<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/NCT04468984</url>
  </required_header>
  <id_info>
    <org_study_id>M20-178</org_study_id>
    <secondary_id>2020-000557-27</secondary_id>
    <nct_id>NCT04468984</nct_id>
  </id_info>
  <brief_title>Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis</brief_title>
  <acronym>TRANSFORM-2</acronym>
  <official_title>A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Navitoclax in Combination With Ruxolitinib Versus Best Available Therapy in Subjects With Relapsed/Refractory Myelofibrosis (TRANSFORM-2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Myelofibrosis (MF) is a rare blood cancer, notable for scarring of the bone marrow (the&#xD;
      spongy tissue inside bones) and the spleen becoming larger. The purpose of this study is to&#xD;
      assess safety and change in spleen volume when navitoclax is given in combination with&#xD;
      ruxolitinib, compared to best available therapy, for adult participants with MF.&#xD;
&#xD;
      Navitoclax is an investigational drug (not yet approved) being developed for the treatment of&#xD;
      MF. Participants in this study will be randomly selected (like picking numbers out of a hat)&#xD;
      to be in 1 of 2 treatment arms. Neither participants nor the study doctor will be able to&#xD;
      pick which treatment arm a participants enters. In Arm A, participants will receive&#xD;
      navitoclax in combination with ruxolitinib. In Arm B, participants will receive the best&#xD;
      available therapy (BAT) for MF. Adult participants with a diagnosis of MF that came back or&#xD;
      did not get better after earlier treatment will be enrolled. Approximately 330 participants&#xD;
      will be enrolled in approximately 210 sites across the world.&#xD;
&#xD;
      In Arm A, participants will receive navitoclax tablet by mouth once daily with by mouth&#xD;
      ruxolitinib tablet twice daily. In Arm B, participants will receive the BAT available to the&#xD;
      investigator. Participants will receive the study drug until they experience no benefit&#xD;
      (determined by the investigator), participants cannot tolerate the study drugs, or&#xD;
      participants withdraw consent. The approximate treatment duration is about 3 years.&#xD;
&#xD;
      There may be higher treatment burden for participants in this trial compared to their&#xD;
      standard of care. Participants will attend regular visits during the study at a hospital or&#xD;
      clinic. The effect of treatment will be checked by medical assessments, blood and bone marrow&#xD;
      tests, checking for side effects, and completing questionnaires.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 31, 2020</start_date>
  <completion_date type="Anticipated">January 2, 2031</completion_date>
  <primary_completion_date type="Anticipated">August 15, 2024</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at Week 24 (SVR35W24)</measure>
    <time_frame>At Week 24</time_frame>
    <description>Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT), per International Working Group (IWG) criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants who achieve at least 50% Reduction in Total Symptom Score (TSS)</measure>
    <time_frame>Baseline (Week 0) Up to Week 24</time_frame>
    <description>Reduction in TSS is measured by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at any time</measure>
    <time_frame>Baseline (Week 0) Up to Week 97</time_frame>
    <description>Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT), per International Working Group (IWG) criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Reduction in Grade of Bone Marrow Fibrosis</measure>
    <time_frame>Baseline (Week 0) Up to Week 97</time_frame>
    <description>Reduction in grade of bone marrow fibrosis from baseline as measured by the European consensus grading system will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Anemia Response</measure>
    <time_frame>Baseline (Week 0) Up to Week 97</time_frame>
    <description>Anemia response per International Working Group (IWG) criteria will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Overall Survival</measure>
    <time_frame>Last Visit Up to 5 Years</time_frame>
    <description>Overall survival is defined as the time from start of study to the date of death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Leukemia-free Survival</measure>
    <time_frame>Last Visit Up to 5 Years</time_frame>
    <description>Leukemia free survival is the time from start of study to the date of development of leukemia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Change in Fatigue</measure>
    <time_frame>Baseline (Week 0) Up to Week 24</time_frame>
    <description>Change in fatigue will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Deterioration of Physical Functioning</measure>
    <time_frame>Baseline (Week 0) Up to Week 97</time_frame>
    <description>Time to deterioration of physical functioning is measured by the physical functioning domain of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, or death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with at Least 50% Reduction in TSS</measure>
    <time_frame>Baseline (Week 0) Up to Week 97</time_frame>
    <description>At least 50% reduction in TSS from baseline (at any time) as measured by MFSAF v4.0.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">330</enrollment>
  <condition>Myelofibrosis (MF)</condition>
  <arm_group>
    <arm_group_label>Arm A: Navitoclax + Ruxolitinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive navitoclax tablets once daily and ruxolitinib tablets twice daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B: Best Available Therapy (BAT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive one of the BAT options, per the investigator's discretion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Navitoclax</intervention_name>
    <description>Tablet; Oral</description>
    <arm_group_label>Arm A: Navitoclax + Ruxolitinib</arm_group_label>
    <other_name>ABT-263</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ruxolitinib</intervention_name>
    <description>Tablet; Oral</description>
    <arm_group_label>Arm A: Navitoclax + Ruxolitinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Best Available Therapy (BAT)</intervention_name>
    <description>Tablet/Capsule; Oral or Solution for Subcutaneous Injection</description>
    <arm_group_label>Arm B: Best Available Therapy (BAT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must complete the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 on at least 4 out&#xD;
