<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/NCT04401748</url>
  </required_header>
  <id_info>
    <org_study_id>M15-954</org_study_id>
    <secondary_id>2020-000744-55</secondary_id>
    <nct_id>NCT04401748</nct_id>
  </id_info>
  <brief_title>Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome</brief_title>
  <acronym>Verona</acronym>
  <official_title>A Randomized, Double-Blind, Phase 3 Study Evaluating the Safety and Efficacy of Venetoclax in Combination With Azacitidine in Patients Newly Diagnosed With Higher-Risk Myelodysplastic Syndrome (Higher-Risk MDS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Genentech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </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>
      Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a&#xD;
      person's bone marrow (semi-liquid tissue present in many bones like backbones) to produce&#xD;
      normal blood cells. Some people with MDS have a risk of the disease progressing to acute&#xD;
      myeloid leukemia (AML), and a risk of death from the disease itself. Symptoms of MDS include&#xD;
      fatigue, shortness of breath, unusual paleness due to anemia (low red blood cell count), easy&#xD;
      or unusual bruising, and red spots just beneath the skin caused by bleeding. The purpose of&#xD;
      this study is to see how safe and effective venetoclax and azacitidine (AZA) combination are&#xD;
      when compared to AZA and a placebo (contains no medicine), in participants with newly&#xD;
      diagnosed higher-risk MDS.&#xD;
&#xD;
      Venetoclax is an investigational drug being developed for the treatment of MDS. The study&#xD;
      consists of two treatment arms - In one arm, participants will receive venetoclax and AZA. In&#xD;
      another arm, participants will receive AZA and placebo. Adult participants with newly&#xD;
      diagnosed higher-risk MDS will be enrolled. Around 500 participants will be enrolled in&#xD;
      approximately 220 sites worldwide.&#xD;
&#xD;
      Participants in one arm will receive oral doses of venetoclax tablet and intravenous&#xD;
      (infusion in the vein) or subcutaneous (given under the skin) AZA solution. Participants in&#xD;
      another arm will receive oral doses of placebo tablet and intravenous or subcutaneous AZA&#xD;
      solution.&#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 course of the study at a&#xD;
      hospital or clinic. The effect of the treatment will be checked by medical assessments, blood&#xD;
      and bone marrow tests, checking for side effects, and completing questionnaires.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 10, 2020</start_date>
  <completion_date type="Anticipated">February 14, 2025</completion_date>
  <primary_completion_date type="Anticipated">February 14, 2025</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Up To 5 Years</time_frame>
    <description>OS is defined as the number of days from the date of randomization to the date of death of any cause, or last known date to be alive.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Modified Overall Response (mOR)</measure>
    <time_frame>Up To 5 Years</time_frame>
    <description>mOR [complete remission (CR) + marrow complete remission (mCR) + partial response (PR)] is defined as achieving a CR, mCR, or PR at any time point during the study per the modified International Working Group (IWG) 2006 criteria for myelodysplastic syndrome (MDS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Overall Hematological Improvement (HI)</measure>
    <time_frame>Up to 5 Years</time_frame>
    <description>Overall HI is defined as achieving the response of HI-platelet or HI-neutrophil, or HI-erythroid at any time point during the study prior to post-treatment therapy per the modified IWG 2006 criteria for MDS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Remission (CR)</measure>
    <time_frame>Up To 36 Months</time_frame>
    <description>CR is defined as achieving a complete remission at any time point during the study per the modified International Working Group (IWG) 2006 criteria for myelodysplastic syndrome (MDS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Transfusion Independence (TI) Who are Transfusion Dependent at Baseline</measure>
    <time_frame>Up To 5 Years</time_frame>
    <description>TI is when the participants who were transfusion dependent on red blood cell (RBC) and/or Platelet at baseline achieve transfusion independence post baseline. TI is a period of at least 56 days with no transfusion after the date of the first dose of study drug to the last dose of study drug + 30 days, or 1 day before the date of progressive disease/ relapse from CR or PR per the modified IWG 2006 criteria for MDS, or 1 day before the initiation of post-treatment therapy or 1 day before death, whichever is earliest.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Deterioration in Physical Functioning as Measured by Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scale</measure>
    <time_frame>Up To 5 Years</time_frame>
    <description>Time to deterioration in physical functioning, as measured by the EORTC QLQ-C30 physical functioning score is defined as the time from the date of randomization to the date of death of any cause, or the first time worsening of score from baseline &gt;= a pre-specified threshold. Participants rate items on a 4-point scale, with 1 as &quot;not at all&quot; and 4 as &quot;very much.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form (SF) 7a Scale Score</measure>
    <time_frame>Up To 5 Years</time_frame>
    <description>Fatigue will be assessed using the PROMIS Fatigue SF 7a Global Fatigue Score. PROMIS Fatigue SF 7a is a 7-item questionnaire that assesses the impact and experience of fatigue over the past 7 days. Participants rate items on a 5-point scale, with 1 as &quot;never&quot; an 5 as &quot;always&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response (OR)</measure>
    <time_frame>Up To 5 Years</time_frame>
