<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/NCT04472598</url>
  </required_header>
  <id_info>
    <org_study_id>M16-191</org_study_id>
    <secondary_id>2020-000097-15</secondary_id>
    <nct_id>NCT04472598</nct_id>
  </id_info>
  <brief_title>Study of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis</brief_title>
  <acronym>TRANSFORM-1</acronym>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Of Navitoclax In Combination With Ruxolitinib Versus Ruxolitinib In Subjects With Myelofibrosis (TRANSFORM-1)</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Myelofibrosis is a type of bone marrow cancer that usually develops slowly and disrupts&#xD;
      body's normal production of blood cells. It causes bone marrow scarring, leading to severe&#xD;
      anemia that can cause weakness and fatigue. It can also cause a low number of blood-clotting&#xD;
      cells called platelets, which increases risk of bleeding. Myelofibrosis often causes an&#xD;
      enlarged spleen. The purpose of this study is to see if a combination of navitoclax and&#xD;
      ruxolitinib is more effective and safe in assessment of change in spleen volume when compared&#xD;
      to ruxolitinib in participants with myelofibrosis.&#xD;
&#xD;
      Navitoclax is an investigational drug for the treatment of myelofibrosis. Participants in&#xD;
      this study are divided into two groups, called treatment arms. Each group receives a&#xD;
      different treatment. Adult participants with a diagnosis of myelofibrosis will be enrolled.&#xD;
      Around 230 participants will be enrolled in approximately 190 sites worldwide.&#xD;
&#xD;
      Participants will receive oral navitoclax tablet with oral ruxolitinib tablet or oral&#xD;
      ruxolitinib tablet with oral placebo (no active drug) tablet and treatment may continue&#xD;
      untill the participant cannot tolerate the study drug, or benefit is not achieved, or other&#xD;
      reasons which qualify for discontinuation of the study drug.&#xD;
&#xD;
      There may be a higher treatment burden for participants in this trial compared to their&#xD;
      standard of care. Participants will attend regular visits during the course of the study at a&#xD;
      hospital or clinic. The effect of the treatment will be checked by medical assessments, blood&#xD;
      tests, magnetic resonance imaging (MRI) or computed tomography (CT) scan, bone marrow tests,&#xD;
      checking for side effects, and completing questionnaires.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 29, 2020</start_date>
  <completion_date type="Anticipated">October 19, 2032</completion_date>
  <primary_completion_date type="Actual">April 13, 2023</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</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>Change 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% (SVR35)</measure>
    <time_frame>Baseline (Week 0) Up to Week 96</time_frame>
    <description>Reduction in spleen volume is measured by MRI or CT, per IWG criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of 35% Spleen Volume Reduction (SVR35)</measure>
    <time_frame>Baseline (Week 0) Up to Week 96</time_frame>
    <description>Duration of SVR35 is defined as the time between the date of first response of spleen volume reduction of 35% achievement to the date of the first assessment where the spleen volume is less than 35% reduction from baseline and is at least 25% increase from the nadir (the lowest spleen volume).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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 SF 7a.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Functioning</measure>
    <time_frame>Baseline (Week 0) Up to Week 24</time_frame>
    <description>Change in 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 who achieve Anemia Response</measure>
    <time_frame>Baseline (Week 0) Up to Week 96</time_frame>
    <description>The rate of anemia response will be assessed according to current International Working Group-Myeloproliferative Neoplasms Research and European LeukemiaNet (IWG-MRT/ELN) criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up To approximately 8 Years</time_frame>
    <description>OS is defined as the time from the date of randomization to the date of death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leukemia-Free Survival</measure>
    <time_frame>Up To approximately 8 Years</time_frame>
    <description>Leukemia-free survival is defined as the number of days from the date of randomization to the onset date of documented leukemia, disease progression due to leukemia, or death due to leukemia, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants who Achieve Reduction in Grade of Bone Marrow Fibrosis</measure>
    <time_frame>Baseline (Week 0) Up to Week 96</time_frame>
    <description>Change in grade of bone marrow fibrosis will be measured per the European consensus grading system through bone marrow biopsy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">252</enrollment>
  <condition>Myelofibrosis (MF)</condition>
  <arm_group>
    <arm_group_label>Navitoclax + Ruxolitinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive Navitoclax in combination with Ruxolitinib</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo for Navitoclax + Ruxolitinib</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive placebo for Navitoclax and Ruxolitinib</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Navitoclax</intervention_name>