             of the 7 days immediately prior to the date of randomization and must agree to collect&#xD;
             MFSAF data daily by ePRO device during the study collection window.&#xD;
&#xD;
             -- Has at least 2 symptoms each with an average score &gt;= 3 or an average total score&#xD;
             of &gt;= 12, as measured by the MFSAF v4.0.&#xD;
&#xD;
          -  Documented diagnosis of primary myelofibrosis (MF) as defined by the World Health&#xD;
             Organization (WHO) classification, post polycythemia vera (PPV)-MF, or post essential&#xD;
             thrombocytopenia (PET)-MF, characterized by bone marrow fibrosis grades 2 or 3.&#xD;
&#xD;
          -  Classified as intermediate-2 or high-risk MF, as defined by the Dynamic International&#xD;
             Prognostic Scoring System Plus (DIPSS+).&#xD;
&#xD;
          -  Must currently be on treatment or have received prior treatment with a single Janus&#xD;
             Kinase 2 (JAK2) inhibitor, ruxolitinib, and meet one of the following criteria (in&#xD;
             addition to the minimum splenomegaly and symptom burden also required for&#xD;
             eligibility):&#xD;
&#xD;
               -  Treatment with ruxolitinib for &gt;= 24 weeks that was stopped due to lack of spleen&#xD;
                  response (refractory), or loss of spleen response or symptom control after a&#xD;
                  previous response (relapsed), or was continued despite relapsed/refractory&#xD;
                  status.&#xD;
&#xD;
               -  Treatment with ruxolitinib for &lt; 24 weeks with documented disease progression&#xD;
                  while on therapy as defined by any of the following:&#xD;
&#xD;
                    -  Appearance of new splenomegaly that is palpable to at least 5 cm below the&#xD;
                       left costal margin (LCM) in participants with no evidence of splenomegaly&#xD;
                       prior to the initiation of ruxolitinib.&#xD;
&#xD;
                    -  A &gt;= 100% increase in the palpable distance below the LCM in participants&#xD;
                       with measurable spleen distance 5 to 10 centimeters (cm) prior to the&#xD;
                       initiation of ruxolitinib.&#xD;
&#xD;
                    -  A &gt;= 50% increase in the palpable distance below the LCM in participants&#xD;
                       with measurable spleen distance &gt; 10 cm prior to the initiation of&#xD;
                       ruxolitinib.&#xD;
&#xD;
                    -  A spleen volume increase of &gt;= 25% (as assessed by Magnetic Resonance&#xD;
                       Imaging [MRI] or Computed Tomography [CT] scan) in participants with a&#xD;
                       spleen volume assessment prior to the initiation of ruxolitinib.&#xD;
&#xD;
               -  Prior treatment with ruxolitinib of at least 10 mg twice daily (BID) for &gt;= 28&#xD;
                  days with intolerance defined as new RBC transfusion requirement (at least 2&#xD;
                  units/month for 2 months) while receiving a total daily ruxolitinib dose of &gt;= 30&#xD;
                  mg but unable to reduce dose further due to lack of efficacy.&#xD;
&#xD;
        Note: Participant must not require a ruxolitinib dose less than 10 mg BID (20 mg daily) due&#xD;
        to prior history of ruxolitinibrelated ≥ Grade 3 toxicity.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.&#xD;
&#xD;
          -  Splenomegaly defined as palpable spleen measurement &gt;= 5 cm below left costal margin&#xD;
             or spleen volume &gt;= 450 cm3 as assessed centrally by MRI or CT scan.&#xD;
&#xD;
          -  Baseline platelet count &gt;= 100 × 10^9/L.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Received prior treatment with a BH3-mimetic compound, bromodomain and extra-terminal&#xD;
             (BET) inhibitor, or prior use of &gt; 1 JAK2 inhibitor or stem cell transplant.&#xD;
&#xD;
          -  Eligible for stem cell transplantation at the time of study entry.&#xD;
&#xD;
          -  Receiving medication that interferes with coagulation or platelet function within 3&#xD;
             days prior to the first dose of study drug or during the study treatment period except&#xD;
             for low dose aspirin (up to 100 mg daily) and low molecular weight heparin (LMWH).&#xD;
&#xD;
          -  Receiving anticancer therapy for an active malignancy or MF including chemotherapy,&#xD;
             radiation therapy, hormonal therapy such that at least 5 half-lives of that medication&#xD;
             is completed at least 7 days prior to the first dose of study drug or within 30 days&#xD;
             prior to first dose of study drug, whichever is shorter, and during the study&#xD;
             treatment period (other than any overlapping therapy as part of the selected BAT).&#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>ABBVIE INC.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>ABBVIE CALL CENTER</last_name>
    <phone>844-663-3742</phone>
    <email>abbvieclinicaltrials@abbvie.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ironwood Cancer &amp; Res Ctr /ID# 222162</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224-5665</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Highlands Oncology Group, PA /ID# 221826</name>
      <address>
        <city>Springdale</city>
        <state>Arkansas</state>
        <zip>72762</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Moores Cancer Center at UC San Diego /ID# 219009</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Long Beach Memorial Medical Ct /ID# 224542</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806-1701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Icri /Id# 221967</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90603</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>St. Mary's Hospital Regional Cancer Center /ID# 224229</name>
      <address>
        <city>Grand Junction</city>
        <state>Colorado</state>
        <zip>81501-6132</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Augusta University Georgia Cancer Center /ID# 219051</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912-0003</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>844-663-3742</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Columbus Regional Research Institute /ID# 224410</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904-8915</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Northwest Oncology &amp; Hematology - Elk Grove Village /ID# 222818</name>
      <address>
        <city>Elk Grove Village</city>
        <state>Illinois</state>
