<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/NCT03007147</url>
  </required_header>
  <id_info>
    <org_study_id>AALL1631</org_study_id>
    <secondary_id>NCI-2016-01588</secondary_id>
    <secondary_id>AALL1631</secondary_id>
    <secondary_id>AALL1631</secondary_id>
    <secondary_id>AALL1631</secondary_id>
    <secondary_id>U10CA180886</secondary_id>
    <secondary_id>2017-000705-20</secondary_id>
    <nct_id>NCT03007147</nct_id>
  </id_info>
  <brief_title>Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia</brief_title>
  <official_title>International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones</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>
    <collaborator>
      <agency>EsPhALL network I-BFM Study Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Oncology Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized phase III trial studies how well imatinib mesylate works in combination with&#xD;
      two different chemotherapy regimens in treating patients with newly diagnosed Philadelphia&#xD;
      chromosome positive acute lymphoblastic leukemia (ALL). Imatinib mesylate has been shown to&#xD;
      improve outcomes in children and adolescents with Philadelphia chromosome positive (Ph+) ALL&#xD;
      when given with strong chemotherapy, but the combination has many side effects. This trial is&#xD;
      testing whether a different chemotherapy regimen may work as well as the stronger one but&#xD;
      have fewer side effects when given with imatinib. The trial is also testing how well the&#xD;
      combination of chemotherapy and imatinib works in another group of patients with a type of&#xD;
      ALL that is similar to Ph+ ALL. This type of ALL is called &quot;ABL-class fusion positive ALL&quot;,&#xD;
      and because it is similar to Ph+ ALL, is thought it will respond well to the combination of&#xD;
      agents used to treat Ph+ ALL.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To compare disease-free survival (DFS) of standard risk (SR) pediatric Philadelphia&#xD;
      chromosome (Ph)+ acute lymphoblastic leukemia (ALL) treated with continuous imatinib mesylate&#xD;
      (imatinib) combined with either a high-risk Children's Oncology Group (COG) ALL chemotherapy&#xD;
      backbone or the more intensive European (Es)PhALL chemotherapy backbone.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To compare DFS of SR pediatric Ph+ and ABL-class fusion positive ALL patients treated with&#xD;
      continuous imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the&#xD;
      more intensive EsPhALL chemotherapy backbone.&#xD;
&#xD;
      II. To determine the feasibility of administration of imatinib after allogeneic hematopoietic&#xD;
      stem cell transplantation (HSCT) in high risk Ph+ ALL patients.&#xD;
&#xD;
      III. To determine event-free survival (EFS) of HR pediatric Ph+ ALL patients treated with&#xD;
      EsPhALL chemotherapy, HSCT in first complete remission and post-HSCT imatinib.&#xD;
&#xD;
      IV. To compare rates of grade 3 or higher infections in standard risk (SR) Ph+ ALL patients&#xD;
      between the two randomized arms.&#xD;
&#xD;
      V. To evaluate event free survival (EFS) and overall survival (OS) of all eligible Ph+ALL&#xD;
      patients enrolled on the study.&#xD;
&#xD;
      VI. To evaluate OS in SR Ph+ ALL patients. VII. To evaluate OS in HR Ph+ ALL patients. VIII.&#xD;
      To evaluate EFS and OS of all eligible ABL-class fusion positive ALL patients enrolled on the&#xD;
      study.&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I. To describe the toxicities associated with post-HSCT administration of imatinib in HR&#xD;
      Ph+ALL patients.&#xD;
&#xD;
      II. To evaluate the long-term toxicities in SR Ph+ ALL patients treated with chemotherapy&#xD;
      plus imatinib (no transplant), overall and between both randomized arms.&#xD;
&#xD;
      III. To determine prognostic significance of minimal residual disease (MRD) in Ph+ ALL at&#xD;
      various time points during therapy.&#xD;
&#xD;
      IIIa. To evaluate MRD in HR patients just prior to HSCT and then at regular intervals&#xD;
      post-HSCT and explore the association of these measurements with long-term outcome.&#xD;
&#xD;
      IIIb. To evaluate concordance of MRD assessments made by IGH-T cell receptor (TCR) polymerase&#xD;
      chain reaction (PCR) assay and next generation sequencing (NGS) assays.&#xD;
&#xD;
      IV. To determine prognostic significance of IKZF1 gene aberrations and deletions in Ph+ ALL.&#xD;
&#xD;
      V. To determine frequency and prognostic significance of p190 and p210 BCR-ABL1 fusion&#xD;
      variants in pediatric Ph+ ALL.&#xD;
&#xD;
      VI. To measure adherence to oral chemotherapeutic agents (imatinib, 6-mercaptopurine, and&#xD;
      methotrexate) during the maintenance phase in SR Ph+ ALL patients.&#xD;
&#xD;
      VIa. To identify factors associated with poor adherence. VIb. To determine association&#xD;
      between relapse risk and adherence to each oral chemotherapeutic agent (separately and&#xD;
      combined).&#xD;
&#xD;
      VII. To measure adherence to imatinib after allogeneic HSCT in HR Ph+ ALL patients and&#xD;
      identify factors associated with poor adherence.&#xD;
&#xD;
      VIII. To compare DFS of SR ABL-class fusion positive ALL patients treated with continuous&#xD;
      imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the more intensive&#xD;
      EsPhALL chemotherapy backbone.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      INDUCTION IA PART 1: Patients receive induction IA according to standard of care on days&#xD;
      1-14.&#xD;
&#xD;
      INDUCTION IA PART 2: Patients receive imatinib mesylate orally (PO) once daily (QD) or twice&#xD;
      daily (BID) on days 15-33, prednisolone PO twice daily (BID) or methylprednisolone&#xD;
      intravenously (IV) on days 15-28, vincristine sulfate IV over 1 minute on days 15 and 22,&#xD;
      daunorubicin hydrochloride IV over 1-15 minutes on days 15 and 22, and methotrexate&#xD;
      intrathecally (IT) on day 29.&#xD;
&#xD;
      INDUCTION IB: Patients receive imatinib mesylate PO QD or BID on days 1-35, cyclophosphamide&#xD;
      IV over 30-60 minutes on days 1 and 28, mercaptopurine PO on days 1-28, cytarabine IV or&#xD;
      subcutaneously (SC) on days 3-6, 10-13, 17-20, and 24-27, and methotrexate IT on days 10 and&#xD;
      24.&#xD;
&#xD;
      POST-INDUCTION THERAPY: Patients classified as standard risk are randomized to 1 of 2 arms.&#xD;
      Patients with high risk are assigned to Arm C.&#xD;
&#xD;
      ARM A:&#xD;
&#xD;
      CONSOLIDATION BLOCK 1: Patients receive imatinib mesylate PO QD or BID on days 1-21,&#xD;
      methotrexate IT, cytarabine IT, and therapeutic hydrocortisone IT on day 1, high dose&#xD;
      methotrexate IV over 24 hours on day 1, vincristine sulfate IV over 1 minute on days 1 and 6,&#xD;
      dexamethasone PO BID or IV on days 1-5, cyclophosphamide IV over 30-60 minutes on days 2-4,&#xD;
      leucovorin calcium PO or IV on days 3 and 4, high dose cytarabine IV over 3 hours and&#xD;
      pegaspargase or calaspargase pegol IV over 1-2 hours on day 5, and filgrastim SC on days 7-11&#xD;
      in the absence of disease progression or unexpected toxicity.&#xD;
&#xD;
      CONSOLIDATION BLOCK 2: Patients receive imatinib mesylate PO QD or BID on days 1-21,&#xD;
      methotrexate IT, cytarabine IT, and therapeutic hydrocortisone IT on day 1, high dose&#xD;
      methotrexate IV over 24 hours on day 1, dexamethasone PO BID or IV on days 1-5, vincristine&#xD;
      sulfate IV over 1 minute on days 1 and 6, ifosfamide IV over 1 hour on days 2-4, leucovorin&#xD;
      calcium PO or IV on days 3 and 4, dexrazoxane hydrochloride IV over 5-15 minutes and&#xD;
      daunorubicin hydrochloride IV over 1-15 minutes on day 5, pegaspargase or calaspargase pegol&#xD;
      IV over 1-2 hours on day 6, and filgrastim SC on days 7-11 in the absence of disease&#xD;
      progression or unexpected toxicity.&#xD;
&#xD;
      CONSOLIDATION BLOCK 3: Patients receive imatinib mesylate PO QD or BID on days 1-21, high&#xD;
      dose cytarabine IV over 3 hours on days 1-3, dexamethasone PO BID or IV on days 1-5,&#xD;
      etoposide IV over 1-2 hours on days 3-5, methotrexate IT, cytarabine IT, and therapeutic&#xD;
      hydrocortisone IT on day 5, pegaspargase or calaspargase pegol IV over 1-2 hours on day 6,&#xD;
      and filgrastim SC on days 7-11 in the absence of disease progression or unexpected toxicity.&#xD;
&#xD;
      DELAYED INTENSIFICATION 1 PART 1: Patients receive imatinib mesylate PO QD or BID on days&#xD;
      1-35, methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine&#xD;
      sulfate IV over 1 minute, dexrazoxane hydrochloride IV over 5-15 minutes, and doxorubicin IV&#xD;
      over 1-15 minutes on days 8, 15, 22, and 29, and pegaspargase or calaspargase pegol IV over&#xD;
      1-2 hours on day 8 in the absence of disease progression or unexpected toxicity.&#xD;
&#xD;
      DELAYED INTENSIFICATION 1 PART 2: Patients receive imatinib mesylate PO QD on days 36-63,&#xD;
      cyclophosphamide IV over 30-60 minutes on day 36, thioguanine PO on days 36-49, cytarabine IV&#xD;
      over 1-30 minutes or SC on days 38-41 and 45-48, and methotrexate IT on days 38 and 45in the&#xD;
      absence of disease progression or unexpected toxicity.&#xD;
&#xD;
      INTERIM MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-28,&#xD;
      methotrexate PO on days 1, 8, 15, and 22, and mercaptopurine PO on days 1-28 in the absence&#xD;
      of disease progression or unexpected toxicity.&#xD;
&#xD;
      DELAYED INTENSIFICATION 2 PART 1: Patients receive imatinib mesylate PO QD or BID on days&#xD;
      1-35, methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine&#xD;
      sulfate IV over 1 minute, dexrazoxane hydrochloride IV over 5-15 minutes, and doxorubicin IV&#xD;
      over 1-15 minutes on days 8, 15, 22, and 29, and pegaspargase or calaspargase pegol IV over&#xD;
      1-2 hours on day 8 in the absence of disease progression or unexpected toxicity.&#xD;
&#xD;
      DELAYED INTENSIFICATION 2 PART 2: Patients receive imatinib mesylate PO QD on days 36-49,&#xD;
      cyclophosphamide IV over 30-60 minutes on day 36, thioguanine PO on days 36-49, cytarabine IV&#xD;
      over 1-30 minutes or SC on days 36-39 and 43-46, and methotrexate IT on days 36 and 43 in the&#xD;
      absence of disease progression or unexpected toxicity.&#xD;
&#xD;
      MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-84, methotrexate PO&#xD;
      once weekly (QW) and IT on days 1 and 43 of cycles 1, 2, and 3, and mercaptopurine PO on days&#xD;
      1-84. Cycles with imatinib mesylate and mercaptopurine repeat every 84 days for up to 104&#xD;
      weeks from the start of Induction IA in the absence of disease progression or unexpected&#xD;
      toxicity.&#xD;
&#xD;
      ARM B:&#xD;
&#xD;
      INTERIM MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-63,&#xD;
      vincristine sulfate IV over 1 minute and high dose methotrexate IV over 24 hours on days 1,&#xD;
      15, 29, and 43, leucovorin calcium PO or IV on days 3-4, 17-18, 31-32, and 45-46,&#xD;
      mercaptopurine PO on days 1-56, and methotrexate IT on days 1 and 29 in the absence of&#xD;
      disease progression or unexpected toxicity.&#xD;
&#xD;
      DELAYED INTENSIFICATION PART 1: Patients receive imatinib mesylate PO QD or BID on days 1-28,&#xD;
      methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine&#xD;
      sulfate IV over 1 minute, dexrazoxane hydrochloride IV over 5-15 minutes, and doxorubicin IV&#xD;
      over 1-15 minutes on days 1, 8, and 15, and pegaspargase or calaspargase pegol IV over 1-2&#xD;
      hours or IM on day 4 in the absence of disease progression or unexpected toxicity.&#xD;
&#xD;
      DELAYED INTENSIFICATION PART 2: Patients receive imatinib mesylate PO QD on days 29-56,&#xD;
      cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on days 29-42, cytarabine IV&#xD;
      over 1-30 minutes or SC on days 29-32 and 36-39, methotrexate IT on days 29 and 36,&#xD;
      vincristine sulfate IV over 1 minute on days 43 and 50, and pegaspargase or calaspargase&#xD;
      pegol IV over 1-2 hours on day 43 in the absence of disease progression or unexpected&#xD;
      toxicity.&#xD;
&#xD;
      INTERIM MAINTENANCE WITH CAPIZZI METHOTREXATE: Patients receive imatinib mesylate PO QD or&#xD;
      BID on days 1-56, vincristine sulfate IV over 1 minute and methotrexate IV over 2-15 minutes&#xD;
      on days 1, 11, 21, 31, and 41, methotrexate IT on days 1 and 31, and pegaspargase or&#xD;
      calaspargase pegol IV over 1-2 hours on days 2 and 22 in the absence of disease progression&#xD;
      or unexpected toxicity.&#xD;
&#xD;
      MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-84, vincristine&#xD;
      sulfate IV over 1 minute on days 1, 29, and 57, prednisolone PO BID (or methylprednisolone IV&#xD;
      for cycle 1 and 2) on days 1-5, 29-33, and 57-61, mercaptopurine PO on days 1-84,&#xD;
      methotrexate PO QW, and methotrexate IT on day 1 (and day 29 for cycle 1 and 2). Cycles&#xD;
      repeat every 84 days for up to 104 weeks from the start of Induction IA in the absence of&#xD;
      disease progression or unexpected toxicity.&#xD;
&#xD;
      ARM C:&#xD;
&#xD;
      CONSOLIDATION BLOCK 1: Patients receive imatinib mesylate, methotrexate, cytarabine,&#xD;
      therapeutic hydrocortisone, high dose methotrexate, vincristine sulfate, dexamethasone,&#xD;
      leucovorin calcium, high dose cytarabine, and pegaspargase or calaspargase pegol as in Arm A&#xD;
      Consolidation Block 1, and filgrastim SC on day 7 in the absence of disease progression or&#xD;
      unexpected toxicity.&#xD;
&#xD;
      CONSOLIDATION BLOCK 2: Patients receive imatinib mesylate, methotrexate, cytarabine,&#xD;
      therapeutic hydrocortisone, high dose methotrexate, dexamethasone, vincristine sulfate,&#xD;
      ifosfamide, leucovorin calcium, dexrazoxane hydrochloride, daunorubicin hydrochloride,&#xD;
      pegaspargase or calaspargase pegol, and filgrastim as Arm A Consolidation Block 2 in the&#xD;
      absence of disease progression or unexpected toxicity.&#xD;
&#xD;
      CONSOLIDATION BLOCK 3: Patients receive imatinib mesylate, dexamethasone, etoposide,&#xD;
      methotrexate, cytarabine, therapeutic hydrocortisone, pegaspargase or calaspargase pegol, and&#xD;
      filgrastim as in Arm A Consolidation Block 3, and high dose cytarabine IV over 3 hours on&#xD;
      days 1-2 in the absence of disease progression or unexpected toxicity.&#xD;
&#xD;
      HSCT: Patients undergo HSCT on day 0. Patients who do not proceed to HSCT receive Delayed&#xD;
      Intensification 1, Interim Maintenance, Delayed Intensification 2, and Maintenance as in Arm&#xD;
      A.&#xD;
&#xD;
      POST-HSCT: Patients receive imatinib mesylate PO QD or BID starting on days 56-365 in the in&#xD;
