arm_group_label>
    <arm_group_label>Phase 2: Selinexor 40 mg + R-GDP</arm_group_label>
    <arm_group_label>Phase 2: Selinexor 60 mg + R-GDP</arm_group_label>
    <arm_group_label>Phase 3: Placebo + R-GDP followed by Placebo</arm_group_label>
    <arm_group_label>Phase 3: Selinexor (Selected Dose) + R-GDP followed by Placebo</arm_group_label>
    <arm_group_label>Phase 3: Selinexor (Selected Dose) + R-GDP followed by Selinexor 60 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Selinexor (continuous therapy)</intervention_name>
    <description>Dose: 60 mg QW for each 28-day cycle until PD; Route of administration: oral</description>
    <arm_group_label>Phase 2: Selinexor 40 mg + R-GDP</arm_group_label>
    <arm_group_label>Phase 2: Selinexor 60 mg + R-GDP</arm_group_label>
    <arm_group_label>Phase 3: Selinexor (Selected Dose) + R-GDP followed by Selinexor 60 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo matching for Selinexor (continuous therapy)</intervention_name>
    <description>Dose: Placebo matching for 60 mg selinexor QW for each 28-day cycle until PD; Route of administration: oral</description>
    <arm_group_label>Phase 3: Placebo + R-GDP followed by Placebo</arm_group_label>
    <arm_group_label>Phase 3: Selinexor (Selected Dose) + R-GDP followed by Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have pathologically confirmed de novo DLBCL or DLBCL transformed from previously&#xD;
             diagnosed indolent lymphoma (e.g., follicular lymphoma). Patient with high-grade&#xD;
             lymphoma with c-MYC, Bcl2 and/or Bcl6 rearrangements are eligible (only for Phase 2).&#xD;
             (Documentation to be provided).&#xD;
&#xD;
          -  Have received at least 1 but no more than 3 prior lines of systemic therapy for the&#xD;
             treatment of DLBCL with relapsed or refractory disease following their most recent&#xD;
             regimen.&#xD;
&#xD;
               -  Salvage chemoimmunotherapy followed by stem cell transplantation will be&#xD;
                  considered as 1 line of systemic therapy.&#xD;
&#xD;
               -  Maintenance therapy will not be counted as a separate line of systemic therapy.&#xD;
&#xD;
               -  Radiation with curative intent for localized DLBCL will not be counted as 1 line&#xD;
                  of systemic therapy.&#xD;
&#xD;
          -  Positron emission tomography (PET) positive measurable disease with at least 1 node&#xD;
             having the longest diameter (LDi) greater than (&gt;) 1.5 centimeter (cm) or 1 extranodal&#xD;
             lesion with LDi &gt;1 cm (per the Lugano Criteria 2014). The Deauville 5-point scale&#xD;
             (D5PS) score assessed on the FDG PET/CT should be between 3 to 5.&#xD;
&#xD;
          -  Not intended for HSCT or CAR-T cell therapy based on objective clinical criteria&#xD;
             determined by the treating physician. Patients who cannot receive HSCT due to active&#xD;
             disease are allowed on study (up to approximately 15 percent [%] of patients enrolled&#xD;
             in each Phase). Documentation on lack of intention to proceed to receive HSCT or CAR-T&#xD;
             therapy must be provided by the treating physician.&#xD;
&#xD;
          -  Adequate bone marrow function at screening, defined as:&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) ≥1*10^9 per liter (/L).&#xD;
&#xD;
               -  Platelet count ≥100*10^9/L (without platelet transfusion less than [&lt;] 14 days&#xD;
                  prior to Cycle 1 Day 1 [C1D1]).&#xD;
&#xD;
               -  Hemoglobin ≥8.5 gram per deciliter (g/dL) (without red blood cell transfusion &lt;14&#xD;
                  days prior to C1D1).&#xD;
&#xD;
          -  Circulating lymphocytes less than or equal to (≤) 50*10^9/L.&#xD;
&#xD;
          -  Adequate liver and kidney function, defined as:&#xD;
&#xD;
               -  Aspartate transaminase (AST) or alanine transaminase (ALT) ≤2.5*upper limit of&#xD;
                  normal (ULN), or ≤5*ULN in cases with known lymphoma involvement in the liver.&#xD;
&#xD;
               -  Serum total bilirubin ≤2*ULN, or ≤5*ULN if due to Gilbert syndrome or in cases&#xD;
                  with known lymphoma involvement in the liver.&#xD;
&#xD;
               -  Calculated creatinine clearance (CrCl) ≥30 milliliter per minute (mL/min) based&#xD;
                  on Cockcroft-Gault formula.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.&#xD;
&#xD;
          -  An estimated life expectancy of &gt;3 months at Screening.&#xD;
&#xD;
          -  Patients with primary refractory DLBCL defined as no response or relapse within 6&#xD;
             months after ending first-line treatment, will be allowed in the study.&#xD;
&#xD;
          -  Agree to highly effective contraception during the duration of the study with&#xD;
