<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/NCT03817398</url>
  </required_header>
  <id_info>
    <org_study_id>AAML18P1</org_study_id>
    <secondary_id>NCI-2018-03439</secondary_id>
    <secondary_id>AAML18P1</secondary_id>
    <secondary_id>AAML18P1</secondary_id>
    <secondary_id>U10CA180886</secondary_id>
    <nct_id>NCT03817398</nct_id>
  </id_info>
  <brief_title>Stopping Tyrosine Kinase Inhibitors in Affecting Treatment-Free Remission in Patients With Chronic Phase Chronic Myeloid Leukemia</brief_title>
  <official_title>Stopping Tyrosine Kinase Inhibitors (TKI) to Assess Treatment-Free Remission (TFR) in Pediatric Chronic Myeloid Leukemia - Chronic Phase (CML-CP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Oncology Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Oncology Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</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>
      This phase II trial studies how stopping tyrosine kinase inhibitors will affect&#xD;
      treatment-free remission in patients with chronic myeloid leukemia in chronic phase. When the&#xD;
      level of disease is very low, it's called molecular remission. TKIs are a type of medication&#xD;
      that help keep this level low. However, after being in molecular remission for a specific&#xD;
      amount of time, it may not be necessary to take tyrosine kinase inhibitors. It is not yet&#xD;
      known whether stopping tyrosine kinase inhibitors will help patients with chronic myeloid&#xD;
      leukemia in chronic phase continue or re-achieve molecular remission.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the 2-year treatment free remission (TFR) rate of children, adolescents, and&#xD;
      young adults with chronic myeloid leukemia - chronic phase (CML-CP) following discontinuation&#xD;
      tyrosine kinase inhibitor (TKI).&#xD;
&#xD;
      II. To estimate the re-induction rate and maintenance of molecular remission (BCR-ABL1 =&lt;&#xD;
      0.1%) at 1 year after restarting TKI for children, adolescents, and young adults.&#xD;
&#xD;
      SECONDARY OBJECTIVE:&#xD;
&#xD;
      I. To describe clinical factors and laboratory correlates affecting the persistence of major&#xD;
      molecular remission (MMR) and re-initiation of treatment after stopping TKI (e.g. patient&#xD;
      demographics, duration and level of prior molecular remission, duration and type of TKI,&#xD;
      clinical presentation at diagnosis and immune studies).&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I. To describe change in height standard deviation score over time in patients who are able&#xD;
      to discontinue their TKI.&#xD;
&#xD;
      II. To describe the long-term health outcomes including but not limited to gonadal function,&#xD;
      endocrine function, and bone metabolism in patients who are able to discontinue TKI as well&#xD;
      as those that need to restart TKIs.&#xD;
&#xD;
      III. To describe differences in patient-reported health status after stopping TKIs, including&#xD;
      those who need to resume TKI after stopping.&#xD;
&#xD;
      IV. To describe the incidence and characteristics of TKI withdrawal syndrome in children.&#xD;
&#xD;
      V. To evaluate changes in neurocognitive outcomes of patients enrolled on this study using a&#xD;
      patient-completed, performance-based, computerized measure of neuropsychological functioning&#xD;
      and a parent-report/self-report questionnaire.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients stop taking TKI medication within 10 days after enrollment. Patients undergo&#xD;
      peripheral blood collection to monitor loss of MMR every 4 weeks in year 1, every 6 weeks in&#xD;
      year 2, and every 12 weeks in year 3. Patients who lose their molecular remission may restart&#xD;
      TKI medication and are monitored every 4 weeks in year 1, every 6 weeks in year 2, and every&#xD;
      12 weeks in year 3.&#xD;
&#xD;
      After completion of study treatment, patients are followed up annually.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 15, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2026</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2026</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment-free remission (TFR)</measure>
    <time_frame>From date of TKI discontinuation to the date of the first event (molecular recurrence, hematologic relapse, cytogenetic relapse, re-initiation of TKI therapy, second malignant neoplasm, or death) or censoring, assessed up to 2 years</time_frame>
    <description>The Kaplan Meier method will be used to estimate 2-year TFR along with a 95% confidence interval.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Major molecular remission (MMR/MR3)</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>For patients re-initiating tyrosine kinase inhibitor (TKI) therapy, the cumulative incidence of major molecular remission will be calculated from the time of re-initiating TKI therapy treating deaths prior to achieving major molecular remission as competing events.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical factors and laboratory correlates affecting persistence of MMR</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Clinical factors and laboratory correlates (e.g. duration and level of prior molecular remission, risk score, duration and type of TKI, disease scoring system and immune studies etc.) affecting persistence of MMR and re-initiation of treatment after stopping TKI will be assessed by Cox proportional hazard regression models.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive</condition>
  <arm_group>
    <arm_group_label>Basic Science (stop taking TKI, biospecimen collection)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients stop taking TKI medication within 10 days after enrollment. Patients undergo peripheral blood collection to monitor loss of MMR every 4 weeks in year 1, every 6 weeks in year 2, and every 12 weeks in year 3. Patients who lose their molecular remission may restart TKI medication and are monitored every 4 weeks in year 1, every 6 weeks in year 2, and every 12 weeks in year 3.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biospecimen Collection</intervention_name>
    <description>Undergo blood collection</description>
    <arm_group_label>Basic Science (stop taking TKI, biospecimen collection)</arm_group_label>
    <other_name>Biological Sample Collection</other_name>
    <other_name>Biospecimen Collected</other_name>
    <other_name>Specimen Collection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Drug Withdrawn</intervention_name>
    <description>Stop taking TKI medication</description>
    <arm_group_label>Basic Science (stop taking TKI, biospecimen collection)</arm_group_label>
    <other_name>Discontinued</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Basic Science (stop taking TKI, biospecimen collection)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Basic Science (stop taking TKI, biospecimen collection)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tyrosine Kinase Inhibitor</intervention_name>
    <description>Re-start TKI medication</description>
    <arm_group_label>Basic Science (stop taking TKI, biospecimen collection)</arm_group_label>
    <other_name>Protein Tyrosine Kinase Inhibitors</other_name>
    <other_name>PTK Inhibitors</other_name>
    <other_name>TK Inhibitors</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient must have been diagnosed with CML-CP at &lt; 18 years of age.&#xD;
&#xD;
          -  Patient must have histologic verification of CML-CP at original diagnosis&#xD;
&#xD;
          -  Patient must be in molecular remission (MR) with a BCR-ABL1 level of =&lt; 0.01% BCR-ABL1&#xD;
             as measured using the International Scale (IS) by RQ-PCR for &gt;= 2 consecutive years at&#xD;
             the time of enrollment&#xD;
&#xD;
               -  Please note: The lab evaluating disease status and molecular response for this&#xD;