      the absence of disease progression or unexpected toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up every year for 3 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 28, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2027</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2027</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease free survival (DFS) of Randomized Arms (standard risk [SR] Philadelphia chromosome [Ph+] acute lymphoblastic leukemia [ALL] patients)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Three-year DFS and 95% confidence intervals (CI) of SR Ph+ ALL patients treated continuous imatinib mesylate with high risk Children's Oncology Group (COG)-ALL chemotherapy backbone or more intensive European (Es)PhALL chemotherapy backbone.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DFS on Randomized Arms (SR Ph+ ALL and ABL-class fusion positive patients)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Three-year DFS (time from randomization to relapse, second malignancy, or death in complete remission) and 95% CI of SR pediatric Ph+ and ABL-class fusion positive patients treated with continuous imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of post hematopoietic stem cell transplantation (HSCT) imatinib mesylate administration after allogenic HSCT in high risk Ph+ ALL patients</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>The proportion of patients who receive at least 75% of intended doses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event free survival (EFS) of high risk pediatric Ph+ ALL patients treated with EsPhALL chemotherapy, HSCT in first complete remission, and post-HSCT imatinib mesylate</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Three-year EFS and 95% CI for high risk pediatric Ph+ ALL patients treated with EsPhALL chemotherapy, HSCT in first complete remission, and post-HSCT imatinib mesylate. EFS is defined as the time from the date of bone marrow for minimal residual disease (MRD) assessment at end-IB to first event (resistant disease [MRD &gt;= 10-2 or morphologic residual disease at end of consolidation block 3], relapse, progressive disease [i.e., MRD &gt;= 10-2 at two post-HSCT time points separated by at least 2 weeks], second malignancy, or death in complete remission), or time to last follow-up for patients without events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of grade 3 or higher infections in standard risk Ph+ ALL patients in the two randomized arms</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The rate of infections during the post IB/pre-maintenance phases of treatment will be described for each randomization group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EFS of all Ph+ patients</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Three-year EFS and 95% CI for Ph+ ALL patients. EFS here is defined as the time from enrollment until resistant disease, relapse, progressive disease post-HSCT, second malignant, or death, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS) of all Ph+ patients</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Three-year OS and 95% CI for Ph+ ALL patients. OS is defined as the time from study enrollment to death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS of SR Ph+ patients</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Three-year OS (time from randomization to death from any cause) and 95% CI of SR pediatric Ph+ patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS of SR Ph+ patients by randomization group</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Three-year OS (time from randomization to death from any cause) and 95% CI of SR pediatric Ph+ patients by randomization group: treated with continuous imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS of high risk Ph+ patients</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Three-year OS (time from the date of MRD assessment at end-IB to death from any cause) and 95% CI of HR pediatric Ph+ patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EFS of all eligibility ABL-class fusion positive ALL patients</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Three-year EFS (time from enrollment until resistant disease, relapse, progressive disease post-HSCT, second malignancy, or death, whichever occurs first) and 95% CI of ABL-class fusion positive patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS of all eligibility ABL-class fusion positive ALL patients</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Three-year OS (the time from study enrollment to death from any cause) and 95% CI of ABL-class fusion positive patients.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of toxicities associated with post-HSCT administration of imatinib mesylate</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Evaluated according to NCI CTCAE version 5.0. Frequencies of target toxicities in high risk patients after the initiation of post-HSCT imatinib mesylate will be described. For the high risk patients, the specific targeted toxicities will include grade 4 neutropenia, grade 4 thrombocytopenia, grade 3 or higher bilirubin, grade 4 or higher transaminitis, and grade 3 or higher infection.</description>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of long-term toxicities in patients treated with chemotherapy plus imatinib mesylate (no transplant) in both arms</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Evaluated according to NCI CTCAE version 5.0. Frequencies of long-term toxicities will be described and differences between randomized arms will be explored. Specific long-term toxicities to be explored include cardiac (echocardiographic abnormalities, including decreased left ventricular (LV) function and decreased LV wall thickness), growth (linear height, bone age), and second malignant neoplasm.</description>
  </other_outcome>
  <other_outcome>
    <measure>MRD measured by IGH-T cell receptor (TCR) polymerase chain reaction (PCR) and next generation sequencing (NGS) assay</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>For all patients, frequencies and prognostic significance (DFS, EFS, OS) will be explored for MRD levels (i.e., MRD negative, detectable at &lt; 5 x 10^-4, and dectectable at &gt;= 5 x 10^-4) at end of Induction IB.</description>
  </other_outcome>
  <other_outcome>
    <measure>MRD in high risk Ph+ patients measured by IGH-TCR PCR and NGS assay</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>The outcome of high risk Ph+ patients will be described, including proportion of patients who achieve MRD-negativity just prior to HSCT, and at regular intervals post-HSCT. Associations between these findings and long-term outcomes (e.g., OS, DFS) will be explored.</description>
  </other_outcome>
  <other_outcome>
    <measure>MRD assessments made by IGH-TCR PCR assay and NGS assay</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Concordance of MRD assessments made by IGH-TCR PCR assay and NGS assay will be described and evaluated. Scatter plots and diagrams will be used to examine agreements and patterns of agreement or any differences found. Concordance will be explored both for the overall cohort, as well as by risk group. The increased sensitivity of the NGS will be closely examined to find cases where the MRD levels are detectable by NGS but undetectable by PCR, as well as cases in which one test yields results and the other does not (test failure). Prognostic relationships on outcomes for these subjects will be inspected.</description>
  </other_outcome>
  <other_outcome>
    <measure>IKZF1 gene aberrations and deletions</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>For both standard risk and high risk groups, frequencies and prognostic significance (OS, DFS) will be explored for IKZF1 gene aberrations and deletions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Frequency of p190 and p210 BCR-ABL1 fusion variants</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>For both standard risk and high risk groups, frequencies and prognostic significance (OS, DFS) will be explored for p190 and p210 BCR-ABL1 fusion variants in pediatric Ph+ ALL.</description>
  </other_outcome>
  <other_outcome>
    <measure>Adherence to oral chemotherapeutic agents in standard risk Ph+ ALL patients</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Adherence to imatinib mesylate, 6-mercaptopurine, and methotrexate will be evaluated in COG-enrolled participants using an electronic monitoring device. Adherence rate will be computed for each month of adherence monitoring. Longitudinal binomial regression will be conducted using generalized estimating equation methods by modeling monthly adherence rate as an unstructured mean model using five indicator variables of time for the study months. Time in months will also be treated as a continuous variable to explore temporal trends in adherence rate. Compound symmetry will be assumed as the working correlation matrix over time. Covariates that will be considered for adjustment include those hypothesized to be predictors of adherence, annual household income, parental education, time since start of maintenance, risk classification for ALL, and imatinib, 6-mercaptopurine (6MP), and methotrexate dose-intensity.</description>
  </other_outcome>
  <other_outcome>
    <measure>Adherence to imatinib mesylate after allogeneic HSCT in high risk Ph+ ALL patients</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Longitudinal binomial regression will be conducted using generalized estimating equation methods by modeling monthly adherence rate as an unstructured mean model using five indicator variables of time for the study months. Time in months will also be treated as a continuous variable to explore temporal trends in adherence rate. Compound symmetry will be assumed as the working correlation matrix over time. Covariates that will be considered for adjustment include those hypothesized to be predictors of adherence, annual household income, parental education, time since start of maintenance, risk classification for ALL, and imatinib, 6MP, and methotrexate dose-intensity.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">475</enrollment>
  <condition>Acute Lymphoblastic Leukemia</condition>
  <condition>B Acute Lymphoblastic Leukemia</condition>
  <condition>Mixed Phenotype Acute Leukemia</condition>
  <condition>T Acute Lymphoblastic Leukemia</condition>
  <arm_group>
    <arm_group_label>Arm A (imatinib mesylate, EsPhALL chemotherapy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>See Detailed Description</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B (imatinib mesylate, COG/BFM chemotherapy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>See Detailed Description.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>See Detailed Description</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Allogeneic Hematopoietic Stem Cell Transplantation</intervention_name>
    <description>Undergo HSCT</description>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
    <other_name>Allogeneic</other_name>
    <other_name>Allogeneic Hematopoietic Cell Transplantation</other_name>
    <other_name>Allogeneic Stem Cell Transplantation</other_name>
    <other_name>HSC</other_name>
    <other_name>HSCT</other_name>
    <other_name>Stem Cell Transplantation, Allogeneic</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calaspargase Pegol</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Arm A (imatinib mesylate, EsPhALL chemotherapy)</arm_group_label>
    <arm_group_label>Arm B (imatinib mesylate, COG/BFM chemotherapy)</arm_group_label>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
    <other_name>Asparaginase (Escherichia coli Isoenzyme II), Conjugate with alpha-(((2,5-Dioxo-1-pyrrolidinyl)oxy)carbonyl)-omega-methoxypoly(oxy-1,2-ethanediyl)</other_name>
    <other_name>Asparlas</other_name>
    <other_name>Calaspargase Pegol-mknl</other_name>
    <other_name>EZN-2285</other_name>
    <other_name>SC-PEG E. Coli L-Asparaginase</other_name>
    <other_name>Succinimidyl Carbonate Monomethoxypolyethylene Glycol E. coli L-Asparaginase</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Arm A (imatinib mesylate, EsPhALL chemotherapy)</arm_group_label>
    <arm_group_label>Arm B (imatinib mesylate, COG/BFM chemotherapy)</arm_group_label>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
    <other_name>(-)-Cyclophosphamide</other_name>
    <other_name>2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate</other_name>
    <other_name>Carloxan</other_name>
    <other_name>Ciclofosfamida</other_name>
    <other_name>Ciclofosfamide</other_name>
    <other_name>Cicloxal</other_name>
    <other_name>Clafen</other_name>
    <other_name>Claphene</other_name>
    <other_name>CP monohydrate</other_name>
    <other_name>CTX</other_name>
    <other_name>CYCLO-cell</other_name>
    <other_name>Cycloblastin</other_name>
    <other_name>Cycloblastine</other_name>
    <other_name>Cyclophospham</other_name>
    <other_name>Cyclophosphamid monohydrate</other_name>
    <other_name>Cyclophosphamide Monohydrate</other_name>
    <other_name>Cyclophosphamidum</other_name>
    <other_name>Cyclophosphan</other_name>
    <other_name>Cyclophosphane</other_name>
    <other_name>Cyclophosphanum</other_name>
    <other_name>Cyclostin</other_name>
    <other_name>Cyclostine</other_name>
    <other_name>Cytophosphan</other_name>
    <other_name>Cytophosphane</other_name>
    <other_name>Cytoxan</other_name>
    <other_name>Fosfaseron</other_name>
    <other_name>Genoxal</other_name>
    <other_name>Genuxal</other_name>
    <other_name>Ledoxina</other_name>
    <other_name>Mitoxan</other_name>
    <other_name>Neosar</other_name>
    <other_name>Revimmune</other_name>
    <other_name>Syklofosfamid</other_name>
    <other_name>WR- 138719</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cytarabine</intervention_name>
    <description>Given IV, SC, or IT</description>
    <arm_group_label>Arm A (imatinib mesylate, EsPhALL chemotherapy)</arm_group_label>
    <arm_group_label>Arm B (imatinib mesylate, COG/BFM chemotherapy)</arm_group_label>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
    <other_name>.beta.-Cytosine arabinoside</other_name>
    <other_name>1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone</other_name>
    <other_name>1-.beta.-D-Arabinofuranosylcytosine</other_name>
    <other_name>1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone</other_name>
    <other_name>1-Beta-D-arabinofuranosylcytosine</other_name>
    <other_name>1.beta.-D-Arabinofuranosylcytosine</other_name>
    <other_name>2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-</other_name>
    <other_name>2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-</other_name>
    <other_name>Alexan</other_name>
    <other_name>Ara-C</other_name>
    <other_name>ARA-cell</other_name>
    <other_name>Arabine</other_name>
    <other_name>Arabinofuranosylcytosine</other_name>
    <other_name>Arabinosylcytosine</other_name>
    <other_name>Aracytidine</other_name>
    <other_name>Aracytin</other_name>
    <other_name>Aracytine</other_name>
    <other_name>Beta-Cytosine Arabinoside</other_name>
    <other_name>CHX-3311</other_name>
    <other_name>Cytarabinum</other_name>
    <other_name>Cytarbel</other_name>
    <other_name>Cytosar</other_name>
    <other_name>Cytosine Arabinoside</other_name>
    <other_name>Cytosine-.beta.-arabinoside</other_name>
    <other_name>Cytosine-beta-arabinoside</other_name>
    <other_name>Erpalfa</other_name>
    <other_name>Starasid</other_name>
    <other_name>Tarabine PFS</other_name>
    <other_name>U 19920</other_name>
    <other_name>U-19920</other_name>
    <other_name>Udicil</other_name>
    <other_name>WR-28453</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daunorubicin Hydrochloride</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Arm A (imatinib mesylate, EsPhALL chemotherapy)</arm_group_label>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
    <other_name>Cerubidin</other_name>
    <other_name>Cerubidine</other_name>
    <other_name>Cloridrato de Daunorubicina</other_name>
    <other_name>Daunoblastin</other_name>
    <other_name>Daunoblastina</other_name>
    <other_name>Daunoblastine</other_name>
    <other_name>Daunomycin Hydrochloride</other_name>
    <other_name>Daunomycin, hydrochloride</other_name>
    <other_name>Daunorubicin.HCl</other_name>
    <other_name>Daunorubicini Hydrochloridum</other_name>
    <other_name>FI-6339</other_name>
    <other_name>Ondena</other_name>
    <other_name>RP-13057</other_name>
    <other_name>Rubidomycin Hydrochloride</other_name>
    <other_name>Rubilem</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Given PO or IV</description>
    <arm_group_label>Arm A (imatinib mesylate, EsPhALL chemotherapy)</arm_group_label>
    <arm_group_label>Arm B (imatinib mesylate, COG/BFM chemotherapy)</arm_group_label>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
    <other_name>Aacidexam</other_name>
    <other_name>Adexone</other_name>
    <other_name>Aknichthol Dexa</other_name>
    <other_name>Alba-Dex</other_name>
    <other_name>Alin</other_name>
    <other_name>Alin Depot</other_name>
    <other_name>Alin Oftalmico</other_name>
    <other_name>Amplidermis</other_name>
    <other_name>Anemul mono</other_name>
    <other_name>Auricularum</other_name>
    <other_name>Auxiloson</other_name>
    <other_name>Baycadron</other_name>
    <other_name>Baycuten</other_name>
    <other_name>Baycuten N</other_name>
    <other_name>Cortidexason</other_name>
    <other_name>Cortisumman</other_name>
    <other_name>Decacort</other_name>
    <other_name>Decadrol</other_name>
    <other_name>Decadron</other_name>
    <other_name>Decadron DP</other_name>
    <other_name>Decalix</other_name>
    <other_name>Decameth</other_name>
    <other_name>Decasone R.p.</other_name>
    <other_name>Dectancyl</other_name>
    <other_name>Dekacort</other_name>
    <other_name>Deltafluorene</other_name>
    <other_name>Deronil</other_name>
    <other_name>Desamethasone</other_name>
    <other_name>Desameton</other_name>
    <other_name>Dexa-Mamallet</other_name>