             contraception use continuing for 12 months after the last dose of study treatment&#xD;
&#xD;
          -  Female patients of childbearing potential must have a negative serum pregnancy test at&#xD;
             Screening and agree to use highly effective methods of contraception throughout the&#xD;
             study and for 12 months following the last dose of study treatment (except patients&#xD;
             with Non-Childbearing potential: Age &gt;50 years and naturally amenorrhoeic for &gt;1 year,&#xD;
             or previous bilateral salpingo-oophorectomy, or hysterectomy).&#xD;
&#xD;
          -  Male patients who are sexually active must use highly effective methods of&#xD;
             contraception throughout the study and for 12 months following the last dose of study&#xD;
             treatment. Male patients must agree not to donate sperm during the study treatment&#xD;
             period and for 12 months following the last dose of study treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma, composite lymphoma&#xD;
             (Hodgkin's lymphoma + non-Hodgkin's lymphoma [NHL]), DLBCL transformed from diseases&#xD;
             other than indolent NHL; primary mediastinal (thymic) large B-cell lymphoma (PMBL);&#xD;
             T-cell rich large B-cell lymphoma.&#xD;
&#xD;
          -  Previous treatment with selinexor or other XPO1 inhibitors.&#xD;
&#xD;
          -  Contraindication to any drug contained in the combination therapy regimen (SR-GDP).&#xD;
&#xD;
          -  Known active central nervous system or meningeal involvement by DLBCL at time of&#xD;
             Screening.&#xD;
&#xD;
          -  Use of any standard or experimental anti-DLBCL therapy (including nonpalliative&#xD;
             radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer&#xD;
             therapy) &lt;21 days prior to C1D1 (prednisone &lt;30 mg or equivalent is permitted;&#xD;
             palliative radiation is permitted only if on non-target lesions).&#xD;
&#xD;
          -  Any AE, by C1D1, which has not recovered to Grade ≤1 (Common Terminology Criteria for&#xD;
             Adverse Events [CTCAE], v.5.0), or returned to baseline, related to the previous DLBCL&#xD;
             therapy, except hematological abnormalities (as specified in the inclusion criteria)&#xD;
             and alopecia.&#xD;
&#xD;
          -  Major surgery &lt;14 days of Cycle 1 Day 1.&#xD;
&#xD;
          -  Hematopoietic stem cell transplantation/CAR-T therapy as follows:&#xD;
&#xD;
               -  Autologous stem cell transplant (SCT) &lt;100 days or allogeneic-SCT &lt;180 days prior&#xD;
                  to C1D1&#xD;
&#xD;
               -  Active graft-versus-host disease (GVHD) after allogeneic SCT (or cannot&#xD;
                  discontinue GVHD treatment or prophylaxis)&#xD;
&#xD;
               -  CAR-T cell infusion &lt;90 days prior to Cycle 1&#xD;
&#xD;
          -  Neuropathy Grade ≥2 (CTCAE, v.5.0).&#xD;
&#xD;
          -  Any life-threatening illness, medical condition, or organ system dysfunction which, in&#xD;
             the Investigator's opinion, could compromise the patient's safety, or being compliant&#xD;
             with the study procedures.&#xD;
&#xD;
          -  Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics,&#xD;
             antivirals, or antifungals within 7 days prior to first dose of study treatment;&#xD;
             however, prophylactic use of these agents is acceptable (including parenteral).&#xD;
&#xD;
          -  Patient with active hepatitis B virus (HBV), hepatitis C virus (HCV), or human&#xD;
             immunodeficiency virus (HIV) infections:&#xD;
&#xD;
               -  Patient with active HBV are allowed if antiviral therapy for hepatitis B has been&#xD;
                  given for &gt;8 weeks and viral load is &lt;100 International units (IU)/mL prior to&#xD;
                  first dose of study treatment.&#xD;
&#xD;
               -  Patients with known history of HCV or found to be HCV antibody positive on&#xD;
                  screening, are allowed if there is documentation of negative viral load per&#xD;
                  institutional standard.&#xD;
&#xD;
               -  Patients with HIV are allowed if they have a negative viral load per&#xD;
                  institutional standard, and no history of acquired immune deficiency syndrome&#xD;
                  (AIDS)-defining opportunistic infections in the last year.&#xD;
&#xD;
          -  Inability to swallow tablets, malabsorption syndrome, or any other gastrointestinal&#xD;
             (GI) disease or dysfunction that could interfere with absorption of study treatment.&#xD;
&#xD;
          -  Breastfeeding or pregnant women.&#xD;
&#xD;