                  study must be College of American Pathology (CAP) and/or Clinical Laboratory&#xD;
                  Improvement Amendments (CLIA) certified (United States [US] only), sites in other&#xD;
                  countries must be certified by their accredited authorities. All labs must use&#xD;
                  the International Scale guidelines with a sensitivity of detection assay =&lt; 0.01%&#xD;
                  BCR-ABL1 and be able to report results in =&lt; 2 weeks&#xD;
&#xD;
          -  Patient must have received any TKI for a minimum of 3 consecutive years at time of&#xD;
             enrollment&#xD;
&#xD;
          -  Patient agrees to discontinue TKI therapy&#xD;
&#xD;
          -  REGULATORY REQUIREMENTS&#xD;
&#xD;
          -  All patients and/or their parents or legal guardians must sign a written informed&#xD;
             consent&#xD;
&#xD;
          -  All institutional, Food and Drug Administration (FDA), and National Cancer Institute&#xD;
             (NCI) requirements for human studies must be met&#xD;
&#xD;
          -  ELIGIBILITY FOR PATIENT-REPORTED OUTCOMES (PROs):&#xD;
&#xD;
          -  Age &gt;= 8 years at the time of enrollment&#xD;
&#xD;
          -  Ability to understand English or Spanish&#xD;
&#xD;
          -  Cognitive ability to complete instruments according to the primary team&#xD;
&#xD;
          -  ELIGIBILITY FOR AAML18P1 NEUROCOGNITIVE STUDY:&#xD;
&#xD;
          -  Patient must be 5 years or older at the time of enrollment&#xD;
&#xD;
          -  English-, French- or Spanish-speaking&#xD;
&#xD;
          -  No known history of neurodevelopmental disorder prior to diagnosis of CML (e.g., Down&#xD;
             syndrome, Fragile X, William syndrome, mental retardation)&#xD;
&#xD;
          -  No significant visual or motor impairment that would prevent computer use or&#xD;
             recognition of visual test stimuli&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known T3151 mutation&#xD;
&#xD;
          -  Additional clonal chromosomal abnormalities in Philadelphia chromosome (Ph) positive&#xD;
             (+) cells at any time prior to enrollment that include &quot;major route&quot; abnormalities&#xD;
             (second Ph, trisomy 8, isochromosome 17q, trisomy 19), complex karyotype or&#xD;
             abnormalities of 3q26.2&#xD;
&#xD;
          -  History of accelerated phase or blast crisis CML&#xD;
&#xD;
          -  Female patients who are pregnant&#xD;
&#xD;
          -  Lactating females are not eligible unless they have agreed not to breastfeed their&#xD;
             infants&#xD;
&#xD;
          -  Female patients of childbearing potential are not eligible unless a negative pregnancy&#xD;
             test result has been obtained&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sonali Chaudhury</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Oncology Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Alabama</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>205-638-9285</phone>
      <email>oncologyresearch@peds.uab.edu</email>
    </contact>
    <investigator>
      <last_name>Matthew A. Kutny</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>USA Health Strada Patient Care Center</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36604</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-388-8721</phone>
    </contact>
    <investigator>
      <last_name>Hamayun Imran</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Banner Children's at Desert</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>480-412-3100</phone>
    </contact>
    <investigator>
      <last_name>Joseph C. Torkildson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Banner University Medical Center - Tucson</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85719</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>UACC-IIT@uacc.arizona.edu</email>
    </contact>
    <investigator>
      <last_name>Holly E. Pariury</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Arkansas Children's Hospital</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202-3591</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>501-364-7373</phone>
    </contact>
    <investigator>
      <last_name>David L. Becton</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Downey Medical Center</name>
      <address>
        <city>Downey</city>
        <state>California</state>
        <zip>90242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>626-564-3455</phone>
    </contact>
    <investigator>
      <last_name>Robert M. Cooper</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Miller Children's and Women's Hospital Long Beach</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>562-933-5600</phone>
    </contact>
    <investigator>
      <last_name>Jacqueline N. Casillas</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>323-361-4110</phone>
    </contact>
    <investigator>
      <last_name>Leo Mascarenhas</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cedars Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>310-423-8965</phone>
    </contact>
    <investigator>
      <last_name>Fataneh (Fae) Majlessipour</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mattel Children's Hospital UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>310-825-6708</phone>
    </contact>
    <investigator>
      <last_name>Satiro N. De Oliveira</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Valley Children's Hospital</name>
      <address>
        <city>Madera</city>
        <state>California</state>
        <zip>93636</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>559-353-3000</phone>
      <email>Research@valleychildrens.org</email>
    </contact>
    <investigator>
      <last_name>Karen S. Fernandez</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UCSF Benioff Children's Hospital Oakland</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94609</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>510-428-3324</phone>
      <email>Carla.Golden@ucsf.edu</email>
    </contact>
    <investigator>
      <last_name>Carla B. Golden</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-Oakland</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Aarati V. Rao</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Orange County</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>714-509-8646</phone>
      <email>oncresearch@choc.org</email>
    </contact>
    <investigator>
      <last_name>Elyssa M. Rubin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lucile Packard Children's Hospital Stanford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-694-0012</phone>
      <email>ccto-office@stanford.edu</email>
    </contact>
    <investigator>
      <last_name>Jay Michael S. Balagtas</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of California Davis Comprehensive Cancer Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>916-734-3089</phone>
    </contact>
    <investigator>
      <last_name>Marcio H. Malogolowkin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rady Children's Hospital - San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>858-966-5934</phone>
    </contact>
    <investigator>
      <last_name>William D. Roberts</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>303-764-5056</phone>
      <email>josh.b.gordon@nsmtp.kp.org</email>
    </contact>
    <investigator>
      <last_name>Kelly W. Maloney</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>303-839-6000</phone>
    </contact>
    <investigator>
      <last_name>Jennifer J. Clark</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Connecticut Children's Medical Center</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>860-545-9981</phone>
    </contact>
    <investigator>
      <last_name>Michael S. Isakoff</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Alfred I duPont Hospital for Children</name>
      <address>
        <city>Wilmington</city>
        <state>Delaware</state>