    <other_name>Dexa-Rhinosan</other_name>
    <other_name>Dexa-Scheroson</other_name>
    <other_name>Dexa-sine</other_name>
    <other_name>Dexacortal</other_name>
    <other_name>Dexacortin</other_name>
    <other_name>Dexafarma</other_name>
    <other_name>Dexafluorene</other_name>
    <other_name>Dexalocal</other_name>
    <other_name>Dexamecortin</other_name>
    <other_name>Dexameth</other_name>
    <other_name>Dexamethasone Intensol</other_name>
    <other_name>Dexamethasonum</other_name>
    <other_name>Dexamonozon</other_name>
    <other_name>Dexapos</other_name>
    <other_name>Dexinoral</other_name>
    <other_name>Dexone</other_name>
    <other_name>Dinormon</other_name>
    <other_name>Dxevo</other_name>
    <other_name>Fluorodelta</other_name>
    <other_name>Fortecortin</other_name>
    <other_name>Gammacorten</other_name>
    <other_name>Hemady</other_name>
    <other_name>Hexadecadrol</other_name>
    <other_name>Hexadrol</other_name>
    <other_name>Lokalison-F</other_name>
    <other_name>Loverine</other_name>
    <other_name>Methylfluorprednisolone</other_name>
    <other_name>Millicorten</other_name>
    <other_name>Mymethasone</other_name>
    <other_name>Orgadrone</other_name>
    <other_name>Spersadex</other_name>
    <other_name>TaperDex</other_name>
    <other_name>Visumetazone</other_name>
    <other_name>ZoDex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexrazoxane Hydrochloride</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Arm A (imatinib mesylate, EsPhALL chemotherapy)</arm_group_label>
    <arm_group_label>Arm B (imatinib mesylate, COG/BFM chemotherapy)</arm_group_label>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
    <other_name>Cardioxane</other_name>
    <other_name>Totect</other_name>
    <other_name>Zinecard</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxorubicin</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Arm A (imatinib mesylate, EsPhALL chemotherapy)</arm_group_label>
    <arm_group_label>Arm B (imatinib mesylate, COG/BFM chemotherapy)</arm_group_label>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
    <other_name>Adriablastin</other_name>
    <other_name>Hydroxydaunomycin</other_name>
    <other_name>Hydroxyl Daunorubicin</other_name>
    <other_name>Hydroxyldaunorubicin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etoposide</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Arm A (imatinib mesylate, EsPhALL chemotherapy)</arm_group_label>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
    <other_name>Demethyl Epipodophyllotoxin Ethylidine Glucoside</other_name>
    <other_name>EPEG</other_name>
    <other_name>Lastet</other_name>
    <other_name>Toposar</other_name>
    <other_name>Vepesid</other_name>
    <other_name>VP 16</other_name>
    <other_name>VP 16-213</other_name>
    <other_name>VP-16</other_name>
    <other_name>VP-16-213</other_name>
    <other_name>VP16</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Filgrastim</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Arm A (imatinib mesylate, EsPhALL chemotherapy)</arm_group_label>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
    <other_name>Filgrastim-aafi</other_name>
    <other_name>Filgrastim-ayow</other_name>
    <other_name>G-CSF</other_name>
    <other_name>Neupogen</other_name>
    <other_name>Nivestym</other_name>
    <other_name>r-metHuG-CSF</other_name>
    <other_name>Recombinant Methionyl Human Granulocyte Colony Stimulating Factor</other_name>
    <other_name>Releuko</other_name>
    <other_name>rG-CSF</other_name>
    <other_name>Tevagrastim</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ifosfamide</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Arm A (imatinib mesylate, EsPhALL chemotherapy)</arm_group_label>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
    <other_name>Asta Z 4942</other_name>
    <other_name>Asta Z-4942</other_name>
    <other_name>Cyfos</other_name>
    <other_name>Holoxan</other_name>
    <other_name>Holoxane</other_name>
    <other_name>Ifex</other_name>
    <other_name>IFO</other_name>
    <other_name>IFO-Cell</other_name>
    <other_name>Ifolem</other_name>
    <other_name>Ifomida</other_name>
    <other_name>Ifomide</other_name>
    <other_name>Ifosfamidum</other_name>
    <other_name>Ifoxan</other_name>
    <other_name>IFX</other_name>
    <other_name>Iphosphamid</other_name>
    <other_name>Iphosphamide</other_name>
    <other_name>Iso-Endoxan</other_name>
    <other_name>Isoendoxan</other_name>
    <other_name>Isophosphamide</other_name>
    <other_name>Mitoxana</other_name>
    <other_name>MJF 9325</other_name>
    <other_name>MJF-9325</other_name>
    <other_name>Naxamide</other_name>
    <other_name>Seromida</other_name>
    <other_name>Tronoxal</other_name>
    <other_name>Z 4942</other_name>
    <other_name>Z-4942</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Imatinib Mesylate</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Arm A (imatinib mesylate, EsPhALL chemotherapy)</arm_group_label>
    <arm_group_label>Arm B (imatinib mesylate, COG/BFM chemotherapy)</arm_group_label>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
    <other_name>CGP 57148</other_name>
    <other_name>CGP57148B</other_name>
    <other_name>Gleevec</other_name>
    <other_name>Glivec</other_name>
    <other_name>STI 571</other_name>
    <other_name>STI-571</other_name>
    <other_name>STI571</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Arm A (imatinib mesylate, EsPhALL chemotherapy)</arm_group_label>
    <arm_group_label>Arm B (imatinib mesylate, COG/BFM chemotherapy)</arm_group_label>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Leucovorin Calcium</intervention_name>
    <description>Given PO or IV</description>
    <arm_group_label>Arm A (imatinib mesylate, EsPhALL chemotherapy)</arm_group_label>
    <arm_group_label>Arm B (imatinib mesylate, COG/BFM chemotherapy)</arm_group_label>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
    <other_name>Adinepar</other_name>
    <other_name>Calcifolin</other_name>
    <other_name>Calcium (6S)-Folinate</other_name>
    <other_name>Calcium Folinate</other_name>
    <other_name>Calcium Leucovorin</other_name>
    <other_name>Calfolex</other_name>
    <other_name>Calinat</other_name>
    <other_name>Cehafolin</other_name>
    <other_name>Citofolin</other_name>
    <other_name>Citrec</other_name>
    <other_name>Citrovorum Factor</other_name>
    <other_name>Cromatonbic Folinico</other_name>
    <other_name>Dalisol</other_name>
    <other_name>Disintox</other_name>
    <other_name>Divical</other_name>
    <other_name>Ecofol</other_name>
    <other_name>Emovis</other_name>
    <other_name>Factor, Citrovorum</other_name>
    <other_name>Flynoken A</other_name>
    <other_name>Folaren</other_name>
    <other_name>Folaxin</other_name>
    <other_name>FOLI-cell</other_name>
    <other_name>Foliben</other_name>
    <other_name>Folidan</other_name>
    <other_name>Folidar</other_name>
    <other_name>Folinac</other_name>
    <other_name>Folinate Calcium</other_name>
    <other_name>folinic acid</other_name>
    <other_name>Folinic Acid Calcium Salt Pentahydrate</other_name>
    <other_name>Folinoral</other_name>
    <other_name>Folinvit</other_name>
    <other_name>Foliplus</other_name>
    <other_name>Folix</other_name>
    <other_name>Imo</other_name>
    <other_name>Lederfolat</other_name>
    <other_name>Lederfolin</other_name>
    <other_name>Leucosar</other_name>
    <other_name>leucovorin</other_name>
    <other_name>Rescufolin</other_name>
    <other_name>Rescuvolin</other_name>
    <other_name>Tonofolin</other_name>
    <other_name>Wellcovorin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mercaptopurine</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Arm A (imatinib mesylate, EsPhALL chemotherapy)</arm_group_label>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
    <other_name>3H-Purine-6-thiol</other_name>
    <other_name>6 MP</other_name>
    <other_name>6 Thiohypoxanthine</other_name>
    <other_name>6 Thiopurine</other_name>
    <other_name>6-Mercaptopurine</other_name>
    <other_name>6-Mercaptopurine Monohydrate</other_name>
    <other_name>6-MP</other_name>
    <other_name>6-Purinethiol</other_name>
    <other_name>6-Thiopurine</other_name>
    <other_name>6-Thioxopurine</other_name>
    <other_name>6H-Purine-6-thione, 1,7-dihydro- (9CI)</other_name>
    <other_name>7-Mercapto-1,3,4,6-tetrazaindene</other_name>
    <other_name>Alti-Mercaptopurine</other_name>
    <other_name>Azathiopurine</other_name>
    <other_name>Bw 57-323H</other_name>
    <other_name>Flocofil</other_name>
    <other_name>Ismipur</other_name>
    <other_name>Leukerin</other_name>
    <other_name>Leupurin</other_name>
    <other_name>Mercaleukim</other_name>
    <other_name>Mercaleukin</other_name>
    <other_name>Mercaptina</other_name>
    <other_name>Mercaptopurinum</other_name>
    <other_name>Mercapurin</other_name>
    <other_name>Mern</other_name>
    <other_name>NCI-C04886</other_name>
    <other_name>Puri-Nethol</other_name>
    <other_name>Purimethol</other_name>
    <other_name>Purine, 6-mercapto-</other_name>
    <other_name>Purine-6-thiol (8CI)</other_name>
    <other_name>Purine-6-thiol, monohydrate</other_name>
    <other_name>Purinethiol</other_name>
    <other_name>Purinethol</other_name>
    <other_name>U-4748</other_name>
    <other_name>WR-2785</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mercaptopurine</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Arm A (imatinib mesylate, EsPhALL chemotherapy)</arm_group_label>
    <arm_group_label>Arm B (imatinib mesylate, COG/BFM chemotherapy)</arm_group_label>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
    <other_name>3H-Purine-6-thiol</other_name>
    <other_name>6 MP</other_name>
    <other_name>6 Thiohypoxanthine</other_name>
    <other_name>6 Thiopurine</other_name>
    <other_name>6-Mercaptopurine</other_name>
    <other_name>6-Mercaptopurine Monohydrate</other_name>
    <other_name>6-MP</other_name>
    <other_name>6-Purinethiol</other_name>
    <other_name>6-Thiopurine</other_name>
    <other_name>6-Thioxopurine</other_name>
    <other_name>6H-Purine-6-thione, 1,7-dihydro- (9CI)</other_name>
    <other_name>7-Mercapto-1,3,4,6-tetrazaindene</other_name>
    <other_name>Alti-Mercaptopurine</other_name>
    <other_name>Azathiopurine</other_name>
    <other_name>Bw 57-323H</other_name>
    <other_name>Flocofil</other_name>
    <other_name>Ismipur</other_name>
    <other_name>Leukerin</other_name>
    <other_name>Leupurin</other_name>
    <other_name>Mercaleukim</other_name>
    <other_name>Mercaleukin</other_name>
    <other_name>Mercaptina</other_name>
    <other_name>Mercaptopurinum</other_name>
    <other_name>Mercapurin</other_name>
    <other_name>Mern</other_name>
    <other_name>NCI-C04886</other_name>
    <other_name>Puri-Nethol</other_name>
    <other_name>Purimethol</other_name>
    <other_name>Purine, 6-mercapto-</other_name>
    <other_name>Purine-6-thiol (8CI)</other_name>
    <other_name>Purine-6-thiol, monohydrate</other_name>
    <other_name>Purinethiol</other_name>
    <other_name>Purinethol</other_name>
    <other_name>U-4748</other_name>
    <other_name>WR-2785</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methotrexate</intervention_name>
    <description>Given IT</description>
    <arm_group_label>Arm A (imatinib mesylate, EsPhALL chemotherapy)</arm_group_label>
    <arm_group_label>Arm B (imatinib mesylate, COG/BFM chemotherapy)</arm_group_label>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
    <other_name>Abitrexate</other_name>
    <other_name>Alpha-Methopterin</other_name>
    <other_name>Amethopterin</other_name>
    <other_name>Brimexate</other_name>
    <other_name>CL 14377</other_name>
    <other_name>CL-14377</other_name>
    <other_name>Emtexate</other_name>
    <other_name>Emthexat</other_name>
    <other_name>Emthexate</other_name>
    <other_name>Farmitrexat</other_name>
    <other_name>Fauldexato</other_name>
    <other_name>Folex</other_name>
    <other_name>Folex PFS</other_name>
    <other_name>Lantarel</other_name>
    <other_name>Ledertrexate</other_name>
    <other_name>Lumexon</other_name>
    <other_name>Maxtrex</other_name>
    <other_name>Medsatrexate</other_name>
    <other_name>Metex</other_name>
    <other_name>Methoblastin</other_name>
    <other_name>Methotrexate LPF</other_name>
    <other_name>Methotrexate Methylaminopterin</other_name>
    <other_name>Methotrexatum</other_name>
    <other_name>Metotrexato</other_name>
    <other_name>Metrotex</other_name>
    <other_name>Mexate</other_name>
    <other_name>Mexate-AQ</other_name>
    <other_name>MTX</other_name>
    <other_name>Novatrex</other_name>
    <other_name>Rheumatrex</other_name>
    <other_name>Texate</other_name>
    <other_name>Tremetex</other_name>
    <other_name>Trexeron</other_name>
    <other_name>Trixilem</other_name>
    <other_name>WR-19039</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methylprednisolone</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Arm A (imatinib mesylate, EsPhALL chemotherapy)</arm_group_label>
    <arm_group_label>Arm B (imatinib mesylate, COG/BFM chemotherapy)</arm_group_label>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
    <other_name>Adlone</other_name>
    <other_name>Caberdelta M</other_name>
    <other_name>DepMedalone</other_name>
    <other_name>Depo Moderin</other_name>
    <other_name>Depo-Nisolone</other_name>
    <other_name>Duralone</other_name>
    <other_name>Emmetipi</other_name>
    <other_name>Esametone</other_name>
    <other_name>Firmacort</other_name>
    <other_name>Medlone 21</other_name>
    <other_name>Medrate</other_name>
    <other_name>Medrol</other_name>
    <other_name>Medrol Veriderm</other_name>
    <other_name>Medrone</other_name>
    <other_name>Mega-Star</other_name>
    <other_name>Meprolone</other_name>
    <other_name>Methylprednisolonum</other_name>
    <other_name>Metilbetasone Solubile</other_name>
    <other_name>Metrocort</other_name>
    <other_name>Metypresol</other_name>
    <other_name>Metysolon</other_name>
    <other_name>Predni-M-Tablinen</other_name>
    <other_name>Prednilen</other_name>
    <other_name>Radilem</other_name>
    <other_name>Sieropresol</other_name>
    <other_name>Solpredone</other_name>
    <other_name>Summicort</other_name>
    <other_name>Urbason</other_name>
    <other_name>Veriderm Medrol</other_name>
    <other_name>Wyacort</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pegaspargase</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Arm A (imatinib mesylate, EsPhALL chemotherapy)</arm_group_label>
    <arm_group_label>Arm B (imatinib mesylate, COG/BFM chemotherapy)</arm_group_label>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
    <other_name>L-Asparaginase with Polyethylene Glycol</other_name>
    <other_name>Oncaspar</other_name>
    <other_name>Oncaspar-IV</other_name>
    <other_name>PEG-Asparaginase</other_name>
    <other_name>PEG-L-Asparaginase</other_name>
    <other_name>PEG-L-Asparaginase (Enzon - Kyowa Hakko)</other_name>
    <other_name>PEGLA</other_name>
    <other_name>Polyethylene Glycol L-Asparaginase</other_name>
    <other_name>Polyethylene Glycol-L-Asparaginase</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisolone</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Arm A (imatinib mesylate, EsPhALL chemotherapy)</arm_group_label>
    <arm_group_label>Arm B (imatinib mesylate, COG/BFM chemotherapy)</arm_group_label>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
    <other_name>(11beta)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione</other_name>
    <other_name>.delta.1-Hydrocortisone</other_name>
    <other_name>Adnisolone</other_name>
    <other_name>Aprednislon</other_name>
    <other_name>Capsoid</other_name>
    <other_name>Cortalone</other_name>
    <other_name>Cortisolone</other_name>
    <other_name>Dacortin H</other_name>
    <other_name>Decaprednil</other_name>
    <other_name>Decortin H</other_name>
    <other_name>Delta(1)Hydrocortisone</other_name>
    <other_name>Delta- Cortef</other_name>
    <other_name>Delta-Cortef</other_name>
    <other_name>Delta-Diona</other_name>
    <other_name>Delta-F</other_name>
    <other_name>Delta-Phoricol</other_name>
    <other_name>Delta1-dehydro-hydrocortisone</other_name>
    <other_name>Deltacortril</other_name>
    <other_name>Deltahydrocortisone</other_name>
    <other_name>Deltasolone</other_name>
    <other_name>Deltidrosol</other_name>
    <other_name>Dhasolone</other_name>
    <other_name>Di-Adreson-F</other_name>
    <other_name>Dontisolon D</other_name>
