<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/NCT02226965</url>
  </required_header>
  <id_info>
    <org_study_id>PNT2258-03-DLBCL</org_study_id>
    <nct_id>NCT02226965</nct_id>
  </id_info>
  <brief_title>PNT2258 for Treatment of Patients With r/r DLBCL (Wolverine)</brief_title>
  <official_title>A Phase II Study of PNT2258 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sierra Oncology LLC - a GSK company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sierra Oncology LLC - a GSK company</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It is a&#xD;
      multi-center, nonrandomized, open label, phase II investigation of PNT2258 to characterize&#xD;
      anti-tumor activity and collect safety data on patients with relapsed or refractory (r/r)&#xD;
      diffuse large B-cell lymphoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Actual">August 22, 2018</completion_date>
  <primary_completion_date type="Actual">July 11, 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Response Rate</measure>
    <time_frame>19 months</time_frame>
    <description>The proportion of patients with complete response (CR/complete metabolic response [CMR]) or partial response (PR/partial metabolic response [PMR]) according to the revised 2014 International Working Group (IWG) criteria for lymphoma (Cheson 2014)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate</measure>
    <time_frame>19 months</time_frame>
    <description>The proportion of patients who have a response of stable disease (SD/no metabolic response [NMR]) or better by investigator assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Response</measure>
    <time_frame>19 months</time_frame>
    <description>The number of months from Cycle 1 Day 1 until the date of the first documented response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival</measure>
    <time_frame>19 months</time_frame>
    <description>The number of months from C1D1 until the date of DLBCL progression or death from any cause, or to the last date at which progression status was adequately assessed for censored observation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety - Assessment of Adverse Events</measure>
    <time_frame>36 months</time_frame>
    <description>Characterization of the type, frequency, severity, timing of onset, duration, and relationship to study drug of any treatment-emergent adverse events, laboratory abnormalities, serious adverse events or adverse events leading to discontinuation of study treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>19 months</time_frame>
    <description>The number of months from C1D1 until the date of death from any cause, or to the last date at which survival status was adequately assessed for censored observations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Overall Response</measure>
    <time_frame>19 months</time_frame>
    <description>The time from the initial CMR or PMR until the date of progression or death from any cause, or to the last date at which progression status was adequately assessed for censored observations</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Lymphoma, Diffuse Large B-Cell</condition>
  <arm_group>
    <arm_group_label>PNT2258</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PNT2258 will be administered at 120 mg/m2 on days 1-5 of a 21-day cycle. Treatment may continue unless there is disease progression or the occurrence of unacceptable toxicity for a total of 8 &quot;induction&quot; cycles of therapy. Subjects with CR/CMR, PR/PMR or SD/NMR at the end-of-cycle 8 scan then receive ongoing PNT2258 therapy at a dose of 100 mg/m2 on days 1-4 of a 28 day cycle until progressive disease, the occurrence of unacceptable toxicity, non-compliance, voluntary withdrawal or if in the opinion of the investigator the subject is no longer benefiting from exposure to PNT2258.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PNT2258</intervention_name>
    <arm_group_label>PNT2258</arm_group_label>
    <other_name>DNAi, BCL2 targeted therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Histologically confirmed diffuse large B-cell lymphoma that is refractory to prior therapy&#xD;
        or relapsed after prior therapy.&#xD;
&#xD;
        FDG PET-CT (disease) positive baseline scan with measurable disease.&#xD;
&#xD;
        The patient must have received prior therapy that included:&#xD;
&#xD;
          -  CD20-targeted therapy (for example, rituximab),&#xD;
&#xD;
          -  Alkylating agent (for example, cyclophosphomide), and&#xD;
&#xD;
          -  Steroid, unless the patient is steroid intolerant&#xD;
&#xD;
        Exposure to at least 1 or 2 (but no more than 3) prior systemic cytotoxic chemotherapeutic&#xD;
        regimens.&#xD;
&#xD;
        Note: Only those subjects who are not eligible for high-dose chemotherapy and autologous&#xD;
        stem cell transplant (HD-ASCT), or who refuse HD-ASCT, are eligible with exposure to only 1&#xD;
        prior cytotoxic chemotherapeutic regimen.&#xD;
&#xD;
        ECOG performance status of 0-1.&#xD;