    <description>Tablet; Oral</description>
    <arm_group_label>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>Navitoclax + Ruxolitinib</arm_group_label>
    <arm_group_label>Placebo for Navitoclax + Ruxolitinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for Navitoclax</intervention_name>
    <description>Tablet; Oral</description>
    <arm_group_label>Placebo for Navitoclax + Ruxolitinib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented diagnosis of Primary MyeloFibrosis (MF) as defined by World Health&#xD;
             Organization (WHO) classification or Secondary MF (post polycythemia vera [PPV] - MF&#xD;
             or Post Essential Thrombocytopenia [PET] - MF) .&#xD;
&#xD;
          -  Must be able to complete the MF Symptom Assessment Form (MFSAF) v4.0 on at least 4 out&#xD;
             of 7 days immediately preceding the date of randomization.&#xD;
&#xD;
             -- Must have at least 2 symptoms with a score &gt;=3 or a total score of &gt;=12, as&#xD;
             measured by the MFSAF v4.0.&#xD;
&#xD;
          -  Classified as intermediate-2, or high-Risk MF as defined by the Dynamic International&#xD;
             Prognostic Scoring System Plus (DIPSS+).&#xD;
&#xD;
          -  Has splenomegaly defined as spleen palpation measurement &gt;= 5 centimeters (cm) below&#xD;
             costal margin or spleen volume greater than or equal to 450 cubic cm as assessed&#xD;
             centrally by magnetic resonance imaging (MRI) or computed tomography (CT) scan.&#xD;
&#xD;
          -  Ineligible for stem cell transplantation at time of study entry due to age,&#xD;
             comorbidities, or unfit for unrelated or unmatched donor transplant and other criteria&#xD;
             per National Comprehensive Cancer Network guidelines.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with a Janus Kinase-2 (JAK-2) inhibitor.&#xD;
&#xD;
          -  Prior treatment with a B-cell lymphoma 2 homology 3 (BH3)-mimetic compound or&#xD;
             bromodomain and extra-terminal motif (BET) inhibitor or stem cell transplant.&#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 milligram daily) and low molecular weight heparin&#xD;
             (LMWH).&#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>
  <location>
    <facility>
      <name>Highlands Oncology Group, PA /ID# 221824</name>
      <address>
        <city>Springdale</city>
        <state>Arkansas</state>
        <zip>72762</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Medical Foundation /ID# 241646</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moores Cancer Center at UC San Diego /ID# 218012</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers, LLP- Littleton /ID# 222562</name>
      <address>
        <city>Littleton</city>
        <state>Colorado</state>
        <zip>80120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynn Cancer Institute, Boca /ID# 230687</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialist - South /ID# 221726</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33901-8108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists - North /ID# 221727</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33705-1449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists - East /ID# 221728</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University /ID# 221562</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322-1013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Augusta University Georgia Cancer Center /ID# 221551</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912-0003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbus Regional Research Institute /ID# 227272</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904-8915</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center /ID# 221581</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid Illinois Hematology &amp; Oncology Associates, Ltd /ID# 224204</name>
      <address>
        <city>Normal</city>
        <state>Illinois</state>
        <zip>61761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana Blood &amp; Marrow Transpl /ID# 221586</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Cancer Center /ID# 218144</name>
      <address>
        <city>Fairway</city>
        <state>Kansas</state>
        <zip>66205-2528</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital /ID# 221559</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center /ID# 224261</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215-5400</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute /ID# 218010</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 221658</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Oncology Hematology /ID# 227357</name>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <zip>55435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MidAmerica Division, Inc. /ID# 221743</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack Univ Med Ctr /ID# 221654</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health - Monter Cancer Center /ID# 222996</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College /ID# 220933</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gabrail Cancer Center Research /ID# 230488</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology Hematology Care, Inc. /ID# 222556</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45236-2725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University /ID# 