    <other_name>Estilsona</other_name>
    <other_name>Fisopred</other_name>
    <other_name>Frisolona</other_name>
    <other_name>Gupisone</other_name>
    <other_name>Hostacortin H</other_name>
    <other_name>Hydeltra</other_name>
    <other_name>Hydeltrasol</other_name>
    <other_name>Klismacort</other_name>
    <other_name>Kuhlprednon</other_name>
    <other_name>Lenisolone</other_name>
    <other_name>Lepi-Cortinolo</other_name>
    <other_name>Linola-H N</other_name>
    <other_name>Linola-H-Fett N</other_name>
    <other_name>Longiprednil</other_name>
    <other_name>Metacortandralone</other_name>
    <other_name>Meti Derm</other_name>
    <other_name>Meticortelone</other_name>
    <other_name>Opredsone</other_name>
    <other_name>Panafcortelone</other_name>
    <other_name>Precortisyl</other_name>
    <other_name>Pred-Clysma</other_name>
    <other_name>Predeltilone</other_name>
    <other_name>Predni-Coelin</other_name>
    <other_name>Predni-Helvacort</other_name>
    <other_name>Prednicortelone</other_name>
    <other_name>Prednisolonum</other_name>
    <other_name>Prelone</other_name>
    <other_name>Prenilone</other_name>
    <other_name>Sterane</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm A (imatinib mesylate, EsPhALL chemotherapy)</arm_group_label>
    <arm_group_label>Arm B (imatinib mesylate, COG/BFM chemotherapy)</arm_group_label>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Therapeutic Hydrocortisone</intervention_name>
    <description>Given IT</description>
    <arm_group_label>Arm A (imatinib mesylate, EsPhALL chemotherapy)</arm_group_label>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
    <other_name>Aeroseb-HC</other_name>
    <other_name>Barseb HC</other_name>
    <other_name>Barseb-HC</other_name>
    <other_name>Cetacort</other_name>
    <other_name>Cort-Dome</other_name>
    <other_name>Cortef</other_name>
    <other_name>Cortenema</other_name>
    <other_name>Cortifan</other_name>
    <other_name>Cortisol</other_name>
    <other_name>Cortispray</other_name>
    <other_name>Cortril</other_name>
    <other_name>Dermacort</other_name>
    <other_name>Domolene</other_name>
    <other_name>Eldecort</other_name>
    <other_name>Hautosone</other_name>
    <other_name>Heb-Cort</other_name>
    <other_name>Hydrocortisone</other_name>
    <other_name>Hydrocortone</other_name>
    <other_name>Hytone</other_name>
    <other_name>Komed-HC</other_name>
    <other_name>Nutracort</other_name>
    <other_name>Proctocort</other_name>
    <other_name>Rectoid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Thioguanine</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Arm A (imatinib mesylate, EsPhALL chemotherapy)</arm_group_label>
    <arm_group_label>Arm B (imatinib mesylate, COG/BFM chemotherapy)</arm_group_label>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
    <other_name>2-Amino 6MP</other_name>
    <other_name>2-Amino-1,7-dihydro-6H-purine-6-thione</other_name>
    <other_name>2-Amino-6-mercaptopurine</other_name>
    <other_name>2-Amino-6-purinethiol</other_name>
    <other_name>2-Aminopurin-6-thiol</other_name>
    <other_name>2-Aminopurine-6(1H)-thione</other_name>
    <other_name>2-Aminopurine-6-thiol</other_name>
    <other_name>2-Aminopurine-6-thiol Hemihydrate</other_name>
    <other_name>2-Mercapto-6-aminopurine</other_name>
    <other_name>6-Amino-2-mercaptopurine</other_name>
    <other_name>6-Mercapto-2-aminopurine</other_name>
    <other_name>6-Mercaptoguanine</other_name>
    <other_name>6-TG</other_name>
    <other_name>6H-Purine-6-thione, 2-amino-1,7-dihydro- (9CI)</other_name>
    <other_name>BW 5071</other_name>
    <other_name>Lanvis</other_name>
    <other_name>Tabloid</other_name>
    <other_name>Thioguanine Hemihydrate</other_name>
    <other_name>Thioguanine Hydrate</other_name>
    <other_name>Tioguanin</other_name>
    <other_name>Tioguanine</other_name>
    <other_name>Wellcome U3B</other_name>
    <other_name>WR-1141</other_name>
    <other_name>X 27</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vincristine Sulfate</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Arm A (imatinib mesylate, EsPhALL chemotherapy)</arm_group_label>
    <arm_group_label>Arm B (imatinib mesylate, COG/BFM chemotherapy)</arm_group_label>
    <arm_group_label>Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)</arm_group_label>
    <other_name>Kyocristine</other_name>
    <other_name>Leurocristine Sulfate</other_name>
    <other_name>Leurocristine, sulfate</other_name>
    <other_name>Oncovin</other_name>
    <other_name>Vincasar</other_name>
    <other_name>Vincosid</other_name>
    <other_name>Vincrex</other_name>
    <other_name>Vincristine, sulfate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For patients enrolled on APEC14B1 prior to enrollment on AALL1631, the required&#xD;
             diagnostic bone marrow sample has been fulfilled&#xD;
&#xD;
               -  For patients who have not previously enrolled on APEC14B1 prior to enrollment on&#xD;
                  AALL1631, a baseline diagnostic sample (or peripheral blood sample with blasts if&#xD;
                  marrow sample unavailable) must be available to develop an MRD probe&#xD;
&#xD;
               -  In addition, laboratory reports detailing evidence of BCR-ABL1 fusion or&#xD;
                  ABL-class fusion must be submitted for rapid central review within 72 hours of&#xD;
                  study enrollment&#xD;
&#xD;
          -  &gt;= 1 year (365 days) and =&lt; 21 years at ALL diagnosis&#xD;
&#xD;
          -  Ph+ (BCR-ABL1 fusion): newly diagnosed de novo ALL (B-ALL or T-ALL) or mixed&#xD;
             phenotypic acute leukemia (MPAL meeting 2016 World Health Organization [WHO]&#xD;
             definition) with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in&#xD;
             situ hybridization (FISH) and/or molecular methodologies&#xD;
&#xD;
          -  ABL-class fusion: newly diagnosed B-ALL with definitive evidence of ABL-class fusions.&#xD;
             ABL-class fusions are defined as those involving the following genes: ABL1, ABL2,&#xD;
             CSF1R, PDGFRB, PDGFRA. Methods of detection include fluorescence in-situ hybridization&#xD;
             (FISH, e.g. using break-apart or colocalization signals probes), multiplex or&#xD;
             singleplex reverse-transcription polymerase chain reaction (RT-PCR), whole&#xD;
             transcriptome or panel-based ribonucleic acid (RNA)-sequencing (e.g. TruSight RNA&#xD;
             Pan-Cancer Panel; Illumina, San Diego, CA, USA or similar)&#xD;
&#xD;
          -  Ph+ patients must have previously started Induction therapy, which includes&#xD;
             vincristine, a corticosteroid, pegaspargase, with or without anthracycline, and/or&#xD;
             other standard cytotoxic chemotherapy&#xD;
&#xD;
          -  Ph+ patients have not received more than 14 days of multiagent Induction therapy&#xD;
             beginning with the first dose of vinCRIStine&#xD;
&#xD;
          -  Ph+ patients may have started imatinib prior to study entry but have not received more&#xD;
             than 14 days of imatinib&#xD;
&#xD;
          -  ABL-class fusion patients must have previously completed the 4 or 5 weeks of&#xD;
             multiagent Induction chemotherapy (Induction IA phase)&#xD;
&#xD;
          -  ABL-class fusion patients may have started imatinib during Induction IA, at the same&#xD;
             time of or after the first vinCRIStine dose&#xD;
&#xD;
          -  Patients must have a performance status corresponding to Eastern Cooperative Oncology&#xD;
             Group (ECOG) scores of 0, 1, or 2&#xD;
&#xD;
          -  Direct bilirubin =&lt; 2.0 mg/dL&#xD;
&#xD;
          -  Shortening fraction of &gt;= 27% by echocardiogram&#xD;
&#xD;
          -  Ejection fraction of &gt;= 50% by radionuclide angiogram or echocardiogram&#xD;
&#xD;
          -  Corrected QT interval, QTc &lt; 480 msec&#xD;
&#xD;
               -  Note: Repeat echocardiogram and electrocardiogram are not required if they were&#xD;
                  performed at or after initial ALL diagnosis, before study enrollment&#xD;
&#xD;
          -  Creatinine clearance or radioisotope glomerular filtration rate (GFR) &gt;= 70&#xD;
             mL/min/1.73 m^2 or serum creatinine within normal limits based on age/gender, as&#xD;
             follows:&#xD;
&#xD;
               -  1 to &lt; 2 years: maximum serum creatinine 0.6 mg/dL (both male and female)&#xD;
&#xD;
               -  2 to &lt; 6 years: maximum serum creatinine 0.8 mg/dL (both male and female)&#xD;
&#xD;
               -  6 to &lt; 10 years: maximum serum creatinine 1 mg/dL (both male and female)&#xD;
&#xD;
               -  10 to &lt; 13 years: maximum serum creatinine 1.2 mg/dL (both male and female)&#xD;
&#xD;
               -  13 to &lt; 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)&#xD;
&#xD;
               -  &gt;= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known history of chronic myelogenous leukemia (CML)&#xD;
&#xD;
          -  ALL developing after a previous cancer treated with cytotoxic chemotherapy&#xD;
&#xD;
          -  Active, uncontrolled infection, or active systemic illness that requires ongoing&#xD;
             vasopressor support or mechanical ventilation&#xD;
&#xD;
          -  Down syndrome&#xD;
&#xD;
          -  Pregnancy and breast feeding&#xD;
&#xD;
               -  Female patients who are pregnant since fetal toxicities and teratogenic effects&#xD;
                  have been noted for several of the study drugs; a pregnancy test is required for&#xD;
                  female patients of childbearing potential&#xD;
&#xD;
               -  Lactating females who plan to breastfeed their infants&#xD;
&#xD;
               -  Sexually active patients of reproductive potential who have not agreed to use an&#xD;
                  effective contraceptive method for the duration of treatment according to&#xD;
                  protocol&#xD;
&#xD;
          -  Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart&#xD;
             block&#xD;
&#xD;
          -  Prior treatment with dasatinib, or any TKI other than imatinib&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lewis B Silverman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Oncology Group</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Prof Andrea Biondi</last_name>
    <role>Principal Investigator</role>
    <affiliation>EsPhALL network I-BFM Study 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>Providence Alaska Medical Center</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99508</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>907-212-6871</phone>
      <email>AKPAMC.OncologyResearchSupport@providence.org</email>
    </contact>
    <investigator>
      <last_name>Brenda J. Wittman</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>Phoenix Childrens Hospital</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>602-546-0920</phone>
    </contact>
    <investigator>
      <last_name>Dana B. Salzberg</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>City of Hope Comprehensive Cancer Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-826-4673</phone>
      <email>becomingapatient@coh.org</email>
    </contact>
    <investigator>
      <last_name>Anna B. Pawlowska</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Loma Linda University Medical Center</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>909-558-4050</phone>
    </contact>
    <investigator>
      <last_name>Albert Kheradpour</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>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>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>UCSF Medical Center-Mission Bay</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-827-3222</phone>
      <email>cancertrials@ucsf.edu</email>
    </contact>
    <investigator>
      <last_name>Anya Levinson</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>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>203-785-5702</phone>
      <email>canceranswers@yale.edu</email>
    </contact>
    <investigator>
      <last_name>Stephanie A. Massaro</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>Emi H. Caywood</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>Broward Health Medical Center</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33316</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>Hector M. Rodriguez-Cortes</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>Emi H. Caywood</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Palms West Radiation Therapy</name>
      <address>
        <city>Loxahatchee Groves</city>
        <state>Florida</state>
        <zip>33470</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </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>Miami Cancer Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>786-596-2000</phone>
    </contact>
    <investigator>
      <last_name>Doured Daghistani</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>AdventHealth Orlando</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>407-303-2090</phone>
      <email>FH.Cancer.Research@flhosp.org</email>
    </contact>
    <investigator>
      <last_name>Fouad M. Hajjar</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>Emi H. Caywood</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>Johns Hopkins All Children's Hospital</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>727-767-4784</phone>
      <email>Ashley.Repp@jhmi.edu</email>
    </contact>
    <investigator>
      <last_name>Jennifer L. Mayer</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>Augusta University Medical Center</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>706-721-2388</phone>
      <email>ga_cares@augusta.edu</email>
    </contact>
    <investigator>
      <last_name>Colleen H. McDonough</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Medical Center of Central Georgia</name>
      <address>
        <city>Macon</city>
        <state>Georgia</state>
        <zip>31201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>478-633-2152</phone>
      <email>weatherall.andrew@navicenthealth.org</email>
    </contact>
    <investigator>
      <last_name>Sushmita Nair</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>Elaine R. Morgan</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>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>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>Ascension Saint Vincent Indianapolis Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>317-338-2194</phone>
      <email>research@stvincent.org</email>
    </contact>
    <investigator>
      <last_name>Bassem I. Razzouk</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>Ochsner Medical Center Jefferson</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </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>Kenneth J. Cohen</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>Massachusetts General Hospital Cancer Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-726-5130</phone>
    </contact>
    <investigator>
      <last_name>Lewis B. Silverman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>Lewis B. Silverman</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>Emily B. Walling</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ascension Saint John Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48236</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>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </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>Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-639-6918</phone>
      <email>cancer.research.nurse@dartmouth.edu</email>
    </contact>
    <investigator>
      <last_name>Angela Ricci</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>Active, not recruiting</status>
  </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>Saint Peter's University Hospital</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>732-745-8600</phone>
      <phone_ext>6163</phone_ext>
      <email>kcovert@saintpetersuh.com</email>
    </contact>
    <investigator>
      <last_name>Nibal A. Zaghloul</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>Newark Beth Israel Medical Center</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>973-926-7230</phone>
      <email>Christine.Kosmides@rwjbh.org</email>
    </contact>
    <investigator>
      <last_name>Teena Bhatla</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>University of New Mexico Cancer Center</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>505-925-0348</phone>