        <zip>19803</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>302-651-5572</phone>
      <email>Allison.bruce@nemours.org</email>
    </contact>
    <investigator>
      <last_name>Scott M. Bradfield</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>MedStar Georgetown University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Children's National Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>202-884-2549</phone>
    </contact>
    <investigator>
      <last_name>Jeffrey S. Dome</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Golisano Children's Hospital of Southwest Florida</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33908</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>239-343-5333</phone>
      <email>molly.arnstrom@leehealth.org</email>
    </contact>
    <investigator>
      <last_name>Emad K. Salman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Florida Health Science Center - Gainesville</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>352-273-8010</phone>
      <email>cancer-center@ufl.edu</email>
    </contact>
    <investigator>
      <last_name>William B. Slayton</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Regional Hospital/Joe DiMaggio Children's Hospital</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>954-265-1847</phone>
      <email>OHR@mhs.net</email>
    </contact>
    <investigator>
      <last_name>Iftikhar Hanif</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nemours Children's Clinic-Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>302-651-5572</phone>
      <email>Allison.bruce@nemours.org</email>
    </contact>
    <investigator>
      <last_name>Scott M. Bradfield</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Miami Miller School of Medicine-Sylvester Cancer Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>305-243-2647</phone>
    </contact>
    <investigator>
      <last_name>Julio C. Barredo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nicklaus Children's Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>888-624-2778</phone>
    </contact>
    <investigator>
      <last_name>Ziad A. Khatib</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Arnold Palmer Hospital for Children</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>321-841-5357</phone>
      <email>Jennifer.spinelli@orlandohealth.com</email>
    </contact>
    <investigator>
      <last_name>Amy A. Smith</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nemours Children's Hospital</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32827</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>302-651-5572</phone>
      <email>Allison.bruce@nemours.org</email>
    </contact>
    <investigator>
      <last_name>Scott M. Bradfield</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sacred Heart Hospital</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32504</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>850-416-4611</phone>
      <email>eebrou@ascension.org</email>
    </contact>
    <investigator>
      <last_name>Erlyn C. Smith</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tampa General Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>813-844-7829</phone>
      <email>syapchanyk@tgh.org</email>
    </contact>
    <investigator>
      <last_name>Andrew J. Galligan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Joseph's Hospital/Children's Hospital-Tampa</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33607</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>813-357-0849</phone>
      <email>jennifer.manns@baycare.org</email>
    </contact>
    <investigator>
      <last_name>Don E. Eslin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Mary's Hospital</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>561-881-2815</phone>
    </contact>
    <investigator>
      <last_name>Muaz A. Alrazzak</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Healthcare of Atlanta - Egleston</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>404-785-2025</phone>
      <email>Leann.Schilling@choa.org</email>
    </contact>
    <investigator>
      <last_name>Daniel J. Bergsagel</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Health University Medical Center</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31404</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>912-350-7887</phone>
      <email>Lorraine.OHara@hcahealthcare.com</email>
    </contact>
    <investigator>
      <last_name>Andrew L. Pendleton</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kapiolani Medical Center for Women and Children</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96826</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-983-6090</phone>
    </contact>
    <investigator>
      <last_name>Wade T. Kyono</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Cancer Institute - Boise</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83712</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>208-381-2774</phone>
      <email>eslinget@slhs.org</email>
    </contact>
    <investigator>
      <last_name>Martha M. Pacheco</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lurie Children's Hospital-Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>773-880-4562</phone>
    </contact>
    <investigator>
      <last_name>Jenna Rossoff</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Illinois</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>312-355-3046</phone>
    </contact>
    <investigator>
      <last_name>Mary L. Schmidt</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Chicago Comprehensive Cancer Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>773-702-8222</phone>
      <email>cancerclinicaltrials@bsd.uchicago.edu</email>
    </contact>
    <investigator>
      <last_name>Gabrielle Lapping-Carr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>708-226-4357</phone>
    </contact>
    <investigator>
      <last_name>Eugene Suh</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Advocate Children's Hospital-Oak Lawn</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>847-723-7570</phone>
    </contact>
    <investigator>
      <last_name>Rebecca E. McFall</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Advocate Children's Hospital-Park Ridge</name>
      <address>
        <city>Park Ridge</city>
        <state>Illinois</state>
        <zip>60068</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>helpdesk@childrensoncologygroup.org</email>
    </contact>
    <investigator>
      <last_name>Rebecca E. McFall</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Jude Midwest Affiliate</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>888-226-4343</phone>
    </contact>
    <investigator>
      <last_name>Prerna Kumar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Southern Illinois University School of Medicine</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62702</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>217-545-7929</phone>
    </contact>
    <investigator>
      <last_name>Gregory P. Brandt</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northwestern Medicine Central DuPage Hospital</name>
      <address>
        <city>Winfield</city>
        <state>Illinois</state>
        <zip>60190</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>630-315-1918</phone>
      <email>Claudine.Gamster@CadenceHealth.org</email>
    </contact>
    <investigator>
      <last_name>Jenna Rossoff</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Riley Hospital for Children</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-248-1199</phone>
    </contact>
    <investigator>
      <last_name>Sandeep Batra</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Blank Children's Hospital</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50309</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>515-241-8912</phone>
      <email>samantha.mallory@unitypoint.org</email>
    </contact>
    <investigator>