        <zip>60007-3361</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical Ctr /ID# 219048</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Indiana Blood &amp; Marrow Transpl /ID# 221587</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46237</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tulane Medical Center - New Orleans /ID# 222940</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112-2600</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic Foundation-New Orleans /ID# 222777</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>American Oncology Partners of Maryland, PA /ID# 222836</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute /ID# 218998</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>844-663-3742</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Michigan /ID# 218463</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>844-663-3742</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System /ID# 221190</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>William Beaumont Hospital /ID# 222705</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073-6710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Saint Louis University Cancer Center /ID# 222287</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110-2539</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Summit Medical Group-Florham Park /ID# 222620</name>
      <address>
        <city>Florham Park</city>
        <state>New Jersey</state>
        <zip>07932-1049</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hackensack Univ Med Ctr /ID# 219047</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>844-663-3742</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Cancer Institute at St. Francis Hospital /ID# 231782</name>
      <address>
        <city>Greenvale</city>
        <state>New York</state>
        <zip>11548-1219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Manhattan Hematology Oncology MHO Associates /ID# 223193</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016-6028</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center-Koch Center /ID# 221081</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065-6007</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Medical Center /ID# 222899</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157-0001</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>MetroHealth Medical Center /ID# 222650</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania /ID# 219001</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104-4238</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>844-663-3742</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fox Chase Cancer Center /ID# 223955</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Houston Methodist Hospital /ID# 223103</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University of Texas Health San Antonio MD Anderson Cancer Center /ID# 233942</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Utah Cancer Specialists Salt Lake Clinic /ID# 221962</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Specialists - Fairfax /ID# 223016</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Providence Everett /ID# 223130</name>
      <address>
        <city>Everett</city>
        <state>Washington</state>
        <zip>98201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Yakima Valley Memorial Hosp /ID# 224368</name>
      <address>
        <city>Yakima</city>
        <state>Washington</state>
        <zip>98902-6388</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>HSHS St. Vincent Hospital /ID# 224468</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54301</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Kinghorn Cancer Centre /ID# 221097</name>
      <address>
        <city>Darlinghurst</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Border Medical Oncology Research Unit Albury Wodonga Regional Cancer Centre /ID# 223848</name>
      <address>
        <city>East Albury</city>
        <state>New South Wales</state>
        <zip>2640</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Calvary Mater Newcastle /ID# 224324</name>
      <address>
        <city>Waratah</city>
        <state>New South Wales</state>
        <zip>2298</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Alfred Health /ID# 221096</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Royal Perth Hospital /ID# 221099</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6000</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum St. Poelten /ID# 221709</name>
      <address>
        <city>Sankt Poelten</city>
        <state>Niederoesterreich</state>
        <zip>3100</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ordensklinikum Linz GmbH Elisabethinen /ID# 220914</name>
      <address>
        <city>Linz</city>
        <state>Oberoesterreich</state>
        <zip>4010</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Klinikum Wels-Grieskirchen GmbH /ID# 220915</name>
      <address>
        <city>Wels</city>
        <state>Oberoesterreich</state>
        <zip>4600</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitaet Graz /ID# 220919</name>
      <address>
        <city>Graz</city>
        <state>Steiermark</state>
        <zip>8010</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitaet Wien /ID# 220911</name>
      <address>
        <city>Vienna</city>
        <state>Wien</state>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hanusch Krankenhaus /ID# 220912</name>
      <address>
        <city>Wien</city>
        <zip>1140</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UCL Saint-Luc /ID# 224221</name>
      <address>
        <city>Woluwe-Saint-Lambert</city>
        <state>Bruxelles-Capitale</state>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Grand Hopital de Charleroi /ID# 224827</name>
      <address>
        <city>Charleroi</city>
        <state>Hainaut</state>
        <zip>6000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UZ Gent /ID# 220841</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AZ-Delta /ID# 221469</name>
      <address>
        <city>Roeselare</city>
        <state>West-Vlaanderen</state>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>ZNA Stuivenberg /ID# 221468</name>
      <address>
        <city>Antwerp</city>
        <zip>2060</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Vitaz /Id# 228150</name>
      <address>
        <city>Sint-Niklaas</city>
        <zip>9100</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UMHAT Alexandrovska EAD /ID# 231652</name>
      <address>