&#xD;
        The patient must be a stable baseline with CTCAE grade ≤ 2 regarding any acute or chronic&#xD;
        toxicity associated with prior therapy, and have discontinued prior anti-cancer therapy for&#xD;
        ≥ 14 days prior to C1D1; mitomycin-C for at least 6 weeks prior to C1D1; SCT ≥ 2 months&#xD;
        prior to C1D1.&#xD;
&#xD;
        Note: Palliative steroids for control of disease-related symptoms are allowed and&#xD;
        maintenance hormone therapy is allowed.&#xD;
&#xD;
        Adequate organ function including:&#xD;
&#xD;
          -  Hematologic: ANC ≥ 0.5 x 10^9/L. and platelets ≥ 50 x 10^9/L.&#xD;
&#xD;
          -  Hepatic: Total Bilirubin ≤ 2 x ULN (patients with Gilbert's syndrome must have total&#xD;
             bilirubin ≤ 3 x ULN) and serum transaminase levels ≤ 2.5 x ULN. In the case of known&#xD;
             liver metastasis (i.e., radiological or biopsy documented), serum transaminase levels&#xD;
             must be ≤ 5 x ULN.&#xD;
&#xD;
          -  Renal: Serum creatinine ≤ 2 x ULN, or creatinine clearance ≥ 60 mL/min/1.73 m2 for&#xD;
             subjects with serum creatinine levels above 2 x ULN.&#xD;
&#xD;
        Willingness to: 1.) undergo pre-treatment biopsy to obtain adequate tissue for analysis&#xD;
        (e.g., core needle, excisional or incisional tumor biopsy) or 2.) provide archived tumor&#xD;
        (e.g., FFPE block) for analysis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Eligibility for high-dose chemotherapy (HDT) and stem cell transplant (SCT). Note: Subjects&#xD;
        who progressed ≥ 2 months after HDT/SCT are eligible&#xD;
&#xD;
        Concurrent malignancies requiring treatment.&#xD;
&#xD;
        Primary mediastinal (thymic) large B-cell lymphoma&#xD;
&#xD;
        Symptomatic CNS or leptomeningeal involvement of lymphoma.&#xD;
&#xD;
        Concurrent clinically significant illness, medical condition, surgical history, physical&#xD;
        finding, electrocardiogram or laboratory finding that, in the opinion of the investigator,&#xD;
        could adversely affect the safety of the patient or impair the assessment of the study&#xD;
        results.&#xD;
&#xD;
        Signs or symptoms of heart failure characterized as greater than NYHA Class II or other&#xD;
        significant cardiac abnormalities.&#xD;
&#xD;
        Pregnant or breast-feeding.&#xD;
&#xD;
        Prior exposure to PNT2258.&#xD;
&#xD;
        Life expectancy less than 3 months.&#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_official>
    <last_name>Barbara Klencke, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Sierra Oncology LLC - a GSK company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Long Beach Memorial Medical Center</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Blood and Cancer Institute</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynn Cancer Institute</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bond Clinic, P.A.</name>
      <address>
        <city>Winter Haven</city>
        <state>Florida</state>
        <zip>33880</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Regents University</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Horizon Oncology Research, Inc.</name>
      <address>
        <city>Lafayette</city>
        <state>Indiana</state>
        <zip>47905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UHC Oncology</name>
      <address>
        <city>Lafayette</city>
        <state>Louisiana</state>
        <zip>70506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Maryland Health System</name>
      <address>
        <city>Cumberland</city>
        <state>Maryland</state>
        <zip>21502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Health Saint Mary's</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. John Hospital and Medical Center</name>
      <address>
        <city>Grosse Pointe Woods</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan State University</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Beaumont Hospital</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUNY Upstate Medical University</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bon Secours Saint Francis Cancer Center</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avera Research Institute</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Research Institute</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M.D. Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tyler Hematology Oncology</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Specialists</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peninsula Cancer Institute</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <zip>23601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Oncology Associates, PS</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion de Investigacion</name>
      <address>
        <city>San Juan</city>
        <zip>00927</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <results_first_submitted>April 8, 2020</results_first_submitted>