          -  Inability or unwillingness to sign an informed consent form (ICF).&#xD;
&#xD;
          -  In the opinion of the Investigator, patient who are significantly below their ideal&#xD;
             body weight.&#xD;
&#xD;
          -  Patients who received a live attenuated vaccine within prior 28 days of the first dose&#xD;
             of study treatment.&#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>Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sujith Kalmadi, MD</last_name>
      <phone>480-821-2838</phone>
      <email>kalmadi@ironwoodcrc.com</email>
    </contact>
    <investigator>
      <last_name>Sujith Kalmadi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Arizona Oncology Associates</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85711</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sudhir Manda, MD</last_name>
      <phone>520-886-0206</phone>
      <email>sudhir.manda@usoncology.com</email>
    </contact>
    <investigator>
      <last_name>Sudhir Manda, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Oncology Institute of Hope &amp; Innovation</name>
      <address>
        <city>Cerritos</city>
        <state>California</state>
        <zip>90703</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amitabha Mazumder, MD</last_name>
      <email>amitabhamazumder@theoncologyinstitute.com</email>
    </contact>
    <investigator>
      <last_name>Amitabha Mazumder, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Investigative Clinical Research of Indiana, LLC</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Norton Cancer Institute, St. Matthews</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40207</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Don Stevens, MD</last_name>
      <phone>502-899-3366</phone>
      <email>don.stevens@nortonhealthcare.org</email>
    </contact>
    <investigator>
      <last_name>Don Stevens, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tulane Cancer Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Maryland Greenebaum Comprehensive Cancer Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Seung Tae Lee, MD</last_name>
      <phone>410-328-8708</phone>
      <email>seunglee@umm.edu</email>
    </contact>
    <investigator>
      <last_name>Seung Tae Lee, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada - Town Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89169</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>New Mexico Cancer Care Alliance</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Stony Brook</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Jandl, MD</last_name>
      <phone>631-638-1000</phone>
      <email>thomas.jandl@stonybrookmedicine.edu</email>
    </contact>
    <investigator>
      <last_name>Thomas Jandl, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gabrail Cancer Center Research LLC</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Medical City Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Presbyterian Dallas Cancer Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Sammons</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Moshe Yair Levy, MD</last_name>
      <phone>214-370-1000</phone>
      <email>yair.levy@usoncology.com</email>
    </contact>
    <investigator>
      <last_name>Moshe Yair Levy, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Fort Worth</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Plano East</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75075</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Tyler</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75702</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Habte Yimer, MD</last_name>
      <phone>903-579-9800</phone>
      <email>habte.yimer@usoncology.com</email>
    </contact>
    <investigator>
      <last_name>Habte Yimer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Tyler DBA UT Health East Texas HOPE Cancer Center</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75702</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marc Usrey, MD</last_name>
      <phone>903-595-7044</phone>
      <email>Marc.Usrey@uthct.edu</email>
    </contact>
    <investigator>
      <last_name>Marc Usrey, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Providence Regional Cancer Partnership</name>
      <address>
        <city>Everett</city>
        <state>Washington</state>
        <zip>98201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Kepler Universitaetskrankenhaus Med Campu III - Onkologie</name>
      <address>
        <city>Linz</city>
        <zip>4021</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Vienna, Medical Clinic I, Hematology</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hospital Hietzing</name>
      <address>
        <city>Vienna</city>