221584</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Hillman Cancer Ctr /ID# 218134</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thompson Cancer Survival Ctr /ID# 231689</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37916</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center /ID# 217994</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Northeast Texas /ID# 241813</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Utah Cancer Specialists Salt Lake Clinic /ID# 221961</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah /ID# 221009</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112-5500</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Specialists - Fairfax /ID# 242682</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Puget Sound Health Care System /ID# 231691</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98108-1597</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Kinghorn Cancer Centre /ID# 221503</name>
      <address>
        <city>Darlinghurst</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Border Medical Oncology Research Unit Albury Wodonga Regional Cancer Centre /ID# 231311</name>
      <address>
        <city>East Albury</city>
        <state>New South Wales</state>
        <zip>2640</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gosford Hospital /ID# 221499</name>
      <address>
        <city>Gosford</city>
        <state>New South Wales</state>
        <zip>2250</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liverpool Hospital /ID# 221803</name>
      <address>
        <city>Liverpool</city>
        <state>New South Wales</state>
        <zip>2170</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Townsville University Hospital /ID# 229794</name>
      <address>
        <city>Douglas</city>
        <state>Queensland</state>
        <zip>4814</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peter MacCallum Cancer Ctr /ID# 229795</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alfred Health /ID# 221501</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Perth Hospital /ID# 223203</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordensklinikum Linz GmbH Elisabethinen /ID# 220813</name>
      <address>
        <city>Linz</city>
        <state>Oberoesterreich</state>
        <zip>4010</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Wels-Grieskirchen GmbH /ID# 220901</name>
      <address>
        <city>Wels</city>
        <state>Oberoesterreich</state>
        <zip>4600</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitaet Graz /ID# 220910</name>
      <address>
        <city>Graz</city>
        <state>Steiermark</state>
        <zip>8010</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitaet Wien /ID# 220906</name>
      <address>
        <city>Vienna</city>
        <state>Wien</state>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hanusch Krankenhaus /ID# 220909</name>
      <address>
        <city>Wien</city>
        <zip>1140</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU UCL Namur - site Godinne /ID# 221127</name>
      <address>
        <city>Godinne</city>
        <state>Namur</state>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent /ID# 221125</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Leuven /ID# 218806</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ-Delta /ID# 221466</name>
      <address>
        <city>Roeselare</city>
        <state>West-Vlaanderen</state>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ZNA Stuivenberg /ID# 221465</name>
      <address>
        <city>Antwerp</city>
        <zip>2060</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint-Jan Brugge /ID# 218805</name>
      <address>
        <city>Brugge</city>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 218874</name>
      <address>
        <city>Liege</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitaz /Id# 229861</name>
      <address>
        <city>Sint-Niklaas</city>
        <zip>9100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT Alexandrovska EAD /ID# 231056</name>
      <address>
        <city>Sofiya</city>
        <state>Sofia</state>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT Dr Georgi Stranski EAD /ID# 231161</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT Sveti Georgi /ID# 231053</name>
      <address>
        <city>Plovdiv</city>
        <zip>4002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acibadem City Clinic Tokuda University Hospital EAD /ID# 231036</name>
      <address>
        <city>Sofia</city>
        <zip>1407</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT Sveti Ivan Rilski /ID# 231028</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Victoria Hospital /ID# 222636</name>
      <address>
        <city>Barrie</city>
        <state>Ontario</state>
        <zip>L4M 6M2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juravinski Cancer Centre /ID# 221752</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 1C3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakeridge Health - Oshawa /ID# 222080</name>
      <address>
        <city>Oshawa</city>
        <state>Ontario</state>
        <zip>L1G 2B9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niagara Health System /ID# 230994</name>
      <address>
        <city>St Catharines</city>
        <state>Ontario</state>
        <zip>L2S 0A9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHUQ- Hôpital de l'Enfant-Jesus /ID# 221754</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <zip>G1J 1Z4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital Dubrava /ID# 230795</name>