  <results_first_submitted_qc>April 8, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 22, 2020</results_first_posted>
  <last_update_submitted>June 14, 2023</last_update_submitted>
  <last_update_submitted_qc>June 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PNT2258</keyword>
  <keyword>DLBCL</keyword>
  <keyword>Diffuse Large B-cell Lymphoma</keyword>
  <keyword>NHL</keyword>
  <keyword>Non-Hodgkin's Lymphoma</keyword>
  <keyword>Lymphoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was initiated in December 2014 and the first subject was enrolled on 10 December 2014. A total of 60 subjects were screened. Enrollment was closed as of 07 June 2016. Subjects were enrolled at oncology clinics in the USA.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>PNT2258</title>
          <description>PNT2258 was administered at a dose of 120 mg/m2, as a 3 - 4 hour intravenous (IV) infusion on days 1 through 5 of 21-day induction phase cycles (for eight cycles), followed by continuation phase therapy at a dose of 100 mg/m2, as a 2 - 3 hour intravenous (IV) infusion on days 1 through 4 of a 28-day cycle.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All patients who passed the screening in the study</population>
      <group_list>
        <group group_id="B1">
          <title>PNT2258</title>
          <description>PNT2258 was administered at a dose of 120 mg/m2, as a 3 - 4 hour intravenous (IV) infusion on days 1 through 5 of 21-day induction phase cycles (for eight cycles), followed by continuation phase therapy at a dose of 100 mg/m2, as a 2 - 3 hour intravenous (IV) infusion on days 1 through 4 of a 28-day cycle.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="45"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64" lower_limit="26" upper_limit="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Response Rate</title>
        <description>The proportion of patients with complete response (CR/complete metabolic response [CMR]) or partial response (PR/partial metabolic response [PMR]) according to the revised 2014 International Working Group (IWG) criteria for lymphoma (Cheson 2014)</description>
        <time_frame>19 months</time_frame>
        <population>All enrolled population: All patients who passed the screening in the study</population>
        <group_list>
          <group group_id="O1">
            <title>PNT2258</title>
            <description>PNT2258 was administered at a dose of 120 mg/m2, as a 3 - 4 hour intravenous (IV) infusion on days 1 through 5 of 21-day induction phase cycles (for eight cycles), followed by continuation phase therapy at a dose of 100 mg/m2, as a 2 - 3 hour intravenous (IV) infusion on days 1 through 4 of a 28-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate</title>
          <description>The proportion of patients with complete response (CR/complete metabolic response [CMR]) or partial response (PR/partial metabolic response [PMR]) according to the revised 2014 International Working Group (IWG) criteria for lymphoma (Cheson 2014)</description>
          <population>All enrolled population: All patients who passed the screening in the study</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.1" lower_limit="3.7" upper_limit="24.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Control Rate</title>
        <description>The proportion of patients who have a response of stable disease (SD/no metabolic response [NMR]) or better by investigator assessment</description>
        <time_frame>19 months</time_frame>
        <population>All enrolled population: All patients who passed the screening in the study</population>
        <group_list>
          <group group_id="O1">
            <title>PNT2258</title>
            <description>PNT2258 was administered at a dose of 120 mg/m2, as a 3 - 4 hour intravenous (IV) infusion on days 1 through 5 of 21-day induction phase cycles (for eight cycles), followed by continuation phase therapy at a dose of 100 mg/m2, as a 2 - 3 hour intravenous (IV) infusion on days 1 through 4 of a 28-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Control Rate</title>
          <description>The proportion of patients who have a response of stable disease (SD/no metabolic response [NMR]) or better by investigator assessment</description>
          <population>All enrolled population: All patients who passed the screening in the study</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0" lower_limit="9.6" upper_limit="34.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Response</title>
        <description>The number of months from Cycle 1 Day 1 until the date of the first documented response</description>
        <time_frame>19 months</time_frame>
        <population>All enrolled population: All patients who passed the screening in the study</population>
        <group_list>
          <group group_id="O1">
            <title>PNT2258</title>