      <last_name>Samantha L. Mallory</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Iowa/Holden Comprehensive Cancer Center</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-237-1225</phone>
    </contact>
    <investigator>
      <last_name>David S. Dickens</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Kentucky/Markey Cancer Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>859-257-3379</phone>
    </contact>
    <investigator>
      <last_name>James T. Badgett</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Norton Children's Hospital</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>502-629-5500</phone>
      <email>CancerResource@nortonhealthcare.org</email>
    </contact>
    <investigator>
      <last_name>Ashok B. Raj</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital New Orleans</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>CHResearch@lcmchealth.org</email>
    </contact>
    <investigator>
      <last_name>Lolie C. Yu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ochsner Medical Center Jefferson</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>504-842-8084</phone>
      <email>Elisemarie.curry@ochsner.org</email>
    </contact>
    <investigator>
      <last_name>Craig Lotterman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Eastern Maine Medical Center</name>
      <address>
        <city>Bangor</city>
        <state>Maine</state>
        <zip>04401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Maine Children's Cancer Program</name>
      <address>
        <city>Scarborough</city>
        <state>Maine</state>
        <zip>04074</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>207-396-7581</phone>
      <email>sverwys@mmc.org</email>
    </contact>
    <investigator>
      <last_name>Eric C. Larsen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sinai Hospital of Baltimore</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>410-601-6120</phone>
      <email>pridgely@lifebridgehealth.org</email>
    </contact>
    <investigator>
      <last_name>Jason M. Fixler</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University/Sidney Kimmel Cancer Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>410-955-8804</phone>
      <email>jhcccro@jhmi.edu</email>
    </contact>
    <investigator>
      <last_name>Alan D. Friedman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Walter Reed National Military Medical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20889-5600</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>301-319-2100</phone>
    </contact>
    <investigator>
      <last_name>Allen I. Stering</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tufts Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-442-3324</phone>
    </contact>
    <investigator>
      <last_name>Jessica A. Pollard</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UMass Memorial Medical Center - University Campus</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>508-856-3216</phone>
      <email>cancer.research@umassmed.edu</email>
    </contact>
    <investigator>
      <last_name>Stefanie R. Lowas</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>C S Mott Children's Hospital</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-865-1125</phone>
    </contact>
    <investigator>
      <last_name>Joshua W. Goldman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Michigan</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>helpdesk@childrensoncologygroup.org</email>
    </contact>
    <investigator>
      <last_name>Sureyya Savasan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Wayne State University/Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Michigan State University Clinical Center</name>
      <address>
        <city>East Lansing</city>
        <state>Michigan</state>
        <zip>48824-7016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>517-975-9547</phone>
    </contact>
    <investigator>
      <last_name>Laura E. Agresta</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Helen DeVos Children's Hospital at Spectrum Health</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>616-391-1230</phone>
      <email>crcwm-regulatory@crcwm.org</email>
    </contact>
    <investigator>
      <last_name>Kathleen J. Yost</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bronson Methodist Hospital</name>
      <address>
        <city>Kalamazoo</city>
        <state>Michigan</state>
        <zip>49007</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>616-391-1230</phone>
      <email>crcwm-regulatory@crcwm.org</email>
    </contact>
    <investigator>
      <last_name>Kathleen J. Yost</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beaumont Children's Hospital-Royal Oak</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>248-551-7695</phone>
    </contact>
    <investigator>
      <last_name>Laura K. Gowans</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospitals and Clinics of Minnesota - Minneapolis</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>612-813-5193</phone>
    </contact>
    <investigator>
      <last_name>Michael K. Richards</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Minnesota/Masonic Cancer Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>612-624-2620</phone>
    </contact>
    <investigator>
      <last_name>Peter M. Gordon</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>601-815-6700</phone>
    </contact>
    <investigator>
      <last_name>Betty L. Herrington</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Columbia Regional</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>helpdesk@childrensoncologygroup.org</email>
    </contact>
    <investigator>
      <last_name>Barbara A. Gruner</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Mercy Hospitals and Clinics</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>816-302-6808</phone>
      <email>rryan@cmh.edu</email>
    </contact>
    <investigator>
      <last_name>Keith J. August</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-600-3606</phone>
      <email>info@siteman.wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Jeffrey A. Magee</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Saint Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>314-251-7066</phone>
    </contact>
    <investigator>
      <last_name>Robin D. Hanson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital and Medical Center of Omaha</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>402-955-3949</phone>
    </contact>
    <investigator>
      <last_name>Jill C. Beck</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>402-559-6941</phone>
      <email>unmcrsa@unmc.edu</email>
    </contact>
    <investigator>
      <last_name>Jill C. Beck</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Medical Center of Southern Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>702-384-0013</phone>
      <email>research@sncrf.org</email>
    </contact>
    <investigator>
      <last_name>Alan K. Ikeda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sunrise Hospital and Medical Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>702-384-0013</phone>
      <email>research@sncrf.org</email>
    </contact>
    <investigator>
      <last_name>Alan K. Ikeda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Alliance for Childhood Diseases/Cure 4 the Kids Foundation</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89135</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>702-384-0013</phone>
      <email>research@sncrf.org</email>
    </contact>
    <investigator>
      <last_name>Alan K. Ikeda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Summerlin Hospital Medical Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89144</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>702-384-0013</phone>
      <email>research@sncrf.org</email>
    </contact>
    <investigator>
      <last_name>Alan K. Ikeda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Renown Regional Medical Center</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89502</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>702-384-0013</phone>