      <address>
        <city>Zagreb</city>
        <state>Grad Zagreb</state>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinicka bolnica Merkur /ID# 231155</name>
      <address>
        <city>Zagreb</city>
        <state>Grad Zagreb</state>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinicki bolnicki centar Zagreb /ID# 230793</name>
      <address>
        <city>Zagreb</city>
        <state>Grad Zagreb</state>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinicki bolnicki centar Split /ID# 230796</name>
      <address>
        <city>Split</city>
        <state>Splitsko-dalmatinska Zupanija</state>
        <zip>21000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HCL - Hopital Lyon Sud /ID# 222913</name>
      <address>
        <city>Pierre Benite CEDEX</city>
        <state>Auvergne-Rhone-Alpes</state>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU NIMES - Hopital Caremeau /ID# 219114</name>
      <address>
        <city>Nimes CEDEX 9</city>
        <state>Gard</state>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bordeaux - Hopital Haut Leveque /ID# 222518</name>
      <address>
        <city>Pessac</city>
        <state>Gironde</state>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Roubaix - Hopital Victor Provo /ID# 219116</name>
      <address>
        <city>Roubaix Cedex 1</city>
        <state>Hauts-de-France</state>
        <zip>59100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Avicenne - APHP /ID# 221286</name>
      <address>
        <city>Bobigny</city>
        <state>Ile-de-France</state>
        <zip>93000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes, Hotel Dieu -HME /ID# 219113</name>
      <address>
        <city>Nantes</city>
        <state>Pays-de-la-Loire</state>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de CHAMBERY /ID# 224506</name>
      <address>
        <city>Chambery</city>
        <state>Savoie</state>
        <zip>73000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Angers /Id# 219115</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AP-HP - Hopital Saint-Louis /ID# 221288</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AP-HP - Hopital Necker /ID# 231318</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICANS - Institut de Cancérologie Strasbourg Europe /ID# 229978</name>
      <address>
        <city>Strasbourg Cedex</city>
        <zip>67033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Mannheim /ID# 221523</name>
      <address>
        <city>Mannheim</city>
        <state>Baden-Wuerttemberg</state>
        <zip>68167</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haemato-Onkologie /ID# 221061</name>
      <address>
        <city>Muenchen</city>
        <state>Bayern</state>
        <zip>81241</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Aachen /ID# 221519</name>
      <address>
        <city>Aachen</city>
        <state>Nordrhein-Westfalen</state>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 221347</name>
      <address>
        <city>Dresden</city>
        <state>Sachsen</state>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Essen /ID# 221522</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OncoResearch Lerchenfeld GmbH /ID# 230867</name>
      <address>
        <city>Hamburg</city>
        <zip>22081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 221520</name>
      <address>
        <city>Munich</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens Laiko /ID# 230785</name>
      <address>
        <city>Athens</city>
        <state>Attiki</state>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University General Hospital Attikon /ID# 230784</name>
      <address>
        <city>Athens</city>
        <state>Attiki</state>
        <zip>12462</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 230786</name>
      <address>
        <city>Athens</city>
        <zip>10676</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Chaim Sheba Medical Center /ID# 219137</name>
      <address>
        <city>Ramat Gan</city>
        <state>Tel-Aviv</state>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center /ID# 219134</name>
      <address>
        <city>Tel Aviv-Yafo</city>
        <state>Tel-Aviv</state>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center-Hebrew University /ID# 219110</name>
      <address>
        <city>Jerusalem</city>
        <state>Yerushalayim</state>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Assaf Harofeh Medical Center /ID# 222957</name>
      <address>
        <city>Be'Er Ya'Akov</city>
        <zip>70300</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus /ID# 219120</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meir Medical Center /ID# 221374</name>
      <address>
        <city>Kfar Saba</city>
        <zip>4428164</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 219083</name>
      <address>
        <city>Rome</city>
        <state>Lazio</state>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 221907</name>
      <address>
        <city>Bergamo</city>
        <zip>24127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 220867</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Spedali civili di Brescia /ID# 241273</name>
      <address>
        <city>Brescia</city>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 219085</name>
      <address>
        <city>Catania</city>