            <description>PNT2258 was administered at a dose of 120 mg/m2, as a 3 - 4 hour intravenous (IV) infusion on days 1 through 5 of 21-day induction phase cycles (for eight cycles), followed by continuation phase therapy at a dose of 100 mg/m2, as a 2 - 3 hour intravenous (IV) infusion on days 1 through 4 of a 28-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Response</title>
          <description>The number of months from Cycle 1 Day 1 until the date of the first documented response</description>
          <population>All enrolled population: All patients who passed the screening in the study</population>
          <units>months</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" lower_limit="1.9" upper_limit="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-free Survival</title>
        <description>The number of months from C1D1 until the date of DLBCL progression or death from any cause, or to the last date at which progression status was adequately assessed for censored observation</description>
        <time_frame>19 months</time_frame>
        <population>All enrolled population: All patients who passed the screening in the study</population>
        <group_list>
          <group group_id="O1">
            <title>PNT2258</title>
            <description>PNT2258 was administered at a dose of 120 mg/m2, as a 3 - 4 hour intravenous (IV) infusion on days 1 through 5 of 21-day induction phase cycles (for eight cycles), followed by continuation phase therapy at a dose of 100 mg/m2, as a 2 - 3 hour intravenous (IV) infusion on days 1 through 4 of a 28-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival</title>
          <description>The number of months from C1D1 until the date of DLBCL progression or death from any cause, or to the last date at which progression status was adequately assessed for censored observation</description>
          <population>All enrolled population: All patients who passed the screening in the study</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" lower_limit="1.4" upper_limit="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety - Assessment of Adverse Events</title>
        <description>Characterization of the type, frequency, severity, timing of onset, duration, and relationship to study drug of any treatment-emergent adverse events, laboratory abnormalities, serious adverse events or adverse events leading to discontinuation of study treatment</description>
        <time_frame>36 months</time_frame>
        <population>Safety population: All patients who received at least 1 dose of PNT2258</population>
        <group_list>
          <group group_id="O1">
            <title>PNT2258</title>
            <description>PNT2258 was administered at a dose of 120 mg/m2, as a 3 - 4 hour intravenous (IV) infusion on days 1 through 5 of 21-day induction phase cycles (for eight cycles), followed by continuation phase therapy at a dose of 100 mg/m2, as a 2 - 3 hour intravenous (IV) infusion on days 1 through 4 of a 28-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety - Assessment of Adverse Events</title>
          <description>Characterization of the type, frequency, severity, timing of onset, duration, and relationship to study drug of any treatment-emergent adverse events, laboratory abnormalities, serious adverse events or adverse events leading to discontinuation of study treatment</description>
          <population>Safety population: All patients who received at least 1 dose of PNT2258</population>
          <units>participants reporting at least 1 AE</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival</title>
        <description>The number of months from C1D1 until the date of death from any cause, or to the last date at which survival status was adequately assessed for censored observations</description>
        <time_frame>19 months</time_frame>
        <population>All enrolled population: All patients who passed the screening in the study</population>
        <group_list>
          <group group_id="O1">
            <title>PNT2258</title>
            <description>PNT2258 was administered at a dose of 120 mg/m2, as a 3 - 4 hour intravenous (IV) infusion on days 1 through 5 of 21-day induction phase cycles (for eight cycles), followed by continuation phase therapy at a dose of 100 mg/m2, as a 2 - 3 hour intravenous (IV) infusion on days 1 through 4 of a 28-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <description>The number of months from C1D1 until the date of death from any cause, or to the last date at which survival status was adequately assessed for censored observations</description>
          <population>All enrolled population: All patients who passed the screening in the study</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8" lower_limit="0.3" upper_limit="19.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Overall Response</title>
        <description>The time from the initial CMR or PMR until the date of progression or death from any cause, or to the last date at which progression status was adequately assessed for censored observations</description>
        <time_frame>19 months</time_frame>
        <population>All enrolled population: All patients who passed the screening in the study</population>