      <email>HSC-ClinicalTrialInfo@salud.unm.edu</email>
    </contact>
    <investigator>
      <last_name>Jessica M. Valdez</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Presbyterian Hospital</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>505-559-6113</phone>
      <email>wburman@phs.org</email>
    </contact>
    <investigator>
      <last_name>Xiaxin Li</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>Maimonides Medical Center</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>718-765-2500</phone>
    </contact>
    <investigator>
      <last_name>Mahmut Y. Celiker</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>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>212-263-4432</phone>
      <email>cancertrials@nyulangone.org</email>
    </contact>
    <investigator>
      <last_name>Chana L. Glasser</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>Laura and Isaac Perlmutter Cancer Center at NYU Langone</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>CancerTrials@nyulangone.org</email>
    </contact>
    <investigator>
      <last_name>Elizabeth A. Raetz</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>212-824-7309</phone>
      <email>CCTO@mssm.edu</email>
    </contact>
    <investigator>
      <last_name>Gary D. Crouch</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>Kavitha Ramaswamy</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>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>585-275-5830</phone>
    </contact>
    <investigator>
      <last_name>Craig A. Mullen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>888-275-3853</phone>
    </contact>
    <investigator>
      <last_name>Lars M. Wagner</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>Maureen M. O'Brien</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>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>Susan R. Rheingold</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>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>843-792-9321</phone>
      <email>hcc-clinical-trials@musc.edu</email>
    </contact>
    <investigator>
      <last_name>Jacqueline M. Kraveka</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>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>Debra L. Friedman</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>Cook Children's Medical Center</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>682-885-2103</phone>
      <email>CookChildrensResearch@cookchildrens.org</email>
    </contact>
    <investigator>
      <last_name>Kenneth M. Heym</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>Karen R. Rabin</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>Scott and White Memorial Hospital</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76508</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>254-724-5407</phone>
    </contact>
    <investigator>
      <last_name>Nicholas W. McGregor</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>Luke D. Maese</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Vermont and State Agricultural College</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>802-656-8990</phone>
      <email>rpo@uvm.edu</email>
    </contact>
    <investigator>
      <last_name>Jessica L. Heath</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>Naval Medical Center - Portsmouth</name>
      <address>
        <city>Portsmouth</city>
        <state>Virginia</state>
        <zip>23708-2197</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>757-953-5939</phone>
    </contact>
    <investigator>
      <last_name>Bethany M. Mikles</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>Jordyn R. Griffin</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>Edwards Comprehensive Cancer Center</name>
      <address>
        <city>Huntington</city>
        <state>West Virginia</state>
        <zip>25701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>304-399-6566</phone>
      <email>Christina.Cole@chhi.org</email>
    </contact>
    <investigator>
      <last_name>Mark A. Ranalli</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>West Virginia University Healthcare</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>304-293-7374</phone>
      <email>cancertrialsinfo@hsc.wvu.edu</email>
    </contact>
    <investigator>
      <last_name>Ashley E. Meyer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Vincent Hospital Cancer Center Green Bay</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54301</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>920-433-8889</phone>
      <email>ewd_research_admin@hshs.org</email>
    </contact>
    <investigator>
      <last_name>Catherine A. Long</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>Children's Hospital of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>414-955-4727</phone>
      <email>MACCCTO@mcw.edu</email>
    </contact>
    <investigator>
      <last_name>Michael J. Burke</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>Sydney Children's Hospital</name>
      <address>
        <city>Randwick</city>
        <state>New South Wales</state>
        <zip>2031</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>(02) 9382-1721</phone>
    </contact>
    <investigator>
      <last_name>Draga Barbaric</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>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>61-2-9845 1400</phone>
    </contact>
    <investigator>
      <last_name>Bhavna Padhye</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Queensland Children's Hospital</name>
      <address>
        <city>South Brisbane</city>
        <state>Queensland</state>
        <zip>4101</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>61 7 3068 1111</phone>
    </contact>
    <investigator>
      <last_name>Christopher J. Fraser</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Hospital for Children</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6008</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </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>St. Anna Children's Hospital</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr. A Attarbashi</last_name>
      <phone>43(1)40470-4780</phone>
      <email>andishe.attarbaschi@stanna.at</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospitals Leuven</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Prof. Anne Uyttebroeck</last_name>
      <phone>32 16 34 39 72</phone>
      <email>anne.uyttebroeck@uzleuven.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Alberta Children's Hospital</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T3B 6A8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>403-220-6898</phone>
      <email>research4kids@ucalgary.ca</email>
    </contact>
    <investigator>
      <last_name>Victor A. Lewis</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>British Columbia Children's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6H 3V4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>604-875-2345</phone>
      <phone_ext>6477</phone_ext>
    </contact>
    <investigator>
      <last_name>David B. Dix</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>Kingston Health Sciences Centre</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 2V7</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>613-549-6666</phone>
      <email>cc-clinicaltrials@kgh.kari.net</email>
    </contact>
    <investigator>
      <last_name>Laura Wheaton</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>Sumit Gupta</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 Sherbrooke-Fleurimont</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>819-820-6480</phone>
      <email>crcinformation.chus@ssss.gouv.qc.ca</email>
    </contact>
    <investigator>
      <last_name>Josee Brossard</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Jim Pattison Children's Hospital</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7N 0W8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>306-766-5573</phone>
    </contact>
    <investigator>
      <last_name>Kathleen Felton</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saskatoon Cancer Centre</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7N 4H4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Suspended</status>
  </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>Hospital Roberto del Rio-Universidad de Chile</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr. M. Campbell</last_name>
      <phone>56 225758470</phone>
      <email>myriamcampbellb@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Motol</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Prof. J. Stary</last_name>
      <phone>42 22 443 6401</phone>
      <email>jan.stary@lfmotol.cuni.cz</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tampere University Hospital</name>
      <address>
        <city>Tampere</city>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr. Oli Lohi</last_name>
      <phone>358 311 67836</phone>
      <email>oli.lohi@pshp.fi</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Hopital Sud</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr. V. Gandemer</last_name>
      <phone>33 229265835</phone>
      <email>virginie.gandmer@chu-rennes.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitatsklinik Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr. G Escherich</last_name>
      <phone>49 40 74105 3796</phone>
      <email>escherich@uke.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Medical Center Chleswig-Campus Kiel</name>
      <address>
        <city>Schleswig</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr. M. Schrappe</last_name>
      <phone>49(0) 431-500 20100</phone>
      <phone_ext>20102</phone_ext>
      <email>m.schrappe@pediatrics.uni-kiel.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hong Kong Children's Hospital</name>
      <address>
        <city>Kowloon Bay</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr. Chi-Kong Li</last_name>
      <phone>85 226321019</phone>
      <email>ckli@cuhk.edu.hk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Schneider Children's Medical Center of Israel</name>
      <address>
        <city>Petah-Tikva</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr. Sarah Elitzur</last_name>
      <phone>972 39253669</phone>
      <email>sarhae@clalit.org.il</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Prof Andrea Biondi</name>
      <address>
        <city>Monza</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Prof Andrea Biondi</last_name>
      <phone>+390392336816</phone>
      <phone_ext>3513</phone_ext>
      <email>abiondi.unimib@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Princess Maxima Center for Pediatric Oncology</name>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Prof. R Pieters</last_name>
      <phone>31 88 972 85 89</phone>
      <email>r.pieters@prinsesmaximacentrum.nl</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Starship Children's Hospital</name>
      <address>
        <city>Grafton</city>
        <state>Auckland</state>
        <zip>1145</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>0800 728 436</phone>
    </contact>
    <investigator>
      <last_name>Peter J. Bradbeer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Christchurch Hospital</name>
      <address>
        <city>Christchurch</city>
        <zip>8011</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>03 364 0640</phone>
    </contact>
    <investigator>
      <last_name>Siobhan F. Cross</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>
    <facility>
      <name>San Jorge Children's Hospital</name>
      <address>
        <city>San Juan</city>
        <zip>00912</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Pediatric Hospital</name>
      <address>
        <city>San Juan</city>
        <zip>00926</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>787-474-0333</phone>
    </contact>
    <investigator>
      <last_name>Maria E. Echevarria</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>King Faisal Specialist Hospital and Research Centre</name>
      <address>
        <city>Riyadh</city>
        <zip>11211</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Skane University Hospital</name>
      <address>
        <city>Lund</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr. Dominik Turkiewicz</last_name>
      <phone>46 46 178323</phone>
      <email>dominik.turkiewicz@skane.se</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Children's Hospital</name>
      <address>
        <city>Zurich</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Prof. Dr. Nicole Bodmer</last_name>
      <phone>44 41 266 8240</phone>
      <email>nicole.bodmer@kispi.uzh.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Czechia</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hong Kong</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>New Zealand</country>
    <country>Puerto Rico</country>
    <country>Saudi Arabia</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>China</country>
    <country>United Kingdom</country>
  </removed_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>September 15, 2023</last_update_submitted>
  <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 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>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
    <mesh_term>Precursor T-Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Philadelphia Chromosome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium, Dietary</mesh_term>
    <mesh_term>Leucovorin</mesh_term>
    <mesh_term>Folic Acid</mesh_term>
    <mesh_term>Cytarabine</mesh_term>
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>Methylprednisolone</mesh_term>
    <mesh_term>Methylprednisolone Acetate</mesh_term>
    <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Prednisolone acetate</mesh_term>
    <mesh_term>Hydrocortisone</mesh_term>
    <mesh_term>Hydrocortisone 17-butyrate 21-propionate</mesh_term>
    <mesh_term>Hydrocortisone acetate</mesh_term>
    <mesh_term>Hydrocortisone hemisuccinate</mesh_term>
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Ifosfamide</mesh_term>
    <mesh_term>Isophosphamide mustard</mesh_term>
    <mesh_term>Doxorubicin</mesh_term>
    <mesh_term>Liposomal doxorubicin</mesh_term>
    <mesh_term>Methotrexate</mesh_term>
    <mesh_term>Etoposide</mesh_term>
    <mesh_term>Vincristine</mesh_term>
    <mesh_term>Etoposide phosphate</mesh_term>
    <mesh_term>Imatinib Mesylate</mesh_term>
    <mesh_term>Daunorubicin</mesh_term>
    <mesh_term>Asparaginase</mesh_term>
    <mesh_term>Mercaptopurine</mesh_term>
    <mesh_term>Podophyllotoxin</mesh_term>
    <mesh_term>Pegaspargase</mesh_term>
    <mesh_term>Thioguanine</mesh_term>
    <mesh_term>Dexrazoxane</mesh_term>
    <mesh_term>Razoxane</mesh_term>
    <mesh_term>Azathioprine</mesh_term>
    <mesh_term>Lenograstim</mesh_term>
    <mesh_term>Prednisolone hemisuccinate</mesh_term>
    <mesh_term>Prednisolone phosphate</mesh_term>
    <mesh_term>BB 1101</mesh_term>
    <mesh_term>Calcium</mesh_term>
    <mesh_term>2-Aminopurine</mesh_term>
    <mesh_term>Levoleucovorin</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/NCT03007147
org study id: AALL1631
secondary id: NCI-2016-01588
secondary id: AALL1631
secondary id: AALL1631
secondary id: AALL1631
secondary id: U10CA180886
secondary id: 2017-000705-20
nct id: NCT03007147
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This randomized phase III trial studies how well imatinib mesylate works in combination with
      two different chemotherapy regimens in treating patients with newly diagnosed Philadelphia
      chromosome positive acute lymphoblastic leukemia (ALL). Imatinib mesylate has been shown to
      improve outcomes in children and adolescents with Philadelphia chromosome positive (Ph+) ALL
      when given with strong chemotherapy, but the combination has many side effects. This trial is
      testing whether a different chemotherapy regimen may work as well as the stronger one but
      have fewer side effects when given with imatinib. The trial is also testing how well the
      combination of chemotherapy and imatinib works in another group of patients with a type of
      ALL that is similar to Ph+ ALL. This type of ALL is called "ABL-class fusion positive ALL",
      and because it is similar to Ph+ ALL, is thought it will respond well to the combination of
      agents used to treat Ph+ ALL.
PRIMARY OBJECTIVE:

      I. To compare disease-free survival (DFS) of standard risk (SR) pediatric Philadelphia
      chromosome (Ph)+ acute lymphoblastic leukemia (ALL) treated with continuous imatinib mesylate
      (imatinib) combined with either a high-risk Children's Oncology Group (COG) ALL chemotherapy
      backbone or the more intensive European (Es)PhALL chemotherapy backbone.

      SECONDARY OBJECTIVES:

      I. To compare DFS of SR pediatric Ph+ and ABL-class fusion positive ALL patients treated with
      continuous imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the
      more intensive EsPhALL chemotherapy backbone.

      II. To determine the feasibility of administration of imatinib after allogeneic hematopoietic
      stem cell transplantation (HSCT) in high risk Ph+ ALL patients.

      III. To determine event-free survival (EFS) of HR pediatric Ph+ ALL patients treated with
      EsPhALL chemotherapy, HSCT in first complete remission and post-HSCT imatinib.

      IV. To compare rates of grade 3 or higher infections in standard risk (SR) Ph+ ALL patients
      between the two randomized arms.

      V. To evaluate event free survival (EFS) and overall survival (OS) of all eligible Ph+ALL
      patients enrolled on the study.

      VI. To evaluate OS in SR Ph+ ALL patients. VII. To evaluate OS in HR Ph+ ALL patients. VIII.
      To evaluate EFS and OS of all eligible ABL-class fusion positive ALL patients enrolled on the
      study.

      EXPLORATORY OBJECTIVES:

      I. To describe the toxicities associated with post-HSCT administration of imatinib in HR
      Ph+ALL patients.

      II. To evaluate the long-term toxicities in SR Ph+ ALL patients treated with chemotherapy
      plus imatinib (no transplant), overall and between both randomized arms.

      III. To determine prognostic significance of minimal residual disease (MRD) in Ph+ ALL at
      various time points during therapy.

      IIIa. To evaluate MRD in HR patients just prior to HSCT and then at regular intervals
      post-HSCT and explore the association of these measurements with long-term outcome.

      IIIb. To evaluate concordance of MRD assessments made by IGH-T cell receptor (TCR) polymerase
      chain reaction (PCR) assay and next generation sequencing (NGS) assays.

      IV. To determine prognostic significance of IKZF1 gene aberrations and deletions in Ph+ ALL.

      V. To determine frequency and prognostic significance of p190 and p210 BCR-ABL1 fusion
      variants in pediatric Ph+ ALL.

      VI. To measure adherence to oral chemotherapeutic agents (imatinib, 6-mercaptopurine, and
      methotrexate) during the maintenance phase in SR Ph+ ALL patients.

      VIa. To identify factors associated with poor adherence. VIb. To determine association
      between relapse risk and adherence to each oral chemotherapeutic agent (separately and
      combined).

      VII. To measure adherence to imatinib after allogeneic HSCT in HR Ph+ ALL patients and
      identify factors associated with poor adherence.

      VIII. To compare DFS of SR ABL-class fusion positive ALL patients treated with continuous
      imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the more intensive
      EsPhALL chemotherapy backbone.

      OUTLINE:

      INDUCTION IA PART 1: Patients receive induction IA according to standard of care on days
      1-14.

      INDUCTION IA PART 2: Patients receive imatinib mesylate orally (PO) once daily (QD) or twice
      daily (BID) on days 15-33, prednisolone PO twice daily (BID) or methylprednisolone
      intravenously (IV) on days 15-28, vincristine sulfate IV over 1 minute on days 15 and 22,
      daunorubicin hydrochloride IV over 1-15 minutes on days 15 and 22, and methotrexate
      intrathecally (IT) on day 29.

      INDUCTION IB: Patients receive imatinib mesylate PO QD or BID on days 1-35, cyclophosphamide
      IV over 30-60 minutes on days 1 and 28, mercaptopurine PO on days 1-28, cytarabine IV or
      subcutaneously (SC) on days 3-6, 10-13, 17-20, and 24-27, and methotrexate IT on days 10 and
      24.

      POST-INDUCTION THERAPY: Patients classified as standard risk are randomized to 1 of 2 arms.
      Patients with high risk are assigned to Arm C.

      ARM A:

      CONSOLIDATION BLOCK 1: Patients receive imatinib mesylate PO QD or BID on days 1-21,
      methotrexate IT, cytarabine IT, and therapeutic hydrocortisone IT on day 1, high dose
      methotrexate IV over 24 hours on day 1, vincristine sulfate IV over 1 minute on days 1 and 6,
      dexamethasone PO BID or IV on days 1-5, cyclophosphamide IV over 30-60 minutes on days 2-4,
      leucovorin calcium PO or IV on days 3 and 4, high dose cytarabine IV over 3 hours and
      pegaspargase or calaspargase pegol IV over 1-2 hours on day 5, and filgrastim SC on days 7-11
      in the absence of disease progression or unexpected toxicity.

      CONSOLIDATION BLOCK 2: Patients receive imatinib mesylate PO QD or BID on days 1-21,
      methotrexate IT, cytarabine IT, and therapeutic hydrocortisone IT on day 1, high dose
      methotrexate IV over 24 hours on day 1, dexamethasone PO BID or IV on days 1-5, vincristine
      sulfate IV over 1 minute on days 1 and 6, ifosfamide IV over 1 hour on days 2-4, leucovorin
      calcium PO or IV on days 3 and 4, dexrazoxane hydrochloride IV over 5-15 minutes and
      daunorubicin hydrochloride IV over 1-15 minutes on day 5, pegaspargase or calaspargase pegol
      IV over 1-2 hours on day 6, and filgrastim SC on days 7-11 in the absence of disease
      progression or unexpected toxicity.

      CONSOLIDATION BLOCK 3: Patients receive imatinib mesylate PO QD or BID on days 1-21, high
      dose cytarabine IV over 3 hours on days 1-3, dexamethasone PO BID or IV on days 1-5,
      etoposide IV over 1-2 hours on days 3-5, methotrexate IT, cytarabine IT, and therapeutic
      hydrocortisone IT on day 5, pegaspargase or calaspargase pegol IV over 1-2 hours on day 6,
      and filgrastim SC on days 7-11 in the absence of disease progression or unexpected toxicity.

      DELAYED INTENSIFICATION 1 PART 1: Patients receive imatinib mesylate PO QD or BID on days
      1-35, methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine
      sulfate IV over 1 minute, dexrazoxane hydrochloride IV over 5-15 minutes, and doxorubicin IV
      over 1-15 minutes on days 8, 15, 22, and 29, and pegaspargase or calaspargase pegol IV over
      1-2 hours on day 8 in the absence of disease progression or unexpected toxicity.

      DELAYED INTENSIFICATION 1 PART 2: Patients receive imatinib mesylate PO QD on days 36-63,
      cyclophosphamide IV over 30-60 minutes on day 36, thioguanine PO on days 36-49, cytarabine IV
      over 1-30 minutes or SC on days 38-41 and 45-48, and methotrexate IT on days 38 and 45in the
      absence of disease progression or unexpected toxicity.

      INTERIM MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-28,
      methotrexate PO on days 1, 8, 15, and 22, and mercaptopurine PO on days 1-28 in the absence
      of disease progression or unexpected toxicity.

      DELAYED INTENSIFICATION 2 PART 1: Patients receive imatinib mesylate PO QD or BID on days
      1-35, methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine
      sulfate IV over 1 minute, dexrazoxane hydrochloride IV over 5-15 minutes, and doxorubicin IV
      over 1-15 minutes on days 8, 15, 22, and 29, and pegaspargase or calaspargase pegol IV over
      1-2 hours on day 8 in the absence of disease progression or unexpected toxicity.

      DELAYED INTENSIFICATION 2 PART 2: Patients receive imatinib mesylate PO QD on days 36-49,
      cyclophosphamide IV over 30-60 minutes on day 36, thioguanine PO on days 36-49, cytarabine IV
      over 1-30 minutes or SC on days 36-39 and 43-46, and methotrexate IT on days 36 and 43 in the
      absence of disease progression or unexpected toxicity.

      MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-84, methotrexate PO
      once weekly (QW) and IT on days 1 and 43 of cycles 1, 2, and 3, and mercaptopurine PO on days
      1-84. Cycles with imatinib mesylate and mercaptopurine repeat every 84 days for up to 104
      weeks from the start of Induction IA in the absence of disease progression or unexpected
      toxicity.

      ARM B:

      INTERIM MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-63,
      vincristine sulfate IV over 1 minute and high dose methotrexate IV over 24 hours on days 1,
      15, 29, and 43, leucovorin calcium PO or IV on days 3-4, 17-18, 31-32, and 45-46,
      mercaptopurine PO on days 1-56, and methotrexate IT on days 1 and 29 in the absence of
      disease progression or unexpected toxicity.

      DELAYED INTENSIFICATION PART 1: Patients receive imatinib mesylate PO QD or BID on days 1-28,
      methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine
      sulfate IV over 1 minute, dexrazoxane hydrochloride IV over 5-15 minutes, and doxorubicin IV
      over 1-15 minutes on days 1, 8, and 15, and pegaspargase or calaspargase pegol IV over 1-2
      hours or IM on day 4 in the absence of disease progression or unexpected toxicity.