        <city>Sofiya</city>
        <state>Sofia</state>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UMHAT Dr Georgi Stranski EAD /ID# 231650</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Acibadem City Clinic Tokuda University Hospital EAD /ID# 231649</name>
      <address>
        <city>Sofia</city>
        <zip>1407</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UMHAT Sveti Ivan Rilski /ID# 231651</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UMHAT Sveta Marina /ID# 234119</name>
      <address>
        <city>Varna</city>
        <zip>9010</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Juravinski Cancer Centre /ID# 220887</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 1C3</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ottawa Hospital Research Institute /ID# 238858</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CISSS-CA (Centre Integre de sante et de services sociaux de Chaudiere-Appalache) /ID# 222433</name>
      <address>
        <city>Levis</city>
        <state>Quebec</state>
        <zip>G6V 3Z1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>14188307474</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>McGill University Health Center Research Institute /ID# 222614</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital Dubrava /ID# 230801</name>
      <address>
        <city>Zagreb</city>
        <state>Grad Zagreb</state>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Klinicka bolnica Merkur /ID# 230799</name>
      <address>
        <city>Zagreb</city>
        <state>Grad Zagreb</state>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Klinicki bolnicki centar Zagreb /ID# 230798</name>
      <address>
        <city>Zagreb</city>
        <state>Grad Zagreb</state>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Klinicki bolnicki centar Osijek /ID# 231503</name>
      <address>
        <city>Osijek</city>
        <state>Osjecko-baranjska Zupanija</state>
        <zip>31000</zip>
        <country>Croatia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Klinicki bolnicki centar Split /ID# 230800</name>
      <address>
        <city>Split</city>
        <state>Splitsko-dalmatinska Zupanija</state>
        <zip>21000</zip>
        <country>Croatia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fakultni Nemocnice Brno /ID# 220959</name>
      <address>
        <city>Brno</city>
        <zip>625 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Vseobecna fakultni nemocnice v Praze /ID# 220969</name>
      <address>
        <city>Praha</city>
        <zip>128 08</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Aalborg University Hospital /ID# 224391</name>
      <address>
        <city>Aalborg</city>
        <state>Nordjylland</state>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sjællands Universitetshospital /ID# 224456</name>
      <address>
        <city>Roskilde</city>
        <state>Sjælland</state>
        <zip>4000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>HCL - Hopital Lyon Sud /ID# 222695</name>
      <address>
        <city>Pierre Benite CEDEX</city>
        <state>Auvergne-Rhone-Alpes</state>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU NIMES - Hopital Caremeau /ID# 219128</name>
      <address>
        <city>Nimes CEDEX 9</city>
        <state>Gard</state>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU Bordeaux - Hopital Haut Leveque /ID# 222696</name>
      <address>
        <city>Pessac</city>
        <state>Gironde</state>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital Avicenne - APHP /ID# 221287</name>
      <address>
        <city>Bobigny</city>
        <state>Ile-de-France</state>
        <zip>93000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes, Hotel Dieu -HME /ID# 219127</name>
      <address>
        <city>Nantes</city>
        <state>Pays-de-la-Loire</state>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de CHAMBERY /ID# 223771</name>
      <address>
        <city>Chambery</city>
        <state>Savoie</state>
        <zip>73000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chu Angers /Id# 219129</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AP-HP - Hopital Saint-Louis /ID# 221390</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Mannheim /ID# 221529</name>
      <address>
        <city>Mannheim</city>
        <state>Baden-Wuerttemberg</state>
        <zip>68167</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Stauferklinikum Schwaebisch Gmuend /ID# 223948</name>
      <address>
        <city>Mutlangen</city>
        <state>Baden-Wuerttemberg</state>
        <zip>73557</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Haematologisch-Onkologische Praxis im Zentrum Augsburg /ID# 225025</name>
      <address>
        <city>Augsburg</city>
        <state>Bayern</state>
        <zip>86150</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 221346</name>
      <address>
        <city>Dresden</city>
        <state>Sachsen</state>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Augusta-Kranken-Anstalt gGmbH, Bochum-Mitte /ID# 224695</name>
      <address>
        <city>Bochum</city>
        <zip>44791</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Klinikum Chemnitz gGmbH /ID# 224575</name>
      <address>
        <city>Chemnitz</city>
        <zip>09116</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>OncoResearch Lerchenfeld GmbH /ID# 225034</name>
      <address>
        <city>Hamburg</city>
        <zip>22081</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 221526</name>
      <address>
        <city>Munich</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsmedizin Rostock /ID# 224157</name>
      <address>
        <city>Rostock</city>
        <zip>18057</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens Laiko /ID# 221175</name>
      <address>
        <city>Athens</city>
        <state>Attiki</state>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 221179</name>
      <address>
        <city>Athens</city>
        <zip>10676</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University General Hospital of Patras /ID# 221178</name>
      <address>
        <city>RION Patras Achaia</city>
        <zip>26504</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>General Hospital of Thessaloniki George Papanikolaou /ID# 221463</name>
      <address>
        <city>Thessaloniki</city>
        <zip>57010</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Szegedi Tudomanyegyetem /ID# 220955</name>
      <address>
        <city>Szeged</city>
        <state>Csongrad</state>