      <email>research@sncrf.org</email>
    </contact>
    <investigator>
      <last_name>Alan K. Ikeda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>201-996-2879</phone>
    </contact>
    <investigator>
      <last_name>Burton E. Appel</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Morristown Medical Center</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>973-971-5900</phone>
    </contact>
    <investigator>
      <last_name>Kathryn L. Laurie</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>732-235-8675</phone>
    </contact>
    <investigator>
      <last_name>Marissa Botwinick</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Joseph's Regional Medical Center</name>
      <address>
        <city>Paterson</city>
        <state>New Jersey</state>
        <zip>07503</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>973-754-2207</phone>
      <email>HallL@sjhmc.org</email>
    </contact>
    <investigator>
      <last_name>Alissa Kahn</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Albany Medical Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>518-262-5513</phone>
    </contact>
    <investigator>
      <last_name>Lauren R. Weintraub</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center - Moses Campus</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>718-379-6866</phone>
      <email>eskwak@montefiore.org</email>
    </contact>
    <investigator>
      <last_name>Lisa Gennarini</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-767-9355</phone>
      <email>askroswell@roswellpark.org</email>
    </contact>
    <investigator>
      <last_name>Clare J. Twist</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>NYU Winthrop Hospital</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Steven and Alexandra Cohen Children's Medical Center of New York</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>718-470-3460</phone>
    </contact>
    <investigator>
      <last_name>Arlene S. Redner</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>212-305-6361</phone>
      <email>nr2616@cumc.columbia.edu</email>
    </contact>
    <investigator>
      <last_name>Nobuko Hijiya</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>212-639-7592</phone>
    </contact>
    <investigator>
      <last_name>Christopher J. Forlenza</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>NYP/Weill Cornell Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>212-746-1848</phone>
    </contact>
    <investigator>
      <last_name>Alexander J. Chou</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Stony Brook University Medical Center</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-862-2215</phone>
    </contact>
    <investigator>
      <last_name>Laura E. Hogan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>State University of New York Upstate Medical University</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>315-464-5476</phone>
    </contact>
    <investigator>
      <last_name>Philip M. Monteleone</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>New York Medical College</name>
      <address>
        <city>Valhalla</city>
        <state>New York</state>
        <zip>10595</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>914-594-3794</phone>
    </contact>
    <investigator>
      <last_name>Jessica C. Hochberg</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mission Hospital</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>828-213-7055</phone>
      <email>NCDV.ResearchRegulatory@HCAHealthcare.com</email>
    </contact>
    <investigator>
      <last_name>Douglas J. Scothorn</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UNC Lineberger Comprehensive Cancer Center</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-668-0683</phone>
      <email>cancerclinicaltrials@med.unc.edu</email>
    </contact>
    <investigator>
      <last_name>Thomas B. Alexander</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Carolinas Medical Center/Levine Cancer Institute</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-804-9376</phone>
    </contact>
    <investigator>
      <last_name>Joel A. Kaplan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Novant Health Presbyterian Medical Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>980-201-6360</phone>
      <email>kashah@novanthealth.org</email>
    </contact>
    <investigator>
      <last_name>Jessica A. Bell</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>East Carolina University</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>252-744-1015</phone>
      <email>eubankss@ecu.edu</email>
    </contact>
    <investigator>
      <last_name>Andrea R. Whitfield</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>336-713-6771</phone>
    </contact>
    <investigator>
      <last_name>Thomas W. McLean</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sanford Broadway Medical Center</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58122</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>701-323-5760</phone>
      <email>OncologyClinicalTrialsFargo@sanfordhealth.org</email>
    </contact>
    <investigator>
      <last_name>Samuel J. Milanovich</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Medical Center of Akron</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44308</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>330-543-3193</phone>
    </contact>
    <investigator>
      <last_name>Erin Wright</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>513-636-2799</phone>
      <email>cancer@cchmc.org</email>
    </contact>
    <investigator>
      <last_name>Benjamin E. Mizukawa</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rainbow Babies and Childrens Hospital</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>216-844-5437</phone>
    </contact>
    <investigator>
      <last_name>Duncan S. Stearns</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>866-223-8100</phone>
      <email>TaussigResearch@ccf.org</email>
    </contact>
    <investigator>
      <last_name>Rabi Hanna</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>614-722-6039</phone>
      <email>Melinda.Triplet@nationwidechildrens.org</email>
    </contact>
    <investigator>
      <last_name>Mark A. Ranalli</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dayton Children's Hospital</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45404</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-228-4055</phone>
    </contact>
    <investigator>
      <last_name>Mukund G. Dole</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43606</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>419-824-1842</phone>
      <email>PCIOncResearch@promedica.org</email>
    </contact>
    <investigator>
      <last_name>Jamie L. Dargart</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma Health Sciences Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>405-271-8777</phone>
      <email>ou-clinical-trials@ouhsc.edu</email>
    </contact>
    <investigator>
      <last_name>Rene Y. McNall-Knapp</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Legacy Emanuel Children's Hospital</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97227</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>503-413-2560</phone>
    </contact>
    <investigator>
      <last_name>Janice F. Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>503-494-1080</phone>
      <email>trials@ohsu.edu</email>
    </contact>
    <investigator>
      <last_name>Bill H. Chang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Hospital-Cedar Crest</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>610-402-9543</phone>
      <email>Morgan_M.Horton@lvhn.org</email>
    </contact>
    <investigator>
      <last_name>Jacob A. Troutman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Geisinger Medical Center</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>570-271-5251</phone>