    <description>OR [complete remission (CR) + partial response (PR)] is defined as achieving a CR or PR at any time point during the study per the modified IWG 2006 criteria for MDS.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">531</enrollment>
  <condition>Myelodysplastic Syndrome (MDS)</condition>
  <arm_group>
    <arm_group_label>Arm 1: Venetoclax + Azacitidine (AZA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive venetoclax once daily (QD) (Days 1-14) in combination with AZA QD (7 days of the first 9 days) of each 28 day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2: Placebo + Azacitidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive placebo once daily (QD) (Days 1-14) in combination with AZA QD (7 days of the first 9 days) of each 28 day cycle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Venetoclax</intervention_name>
    <description>Tablet: Oral</description>
    <arm_group_label>Arm 1: Venetoclax + Azacitidine (AZA)</arm_group_label>
    <other_name>ABT-199</other_name>
    <other_name>GDC-0199</other_name>
    <other_name>Venclexta</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azacitidine</intervention_name>
    <description>Subcutaneous (SC) or Intravenous (IV) injection</description>
    <arm_group_label>Arm 1: Venetoclax + Azacitidine (AZA)</arm_group_label>
    <arm_group_label>Arm 2: Placebo + Azacitidine</arm_group_label>
    <other_name>AZA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Tablet; Oral</description>
    <arm_group_label>Arm 2: Placebo + Azacitidine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants with a diagnosis of Myelodysplastic Syndrome (MDS) according to the 2016&#xD;
             World Health Organization (WHO) classification wtih presence of &lt; 20% bone marrow&#xD;
             blasts per marrow biopsy/aspirate at screening.&#xD;
&#xD;
          -  Participants must meet the following disease activity criteria:&#xD;
&#xD;
               -  Overall Revised International Prognostic Scoring System (IPSS-R) score &gt; 3&#xD;
                  (intermediate, high or very high).&#xD;
&#xD;
               -  Eastern Cooperative Oncology Group (ECOG) performance status of &lt;= 2.&#xD;
&#xD;
               -  Hematopoietic stem cell transplant (HSCT) eligible with no pre-arranged HSCT at&#xD;
                  the time of Study Day 1, or HSCT ineligible without plan for HSCT at the time of&#xD;
                  Study Day 1.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior therapy for MDS with any hypomethylating agent, chemotherapy, or allogenic stem&#xD;
             cell transplantation.&#xD;
&#xD;
          -  Prior diagnosis of therapy-related MDS (t-MDS), MDS evolving from a pre-existing&#xD;
             myeloproliferative neoplasm (MPN), MDS/MPN including chronic myelomonocytic leukemia&#xD;
             (CMML), atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia&#xD;
             (JMML) and unclassifiable MDS/MPN.&#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>Providence Medical Foundation /ID# 222633</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, Los Angeles /ID# 221760</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Torrance Memorial Physician Network Cancer Care /ID# 222702</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505-5004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PIH Health Whittier Hospital /ID# 222647</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90602-1006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers /ID# 223723</name>
      <address>
        <city>Boulder</city>
        <state>Colorado</state>
        <zip>80303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University /ID# 222764</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helen F. Graham Cancer Center &amp; Research Institute /ID# 223731</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19713-2055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists - Fort Myers /ID# 221319</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33916</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Healthcare System /ID# 222703</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021-3513</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists - North /ID# 221318</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 - Panhandle /ID# 221315</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308-5304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists - East /ID# 221317</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Mountain State Tumor Institute /ID# 220838</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83712-6267</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University Feinberg School of Medicine /ID# 220843</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611-2927</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center /ID# 221007</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ingalls Memorial Hosp /ID# 220844</name>
      <address>
        <city>Harvey</city>
        <state>Illinois</state>
        <zip>60426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois Cancer Care, PC /ID# 220840</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkview Cancer Institute /ID# 223620</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46845-1739</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas /ID# 222648</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology/Oncology Clinic /ID# 224257</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pontchartrain Cancer Center - Covington /ID# 221005</name>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <zip>70433-7512</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maryland Oncology Hematology /ID# 223776</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21044-3128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital /ID# 225068</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# 225069</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# 219162</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Ann Arbor Healthcare System /ID# 221365</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer &amp; Hematology Centers /ID# 220848</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mmcorc /Id# 221321</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55416</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MidAmerica Division, Inc. /ID# 221895</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada - Horizon Ridge /ID# 222635</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052-2648</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 221003</name>