        <zip>6720</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fejer Megyei Szent Gyorgy Korhaz /ID# 220949</name>
      <address>
        <city>Szekesfehervar</city>
        <state>Fejer</state>
        <zip>8000</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Klinikai Kozpont /ID# 220947</name>
      <address>
        <city>Debrecen</city>
        <state>Hajdu-Bihar</state>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 220948</name>
      <address>
        <city>Kaposvár</city>
        <state>Somogy</state>
        <zip>7400</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 220946</name>
      <address>
        <city>Nyiregyhaza</city>
        <state>Szabolcs-Szatmar-Bereg</state>
        <zip>4400</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Chaim Sheba Medical Center /ID# 219136</name>
      <address>
        <city>Ramat Gan</city>
        <state>Tel-Aviv</state>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center /ID# 219135</name>
      <address>
        <city>Tel Aviv-Yafo</city>
        <state>Tel-Aviv</state>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center-Hebrew University /ID# 219111</name>
      <address>
        <city>Jerusalem</city>
        <state>Yerushalayim</state>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>HaEmek Medical Center /ID# 220839</name>
      <address>
        <city>Afula</city>
        <zip>1834111</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Assuta Ashdod Medical Center /ID# 225281</name>
      <address>
        <city>Ashdod</city>
        <zip>7747629</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Assaf Harofeh Medical Center /ID# 222972</name>
      <address>
        <city>Be'Er Ya'Akov</city>
        <zip>70300</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus /ID# 219121</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Lady Davis Carmel Medical Center /ID# 222973</name>
      <address>
        <city>Haifa</city>
        <zip>34362</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hadassah Mt. Scopus /ID# 253394</name>
      <address>
        <city>Jerusalem</city>
        <zip>9765400</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Galilee Medical Center /ID# 225280</name>
      <address>
        <city>Nahariya</city>
        <zip>2210001</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center /ID# 219139</name>
      <address>
        <city>Petakh Tikva</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 225731</name>
      <address>
        <city>Rome</city>
        <state>Lazio</state>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 219087</name>
      <address>
        <city>Rome</city>
        <state>Lazio</state>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>ASST Monza/Ospedale San Gerardo /ID# 225113</name>
      <address>
        <city>Monza</city>
        <state>Monza E Brianza</state>
        <zip>20900</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 238438</name>
      <address>
        <city>Ancona</city>
        <zip>60126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 221222</name>
      <address>
        <city>Bergamo</city>
        <zip>24127</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 221077</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 219089</name>
      <address>
        <city>Catania</city>
        <zip>95123</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Careggi /ID# 219090</name>
      <address>
        <city>Florence</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Federico II /ID# 224673</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 221078</name>
      <address>
        <city>Palermo</city>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 221220</name>
      <address>
        <city>Reggio Calabria</city>
        <zip>89124</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>A.O.U. Citta della Salute e della Scienza di Torino /ID# 221223</name>
      <address>
        <city>Turin</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 221241</name>
      <address>
        <city>Udine</city>
        <zip>33100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>ASST Sette Laghi /ID# 234183</name>
      <address>
        <city>Varese</city>
        <zip>21100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Azienda ULSS 8 Berica/Ospedale San Bortolo di Vicenza /ID# 221079</name>
      <address>
        <city>Vicenza</city>
        <zip>36100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 221150</name>
      <address>
        <city>Nagoya-shi</city>
        <state>Aichi</state>
        <zip>453-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fujita Health University Hospital /ID# 221598</name>
      <address>
        <city>Toyoake-shi</city>
        <state>Aichi</state>
        <zip>470-1192</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chiba University Hospital /ID# 224546</name>
      <address>
        <city>Chiba-shi</city>
        <state>Chiba</state>
        <zip>260-8677</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital East /ID# 226653</name>
      <address>
        <city>Kashiwa-shi</city>
        <state>Chiba</state>
        <zip>277-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ehime University Hospital /ID# 221158</name>
      <address>
        <city>Toon-shi</city>
        <state>Ehime</state>
        <zip>791-0295</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kyushu University Hospital /ID# 221606</name>
      <address>
        <city>Fukuoka-shi</city>
        <state>Fukuoka</state>
        <zip>812-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fukushima Medical University Hospital /ID# 221877</name>
      <address>
        <city>Fukushima-shi</city>
        <state>Fukushima</state>
        <zip>960-1295</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Gifu University Hospital /ID# 224371</name>
      <address>
        <city>Gifu-shi</city>
        <state>Gifu</state>
        <zip>501-1194</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sapporo Hokuyu Hospital /ID# 221149</name>
      <address>
        <city>Sapporo-shi</city>
        <state>Hokkaido</state>
        <zip>003-0006</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kobe City Medical Center General Hospital /ID# 221156</name>
      <address>
        <city>Kobe-shi</city>
        <state>Hyogo</state>
        <zip>650-0047</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kanazawa University Hospital /ID# 223028</name>
      <address>
        <city>Kanazawa-shi</city>
        <state>Ishikawa</state>
        <zip>920-8641</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Iwate Medical University Hospital /ID# 222044</name>