      DELAYED INTENSIFICATION PART 2: Patients receive imatinib mesylate PO QD on days 29-56,
      cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on days 29-42, cytarabine IV
      over 1-30 minutes or SC on days 29-32 and 36-39, methotrexate IT on days 29 and 36,
      vincristine sulfate IV over 1 minute on days 43 and 50, and pegaspargase or calaspargase
      pegol IV over 1-2 hours on day 43 in the absence of disease progression or unexpected
      toxicity.

      INTERIM MAINTENANCE WITH CAPIZZI METHOTREXATE: Patients receive imatinib mesylate PO QD or
      BID on days 1-56, vincristine sulfate IV over 1 minute and methotrexate IV over 2-15 minutes
      on days 1, 11, 21, 31, and 41, methotrexate IT on days 1 and 31, and pegaspargase or
      calaspargase pegol IV over 1-2 hours on days 2 and 22 in the absence of disease progression
      or unexpected toxicity.

      MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-84, vincristine
      sulfate IV over 1 minute on days 1, 29, and 57, prednisolone PO BID (or methylprednisolone IV
      for cycle 1 and 2) on days 1-5, 29-33, and 57-61, mercaptopurine PO on days 1-84,
      methotrexate PO QW, and methotrexate IT on day 1 (and day 29 for cycle 1 and 2). Cycles
      repeat every 84 days for up to 104 weeks from the start of Induction IA in the absence of
      disease progression or unexpected toxicity.

      ARM C:

      CONSOLIDATION BLOCK 1: Patients receive imatinib mesylate, methotrexate, cytarabine,
      therapeutic hydrocortisone, high dose methotrexate, vincristine sulfate, dexamethasone,
      leucovorin calcium, high dose cytarabine, and pegaspargase or calaspargase pegol as in Arm A
      Consolidation Block 1, and filgrastim SC on day 7 in the absence of disease progression or
      unexpected toxicity.

      CONSOLIDATION BLOCK 2: Patients receive imatinib mesylate, methotrexate, cytarabine,
      therapeutic hydrocortisone, high dose methotrexate, dexamethasone, vincristine sulfate,
      ifosfamide, leucovorin calcium, dexrazoxane hydrochloride, daunorubicin hydrochloride,
      pegaspargase or calaspargase pegol, and filgrastim as Arm A Consolidation Block 2 in the
      absence of disease progression or unexpected toxicity.

      CONSOLIDATION BLOCK 3: Patients receive imatinib mesylate, dexamethasone, etoposide,
      methotrexate, cytarabine, therapeutic hydrocortisone, pegaspargase or calaspargase pegol, and
      filgrastim as in Arm A Consolidation Block 3, and high dose cytarabine IV over 3 hours on
      days 1-2 in the absence of disease progression or unexpected toxicity.

      HSCT: Patients undergo HSCT on day 0. Patients who do not proceed to HSCT receive Delayed
      Intensification 1, Interim Maintenance, Delayed Intensification 2, and Maintenance as in Arm
      A.

      POST-HSCT: Patients receive imatinib mesylate PO QD or BID starting on days 56-365 in the in
      the absence of disease progression or unexpected toxicity.