      <email>HemonCCTrials@geisinger.edu</email>
    </contact>
    <investigator>
      <last_name>Jagadeesh Ramdas</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Penn State Children's Hospital</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>717-531-6012</phone>
    </contact>
    <investigator>
      <last_name>Lisa M. McGregor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>267-425-5544</phone>
      <email>CancerTrials@email.chop.edu</email>
    </contact>
    <investigator>
      <last_name>Richard Aplenc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Christopher's Hospital for Children</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19134</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>215-427-8991</phone>
    </contact>
    <investigator>
      <last_name>Gregory E. Halligan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Pittsburgh of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>412-692-8570</phone>
      <email>jean.tersak@chp.edu</email>
    </contact>
    <investigator>
      <last_name>Jean M. Tersak</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>401-444-1488</phone>
    </contact>
    <investigator>
      <last_name>Jennifer J. Welch</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Prisma Health Richland Hospital</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>864-241-6251</phone>
    </contact>
    <investigator>
      <last_name>Stuart L. Cramer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>BI-LO Charities Children's Cancer Center</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>864-241-6251</phone>
    </contact>
    <investigator>
      <last_name>Aniket Saha</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sanford USD Medical Center - Sioux Falls</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57117-5134</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>605-312-3320</phone>
      <email>OncologyClinicalTrialsSF@SanfordHealth.org</email>
    </contact>
    <investigator>
      <last_name>Kayelyn J. Wagner</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>T C Thompson Children's Hospital</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37403</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>423-778-7289</phone>
    </contact>
    <investigator>
      <last_name>Benjamin A. Mixon</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>East Tennessee Childrens Hospital</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37916</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>865-541-8266</phone>
    </contact>
    <investigator>
      <last_name>Susan E. Spiller</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Jude Children's Research Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>888-226-4343</phone>
      <email>referralinfo@stjude.org</email>
    </contact>
    <investigator>
      <last_name>Raul C. Ribeiro</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital at TriStar Centennial</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>615-342-1919</phone>
    </contact>
    <investigator>
      <last_name>Jennifer A. Domm</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University/Ingram Cancer Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-811-8480</phone>
    </contact>
    <investigator>
      <last_name>Christine M. Smith</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Texas Tech University Health Sciences Center-Amarillo</name>
      <address>
        <city>Amarillo</city>
        <state>Texas</state>
        <zip>79106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>806-354-5411</phone>
    </contact>
    <investigator>
      <last_name>Smita Bhaskaran</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dell Children's Medical Center of Central Texas</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78723</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>512-628-1902</phone>
      <email>TXAUS-DL-SFCHemonc.research@ascension.org</email>
    </contact>
    <investigator>
      <last_name>Shannon M. Cohn</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Driscoll Children's Hospital</name>
      <address>
        <city>Corpus Christi</city>
        <state>Texas</state>
        <zip>78411</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>361-694-5311</phone>
      <email>Crystal.DeLosSantos@dchstx.org</email>
    </contact>
    <investigator>
      <last_name>Nkechi I. Mba</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Medical City Dallas Hospital</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>972-566-5588</phone>
    </contact>
    <investigator>
      <last_name>Stanton C. Goldman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UT Southwestern/Simmons Cancer Center-Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>214-648-7097</phone>
      <email>canceranswerline@UTSouthwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Tamra L. Slone</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>El Paso Children's Hospital</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>915-298-5444</phone>
      <email>ranjan.bista@ttuhsc.edu</email>
    </contact>
    <investigator>
      <last_name>Ranjan Bista</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>713-798-1354</phone>
      <email>burton@bcm.edu</email>
    </contact>
    <investigator>
      <last_name>Michele S. Redell</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-632-6789</phone>
      <email>askmdanderson@mdanderson.org</email>
    </contact>
    <investigator>
      <last_name>Najat C. Daw</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Covenant Children's Hospital</name>
      <address>
        <city>Lubbock</city>
        <state>Texas</state>
        <zip>79410</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>helpdesk@childrensoncologygroup.org</email>
    </contact>
    <investigator>
      <last_name>Kishor M. Bhende</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UMC Cancer Center / UMC Health System</name>
      <address>
        <city>Lubbock</city>
        <state>Texas</state>
        <zip>79415</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>806-775-8590</phone>
    </contact>
    <investigator>
      <last_name>Erin K. Barr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78207</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>210-704-2894</phone>
      <email>bridget.medina@christushealth.org</email>
    </contact>
    <investigator>
      <last_name>Timothy C. Griffin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Methodist Children's Hospital of South Texas</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>210-575-6240</phone>
      <email>Vinod.GidvaniDiaz@hcahealthcare.com</email>
    </contact>
    <investigator>
      <last_name>Jose M. Esquilin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>210-450-3800</phone>
      <email>phoresearchoffice@uthscsa.edu</email>
    </contact>
    <investigator>
      <last_name>Anne-Marie R. Langevin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Primary Children's Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84113</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>801-585-5270</phone>
    </contact>
    <investigator>
      <last_name>Mallorie B. Heneghan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Virginia Cancer Center</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>434-243-6303</phone>
      <email>uvacancertrials@hscmail.mcc.virginia.edu</email>
    </contact>
    <investigator>
      <last_name>William C. Petersen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Inova Fairfax Hospital</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>703-208-6650</phone>
      <email>Stephanie.VanBebber@inova.org</email>
    </contact>
    <investigator>
      <last_name>Robin Y. Dulman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of The King's Daughters</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>757-668-7243</phone>
      <email>CCBDCresearch@chkd.org</email>