      <address>
        <city>Shiwa-gun</city>
        <state>Iwate</state>
        <zip>028-3695</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shonan Kamakura General Hospital /ID# 223030</name>
      <address>
        <city>Kamakura-shi</city>
        <state>Kanagawa</state>
        <zip>247-8533</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kumamoto Shinto General Hospital /ID# 255645</name>
      <address>
        <city>Kumamoto-shi</city>
        <state>Kumamoto</state>
        <zip>862-8655</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kyoto University Hospital /ID# 223008</name>
      <address>
        <city>Kyoto-shi</city>
        <state>Kyoto</state>
        <zip>606-8507</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mie University Hospital /ID# 221665</name>
      <address>
        <city>Tsu-shi</city>
        <state>Mie</state>
        <zip>514-8507</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Miyazaki Hospital /ID# 221821</name>
      <address>
        <city>Miyazaki-shi</city>
        <state>Miyazaki</state>
        <zip>889-1692</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Niigata University Medical &amp; Dental Hospital /ID# 223034</name>
      <address>
        <city>Niigata-shi</city>
        <state>Niigata</state>
        <zip>951-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kurashiki Central Hospital /ID# 221690</name>
      <address>
        <city>Kurashiki-shi</city>
        <state>Okayama</state>
        <zip>710-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Osaka University Hospital /ID# 221159</name>
      <address>
        <city>Suita-shi</city>
        <state>Osaka</state>
        <zip>565-0871</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dokkyo Medical University Saitama Medical Center /ID# 222334</name>
      <address>
        <city>Koshigaya-shi</city>
        <state>Saitama</state>
        <zip>343-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Juntendo University Shizuoka Hospital /ID# 221780</name>
      <address>
        <city>Izunokuni-shi</city>
        <state>Shizuoka</state>
        <zip>410-2295</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Juntendo University Hospital /ID# 221154</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>113-8431</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nippon Medical School Hospital /ID# 221676</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>113-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical University Hospital /ID# 221540</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>160-0023</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Yamanashi Hospital /ID# 221706</name>
      <address>
        <city>Chuo-shi</city>
        <state>Yamanashi</state>
        <zip>409-3821</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital /ID# 220980</name>
      <address>
        <city>Busan</city>
        <zip>49241</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center /ID# 220972</name>
      <address>
        <city>Incheon</city>
        <zip>21565</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital /ID# 219060</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center /ID# 221091</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 219061</name>
      <address>
        <city>Seoul</city>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Aotearoa Clinical Trials /ID# 232201</name>
      <address>
        <city>Papatoetoe</city>
        <state>Auckland</state>
        <zip>2025</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 221161</name>
      <address>
        <city>Lodz</city>
        <state>Lodzkie</state>
        <zip>93-513</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 221124</name>
      <address>
        <city>Lublin</city>
        <state>Lubelskie</state>
        <zip>20-081</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>SP ZOZ Szpital Uniwersytecki w Krakowie /ID# 221160</name>
      <address>
        <city>Krakow</city>
        <state>Malopolskie</state>
        <zip>31-501</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>LUX MED Onkologia - Szpital Szamocka /ID# 221265</name>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <zip>01-748</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Uniwersyteckie Centrum Kliniczne /ID# 221298</name>
      <address>
        <city>Gdansk</city>
        <state>Pomorskie</state>
        <zip>80-214</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>ARS-MEDICAL Sp. z o.o. /ID# 238336</name>
      <address>
        <city>Pila</city>
        <state>Wielkopolskie</state>
        <zip>64-920</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Pratia Onkologia Katowice /ID# 224526</name>
      <address>
        <city>Katowice</city>
        <zip>40-519</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola /ID# 241031</name>
      <address>
        <city>Poznan</city>
        <zip>60-569</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>MTZ Clinical Research Powered by Pratia /ID# 221759</name>
      <address>
        <city>Warszawa</city>
        <zip>02-172</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital del Centro Comprensivo de Cancer de la UPR /ID# 223281</name>
      <address>
        <city>San Juan</city>
        <zip>00927</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Moscow State budget healthcare /ID# 221116</name>
      <address>
        <city>Moscow</city>
        <state>Moskva</state>
        <zip>125284</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital n.a. V.V. Veresaev /ID# 225221</name>
      <address>
        <city>Moscow</city>
        <zip>127644</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 221115</name>
      <address>
        <city>Sankt-Peterburg</city>
        <zip>191024</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Almazov National Medical Research Centre /ID# 221114</name>
      <address>
        <city>Sankt-Peterburg</city>
        <zip>197341</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tula Regional Clinical Hospital /ID# 221302</name>
      <address>
        <city>Tula</city>
        <zip>300053</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>University Clinical Center Serbia /ID# 231058</name>
      <address>
        <city>Belgrade</city>
        <state>Beograd</state>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clin Hosp Ctr Bezanijska Kosa /ID# 231059</name>
      <address>
        <city>Belgrade</city>
        <state>Beograd</state>
        <zip>11080</zip>
        <country>Serbia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinical Center Vojvodina /ID# 231057</name>