        <zip>1130</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Xu Wei</last_name>
      <phone>+86 139-5169-9449</phone>
      <email>Xuwei0484@jsph.org.cn</email>
    </contact>
    <investigator>
      <last_name>Xu Wei</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Soochow University</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <zip>215006</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wu Depei</last_name>
      <phone>+86 139-5110-2021</phone>
      <email>drwudepei@163.com</email>
    </contact>
    <investigator>
      <last_name>Wu Depei</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School</name>
      <address>
        <city>Huangpu</city>
        <state>Shanghai</state>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhao Weili</last_name>
      <phone>+86 135-1211-2076</phone>
      <email>zwl_trial@163.com</email>
    </contact>
    <investigator>
      <last_name>Zhao Weili</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital Fudan University</name>
      <address>
        <city>Xuhui District</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Liu Peng</last_name>
      <phone>+86 138-1769-2514</phone>
      <email>liu.peng@zs-hospital.sh.cn</email>
    </contact>
    <investigator>
      <last_name>Liu Peng</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Huaxi Hospital Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610044</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Zou Liqun</last_name>
      <phone>+86 189-8060-1027</phone>
      <email>zliqun@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Zou Liqun</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The first affiliated Hospital, Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jin Jie</last_name>
      <phone>+86 135-0571-6779</phone>
      <email>jiej0503@163.com</email>
    </contact>
    <investigator>
      <last_name>Jin Jie</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Assuta Ashdod Medical Center</name>
      <address>
        <city>Ashdod</city>
        <zip>7747629</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Merav Leiba, MD</last_name>
      <phone>+972 58 666 9161</phone>
      <email>meravlei@assuta.co.il</email>
    </contact>
    <investigator>
      <last_name>Merav Leiba, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Soroka Medical Center</name>
      <address>
        <city>Beer Sheva</city>
        <zip>8457108</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Itai Levi, MD</last_name>
      <phone>+972 54 4203424</phone>
      <email>etail@clalit.org.il</email>
    </contact>
    <investigator>
      <last_name>Itai Levi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rambam health care campus (Department of Hematology &amp; Bone Marrow Transplantation)</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Wolfson Medical Center</name>
      <address>
        <city>Holon</city>
        <zip>5822012</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>9103401</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petach Tikva</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ronit Gurion, MD</last_name>
      <phone>+972 50 406 5336</phone>
      <email>Ronitgurion@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Ronit Gurion, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Assuta medical centers - Ramat Hachayal</name>
      <address>
        <city>Tel aviv</city>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ofer Shpilberg, MD</last_name>
      <phone>97237644942</phone>
      <email>ofers@assuta.co.il</email>
    </contact>
    <investigator>
      <last_name>Ofer Shpilberg, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>National Cancer Institute</name>
      <address>
        <city>Naples</city>
        <state>Napoli</state>
        <zip>1-80131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antonio Pinto, MD</last_name>
      <phone>+39 81 590 3382</phone>
      <email>a.pinto@istitutotumori.na.it</email>
    </contact>
    <investigator>
      <last_name>Antonio Pinto, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello</name>
      <address>
        <city>Palermo</city>
        <state>Sicilia</state>
        <zip>90146</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Caterina Patti, MD</last_name>
      <phone>+39 91 780 2037</phone>
      <email>k.patti@ospedaliriunitipalermo.it</email>
    </contact>
    <investigator>
      <last_name>Caterina Patti, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>AOU City of Health and Science of Turin</name>
      <address>
        <city>Turin</city>
        <state>Torino</state>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Federica Cavallo, MD</last_name>
      <phone>+39 11 633 4264</phone>
      <email>f.cavallo@unito.it</email>
    </contact>