      <address>
        <city>East Brunswick</city>
        <state>New Jersey</state>
        <zip>08816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Valley Hospital /ID# 232337</name>
      <address>
        <city>Paramus</city>
        <state>New Jersey</state>
        <zip>07652</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Oncology Hematology - Albany Cancer Center /ID# 223778</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12206-5013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University at Buffalo /ID# 221206</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14222</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College /ID# 222898</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stony Brook University Hospital /ID# 224450</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794-8183</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novant Health Presbyterian Medical Center /ID# 222561</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novant Health Forsyth Medical Center /ID# 221004</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology Hematology Care, Inc. /ID# 223724</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45236-2725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bend Memorial Clinic /ID# 220999</name>
      <address>
        <city>Bend</city>
        <state>Oregon</state>
        <zip>97701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Willamette Valley Cancer Institute and Research Center /ID# 223733</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401-6043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Hillman Cancer Ctr /ID# 223201</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avera Cancer Institute /ID# 243461</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology - Chattanooga / McCallie /ID# 221311</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404-3230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology-Nashville Centennial /ID# 220854</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203-1632</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Austin Midtown /ID# 223729</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Medical City Dallas /ID# 223725</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 223727</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246-2003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Forth Worth /ID# 223777</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104-2150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center at Texas Medical Center /ID# 219163</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030-4000</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - San Antonio Medical Center /ID# 223728</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78240-5251</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Scott &amp; White Medical Center- Temple /ID# 221332</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76508-0001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Northeast Texas /ID# 223734</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# 219160</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Specialists - Gainesville /ID# 223726</name>
      <address>
        <city>Gainesville</city>
        <state>Virginia</state>
        <zip>20155-3257</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University Medical Center Main Hospital /ID# 221590</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Institute at Reynolds Crossing /ID# 221002</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Puget Sound Health Care System /ID# 221358</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98108-1597</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blacktown Hospital /ID# 234079</name>
      <address>
        <city>Blacktown</city>
        <state>New South Wales</state>
        <zip>2148</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George Hospital /ID# 221810</name>
      <address>
        <city>Kogarah</city>
        <state>New South Wales</state>
        <zip>2217</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Port Macquarie Base Hospital /ID# 234078</name>
      <address>
        <city>Port Macquarie</city>
        <state>New South Wales</state>
        <zip>2444</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gold coast University Hospital /ID# 222606</name>
      <address>
        <city>SouthPort</city>
        <state>Queensland</state>
        <zip>4215</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital /ID# 221805</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent's Hospital Melbourne /ID# 221809</name>
      <address>
        <city>Fitzroy Melbourne</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Health /ID# 221807</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordensklinikum Linz GmbH Elisabethinen /ID# 221387</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# 221386</name>
      <address>
        <city>Wels</city>
        <state>Oberoesterreich</state>
        <zip>4600</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitaet Wien /ID# 221446</name>
      <address>
        <city>Vienna</city>
        <state>Wien</state>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 221092</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hanusch Krankenhaus /ID# 221093</name>
      <address>
        <city>Wien</city>
        <zip>1140</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCL Saint-Luc /ID# 219066</name>
      <address>
        <city>Woluwe-Saint-Lambert</city>