        <group_list>
          <group group_id="O1">
            <title>PNT2258</title>
            <description>PNT2258 was administered at a dose of 120 mg/m2, as a 3 - 4 hour intravenous (IV) infusion on days 1 through 5 of 21-day induction phase cycles (for eight cycles), followed by continuation phase therapy at a dose of 100 mg/m2, as a 2 - 3 hour intravenous (IV) infusion on days 1 through 4 of a 28-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Overall Response</title>
          <description>The time from the initial CMR or PMR until the date of progression or death from any cause, or to the last date at which progression status was adequately assessed for censored observations</description>
          <population>All enrolled population: All patients who passed the screening in the study</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" lower_limit="0.0" upper_limit="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 months</time_frame>
      <desc>Adverse events were collected until 30 days after the last dose of PNT2258 for each subject</desc>
      <group_list>
        <group group_id="E1">
          <title>PNT2258</title>
          <description>PNT2258 was administered at a dose of 120 mg/m2, as a 3 - 4 hour intravenous (IV) infusion on days 1 through 5 of 21-day induction phase cycles (for eight cycles), followed by continuation phase therapy at a dose of 100 mg/m2, as a 2 - 3 hour intravenous (IV) infusion on days 1 through 4 of a 28-day cycle.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (18.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Escherichia bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Tumor flare</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (18.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="45"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02226965
org study id: PNT2258-03-DLBCL
nct id: NCT02226965
lead sponsor: 
has dmc: Yes
This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It is a
      multi-center, nonrandomized, open label, phase II investigation of PNT2258 to characterize
      anti-tumor activity and collect safety data on patients with relapsed or refractory (r/r)
      diffuse large B-cell lymphoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Response Rate
time frame: 19 months
description: The proportion of patients with complete response (CR/complete metabolic response [CMR]) or partial response (PR/partial metabolic response [PMR]) according to the revised 2014 International Working Group (IWG) criteria for lymphoma (Cheson 2014)
measure: Disease Control Rate
time frame: 19 months
description: The proportion of patients who have a response of stable disease (SD/no metabolic response [NMR]) or better by investigator assessment
measure: Time to Response
time frame: 19 months
description: The number of months from Cycle 1 Day 1 until the date of the first documented response
measure: Progression-free Survival
time frame: 19 months
description: The number of months from C1D1 until the date of DLBCL progression or death from any cause, or to the last date at which progression status was adequately assessed for censored observation
measure: Safety - Assessment of Adverse Events
time frame: 36 months
description: Characterization of the type, frequency, severity, timing of onset, duration, and relationship to study drug of any treatment-emergent adverse events, laboratory abnormalities, serious adverse events or adverse events leading to discontinuation of study treatment
measure: Overall Survival
time frame: 19 months
description: The number of months from C1D1 until the date of death from any cause, or to the last date at which survival status was adequately assessed for censored observations
measure: Duration of Overall Response
time frame: 19 months
description: The time from the initial CMR or PMR until the date of progression or death from any cause, or to the last date at which progression status was adequately assessed for censored observations
arm group label: PNT2258
arm group type: Experimental
description: PNT2258 will be administered at 120 mg/m2 on days 1-5 of a 21-day cycle. Treatment may continue unless there is disease progression or the occurrence of unacceptable toxicity for a total of 8 "induction" cycles of therapy. Subjects with CR/CMR, PR/PMR or SD/NMR at the end-of-cycle 8 scan then receive ongoing PNT2258 therapy at a dose of 100 mg/m2 on days 1-4 of a 28 day cycle until progressive disease, the occurrence of unacceptable toxicity, non-compliance, voluntary withdrawal or if in the opinion of the investigator the subject is no longer benefiting from exposure to PNT2258.
intervention type: Drug
intervention name: PNT2258
arm group label: PNT2258
other name: DNAi, BCL2 targeted therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Barbara Klencke, MD
role: Study Chair
affiliation: Sierra Oncology LLC - a GSK company
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country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 