    <investigator>
      <last_name>Federica Cavallo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>AOU Ospedali Riuniti-Università Politecnica delle Marche Clinica di Ematologia</name>
      <address>
        <city>Ancona</city>
        <zip>60020</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guido Gini, MD</last_name>
      <phone>+39 71 596 4562/4235</phone>
      <email>guido.gini@ospedaliriuniti.marche.it</email>
    </contact>
    <investigator>
      <last_name>Guido Gini, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>AOU Policlinico S.Orsola Malpighi di Bologna, University of Bologna</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Pier Luigi Zinzani, MD</last_name>
      <phone>+39 51 214 3680</phone>
      <email>pierluigi.zinzani@unibo.it</email>
    </contact>
    <investigator>
      <last_name>Pier Luigi Zinzani, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UOC Ematologia ad Indirizzo Oncologico, AORN &quot;Sant'Anna e San Sebastiano&quot;</name>
      <address>
        <city>Caserta</city>
        <zip>81100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ferdinando Frigeri, MD</last_name>
      <phone>+39 82 323 2192</phone>
      <email>ferdinando.frigeri@aorncaserta.it</email>
    </contact>
    <investigator>
      <last_name>Ferdinando Frigeri, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>AOU Maggiore della Carità SCDU Ematologia</name>
      <address>
        <city>Novara</city>
        <zip>28100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gianluca Gaidano, MD</last_name>
      <phone>+39 321 373 2194</phone>
      <email>gianluca.gaidano@med.uniupo.it</email>
    </contact>
    <investigator>
      <last_name>Gianluca Gaidano, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>DIP. Oncologia- Ematologia, UOSD Centro Diagnosie TerapiaDei Linfomi</name>
      <address>
        <city>Pescara</city>
        <zip>65124</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Elsa Pennese, MD</last_name>
      <phone>+39 347 307 9075</phone>
      <email>elsapennese@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Elsa Pennese, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fondatione Policlinico Universitario A. Gemelli</name>
      <address>
        <city>Rome</city>
        <zip>168</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefan Hohaus, MD</last_name>
      <phone>+39 63 015 4180</phone>
      <email>stefan.hohaus@unicatt.it</email>
    </contact>
    <investigator>
      <last_name>Stefan Hohaus, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Pratia MCM Krakow</name>
      <address>
        <city>Krakow</city>
        <state>Lesser</state>
        <zip>30-510</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wojciech Jurczak, MD</last_name>
      <phone>48602338290</phone>
      <email>wojciech.jurczak@pratia.com</email>
    </contact>
    <investigator>
      <last_name>Wojciech Jurczak, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Szpitale pomorskie gdynia dept of haematology</name>
      <address>
        <city>Gdynia</city>
        <state>Pomerania</state>
        <zip>81-519</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wanda Knopinska-Posluszny, MD</last_name>
      <phone>+48 58 726 0570</phone>
      <email>wanda.knopinska@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Wanda Knopinska-Posluszny, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku Uniwersytecki Szpital Kliniczny im. Jana Mikulicza - Radeckiego we Wrocławiu</name>
      <address>
        <city>Wroclaw</city>
        <state>Radeckiego</state>
        <zip>50-367</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tomasz Wrobel</last_name>
      <email>tomasz_wrobel@wp.pl</email>
    </contact>
    <investigator>
      <last_name>Tomasz Wrobel</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Examen sp z o o</name>
      <address>
        <city>Skorzewo</city>
        <state>Wielkopolska</state>
        <zip>60819</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maciej Kazmierczak, MD</last_name>
      <phone>+48506969916</phone>
      <email>kontakt@examen.pl</email>
    </contact>
    <investigator>
      <last_name>Maciej Kazmierczak, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institute of Hematology and Transfusion Medicine</name>
      <address>
        <city>Warsaw</city>
        <zip>00-791</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ewa Lech-Maranda, MD</last_name>
      <phone>48223496454</phone>
      <email>emaranda@ihit.waw.pl</email>
    </contact>
    <investigator>
      <last_name>Ewa Lech-Maranda, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Department of Lymphoid Malignancies, Maria Sklodowska-Curie National Research Institute of Oncology</name>
      <address>