        <zip>95123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Careggi /ID# 219086</name>
      <address>
        <city>Florence</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Sette Laghi /ID# 219084</name>
      <address>
        <city>Varese</city>
        <zip>21100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 239100</name>
      <address>
        <city>Nagoya-shi</city>
        <state>Aichi</state>
        <zip>453-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fujita Health University Hospital /ID# 221537</name>
      <address>
        <city>Toyoake-shi</city>
        <state>Aichi</state>
        <zip>470-1192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiba University Hospital /ID# 239345</name>
      <address>
        <city>Chiba-shi</city>
        <state>Chiba</state>
        <zip>260-8677</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital East /ID# 226093</name>
      <address>
        <city>Kashiwa-shi</city>
        <state>Chiba</state>
        <zip>277-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ehime University Hospital /ID# 221443</name>
      <address>
        <city>Toon-shi</city>
        <state>Ehime</state>
        <zip>791-0295</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyushu University Hospital /ID# 221783</name>
      <address>
        <city>Fukuoka-shi</city>
        <state>Fukuoka</state>
        <zip>812-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukushima Medical University Hospital /ID# 222752</name>
      <address>
        <city>Fukushima-shi</city>
        <state>Fukushima</state>
        <zip>960-1295</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ogaki Municipal Hospital /ID# 240173</name>
      <address>
        <city>Ogaki-shi</city>
        <state>Gifu</state>
        <zip>503-8502</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gunmaken Saiseikai Maebashi Hospital /ID# 242806</name>
      <address>
        <city>Maebashi-shi</city>
        <state>Gunma</state>
        <zip>371-0821</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gunma University Hospital /ID# 221480</name>
      <address>
        <city>Maebashi-shi</city>
        <state>Gunma</state>
        <zip>371-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido University Hospital /ID# 242667</name>
      <address>
        <city>Sapporo-shi</city>
        <state>Hokkaido</state>
        <zip>060-8648</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kobe University Hospital /ID# 246236</name>
      <address>
        <city>Kobe-shi</city>
        <state>Hyogo</state>
        <zip>650-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hitachi General Hospital /ID# 240048</name>
      <address>
        <city>Hitachi-shi</city>
        <state>Ibaraki</state>
        <zip>317-0077</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanazawa University Hospital /ID# 238424</name>
      <address>
        <city>Kanazawa-shi</city>
        <state>Ishikawa</state>
        <zip>920-8641</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Corporation Seijinkai Ikeda Hospital /ID# 242172</name>
      <address>
        <city>Kanoya-shi</city>
        <state>Kagoshima</state>
        <zip>893-0024</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyoto University Hospital /ID# 238423</name>
      <address>
        <city>Kyoto-shi</city>
        <state>Kyoto</state>
        <zip>606-8507</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mie University Hospital /ID# 221664</name>
      <address>
        <city>Tsu-shi</city>
        <state>Mie</state>
        <zip>514-8507</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miyazaki Hospital /ID# 221483</name>
      <address>
        <city>Miyazaki-shi</city>
        <state>Miyazaki</state>
        <zip>889-1692</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kawasaki Medical School Hospital /ID# 221481</name>
      <address>
        <city>Kurashiki-shi</city>
        <state>Okayama</state>
        <zip>701-0192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kurashiki Central Hospital /ID# 221692</name>
      <address>
        <city>Kurashiki-shi</city>
        <state>Okayama</state>
        <zip>710-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansai Medical University Hospital /ID# 221482</name>
      <address>
        <city>Hirakata-shi</city>
        <state>Osaka</state>
        <zip>573-1191</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kindai University Hospital /ID# 221479</name>
      <address>
        <city>Osakasayama-shi</city>
        <state>Osaka</state>
        <zip>589-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka University Hospital /ID# 221478</name>
      <address>
        <city>Suita-shi</city>
        <state>Osaka</state>
        <zip>565-0871</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dokkyo Medical University Saitama Medical Center /ID# 222333</name>
      <address>
        <city>Koshigaya-shi</city>
        <state>Saitama</state>
        <zip>343-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juntendo University Shizuoka Hospital /ID# 221782</name>
      <address>
        <city>Izunokuni-shi</city>
        <state>Shizuoka</state>
        <zip>410-2295</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juntendo University Hospital /ID# 221405</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>113-8431</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nippon Medical School Hospital /ID# 221674</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>113-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Yamanashi Hospital /ID# 221701</name>