      <address>
        <city>Novi Sad</city>
        <state>Vojvodina</state>
        <zip>21000</zip>
        <country>Serbia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Wits Clinical Research Site /ID# 231554</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>2193</zip>
        <country>South Africa</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Alberts Cellular Therapy /ID# 231556</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0044</zip>
        <country>South Africa</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Santiago-CHUS /ID# 221616</name>
      <address>
        <city>Santiago de Compostela</city>
        <state>A Coruna</state>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Central de Asturias /ID# 224815</name>
      <address>
        <city>Oviedo</city>
        <state>Asturias</state>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Germans Trias i Pujol /ID# 233727</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Dr. Negrin /ID# 220923</name>
      <address>
        <city>Las Palmas de Gran Canaria</city>
        <state>Las Palmas</state>
        <zip>35019</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario A Coruna - CHUAC /ID# 224617</name>
      <address>
        <city>A Coruna</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Parc de Salut del Mar /ID# 220922</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Vall d'Hebron /ID# 240979</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de las Nieves /ID# 253936</name>
      <address>
        <city>Granada</city>
        <zip>18014</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre /ID# 233726</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz /ID# 224813</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Regional Universitario de Malaga /ID# 221906</name>
      <address>
        <city>Malaga</city>
        <zip>29011</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Salamanca /ID# 221904</name>
      <address>
        <city>Salamanca</city>
        <zip>37711</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocio /ID# 221932</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Valencia /ID# 220920</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Skane University Hospital Lund /ID# 220834</name>
      <address>
        <city>Lund</city>
        <state>Skane Lan</state>
        <zip>SE 221 41</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitätsspital Basel /ID# 221261</name>
      <address>
        <city>Basel</city>
        <state>Basel-Stadt</state>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Inselspital, Universitätsspital Bern /ID# 223439</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital /ID# 218985</name>
      <address>
        <city>Kaohsiung City</city>
        <state>Kaohsiung</state>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 218980</name>
      <address>
        <city>Kaohsiung</city>
        <zip>807</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital /ID# 218979</name>
      <address>
        <city>Taichung</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chi Mei Hospital - Liouying /ID# 221144</name>
      <address>
        <city>Tainan City</city>
        <zip>73657</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hosp /ID# 221147</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Linkou Chang Gung Memorial Hospital /ID# 218982</name>
      <address>
        <city>Taoyuan City</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Gulhane Askeri Tip Academy /ID# 224568</name>
      <address>
        <city>Ankara</city>
        <zip>06010</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Trakya University Medical Facu /ID# 224572</name>
      <address>
        <city>Edirne, Istanbul</city>
        <zip>22030</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ege University Medical Faculty /ID# 224570</name>
      <address>
        <city>Izmir</city>
        <zip>35040</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mersin University Medical /ID# 224571</name>
      <address>
        <city>Mersin</city>
        <zip>33343</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ondokuz mayis University Facul /ID# 224567</name>
      <address>
        <city>Samsun</city>
        <zip>55200</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>United Lincolnshire Hospitals NHS Trust /ID# 224613</name>
      <address>
        <city>Lincoln</city>
        <state>Lincolnshire</state>
        <zip>LN2 4AX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Guys and St Thomas NHS Foundation Trust /ID# 221041</name>
      <address>
        <city>London</city>
        <state>London, City Of</state>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>James Paget University Hospitals NHS Foundation Trust /ID# 221219</name>
      <address>
        <city>Great Yarmouth</city>
        <state>Norfolk</state>
        <zip>NR31 6LA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Hospitals Birmingham NHS Foundation Trust /ID# 221334</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>NHS Lothian /ID# 224378</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH3 9HE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 221335</name>
      <address>
        <city>Newcastle upon Tyne</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Croatia</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>New Zealand</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>Taiwan</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>September 13, 2023</last_update_submitted>
  <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ABT-263</keyword>
  <keyword>Navitoclax</keyword>
  <keyword>Ruxolitinib</keyword>
  <keyword>MF</keyword>
  <keyword>Myelofibrosis</keyword>
  <keyword>Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Primary Myelofibrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Navitoclax</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/</ipd_time_frame>
    <ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/abbvie/</ipd_url>
  </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/NCT04468984
org study id: M20-178
secondary id: 2020-000557-27
nct id: NCT04468984
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Myelofibrosis (MF) is a rare blood cancer, notable for scarring of the bone marrow (the
      spongy tissue inside bones) and the spleen becoming larger. The purpose of this study is to
      assess safety and change in spleen volume when navitoclax is given in combination with
      ruxolitinib, compared to best available therapy, for adult participants with MF.