        <city>Warszawa</city>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jan Walewski, MD</last_name>
      <phone>+48 22 546 3248</phone>
      <email>jan.walewski@pib-nio.pl</email>
    </contact>
    <investigator>
      <last_name>Jan Walewski, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Pratia Onkologia Katowice</name>
      <address>
        <city>Katowice</city>
        <state>Śląskie</state>
        <zip>40-523</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sebastian Grosicki</last_name>
      <phone>+48 501 714 089</phone>
      <email>sgrosicki@wp.pl</email>
    </contact>
    <investigator>
      <last_name>Sebastian Grosicki</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut català d'oncologia-hospital germans trias i pujol</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>8916</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juan Manuel Sancho, MD</last_name>
      <phone>+34 93 497 8987</phone>
      <email>jsancho@iconcologia.net</email>
    </contact>
    <investigator>
      <last_name>Juan Manuel Sancho, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Vall Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>8035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pau Abrisqueta, MD</last_name>
      <phone>+34 93 489 3000</phone>
      <phone_ext>4895</phone_ext>
      <email>pabrisqueta@vhebron.net</email>
    </contact>
    <investigator>
      <last_name>Pau Abrisqueta, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Institut Catala D'oncolocia</name>
      <address>
        <city>Barcelona</city>
        <zip>9809</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna Sureda, MD</last_name>
      <phone>+34 93 260 7750</phone>
      <email>asureda@iconcologio.net</email>
    </contact>
    <investigator>
      <last_name>Anna Sureda, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Miguel Canales, MD</last_name>
      <phone>+34 91 727 7116</phone>
      <email>mcanales.hematologia@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Miguel Canales, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen del Rocío</name>
      <address>
        <city>Seville</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fatima De la Cruz, MD</last_name>
      <phone>+34 95 501 3277</phone>
      <email>fatimadelacruzv@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Fatima De la Cruz, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>China</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Australia</country>
    <country>France</country>
    <country>Germany</country>
    <country>United Kingdom</country>
  </removed_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>August 22, 2023</last_update_submitted>
  <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Relapsed/Refractory DLBCL</keyword>
  <keyword>Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP)</keyword>
  <keyword>Selinexor</keyword>
  <keyword>Karyopharm</keyword>
  <keyword>KCP-330</keyword>
  <keyword>XPOVIO</keyword>
  <keyword>DLBCL</keyword>
  <keyword>XPORT-DLBCL-030</keyword>
  <keyword>R-GDP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Rituximab</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
  </intervention_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/NCT04442022
org study id: XPORT-DLBCL-030
secondary id: 2020-000605-84
nct id: NCT04442022
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this Phase 2/3 study is to evaluate efficacy and safety of the combination of
      selinexor and R-GDP (SR-GDP) in patients with RR DLBCL who are not intended to receive
      hematopoetic stem cell transplantation (HSCT) or chimeric antigen receptor T cell (CAR-T)
      therapy. This study consists of 3 arms each in Phase 2 and 3. Phase 2 portion of the study
      will assess the two doses of selinexor (40 milligram [mg] or 60 mg) in combination with
      R-GDP, for up to 6 cycles (21-day per cycle), followed by 60 mg selinexor single agent
      continuous therapy for those who have reached a partial or complete response. Phase 3 portion
      of the study will evaluate the selected dose of SR-GDP (identified in Phase 2) versus
      standard R-GDP + matching placebo, for up to 6 cycles (21-day per cycle), followed by placebo
      or 60 mg selinexor single agent continuous therapy for those who have reached partial or
      complete response.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Phase 2 Portion of the Study: open label; Phase 3 Portion of the Study: double blinded
measure: Phase 2: Overall Response Rate (ORR): Based on Lugano Criteria 2014
time frame: From date of initial randomization to the date of disease progression or initiating a new DLBCL treatment (maximum of 5 years from randomization)
measure: Phase 3: Progression-free Survival (PFS): Based on Lugano Criteria 2014