        <state>Bruxelles-Capitale</state>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU UCL Namur - site Godinne /ID# 219064</name>
      <address>
        <city>Godinne</city>
        <state>Namur</state>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent /ID# 218767</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# 218905</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ZNA Middelheim /ID# 218907</name>
      <address>
        <city>Antwerp</city>
        <zip>2020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint-Jan Brugge /ID# 218212</name>
      <address>
        <city>Brugge</city>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pôle Hospitalier Jolimont /ID# 218921</name>
      <address>
        <city>La Louvière</city>
        <zip>7100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Walter Cantidio /ID# 223434</name>
      <address>
        <city>Fortaleza</city>
        <state>Ceara</state>
        <zip>60430-372</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liga Paranaense de Combate ao Câncer /ID# 221341</name>
      <address>
        <city>Curitiba</city>
        <state>Parana</state>
        <zip>81520-060</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sociedade Beneficente Israelita Hospital Albert Einstein /ID# 221370</name>
      <address>
        <city>São Paulo</city>
        <state>Sao Paulo</state>
        <zip>05652-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitário Pedro Ernesto /ID# 223080</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>20551-030</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 221339</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BC Cancer - Surrey /ID# 219098</name>
      <address>
        <city>Surrey</city>
        <state>British Columbia</state>
        <zip>V3V 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottawa Hospital Research Institute /ID# 219105</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Ctr /ID# 219103</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Health Center Research Institute /ID# 222519</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 218973</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4J 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHUQ- Hôpital de l'Enfant-Jesus /ID# 221200</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <zip>G1J 1Z4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong Provincial People's Hospital /ID# 221442</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhujiang Hospital of Southern Medical University /ID# 222071</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510280</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanfang Hospital of Southern Medical University /ID# 224566</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510515</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Hebei Medical University /ID# 222919</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Provincial People's Hospital /ID# 225790</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital /ID# 221447</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital Tongji Medical College of HUST /ID# 221474</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongda Hospital Southeast University /ID# 221849</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital /ID# 221342</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Soochow University /ID# 221640</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <zip>215031</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Nanchang University /ID# 225983</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shaanxi Provincial people's Hospital /ID# 225728</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Sixth People's Hospital /ID# 221546</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200233</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital, Sichuan University /ID# 221601</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Hematology &amp; Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 221567</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 221494</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 225982</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Fourth Affiliated Hospital Zhejiang University School of Medicine /ID# 225918</name>
      <address>
        <city>Yiwu</city>
        <state>Zhejiang</state>
        <zip>322000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University International Hospital /ID# 222987</name>
      <address>
        <city>Beijing</city>
        <zip>102206</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lanzhou University Second Hospital /ID# 225980</name>
      <address>
        <city>Lanzhou</city>
        <zip>730030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shengjing Hospital of China Medical University /ID# 222945</name>
      <address>
        <city>Shenyang</city>
        <zip>110022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University General Hospital /ID# 226810</name>
      <address>
        <city>Tianjin</city>
        <zip>300052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 221475</name>
      <address>
        <city>Wuhan</city>
        <zip>420022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni Nemocnice Brno /ID# 221351</name>
      <address>
        <city>Brno</city>
        <zip>625 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Hradec Kralove /ID# 221163</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>500 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Ostrava /ID# 219143</name>
      <address>
        <city>Ostrava</city>
        <zip>708 52</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Plzen /ID# 221162</name>
      <address>
        <city>Plzen</city>
        <zip>305 99</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ustav hematologie a krevni transfuze /ID# 221350</name>
      <address>
        <city>Praha</city>
        <zip>128 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vseobecna fakultni nemocnice v Praze /ID# 221229</name>