      <address>
        <city>Chuo-shi</city>
        <state>Yamanashi</state>
        <zip>409-3821</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital /ID# 219053</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggido</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University Busan Paik Hospital /ID# 231667</name>
      <address>
        <city>Busan</city>
        <zip>47392</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital /ID# 222087</name>
      <address>
        <city>Busan</city>
        <zip>49241</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyungpook National University Hospital /ID# 231666</name>
      <address>
        <city>Daegu</city>
        <zip>41944</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center /ID# 222089</name>
      <address>
        <city>Incheon</city>
        <zip>21565</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital /ID# 219055</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center /ID# 219054</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center /ID# 221068</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 219056</name>
      <address>
        <city>Seoul</city>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radboud Universitair Medisch Centrum /ID# 218948</name>
      <address>
        <city>Nijmegen</city>
        <state>Gelderland</state>
        <zip>6525 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albert Schweitzer Ziekenhuis /ID# 224015</name>
      <address>
        <city>Dordrecht</city>
        <state>Zuid-Holland</state>
        <zip>3318 AT</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Medisch Centrum Groningen /ID# 218947</name>
      <address>
        <city>Groningen</city>
        <zip>9713 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Medisch Centrum Utrecht /ID# 218949</name>
      <address>
        <city>Utrecht</city>
        <zip>3584 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Middlemore Clinical Trials /ID# 230770</name>
      <address>
        <city>Papatoetoe</city>
        <state>Auckland</state>
        <zip>2025</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow State budget healthcare /ID# 221025</name>
      <address>
        <city>Moscow</city>
        <state>Moskva</state>
        <zip>125284</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic UZI 4D /ID# 221024</name>
      <address>
        <city>Pyatigorsk</city>
        <state>Stavropol Skiy Kray</state>
        <zip>357502</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Republican hospital named after V.A. Baranov /ID# 221412</name>
      <address>
        <city>Petrozavodsk</city>
        <zip>185019</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leningrad Regional Clinical Hospital /ID# 221028</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>194291</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 221029</name>
      <address>
        <city>Sankt-Peterburg</city>
        <zip>191024</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Almazov National Medical Research Centre /ID# 221033</name>
      <address>
        <city>Sankt-Peterburg</city>
        <zip>197341</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tula Regional Clinical Hospital /ID# 221027</name>
      <address>
        <city>Tula</city>
        <zip>300053</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinical Center Serbia /ID# 230854</name>
      <address>
        <city>Belgrade</city>
        <state>Beograd</state>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clin Hosp Ctr Bezanijska Kosa /ID# 230946</name>
      <address>
        <city>Belgrade</city>
        <state>Beograd</state>
        <zip>11080</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinical Center Kragujevac /ID# 230855</name>
      <address>
        <city>Kragujevac</city>
        <state>Sumadijski Okrug</state>
        <zip>34000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Center Vojvodina /ID# 230853</name>
      <address>
        <city>Novi Sad</city>
        <state>Vojvodina</state>
        <zip>21000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wits Clinical Research Site /ID# 232071</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>2193</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wits Clinical Research Site /ID# 232072</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>2193</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albert Alberts Stem Cell Transplant Centre /ID# 232073</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0044</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Santiago-CHUS /ID# 222264</name>
      <address>
        <city>Santiago de Compostela</city>
        <state>A Coruna</state>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Germans Trias i Pujol /ID# 229936</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Dr. Negrin /ID# 220897</name>
      <address>
        <city>Las Palmas de Gran Canaria</city>
        <state>Las Palmas</state>
        <zip>35019</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 230720</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Parc de Salut del Mar /ID# 220913</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Vall d'Hebron /ID# 229690</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 230721</name>
      <address>
        <city>Madrid</city>