time frame: From date of initial randomization to the date of disease progression or death (maximum of 5 years from randomization)
measure: Phase 2: Progression-free Survival: Based on Lugano Criteria 2014
time frame: From date of initial randomization to the date of disease progression or death (maximum of 5 years from randomization)
measure: Phase 2: Overall Survival (OS)
time frame: From date of initial randomization until death (maximum of 5 years from randomization)
measure: Phase 3: Overall Response Rate: Based on Lugano Criteria 2014
time frame: From date of initial randomization to the date of disease progression or initiating a new DLBCL treatment (maximum of 5 years from randomization)
measure: Phase 3: Overall Survival
time frame: From date of initial randomization until death (maximum of 5 years from randomization)
measure: Phase 2: Overall Response Rate at the End of Combination Therapy (ORR-EoC): Based on Lugano Criteria 2014
time frame: From C1D1 (Cycles 1 up to 6; 21 days per cycle) up to 28 days after EoC therapy
measure: Phase 2: Overall Response Rate at the End of Combination Therapy: Based on Modified Lugano Criteria
time frame: From C1D1 (Cycles 1 up to 6; 21 days per cycle) up to 28 days after EoC therapy
measure: Phase 2: Duration of Response (DOR): Based on Lugano Criteria 2014
time frame: From time of first response until disease progression or death (maximum of 5 years from randomization)
measure: Phase 2: Number of Patients with Adverse Events (AEs)
time frame: Up to 30 days after last dose of study drug (maximum of 5 years from randomization)
measure: Phase 3: Overall Response Rate at the End of Combination Therapy: Based on Lugano Criteria 2014
time frame: From C1D1 (Cycles 1 up to 6; 21 days per cycle) up to 28 days after EoC therapy
measure: Phase 3: Overall Response Rate at the End of Combination Therapy: Based on Modified Lugano Criteria
time frame: From C1D1 (Cycles 1 up to 6; 21 days per cycle) up to 28 days after EoC therapy
measure: Phase 3: Duration of Response: Based on Lugano Criteria 2014
time frame: From time of first response until disease progression or death (maximum of 5 years from randomization)
measure: Phase 3: Progression-free Survival: Based on Modified Lugano Criteria
time frame: From date of initial randomization to the date of disease progression or death (maximum of 5 years from randomization)
measure: Phase 3: Number of Patients with Adverse Events
time frame: Up to 30 days after last dose of study drug (maximum of 5 years from randomization)
arm group label: Phase 2: Selinexor 40 mg + R-GDP
arm group type: Experimental
description: Patients with RR DLBCL will receive combination therapy of selinexor 40 mg orally at Day 1, and Day 8 of each 21-day cycle for up to 6 cycles in combination with R-GDP followed by single-agent continuous therapy with selinexor 60 mg orally once weekly (QW) for each 28-day cycle until progressive disease (PD) or unacceptable toxicity.
arm group label: Phase 2: Selinexor 60 mg + R-GDP
arm group type: Experimental
description: Patients with RR DLBCL will receive combination therapy of selinexor 60 mg orally at Day 1 and Day 8 of each 21-day cycle for up to 6 cycles in combination with R-GDP followed by single-agent continuous therapy with selinexor 60 mg orally QW for each 28-day cycle until PD or unacceptable toxicity.
arm group label: Phase 2: R-GDP
arm group type: Active Comparator
description: Patients with RR DLBCL will receive R-GDP on specified days (Days 1, 2, 3, 4, and 8) for each 21-day cycle for up to 6 cycles.
arm group label: Phase 3: Selinexor (Selected Dose) + R-GDP followed by Selinexor 60 mg
arm group type: Experimental
description: Patients with RR DLBCL will receive combination therapy of selinexor (selected dose from Phase 2) at Day 1 and Day 8 of each 21-day cycle for up to 6 cycles in combination with R-GDP followed by selinexor 60 mg orally QW for each 28-day cycle until PD or unacceptable toxicity.
arm group label: Phase 3: Selinexor (Selected Dose) + R-GDP followed by Placebo
arm group type: Experimental
description: Patients with RR DLBCL will receive combination therapy of selinexor (selected dose from Phase 2) at Day 1 and Day 8 of each 21-day cycle for up to 6 cycles in combination with R-GDP followed by matching placebo for selinexor orally QW for each 28-day cycle until PD or unacceptable toxicity.
arm group label: Phase 3: Placebo + R-GDP followed by Placebo
arm group type: Placebo Comparator
description: Patients with RR DLBCL will receive combination therapy of placebo matching for selinexor (selected dose from Phase 2) at Day 1 and Day 8 of each 21-day cycle for up to 6 cycles in combination with R-GDP followed by matching placebo for selinexor orally QW for each 28-day cycle until PD or unacceptable toxicity.