      <address>
        <city>Praha</city>
        <zip>128 08</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nice - Hôpital Archet 1 /ID# 220992</name>
      <address>
        <city>Nice</city>
        <state>Alpes-Maritimes</state>
        <zip>06200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bordeaux - Hopital Haut Leveque /ID# 220989</name>
      <address>
        <city>Pessac</city>
        <state>Gironde</state>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Lille - Hopital Claude Huriez /ID# 220991</name>
      <address>
        <city>Lille</city>
        <state>Hauts-de-France</state>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes, Hotel Dieu -HME /ID# 222074</name>
      <address>
        <city>Nantes</city>
        <state>Pays-de-la-Loire</state>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Henri Duffaut /ID# 225185</name>
      <address>
        <city>Avignon CEDEX 9</city>
        <state>Vaucluse</state>
        <zip>84902</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Grenoble - Hopital Michallon /ID# 220988</name>
      <address>
        <city>La Tronche</city>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AP-HM - Hopital de la Conception /ID# 224882</name>
      <address>
        <city>Marseille</city>
        <zip>13005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AP-HP - Hopital Saint-Louis /ID# 222075</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Henri Becquerel /ID# 220986</name>
      <address>
        <city>Rouen</city>
        <zip>76038</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Mannheim /ID# 221172</name>
      <address>
        <city>Mannheim</city>
        <state>Baden-Wuerttemberg</state>
        <zip>68167</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stauferklinikum Schwaebisch Gmuend /ID# 224917</name>
      <address>
        <city>Mutlangen</city>
        <state>Baden-Wuerttemberg</state>
        <zip>73557</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Duesseldorf /ID# 221169</name>
      <address>
        <city>Düsseldorf</city>
        <state>Nordrhein-Westfalen</state>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Koeln /ID# 234219</name>
      <address>
        <city>Köln</city>
        <state>Nordrhein-Westfalen</state>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Leipzig /ID# 221168</name>
      <address>
        <city>Leipzig</city>
        <state>Sachsen</state>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 221189</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover /ID# 221173</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 221170</name>
      <address>
        <city>Munich</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 221705</name>
      <address>
        <city>Szeged</city>
        <state>Csongrad</state>
        <zip>6725</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fejer Megyei Szent Gyorgy Korhaz /ID# 222953</name>
      <address>
        <city>Szekesfehervar</city>
        <state>Fejer</state>
        <zip>8000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Klinikai Kozpont /ID# 221702</name>
      <address>
        <city>Debrecen</city>
        <state>Hajdu-Bihar</state>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 221703</name>
      <address>
        <city>Kaposvár</city>
        <state>Somogy</state>
        <zip>7400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Josa Andras Okta /ID# 221704</name>
      <address>
        <city>Nyiregyhaza</city>
        <state>Szabolcs-Szatmar-Bereg</state>
        <zip>4400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Chaim Sheba Medical Center /ID# 221110</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# 221896</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# 222006</name>
      <address>
        <city>Jerusalem</city>
        <state>Yerushalayim</state>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus /ID# 221083</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shaare Zedek Medical Center /ID# 233181</name>
      <address>
        <city>Jerusalem</city>
        <zip>91031</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center /ID# 221184</name>
      <address>
        <city>Petakh Tikva</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas /ID# 220815</name>
      <address>
        <city>Rozzano</city>
        <state>Milano</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 220810</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli /ID# 220816</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 220818</name>
      <address>
        <city>Reggio Calabria</city>
        <zip>89124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Sant'Andrea /ID# 220819</name>
      <address>
        <city>Rome</city>
        <zip>00189</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagoya University Hospital /ID# 221566</name>
      <address>
        <city>Nagoya-shi</city>
        <state>Aichi</state>
        <zip>4668560</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Fukui Hospital /ID# 221568</name>
      <address>
        <city>Yoshida-gun</city>
        <state>Fukui</state>
        <zip>910-1193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyushu University Hospital /ID# 223473</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# 222015</name>
      <address>
        <city>Fukushima-shi</city>
        <state>Fukushima</state>
        <zip>960-1295</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chugoku Central Hospital /ID# 222955</name>
      <address>
        <city>Fukuyama-shi</city>
        <state>Hiroshima</state>
        <zip>720-0001</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sapporo Hokuyu Hospital /ID# 222133</name>
      <address>
        <city>Sapporo-shi</city>
        <state>Hokkaido</state>
        <zip>003-0006</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aiiku Hospital /ID# 222351</name>
      <address>
        <city>Sapporo-shi</city>
        <state>Hokkaido</state>