        <zip>28027</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramon y Cajal /ID# 220877</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre /ID# 229691</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de la Victoria /ID# 220878</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Valencia /ID# 220875</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orebro Universitetssjukhuset /ID# 220829</name>
      <address>
        <city>Orebro</city>
        <state>Orebro Lan</state>
        <zip>701 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skane University Hospital Lund /ID# 220835</name>
      <address>
        <city>Lund</city>
        <state>Skane Lan</state>
        <zip>SE 221 41</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sahlgrenska University Hospital /ID# 218776</name>
      <address>
        <city>Gothenburg</city>
        <state>Vastra Gotalands Lan</state>
        <zip>413 45</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital /ID# 218984</name>
      <address>
        <city>Kaohsiung City</city>
        <state>Kaohsiung</state>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital /ID# 218978</name>
      <address>
        <city>Taichung City</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chi Mei Hospital - Liouying /ID# 221145</name>
      <address>
        <city>Tainan City</city>
        <zip>73657</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital /ID# 218976</name>
      <address>
        <city>Taipei City</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hosp /ID# 221146</name>
      <address>
        <city>Taipei City</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Linkou Chang Gung Memorial Hospital /ID# 218983</name>
      <address>
        <city>Taoyuan City</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hacettepe University Medical Faculty /ID# 230759</name>
      <address>
        <city>Ankara</city>
        <zip>06230</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trakya University Medical Facu /ID# 230754</name>
      <address>
        <city>Edirne, Istanbul</city>
        <zip>22030</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bagcilar Medipol Mega Universite Hastanesi /ID# 230757</name>
      <address>
        <city>Istanbul</city>
        <zip>34214</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ege University Medical Faculty /ID# 230753</name>
      <address>
        <city>Izmir</city>
        <zip>35040</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inonu University Medical Faculty /ID# 230758</name>
      <address>
        <city>Malatya</city>
        <zip>44280</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal non-profit enterprise Regional Center of Oncology /ID# 230832</name>
      <address>
        <city>Kharkiv</city>
        <zip>61070</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center &quot;OK!Clinic+&quot; /ID# 230834</name>
      <address>
        <city>Kyiv</city>
        <zip>02091</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Feofaniya Clinical Hospital of State Management of Affairs /ID# 232370</name>
      <address>
        <city>Kyiv</city>
        <zip>03143</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 230833</name>
      <address>
        <city>Lviv</city>
        <zip>79044</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United Lincolnshire Hospitals NHS Trust /ID# 231471</name>
      <address>
        <city>Lincoln</city>
        <state>Lincolnshire</state>
        <zip>LN2 4AX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guys and St Thomas NHS Foundation Trust /ID# 219185</name>
      <address>
        <city>London</city>
        <state>London, City Of</state>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oxford University Hospitals NHS Foundation Trust /ID# 219192</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Birmingham NHS Foundation Trust /ID# 221333</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christie Hospital /ID# 219191</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Croatia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>New Zealand</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Taiwan</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.abbvieclinicaltrials.com/study/?id=M16-191</url>
    <description>Related Info</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>April 26, 2023</last_update_submitted>
  <last_update_submitted_qc>April 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Myelofibrosis</keyword>
  <keyword>Navitoclax</keyword>
  <keyword>Ruxolitinib</keyword>
  <keyword>Cancer</keyword>
  <keyword>ABT-263</keyword>
  <keyword>TRANSFORM-1</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/NCT04472598
org study id: M16-191
secondary id: 2020-000097-15
nct id: NCT04472598
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Myelofibrosis is a type of bone marrow cancer that usually develops slowly and disrupts
      body's normal production of blood cells. It causes bone marrow scarring, leading to severe
      anemia that can cause weakness and fatigue. It can also cause a low number of blood-clotting
      cells called platelets, which increases risk of bleeding. Myelofibrosis often causes an
      enlarged spleen. The purpose of this study is to see if a combination of navitoclax and
      ruxolitinib is more effective and safe in assessment of change in spleen volume when compared
      to ruxolitinib in participants with myelofibrosis.