intervention type: Drug
intervention name: Selinexor (combination therapy)
description: Dose: 40 mg on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral
arm group label: Phase 2: Selinexor 40 mg + R-GDP
intervention type: Drug
intervention name: Selinexor (combination therapy)
description: Dose: 60 mg on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral
arm group label: Phase 2: Selinexor 60 mg + R-GDP
intervention type: Drug
intervention name: Selinexor (combination therapy)
description: Dose: Selected dose of selinexor (from Phase 2) on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral
arm group label: Phase 3: Selinexor (Selected Dose) + R-GDP followed by Placebo
arm group label: Phase 3: Selinexor (Selected Dose) + R-GDP followed by Selinexor 60 mg
intervention type: Drug
intervention name: Placebo matching for Selinexor (combination therapy)
description: Dose: Placebo matching for selected dose of selinexor (from Phase 2) on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral
arm group label: Phase 3: Placebo + R-GDP followed by Placebo
intervention type: Drug
intervention name: Rituximab (combination therapy)
description: Dose: 375 milligram per meter square (mg/m^2) on Day 1; Route of administration: intravenous (IV)
arm group label: Phase 2: Selinexor 40 mg + R-GDP
intervention type: Drug
intervention name: Rituximab (combination therapy)
description: Dose: 375 mg/m^2 on Day 1; Route of administration: IV
arm group label: Phase 2: R-GDP
arm group label: Phase 2: Selinexor 60 mg + R-GDP
arm group label: Phase 3: Placebo + R-GDP followed by Placebo
arm group label: Phase 3: Selinexor (Selected Dose) + R-GDP followed by Placebo
arm group label: Phase 3: Selinexor (Selected Dose) + R-GDP followed by Selinexor 60 mg
intervention type: Drug
intervention name: Gemcitabine (combination therapy)
description: Dose: 1000 mg/m^2 on Days 1 and 8; Route of administration: IV
arm group label: Phase 2: R-GDP
arm group label: Phase 2: Selinexor 40 mg + R-GDP
arm group label: Phase 2: Selinexor 60 mg + R-GDP
arm group label: Phase 3: Placebo + R-GDP followed by Placebo
arm group label: Phase 3: Selinexor (Selected Dose) + R-GDP followed by Placebo
arm group label: Phase 3: Selinexor (Selected Dose) + R-GDP followed by Selinexor 60 mg
intervention type: Drug
intervention name: Dexamethasone (combination therapy)
description: Dose: 40 mg (20 mg if patient is more than 70 years old) on Days 1, 2, 3, and 4; Route of administration: oral or IV
arm group label: Phase 2: R-GDP
arm group label: Phase 2: Selinexor 40 mg + R-GDP
arm group label: Phase 2: Selinexor 60 mg + R-GDP
arm group label: Phase 3: Placebo + R-GDP followed by Placebo
arm group label: Phase 3: Selinexor (Selected Dose) + R-GDP followed by Placebo
arm group label: Phase 3: Selinexor (Selected Dose) + R-GDP followed by Selinexor 60 mg
intervention type: Drug
intervention name: Cisplatin (combination therapy)
description: Dose: 75 mg/m^2 on Day 1; Route of administration: IV
arm group label: Phase 2: R-GDP
arm group label: Phase 2: Selinexor 40 mg + R-GDP
arm group label: Phase 2: Selinexor 60 mg + R-GDP
arm group label: Phase 3: Placebo + R-GDP followed by Placebo
arm group label: Phase 3: Selinexor (Selected Dose) + R-GDP followed by Placebo
arm group label: Phase 3: Selinexor (Selected Dose) + R-GDP followed by Selinexor 60 mg
intervention type: Drug
intervention name: Selinexor (continuous therapy)
description: Dose: 60 mg QW for each 28-day cycle until PD; Route of administration: oral
arm group label: Phase 2: Selinexor 40 mg + R-GDP
arm group label: Phase 2: Selinexor 60 mg + R-GDP
arm group label: Phase 3: Selinexor (Selected Dose) + R-GDP followed by Selinexor 60 mg
intervention type: Drug
intervention name: Placebo matching for Selinexor (continuous therapy)
description: Dose: Placebo matching for 60 mg selinexor QW for each 28-day cycle until PD; Route of administration: oral
arm group label: Phase 3: Placebo + R-GDP followed by Placebo
arm group label: Phase 3: Selinexor (Selected Dose) + R-GDP followed by Placebo
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: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Terminated
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Terminated
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Terminated
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Austria
country: China
country: Israel
country: Italy
country: Poland
country: Spain
country: United States
country: Australia
country: France
country: Germany
country: United Kingdom
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Dexamethasone
mesh term: Rituximab
mesh term: Gemcitabine
sharing ipd: Undecided