        <zip>064-0804</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kobe City Medical Center General Hospital /ID# 221977</name>
      <address>
        <city>Kobe-shi</city>
        <state>Hyogo</state>
        <zip>650-0047</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Mito Medical Center /ID# 222278</name>
      <address>
        <city>Higashi Ibaraki-gun</city>
        <state>Ibaraki</state>
        <zip>311-3193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital /ID# 221976</name>
      <address>
        <city>Sendai-shi</city>
        <state>Miyagi</state>
        <zip>9808574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagasaki University Hospital /ID# 222241</name>
      <address>
        <city>Nagasaki-shi</city>
        <state>Nagasaki</state>
        <zip>852-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama Medical Center /ID# 222310</name>
      <address>
        <city>Okayama-shi</city>
        <state>Okayama</state>
        <zip>701-1192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kindai University Hospital /ID# 222284</name>
      <address>
        <city>Osakasayama-shi</city>
        <state>Osaka</state>
        <zip>589-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Medical Center /ID# 222016</name>
      <address>
        <city>Kawagoe-shi</city>
        <state>Saitama</state>
        <zip>350-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NTT Medical Center Tokyo /ID# 222365</name>
      <address>
        <city>Shinagawa-ku</city>
        <state>Tokyo</state>
        <zip>141-8625</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yamagata University Hospital /ID# 221574</name>
      <address>
        <city>Yamagata-shi</city>
        <state>Yamagata</state>
        <zip>990-9585</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital /ID# 221695</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggido</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yonsei University Health System Severance Hospital /ID# 233171</name>
      <address>
        <city>Seoul</city>
        <state>Seoul Teugbyeolsi</state>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital /ID# 232353</name>
      <address>
        <city>Busan</city>
        <zip>49241</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital /ID# 221226</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center /ID# 221227</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center /ID# 221224</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus Medisch Centrum /ID# 218937</name>
      <address>
        <city>Rotterdam</city>
        <state>Zuid-Holland</state>
        <zip>3015 GD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maxima Medisch Centrum /ID# 223010</name>
      <address>
        <city>Eindhoven</city>
        <zip>5631 BM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisch Spectrum Twente /ID# 223012</name>
      <address>
        <city>Enschede</city>
        <zip>7512 KZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maastricht Universitair Medisch Centrum /ID# 221630</name>
      <address>
        <city>Maastricht</city>
        <zip>6229 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Isala /ID# 223011</name>
      <address>
        <city>Zwolle</city>
        <zip>8025 AB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 233321</name>
      <address>
        <city>Bydgoszcz</city>
        <state>Kujawsko-pomorskie</state>
        <zip>85-168</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 221784</name>
      <address>
        <city>Lodz</city>
        <state>Lodzkie</state>
        <zip>93-513</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 221667</name>
      <address>
        <city>Lublin</city>
        <state>Lubelskie</state>
        <zip>20-081</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LUX MED Onkologia - Szpital Szamocka /ID# 222203</name>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <zip>01-748</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersyteckie Centrum Kliniczne /ID# 222069</name>
      <address>
        <city>Gdansk</city>
        <state>Pomorskie</state>
        <zip>80-214</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pratia Onkologia Katowice /ID# 224728</name>
      <address>
        <city>Katowice</city>
        <zip>40-519</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MTZ Clinical Research Powered by Pratia /ID# 221354</name>
      <address>
        <city>Warszawa</city>
        <zip>02-172</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pan American Center for Oncology Trials, LLC /ID# 221010</name>
      <address>
        <city>Rio Piedras</city>
        <zip>00935</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Caribbean Healthcare System /ID# 221012</name>
      <address>
        <city>San Juan</city>
        <zip>00921-3201</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaluga Regional Clinical Hospital /ID# 221211</name>
      <address>
        <city>Kaluga</city>
        <state>Kaluzhskaya Oblast</state>
        <zip>248007</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic UZI 4D /ID# 221215</name>
      <address>
        <city>Pyatigorsk</city>
        <state>Stavropol Skiy Kray</state>
        <zip>357502</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital n.a. V.V. Veresaev /ID# 225435</name>
      <address>
        <city>Moscow</city>
        <zip>127644</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MMCC Kommunarka /ID# 221213</name>
      <address>
        <city>Moscow</city>
        <zip>129301</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Republican hospital named after V.A. Baranov /ID# 221214</name>
      <address>
        <city>Petrozavodsk</city>
        <zip>185019</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Almazov National Medical Research Centre /ID# 221449</name>
      <address>
        <city>Sankt-Peterburg</city>
        <zip>197341</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Germans Trias i Pujol /ID# 221274</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Quironsalud Madrid /ID# 221275</name>