    </contact>
    <investigator>
      <last_name>Eric J. Lowe</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University/Massey Cancer Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>CTOclinops@vcu.edu</email>
    </contact>
    <investigator>
      <last_name>Gita V. Massey</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Carilion Children's</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24014</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>540-266-6238</phone>
      <email>wpmccarty@carilionclinic.org</email>
    </contact>
    <investigator>
      <last_name>Erwood G. Edwards</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>866-987-2000</phone>
    </contact>
    <investigator>
      <last_name>Sarah E. Leary</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Providence Sacred Heart Medical Center and Children's Hospital</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-228-6618</phone>
      <email>HopeBeginsHere@providence.org</email>
    </contact>
    <investigator>
      <last_name>Judy L. Felgenhauer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mary Bridge Children's Hospital and Health Center</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>253-403-1461</phone>
      <email>research@multicare.org</email>
    </contact>
    <investigator>
      <last_name>Robert G. Irwin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Madigan Army Medical Center</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98431</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>253-968-6144</phone>
      <email>Melissa.a.forouhar.mil@mail.mil</email>
    </contact>
    <investigator>
      <last_name>Melissa A. Forouhar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>West Virginia University Charleston Division</name>
      <address>
        <city>Charleston</city>
        <state>West Virginia</state>
        <zip>25304</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>304-388-9944</phone>
    </contact>
    <investigator>
      <last_name>Mohamad H. Badawi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Carbone Cancer Center</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-622-8922</phone>
    </contact>
    <investigator>
      <last_name>Kenneth B. De Santes</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Marshfield Medical Center-Marshfield</name>
      <address>
        <city>Marshfield</city>
        <state>Wisconsin</state>
        <zip>54449</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-782-8581</phone>
      <email>oncology.clinical.trials@marshfieldresearch.org</email>
    </contact>
    <investigator>
      <last_name>Jon M. Brandt</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>John Hunter Children's Hospital</name>
      <address>
        <city>Hunter Regional Mail Centre</city>
        <state>New South Wales</state>
        <zip>2310</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>(02) 4985 5180</phone>
    </contact>
    <investigator>
      <last_name>Elizabeth L. Hesketh</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital at Westmead</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Monash Medical Center-Clayton Campus</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>(03) 9928 8111</phone>
    </contact>
    <investigator>
      <last_name>Paul J. Wood</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Royal Children's Hospital</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3052</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>61 3 9345 5656</phone>
      <email>Jordan.Hansford@rch.org.au</email>
    </contact>
    <investigator>
      <last_name>Diane Hanna</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Perth Children's Hospital</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>helpdesk@childrensoncologygroup.org</email>
    </contact>
    <investigator>
      <last_name>Marianne B. Phillips</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Alberta Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2B7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>780-407-8798</phone>
      <email>pedsoncologyresearch@ahs.ca</email>
    </contact>
    <investigator>
      <last_name>Sarah J. McKillop</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CancerCare Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3E 0V9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>866-561-1026</phone>
      <email>ctu_web@cancercare.mb.ca</email>
    </contact>
    <investigator>
      <last_name>Issai M. Vanan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>IWK Health Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3K 6R8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>902-470-8520</phone>
      <email>Research@iwk.nshealth.ca</email>
    </contact>
    <investigator>
      <last_name>Craig Erker</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>McMaster Children's Hospital at Hamilton Health Sciences</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 3Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>905-521-2100</phone>
    </contact>
    <investigator>
      <last_name>Uma H. Athale</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>519-685-8306</phone>
    </contact>
    <investigator>
      <last_name>Shayna M. Zelcer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Eastern Ontario</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>613-737-7600</phone>
    </contact>
    <investigator>
      <last_name>Donna L. Johnston</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>416-813-7654</phone>
      <email>ask.CRS@sickkids.ca</email>
    </contact>
    <investigator>
      <last_name>Oussama A. Abla</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Montreal Children's Hospital of the MUHC</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3H 1P3</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>514-412-4445</phone>
      <email>info@thechildren.com</email>
    </contact>
    <investigator>
      <last_name>Sharon B. Abish</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Sainte-Justine</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>514-345-4931</phone>
      <email>yvan.samson@umontreal.ca</email>
    </contact>
    <investigator>
      <last_name>Monia Marzouki</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Quebec</name>
      <address>
        <city>Quebec</city>
        <zip>G1V 4G2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>418-525-4444</phone>
    </contact>
    <investigator>
      <last_name>Bruno Michon</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>HIMA San Pablo Oncologic Hospital</name>
      <address>
        <city>Caguas</city>
        <zip>00726</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>787-653-3434</phone>
    </contact>
    <investigator>
      <last_name>Jhon A. Guerra</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>September 13, 2023</last_update_submitted>
  <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</mesh_term>
    <mesh_term>Leukemia, Myeloid, Chronic-Phase</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tyrosine Protein Kinase Inhibitors</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03817398
org study id: AAML18P1
secondary id: NCI-2018-03439
secondary id: AAML18P1
secondary id: AAML18P1
secondary id: U10CA180886
nct id: NCT03817398
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This phase II trial studies how stopping tyrosine kinase inhibitors will affect
      treatment-free remission in patients with chronic myeloid leukemia in chronic phase. When the
      level of disease is very low, it's called molecular remission. TKIs are a type of medication
      that help keep this level low. However, after being in molecular remission for a specific
      amount of time, it may not be necessary to take tyrosine kinase inhibitors. It is not yet
      known whether stopping tyrosine kinase inhibitors will help patients with chronic myeloid
      leukemia in chronic phase continue or re-achieve molecular remission.