      Navitoclax is an investigational drug (not yet approved) being developed for the treatment of
      MF. Participants in this study will be randomly selected (like picking numbers out of a hat)
      to be in 1 of 2 treatment arms. Neither participants nor the study doctor will be able to
      pick which treatment arm a participants enters. In Arm A, participants will receive
      navitoclax in combination with ruxolitinib. In Arm B, participants will receive the best
      available therapy (BAT) for MF. Adult participants with a diagnosis of MF that came back or
      did not get better after earlier treatment will be enrolled. Approximately 330 participants
      will be enrolled in approximately 210 sites across the world.

      In Arm A, participants will receive navitoclax tablet by mouth once daily with by mouth
      ruxolitinib tablet twice daily. In Arm B, participants will receive the BAT available to the
      investigator. Participants will receive the study drug until they experience no benefit
      (determined by the investigator), participants cannot tolerate the study drugs, or
      participants withdraw consent. The approximate treatment duration is about 3 years.

      There may be higher treatment burden for participants in this trial compared to their
      standard of care. Participants will attend regular visits during the study at a hospital or
      clinic. The effect of treatment will be checked by medical assessments, blood and bone marrow
      tests, checking for side effects, and completing questionnaires.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at Week 24 (SVR35W24)
time frame: At Week 24
description: Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT), per International Working Group (IWG) criteria.
measure: Percentage of Participants who achieve at least 50% Reduction in Total Symptom Score (TSS)
time frame: Baseline (Week 0) Up to Week 24
description: Reduction in TSS is measured by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.
measure: Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at any time
time frame: Baseline (Week 0) Up to Week 97
description: Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT), per International Working Group (IWG) criteria.
measure: Percentage of Participants with Reduction in Grade of Bone Marrow Fibrosis
time frame: Baseline (Week 0) Up to Week 97
description: Reduction in grade of bone marrow fibrosis from baseline as measured by the European consensus grading system will be assessed.
measure: Percentage of Participants with Anemia Response
time frame: Baseline (Week 0) Up to Week 97
description: Anemia response per International Working Group (IWG) criteria will be assessed.
measure: Percentage of Participants with Overall Survival
time frame: Last Visit Up to 5 Years
description: Overall survival is defined as the time from start of study to the date of death from any cause.
measure: Percentage of Participants with Leukemia-free Survival
time frame: Last Visit Up to 5 Years
description: Leukemia free survival is the time from start of study to the date of development of leukemia.
measure: Percentage of Participants with Change in Fatigue
time frame: Baseline (Week 0) Up to Week 24
description: Change in fatigue will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a.
measure: Time to Deterioration of Physical Functioning
time frame: Baseline (Week 0) Up to Week 97
description: Time to deterioration of physical functioning is measured by the physical functioning domain of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, or death.
measure: Percentage of Participants with at Least 50% Reduction in TSS
time frame: Baseline (Week 0) Up to Week 97
description: At least 50% reduction in TSS from baseline (at any time) as measured by MFSAF v4.0.
arm group label: Arm A: Navitoclax + Ruxolitinib
arm group type: Experimental
description: Participants will receive navitoclax tablets once daily and ruxolitinib tablets twice daily.
arm group label: Arm B: Best Available Therapy (BAT)
arm group type: Active Comparator
description: Participants will receive one of the BAT options, per the investigator's discretion.
intervention type: Drug
intervention name: Navitoclax
description: Tablet; Oral
arm group label: Arm A: Navitoclax + Ruxolitinib
other name: ABT-263
intervention type: Drug
intervention name: Ruxolitinib
description: Tablet; Oral
arm group label: Arm A: Navitoclax + Ruxolitinib
intervention type: Drug
intervention name: Best Available Therapy (BAT)
description: Tablet/Capsule; Oral or Solution for Subcutaneous Injection
arm group label: Arm B: Best Available Therapy (BAT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: ABBVIE INC.
role: Study Director
affiliation: AbbVie
last name: ABBVIE CALL CENTER
phone: 844-663-3742
email: abbvieclinicaltrials@abbvie.com
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Completed
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Australia
country: Austria
country: Belgium
country: Bulgaria
country: Canada
country: Croatia
country: Czechia
country: Denmark
country: France
country: Germany
country: Greece
country: Hungary
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: New Zealand
country: Poland
country: Puerto Rico
country: Russian Federation
country: Serbia
country: South Africa
country: Spain
country: Sweden
country: Switzerland
country: Taiwan
country: Turkey
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Primary Myelofibrosis
mesh term: Navitoclax
sharing ipd: Yes
ipd description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
ipd access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
ipd url: https://vivli.org/ourmember/abbvie/