      <address>
        <city>Pozuelo de Alarcon</city>
        <state>Madrid</state>
        <zip>28223</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Vall d'Hebron /ID# 221323</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Reina Sofia /ID# 221273</name>
      <address>
        <city>Cordoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Maranon /ID# 221271</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre /ID# 221272</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Salamanca /ID# 221297</name>
      <address>
        <city>Salamanca</city>
        <zip>37711</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocio /ID# 221276</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario y Politecnico La Fe /ID# 221270</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital /ID# 223573</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# 218987</name>
      <address>
        <city>Taichung City</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital /ID# 218989</name>
      <address>
        <city>Tainan</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chi-Mei Medical Center /ID# 218991</name>
      <address>
        <city>Tainan</city>
        <zip>71004</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erciyes University Medical Fac /ID# 222090</name>
      <address>
        <city>Melikgazi</city>
        <state>Kayseri</state>
        <zip>38030</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hacettepe University Faculty of Medicine /ID# 222094</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ankara City Hospital /ID# 222093</name>
      <address>
        <city>Ankara</city>
        <zip>06800</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akdeniz Universitesi Tip Fakul /ID# 222095</name>
      <address>
        <city>Antalya</city>
        <zip>07059</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ondokuz mayis University Facul /ID# 222091</name>
      <address>
        <city>Samsun</city>
        <zip>55200</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acibadem Maslak Hastanesi /ID# 222072</name>
      <address>
        <city>Tuzla</city>
        <zip>34953</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Bristol NHS Foundation Trust /ID# 222510</name>
      <address>
        <city>Bristol</city>
        <state>Bristol, City Of</state>
        <zip>BS1 3NU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oxford University Hospitals NHS Foundation Trust /ID# 221231</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiff &amp; Vale University Health Board /ID# 221236</name>
      <address>
        <city>Cardiff</city>
        <state>Wales</state>
        <zip>CF14 4XN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS Grampian /ID# 222509</name>
      <address>
        <city>Aberdeen</city>
        <zip>AB15 6RE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Birmingham NHS Foundation Trust /ID# 221233</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London Hospitals NHS Foundation Trust /ID# 221240</name>
      <address>
        <city>London</city>
        <zip>NW1 2PG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Marsden NHS Foundation Trust /ID# 221232</name>
      <address>
        <city>London</city>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Plymouth NHS Trust /ID# 222514</name>
      <address>
        <city>Plymouth</city>
        <zip>PL6 5FP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Dorset NHS Foundation Trust /ID# 221237</name>
      <address>
        <city>Poole</city>
        <zip>BH15 2JB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>China</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.rxabbvie.com</url>
    <description>This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.</description>
  </link>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>April 24, 2023</last_update_submitted>
  <last_update_submitted_qc>April 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MDS</keyword>
  <keyword>Myelodysplastic Syndrome</keyword>
  <keyword>Venetoclax</keyword>
  <keyword>Azacitidine</keyword>
  <keyword>AZA</keyword>
  <keyword>Venclexta</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Preleukemia</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azacitidine</mesh_term>
    <mesh_term>Venetoclax</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/NCT04401748
org study id: M15-954
secondary id: 2020-000744-55
nct id: NCT04401748
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Myelodysplastic Syndrome (MDS) is a group of disorders that gradually affect the ability of a
      person's bone marrow (semi-liquid tissue present in many bones like backbones) to produce
      normal blood cells. Some people with MDS have a risk of the disease progressing to acute
      myeloid leukemia (AML), and a risk of death from the disease itself. Symptoms of MDS include
      fatigue, shortness of breath, unusual paleness due to anemia (low red blood cell count), easy
      or unusual bruising, and red spots just beneath the skin caused by bleeding. The purpose of
      this study is to see how safe and effective venetoclax and azacitidine (AZA) combination are
      when compared to AZA and a placebo (contains no medicine), in participants with newly
      diagnosed higher-risk MDS.

      Venetoclax is an investigational drug being developed for the treatment of MDS. The study
      consists of two treatment arms - In one arm, participants will receive venetoclax and AZA. In
      another arm, participants will receive AZA and placebo. Adult participants with newly
      diagnosed higher-risk MDS will be enrolled. Around 500 participants will be enrolled in
      approximately 220 sites worldwide.

      Participants in one arm will receive oral doses of venetoclax tablet and intravenous
      (infusion in the vein) or subcutaneous (given under the skin) AZA solution. Participants in
      another arm will receive oral doses of placebo tablet and intravenous or subcutaneous AZA
      solution.