PRIMARY OBJECTIVES:

      I. To determine the 2-year treatment free remission (TFR) rate of children, adolescents, and
      young adults with chronic myeloid leukemia - chronic phase (CML-CP) following discontinuation
      tyrosine kinase inhibitor (TKI).

      II. To estimate the re-induction rate and maintenance of molecular remission (BCR-ABL1 =<
      0.1%) at 1 year after restarting TKI for children, adolescents, and young adults.

      SECONDARY OBJECTIVE:

      I. To describe clinical factors and laboratory correlates affecting the persistence of major
      molecular remission (MMR) and re-initiation of treatment after stopping TKI (e.g. patient
      demographics, duration and level of prior molecular remission, duration and type of TKI,
      clinical presentation at diagnosis and immune studies).

      EXPLORATORY OBJECTIVES:

      I. To describe change in height standard deviation score over time in patients who are able
      to discontinue their TKI.

      II. To describe the long-term health outcomes including but not limited to gonadal function,
      endocrine function, and bone metabolism in patients who are able to discontinue TKI as well
      as those that need to restart TKIs.

      III. To describe differences in patient-reported health status after stopping TKIs, including
      those who need to resume TKI after stopping.

      IV. To describe the incidence and characteristics of TKI withdrawal syndrome in children.

      V. To evaluate changes in neurocognitive outcomes of patients enrolled on this study using a
      patient-completed, performance-based, computerized measure of neuropsychological functioning
      and a parent-report/self-report questionnaire.

      OUTLINE:

      Patients stop taking TKI medication within 10 days after enrollment. Patients undergo
      peripheral blood collection to monitor loss of MMR every 4 weeks in year 1, every 6 weeks in
      year 2, and every 12 weeks in year 3. Patients who lose their molecular remission may restart
      TKI medication and are monitored every 4 weeks in year 1, every 6 weeks in year 2, and every
      12 weeks in year 3.

      After completion of study treatment, patients are followed up annually.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Treatment-free remission (TFR)
time frame: From date of TKI discontinuation to the date of the first event (molecular recurrence, hematologic relapse, cytogenetic relapse, re-initiation of TKI therapy, second malignant neoplasm, or death) or censoring, assessed up to 2 years
description: The Kaplan Meier method will be used to estimate 2-year TFR along with a 95% confidence interval.
measure: Major molecular remission (MMR/MR3)
time frame: Up to 1 year
description: For patients re-initiating tyrosine kinase inhibitor (TKI) therapy, the cumulative incidence of major molecular remission will be calculated from the time of re-initiating TKI therapy treating deaths prior to achieving major molecular remission as competing events.
measure: Clinical factors and laboratory correlates affecting persistence of MMR
time frame: Up to 36 months
description: Clinical factors and laboratory correlates (e.g. duration and level of prior molecular remission, risk score, duration and type of TKI, disease scoring system and immune studies etc.) affecting persistence of MMR and re-initiation of treatment after stopping TKI will be assessed by Cox proportional hazard regression models.
arm group label: Basic Science (stop taking TKI, biospecimen collection)
arm group type: Experimental
description: Patients stop taking TKI medication within 10 days after enrollment. Patients undergo peripheral blood collection to monitor loss of MMR every 4 weeks in year 1, every 6 weeks in year 2, and every 12 weeks in year 3. Patients who lose their molecular remission may restart TKI medication and are monitored every 4 weeks in year 1, every 6 weeks in year 2, and every 12 weeks in year 3.
intervention type: Procedure
intervention name: Biospecimen Collection
description: Undergo blood collection
arm group label: Basic Science (stop taking TKI, biospecimen collection)
other name: Biological Sample Collection
other name: Biospecimen Collected
other name: Specimen Collection
intervention type: Other
intervention name: Drug Withdrawn
description: Stop taking TKI medication
arm group label: Basic Science (stop taking TKI, biospecimen collection)
other name: Discontinued
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Basic Science (stop taking TKI, biospecimen collection)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Basic Science (stop taking TKI, biospecimen collection)
intervention type: Drug
intervention name: Tyrosine Kinase Inhibitor
description: Re-start TKI medication
arm group label: Basic Science (stop taking TKI, biospecimen collection)
other name: Protein Tyrosine Kinase Inhibitors
other name: PTK Inhibitors
other name: TK Inhibitors
criteria: 
gender: All
minimum age: N/A
maximum age: 25 Years
healthy volunteers: No
last name: Sonali Chaudhury
role: Principal Investigator
affiliation: Children's Oncology Group
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country: Australia
country: Canada
country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
mesh term: Leukemia, Myeloid, Chronic-Phase
mesh term: Tyrosine Protein Kinase Inhibitors