      Navitoclax is an investigational drug for the treatment of myelofibrosis. Participants in
      this study are divided into two groups, called treatment arms. Each group receives a
      different treatment. Adult participants with a diagnosis of myelofibrosis will be enrolled.
      Around 230 participants will be enrolled in approximately 190 sites worldwide.

      Participants will receive oral navitoclax tablet with oral ruxolitinib tablet or oral
      ruxolitinib tablet with oral placebo (no active drug) tablet and treatment may continue
      untill the participant cannot tolerate the study drug, or benefit is not achieved, or other
      reasons which qualify for discontinuation of the study drug.

      There may be a higher treatment burden for participants in this trial compared to their
      standard of care. Participants will attend regular visits during the course of the study at a
      hospital or clinic. The effect of the treatment will be checked by medical assessments, blood
      tests, magnetic resonance imaging (MRI) or computed tomography (CT) scan, bone marrow tests,
      checking for side effects, and completing questionnaires.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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: Change 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% (SVR35)
time frame: Baseline (Week 0) Up to Week 96
description: Reduction in spleen volume is measured by MRI or CT, per IWG criteria.
measure: Duration of 35% Spleen Volume Reduction (SVR35)
time frame: Baseline (Week 0) Up to Week 96
description: Duration of SVR35 is defined as the time between the date of first response of spleen volume reduction of 35% achievement to the date of the first assessment where the spleen volume is less than 35% reduction from baseline and is at least 25% increase from the nadir (the lowest spleen volume).
measure: 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 SF 7a.
measure: Change in Physical Functioning
time frame: Baseline (Week 0) Up to Week 24
description: Change in 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 who achieve Anemia Response
time frame: Baseline (Week 0) Up to Week 96
description: The rate of anemia response will be assessed according to current International Working Group-Myeloproliferative Neoplasms Research and European LeukemiaNet (IWG-MRT/ELN) criteria.
measure: Overall Survival (OS)
time frame: Up To approximately 8 Years
description: OS is defined as the time from the date of randomization to the date of death from any cause.
measure: Leukemia-Free Survival
time frame: Up To approximately 8 Years
description: Leukemia-free survival is defined as the number of days from the date of randomization to the onset date of documented leukemia, disease progression due to leukemia, or death due to leukemia, whichever occurs first.
measure: Percentage of Participants who Achieve Reduction in Grade of Bone Marrow Fibrosis
time frame: Baseline (Week 0) Up to Week 96
description: Change in grade of bone marrow fibrosis will be measured per the European consensus grading system through bone marrow biopsy.
arm group label: Navitoclax + Ruxolitinib
arm group type: Experimental
description: Participants will receive Navitoclax in combination with Ruxolitinib
arm group label: Placebo for Navitoclax + Ruxolitinib
arm group type: Active Comparator
description: Participants will receive placebo for Navitoclax and Ruxolitinib
intervention type: Drug
intervention name: Navitoclax
description: Tablet; Oral
arm group label: Navitoclax + Ruxolitinib
other name: ABT-263
intervention type: Drug
intervention name: Ruxolitinib
description: Tablet; Oral
arm group label: Navitoclax + Ruxolitinib
arm group label: Placebo for Navitoclax + Ruxolitinib
intervention type: Drug
intervention name: Placebo for Navitoclax
description: Tablet; Oral
arm group label: Placebo for Navitoclax + Ruxolitinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: ABBVIE INC.
role: Study Director
affiliation: AbbVie
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country: Australia
country: Austria
country: Belgium
country: Bulgaria
country: Canada
country: Croatia
country: France
country: Germany
country: Greece
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Netherlands
country: New Zealand
country: Russian Federation
country: Serbia
country: South Africa
country: Spain
country: Sweden
country: Taiwan
country: Turkey
country: Ukraine
country: United Kingdom
country: United States
url: https://www.abbvieclinicaltrials.com/study/?id=M16-191
description: Related Info
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/