      There may be 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
      and 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: Overall survival (OS)
time frame: Up To 5 Years
description: OS is defined as the number of days from the date of randomization to the date of death of any cause, or last known date to be alive.
measure: Modified Overall Response (mOR)
time frame: Up To 5 Years
description: mOR [complete remission (CR) + marrow complete remission (mCR) + partial response (PR)] is defined as achieving a CR, mCR, or PR at any time point during the study per the modified International Working Group (IWG) 2006 criteria for myelodysplastic syndrome (MDS).
measure: Percentage of Participants Achieving Overall Hematological Improvement (HI)
time frame: Up to 5 Years
description: Overall HI is defined as achieving the response of HI-platelet or HI-neutrophil, or HI-erythroid at any time point during the study prior to post-treatment therapy per the modified IWG 2006 criteria for MDS.
measure: Complete Remission (CR)
time frame: Up To 36 Months
description: CR is defined as achieving a complete remission at any time point during the study per the modified International Working Group (IWG) 2006 criteria for myelodysplastic syndrome (MDS).
measure: Percentage of Participants Achieving Transfusion Independence (TI) Who are Transfusion Dependent at Baseline
time frame: Up To 5 Years
description: TI is when the participants who were transfusion dependent on red blood cell (RBC) and/or Platelet at baseline achieve transfusion independence post baseline. TI is a period of at least 56 days with no transfusion after the date of the first dose of study drug to the last dose of study drug + 30 days, or 1 day before the date of progressive disease/ relapse from CR or PR per the modified IWG 2006 criteria for MDS, or 1 day before the initiation of post-treatment therapy or 1 day before death, whichever is earliest.
measure: Time to Deterioration in Physical Functioning as Measured by Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scale
time frame: Up To 5 Years
description: Time to deterioration in physical functioning, as measured by the EORTC QLQ-C30 physical functioning score is defined as the time from the date of randomization to the date of death of any cause, or the first time worsening of score from baseline >= a pre-specified threshold. Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form (SF) 7a Scale Score
time frame: Up To 5 Years
description: Fatigue will be assessed using the PROMIS Fatigue SF 7a Global Fatigue Score. PROMIS Fatigue SF 7a is a 7-item questionnaire that assesses the impact and experience of fatigue over the past 7 days. Participants rate items on a 5-point scale, with 1 as "never" an 5 as "always".
measure: Overall Response (OR)
time frame: Up To 5 Years
description: OR [complete remission (CR) + partial response (PR)] is defined as achieving a CR or PR at any time point during the study per the modified IWG 2006 criteria for MDS.
arm group label: Arm 1: Venetoclax + Azacitidine (AZA)
arm group type: Experimental
description: Participants will receive venetoclax once daily (QD) (Days 1-14) in combination with AZA QD (7 days of the first 9 days) of each 28 day cycle.
arm group label: Arm 2: Placebo + Azacitidine
arm group type: Active Comparator
description: Participants will receive placebo once daily (QD) (Days 1-14) in combination with AZA QD (7 days of the first 9 days) of each 28 day cycle.
intervention type: Drug
intervention name: Venetoclax
description: Tablet: Oral
arm group label: Arm 1: Venetoclax + Azacitidine (AZA)
other name: ABT-199
other name: GDC-0199
other name: Venclexta
intervention type: Drug
intervention name: Azacitidine
description: Subcutaneous (SC) or Intravenous (IV) injection
arm group label: Arm 1: Venetoclax + Azacitidine (AZA)
arm group label: Arm 2: Placebo + Azacitidine
other name: AZA
intervention type: Drug
intervention name: Placebo
description: Tablet; Oral
arm group label: Arm 2: Placebo + Azacitidine
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: Brazil
country: Canada
country: China
country: Czechia
country: France
country: Germany
country: Hungary
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Netherlands
country: Poland
country: Puerto Rico
country: Russian Federation
country: Spain
country: Taiwan
country: Turkey
country: United Kingdom
country: United States
url: https://www.rxabbvie.com
description: This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
responsible party type: Sponsor
mesh term: Preleukemia
mesh term: Myelodysplastic Syndromes
mesh term: Syndrome
mesh term: Azacitidine
mesh term: Venetoclax
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/