      After completion of study treatment, patients are followed up every year for 3 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease free survival (DFS) of Randomized Arms (standard risk [SR] Philadelphia chromosome [Ph+] acute lymphoblastic leukemia [ALL] patients)
time frame: Up to 3 years
description: Three-year DFS and 95% confidence intervals (CI) of SR Ph+ ALL patients treated continuous imatinib mesylate with high risk Children's Oncology Group (COG)-ALL chemotherapy backbone or more intensive European (Es)PhALL chemotherapy backbone.
measure: DFS on Randomized Arms (SR Ph+ ALL and ABL-class fusion positive patients)
time frame: Up to 3 years
description: Three-year DFS (time from randomization to relapse, second malignancy, or death in complete remission) and 95% CI of SR pediatric Ph+ and ABL-class fusion positive patients treated with continuous imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone.
measure: Feasibility of post hematopoietic stem cell transplantation (HSCT) imatinib mesylate administration after allogenic HSCT in high risk Ph+ ALL patients
time frame: Up to 2 years
description: The proportion of patients who receive at least 75% of intended doses.
measure: Event free survival (EFS) of high risk pediatric Ph+ ALL patients treated with EsPhALL chemotherapy, HSCT in first complete remission, and post-HSCT imatinib mesylate
time frame: Up to 3 years
description: Three-year EFS and 95% CI for high risk pediatric Ph+ ALL patients treated with EsPhALL chemotherapy, HSCT in first complete remission, and post-HSCT imatinib mesylate. EFS is defined as the time from the date of bone marrow for minimal residual disease (MRD) assessment at end-IB to first event (resistant disease [MRD >= 10-2 or morphologic residual disease at end of consolidation block 3], relapse, progressive disease [i.e., MRD >= 10-2 at two post-HSCT time points separated by at least 2 weeks], second malignancy, or death in complete remission), or time to last follow-up for patients without events.
measure: Incidence of grade 3 or higher infections in standard risk Ph+ ALL patients in the two randomized arms
time frame: Up to 3 years
description: Evaluated according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The rate of infections during the post IB/pre-maintenance phases of treatment will be described for each randomization group.
measure: EFS of all Ph+ patients
time frame: Up to 3 years
description: Three-year EFS and 95% CI for Ph+ ALL patients. EFS here is defined as the time from enrollment until resistant disease, relapse, progressive disease post-HSCT, second malignant, or death, whichever occurs first.
measure: Overall survival (OS) of all Ph+ patients
time frame: Up to 3 years
description: Three-year OS and 95% CI for Ph+ ALL patients. OS is defined as the time from study enrollment to death from any cause.
measure: OS of SR Ph+ patients
time frame: Up to 3 years
description: Three-year OS (time from randomization to death from any cause) and 95% CI of SR pediatric Ph+ patients
measure: OS of SR Ph+ patients by randomization group
time frame: Up to 3 years
description: Three-year OS (time from randomization to death from any cause) and 95% CI of SR pediatric Ph+ patients by randomization group: treated with continuous imatinib combined with either a high-risk COG-ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone.
measure: OS of high risk Ph+ patients
time frame: Up to 3 years
description: Three-year OS (time from the date of MRD assessment at end-IB to death from any cause) and 95% CI of HR pediatric Ph+ patients.
measure: EFS of all eligibility ABL-class fusion positive ALL patients
time frame: Up to 3 years
description: Three-year EFS (time from enrollment until resistant disease, relapse, progressive disease post-HSCT, second malignancy, or death, whichever occurs first) and 95% CI of ABL-class fusion positive patients.
measure: OS of all eligibility ABL-class fusion positive ALL patients
time frame: Up to 3 years
description: Three-year OS (the time from study enrollment to death from any cause) and 95% CI of ABL-class fusion positive patients.
measure: Incidence of toxicities associated with post-HSCT administration of imatinib mesylate
time frame: Up to 2 years
description: Evaluated according to NCI CTCAE version 5.0. Frequencies of target toxicities in high risk patients after the initiation of post-HSCT imatinib mesylate will be described. For the high risk patients, the specific targeted toxicities will include grade 4 neutropenia, grade 4 thrombocytopenia, grade 3 or higher bilirubin, grade 4 or higher transaminitis, and grade 3 or higher infection.
measure: Incidence of long-term toxicities in patients treated with chemotherapy plus imatinib mesylate (no transplant) in both arms
time frame: Up to 3 years
description: Evaluated according to NCI CTCAE version 5.0. Frequencies of long-term toxicities will be described and differences between randomized arms will be explored. Specific long-term toxicities to be explored include cardiac (echocardiographic abnormalities, including decreased left ventricular (LV) function and decreased LV wall thickness), growth (linear height, bone age), and second malignant neoplasm.
measure: MRD measured by IGH-T cell receptor (TCR) polymerase chain reaction (PCR) and next generation sequencing (NGS) assay
time frame: Up to 6 months
description: For all patients, frequencies and prognostic significance (DFS, EFS, OS) will be explored for MRD levels (i.e., MRD negative, detectable at < 5 x 10^-4, and dectectable at >= 5 x 10^-4) at end of Induction IB.
measure: MRD in high risk Ph+ patients measured by IGH-TCR PCR and NGS assay
time frame: Up to 3 years
description: The outcome of high risk Ph+ patients will be described, including proportion of patients who achieve MRD-negativity just prior to HSCT, and at regular intervals post-HSCT. Associations between these findings and long-term outcomes (e.g., OS, DFS) will be explored.
measure: MRD assessments made by IGH-TCR PCR assay and NGS assay
time frame: Up to 3 years
description: Concordance of MRD assessments made by IGH-TCR PCR assay and NGS assay will be described and evaluated. Scatter plots and diagrams will be used to examine agreements and patterns of agreement or any differences found. Concordance will be explored both for the overall cohort, as well as by risk group. The increased sensitivity of the NGS will be closely examined to find cases where the MRD levels are detectable by NGS but undetectable by PCR, as well as cases in which one test yields results and the other does not (test failure). Prognostic relationships on outcomes for these subjects will be inspected.
measure: IKZF1 gene aberrations and deletions
time frame: Up to 3 years
description: For both standard risk and high risk groups, frequencies and prognostic significance (OS, DFS) will be explored for IKZF1 gene aberrations and deletions.
measure: Frequency of p190 and p210 BCR-ABL1 fusion variants
time frame: Up to 3 years
description: For both standard risk and high risk groups, frequencies and prognostic significance (OS, DFS) will be explored for p190 and p210 BCR-ABL1 fusion variants in pediatric Ph+ ALL.
measure: Adherence to oral chemotherapeutic agents in standard risk Ph+ ALL patients
time frame: Up to 2 years
description: Adherence to imatinib mesylate, 6-mercaptopurine, and methotrexate will be evaluated in COG-enrolled participants using an electronic monitoring device. Adherence rate will be computed for each month of adherence monitoring. Longitudinal binomial regression will be conducted using generalized estimating equation methods by modeling monthly adherence rate as an unstructured mean model using five indicator variables of time for the study months. Time in months will also be treated as a continuous variable to explore temporal trends in adherence rate. Compound symmetry will be assumed as the working correlation matrix over time. Covariates that will be considered for adjustment include those hypothesized to be predictors of adherence, annual household income, parental education, time since start of maintenance, risk classification for ALL, and imatinib, 6-mercaptopurine (6MP), and methotrexate dose-intensity.
measure: Adherence to imatinib mesylate after allogeneic HSCT in high risk Ph+ ALL patients
time frame: Up to 2 years
description: Longitudinal binomial regression will be conducted using generalized estimating equation methods by modeling monthly adherence rate as an unstructured mean model using five indicator variables of time for the study months. Time in months will also be treated as a continuous variable to explore temporal trends in adherence rate. Compound symmetry will be assumed as the working correlation matrix over time. Covariates that will be considered for adjustment include those hypothesized to be predictors of adherence, annual household income, parental education, time since start of maintenance, risk classification for ALL, and imatinib, 6MP, and methotrexate dose-intensity.
arm group label: Arm A (imatinib mesylate, EsPhALL chemotherapy)
arm group type: Experimental
description: See Detailed Description
arm group label: Arm B (imatinib mesylate, COG/BFM chemotherapy)
arm group type: Experimental
description: See Detailed Description.
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
arm group type: Experimental
description: See Detailed Description
intervention type: Procedure
intervention name: Allogeneic Hematopoietic Stem Cell Transplantation
description: Undergo HSCT
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
other name: Allogeneic
other name: Allogeneic Hematopoietic Cell Transplantation
other name: Allogeneic Stem Cell Transplantation
other name: HSC
other name: HSCT
other name: Stem Cell Transplantation, Allogeneic
intervention type: Drug
intervention name: Calaspargase Pegol
description: Given IV
arm group label: Arm A (imatinib mesylate, EsPhALL chemotherapy)
arm group label: Arm B (imatinib mesylate, COG/BFM chemotherapy)
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
other name: Asparaginase (Escherichia coli Isoenzyme II), Conjugate with alpha-(((2,5-Dioxo-1-pyrrolidinyl)oxy)carbonyl)-omega-methoxypoly(oxy-1,2-ethanediyl)
other name: Asparlas
other name: Calaspargase Pegol-mknl
other name: EZN-2285
other name: SC-PEG E. Coli L-Asparaginase
other name: Succinimidyl Carbonate Monomethoxypolyethylene Glycol E. coli L-Asparaginase
intervention type: Drug
intervention name: Cyclophosphamide
description: Given IV
arm group label: Arm A (imatinib mesylate, EsPhALL chemotherapy)
arm group label: Arm B (imatinib mesylate, COG/BFM chemotherapy)
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
other name: (-)-Cyclophosphamide
other name: 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
other name: Carloxan
other name: Ciclofosfamida
other name: Ciclofosfamide
other name: Cicloxal
other name: Clafen
other name: Claphene
other name: CP monohydrate
other name: CTX
other name: CYCLO-cell
other name: Cycloblastin
other name: Cycloblastine
other name: Cyclophospham
other name: Cyclophosphamid monohydrate
other name: Cyclophosphamide Monohydrate
other name: Cyclophosphamidum
other name: Cyclophosphan
other name: Cyclophosphane
other name: Cyclophosphanum
other name: Cyclostin
other name: Cyclostine
other name: Cytophosphan
other name: Cytophosphane
other name: Cytoxan
other name: Fosfaseron
other name: Genoxal
other name: Genuxal
other name: Ledoxina
other name: Mitoxan
other name: Neosar
other name: Revimmune
other name: Syklofosfamid
other name: WR- 138719
intervention type: Drug
intervention name: Cytarabine
description: Given IV, SC, or IT
arm group label: Arm A (imatinib mesylate, EsPhALL chemotherapy)
arm group label: Arm B (imatinib mesylate, COG/BFM chemotherapy)
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
other name: .beta.-Cytosine arabinoside
other name: 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
other name: 1-.beta.-D-Arabinofuranosylcytosine
other name: 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
other name: 1-Beta-D-arabinofuranosylcytosine
other name: 1.beta.-D-Arabinofuranosylcytosine
other name: 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
other name: 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
other name: Alexan
other name: Ara-C
other name: ARA-cell
other name: Arabine
other name: Arabinofuranosylcytosine
other name: Arabinosylcytosine
other name: Aracytidine
other name: Aracytin
other name: Aracytine
other name: Beta-Cytosine Arabinoside
other name: CHX-3311
other name: Cytarabinum
other name: Cytarbel
other name: Cytosar
other name: Cytosine Arabinoside
other name: Cytosine-.beta.-arabinoside
other name: Cytosine-beta-arabinoside
other name: Erpalfa
other name: Starasid
other name: Tarabine PFS
other name: U 19920
other name: U-19920
other name: Udicil
other name: WR-28453
intervention type: Drug
intervention name: Daunorubicin Hydrochloride
description: Given IV
arm group label: Arm A (imatinib mesylate, EsPhALL chemotherapy)
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
other name: Cerubidin
other name: Cerubidine
other name: Cloridrato de Daunorubicina
other name: Daunoblastin
other name: Daunoblastina
other name: Daunoblastine
other name: Daunomycin Hydrochloride
other name: Daunomycin, hydrochloride
other name: Daunorubicin.HCl
other name: Daunorubicini Hydrochloridum
other name: FI-6339
other name: Ondena
other name: RP-13057
other name: Rubidomycin Hydrochloride
other name: Rubilem
intervention type: Drug
intervention name: Dexamethasone
description: Given PO or IV
arm group label: Arm A (imatinib mesylate, EsPhALL chemotherapy)
arm group label: Arm B (imatinib mesylate, COG/BFM chemotherapy)
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
other name: Aacidexam
other name: Adexone
other name: Aknichthol Dexa
other name: Alba-Dex
other name: Alin
other name: Alin Depot
other name: Alin Oftalmico
other name: Amplidermis
other name: Anemul mono
other name: Auricularum
other name: Auxiloson
other name: Baycadron
other name: Baycuten
other name: Baycuten N
other name: Cortidexason
other name: Cortisumman
other name: Decacort
other name: Decadrol
other name: Decadron
other name: Decadron DP
other name: Decalix
other name: Decameth
other name: Decasone R.p.
other name: Dectancyl
other name: Dekacort
other name: Deltafluorene
other name: Deronil
other name: Desamethasone
other name: Desameton
other name: Dexa-Mamallet
other name: Dexa-Rhinosan
other name: Dexa-Scheroson
other name: Dexa-sine
other name: Dexacortal
other name: Dexacortin
other name: Dexafarma
other name: Dexafluorene
other name: Dexalocal
other name: Dexamecortin
other name: Dexameth
other name: Dexamethasone Intensol
other name: Dexamethasonum
other name: Dexamonozon
other name: Dexapos
other name: Dexinoral
other name: Dexone
other name: Dinormon
other name: Dxevo
other name: Fluorodelta
other name: Fortecortin
other name: Gammacorten
other name: Hemady
other name: Hexadecadrol
other name: Hexadrol
other name: Lokalison-F
other name: Loverine
other name: Methylfluorprednisolone
other name: Millicorten
other name: Mymethasone
other name: Orgadrone
other name: Spersadex
other name: TaperDex
other name: Visumetazone
other name: ZoDex
intervention type: Drug
intervention name: Dexrazoxane Hydrochloride
description: Given IV
arm group label: Arm A (imatinib mesylate, EsPhALL chemotherapy)
arm group label: Arm B (imatinib mesylate, COG/BFM chemotherapy)
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
other name: Cardioxane
other name: Totect
other name: Zinecard
intervention type: Drug
intervention name: Doxorubicin
description: Given IV
arm group label: Arm A (imatinib mesylate, EsPhALL chemotherapy)
arm group label: Arm B (imatinib mesylate, COG/BFM chemotherapy)
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
other name: Adriablastin
other name: Hydroxydaunomycin
other name: Hydroxyl Daunorubicin
other name: Hydroxyldaunorubicin
intervention type: Drug
intervention name: Etoposide
description: Given IV
arm group label: Arm A (imatinib mesylate, EsPhALL chemotherapy)
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
other name: Demethyl Epipodophyllotoxin Ethylidine Glucoside
other name: EPEG
other name: Lastet
other name: Toposar
other name: Vepesid
other name: VP 16
other name: VP 16-213
other name: VP-16
other name: VP-16-213
other name: VP16
intervention type: Biological
intervention name: Filgrastim
description: Given IV
arm group label: Arm A (imatinib mesylate, EsPhALL chemotherapy)
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
other name: Filgrastim-aafi
other name: Filgrastim-ayow
other name: G-CSF
other name: Neupogen
other name: Nivestym
other name: r-metHuG-CSF
other name: Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
other name: Releuko
other name: rG-CSF
other name: Tevagrastim
intervention type: Drug
intervention name: Ifosfamide
description: Given IV
arm group label: Arm A (imatinib mesylate, EsPhALL chemotherapy)
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
other name: Asta Z 4942
other name: Asta Z-4942
other name: Cyfos
other name: Holoxan
other name: Holoxane
other name: Ifex
other name: IFO
other name: IFO-Cell
other name: Ifolem
other name: Ifomida
other name: Ifomide
other name: Ifosfamidum
other name: Ifoxan
other name: IFX
other name: Iphosphamid
other name: Iphosphamide
other name: Iso-Endoxan
other name: Isoendoxan
other name: Isophosphamide
other name: Mitoxana
other name: MJF 9325
other name: MJF-9325
other name: Naxamide
other name: Seromida
other name: Tronoxal
other name: Z 4942
other name: Z-4942
intervention type: Drug
intervention name: Imatinib Mesylate
description: Given PO
arm group label: Arm A (imatinib mesylate, EsPhALL chemotherapy)
arm group label: Arm B (imatinib mesylate, COG/BFM chemotherapy)
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
other name: CGP 57148
other name: CGP57148B
other name: Gleevec
other name: Glivec
other name: STI 571
other name: STI-571
other name: STI571
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Arm A (imatinib mesylate, EsPhALL chemotherapy)
arm group label: Arm B (imatinib mesylate, COG/BFM chemotherapy)
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
intervention type: Drug
intervention name: Leucovorin Calcium
description: Given PO or IV
arm group label: Arm A (imatinib mesylate, EsPhALL chemotherapy)
arm group label: Arm B (imatinib mesylate, COG/BFM chemotherapy)
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
other name: Adinepar
other name: Calcifolin
other name: Calcium (6S)-Folinate
other name: Calcium Folinate
other name: Calcium Leucovorin
other name: Calfolex
other name: Calinat
other name: Cehafolin
other name: Citofolin
other name: Citrec
other name: Citrovorum Factor
other name: Cromatonbic Folinico
other name: Dalisol
other name: Disintox
other name: Divical
other name: Ecofol
other name: Emovis
other name: Factor, Citrovorum
other name: Flynoken A
other name: Folaren
other name: Folaxin
other name: FOLI-cell
other name: Foliben
other name: Folidan
other name: Folidar
other name: Folinac
other name: Folinate Calcium
other name: folinic acid
other name: Folinic Acid Calcium Salt Pentahydrate
other name: Folinoral
other name: Folinvit
other name: Foliplus
other name: Folix
other name: Imo
other name: Lederfolat
other name: Lederfolin
other name: Leucosar
other name: leucovorin
other name: Rescufolin
other name: Rescuvolin
other name: Tonofolin
other name: Wellcovorin
intervention type: Drug
intervention name: Mercaptopurine
description: Given PO
arm group label: Arm A (imatinib mesylate, EsPhALL chemotherapy)
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
other name: 3H-Purine-6-thiol
other name: 6 MP
other name: 6 Thiohypoxanthine
other name: 6 Thiopurine
other name: 6-Mercaptopurine
other name: 6-Mercaptopurine Monohydrate
other name: 6-MP
other name: 6-Purinethiol
other name: 6-Thiopurine
other name: 6-Thioxopurine
other name: 6H-Purine-6-thione, 1,7-dihydro- (9CI)
other name: 7-Mercapto-1,3,4,6-tetrazaindene
other name: Alti-Mercaptopurine
other name: Azathiopurine
other name: Bw 57-323H
other name: Flocofil
other name: Ismipur
other name: Leukerin
other name: Leupurin
other name: Mercaleukim
other name: Mercaleukin
other name: Mercaptina
other name: Mercaptopurinum
other name: Mercapurin
other name: Mern
other name: NCI-C04886
other name: Puri-Nethol
other name: Purimethol
other name: Purine, 6-mercapto-
other name: Purine-6-thiol (8CI)
other name: Purine-6-thiol, monohydrate
other name: Purinethiol
other name: Purinethol
other name: U-4748
other name: WR-2785
intervention type: Drug
intervention name: Mercaptopurine
description: Given PO
arm group label: Arm A (imatinib mesylate, EsPhALL chemotherapy)
arm group label: Arm B (imatinib mesylate, COG/BFM chemotherapy)
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
other name: 3H-Purine-6-thiol
other name: 6 MP
other name: 6 Thiohypoxanthine
other name: 6 Thiopurine
other name: 6-Mercaptopurine
other name: 6-Mercaptopurine Monohydrate
other name: 6-MP
other name: 6-Purinethiol
other name: 6-Thiopurine
other name: 6-Thioxopurine
other name: 6H-Purine-6-thione, 1,7-dihydro- (9CI)
other name: 7-Mercapto-1,3,4,6-tetrazaindene
other name: Alti-Mercaptopurine
other name: Azathiopurine
other name: Bw 57-323H
other name: Flocofil
other name: Ismipur
other name: Leukerin
other name: Leupurin
other name: Mercaleukim
other name: Mercaleukin
other name: Mercaptina
other name: Mercaptopurinum
other name: Mercapurin
other name: Mern
other name: NCI-C04886
other name: Puri-Nethol
other name: Purimethol
other name: Purine, 6-mercapto-
other name: Purine-6-thiol (8CI)
other name: Purine-6-thiol, monohydrate
other name: Purinethiol
other name: Purinethol
other name: U-4748
other name: WR-2785
intervention type: Drug
intervention name: Methotrexate
description: Given IT
arm group label: Arm A (imatinib mesylate, EsPhALL chemotherapy)
arm group label: Arm B (imatinib mesylate, COG/BFM chemotherapy)
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
other name: Abitrexate
other name: Alpha-Methopterin
other name: Amethopterin
other name: Brimexate
other name: CL 14377
other name: CL-14377
other name: Emtexate
other name: Emthexat
other name: Emthexate
other name: Farmitrexat
other name: Fauldexato
other name: Folex
other name: Folex PFS
other name: Lantarel
other name: Ledertrexate
other name: Lumexon
other name: Maxtrex
other name: Medsatrexate
other name: Metex
other name: Methoblastin
other name: Methotrexate LPF
other name: Methotrexate Methylaminopterin
other name: Methotrexatum
other name: Metotrexato
other name: Metrotex
other name: Mexate
other name: Mexate-AQ
other name: MTX
other name: Novatrex
other name: Rheumatrex
other name: Texate
other name: Tremetex
other name: Trexeron
other name: Trixilem
other name: WR-19039
intervention type: Drug
intervention name: Methylprednisolone
description: Given IV
arm group label: Arm A (imatinib mesylate, EsPhALL chemotherapy)
arm group label: Arm B (imatinib mesylate, COG/BFM chemotherapy)
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
other name: Adlone
other name: Caberdelta M
other name: DepMedalone
other name: Depo Moderin
other name: Depo-Nisolone
other name: Duralone
other name: Emmetipi
other name: Esametone
other name: Firmacort
other name: Medlone 21
other name: Medrate
other name: Medrol
other name: Medrol Veriderm
other name: Medrone
other name: Mega-Star
other name: Meprolone
other name: Methylprednisolonum
other name: Metilbetasone Solubile
other name: Metrocort
other name: Metypresol
other name: Metysolon
other name: Predni-M-Tablinen
other name: Prednilen
other name: Radilem
other name: Sieropresol
other name: Solpredone
other name: Summicort
other name: Urbason
other name: Veriderm Medrol
other name: Wyacort
intervention type: Drug
intervention name: Pegaspargase
description: Given IV
arm group label: Arm A (imatinib mesylate, EsPhALL chemotherapy)
arm group label: Arm B (imatinib mesylate, COG/BFM chemotherapy)
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
other name: L-Asparaginase with Polyethylene Glycol
other name: Oncaspar
other name: Oncaspar-IV
other name: PEG-Asparaginase
other name: PEG-L-Asparaginase
other name: PEG-L-Asparaginase (Enzon - Kyowa Hakko)
other name: PEGLA
other name: Polyethylene Glycol L-Asparaginase
other name: Polyethylene Glycol-L-Asparaginase
intervention type: Drug
intervention name: Prednisolone
description: Given PO
arm group label: Arm A (imatinib mesylate, EsPhALL chemotherapy)
arm group label: Arm B (imatinib mesylate, COG/BFM chemotherapy)
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
other name: (11beta)-11,17,21-Trihydroxypregna-1,4-diene-3,20-dione
other name: .delta.1-Hydrocortisone
other name: Adnisolone
other name: Aprednislon
other name: Capsoid
other name: Cortalone
other name: Cortisolone
other name: Dacortin H
other name: Decaprednil
other name: Decortin H
other name: Delta(1)Hydrocortisone
other name: Delta- Cortef
other name: Delta-Cortef
other name: Delta-Diona
other name: Delta-F
other name: Delta-Phoricol
other name: Delta1-dehydro-hydrocortisone
other name: Deltacortril
other name: Deltahydrocortisone
other name: Deltasolone
other name: Deltidrosol
other name: Dhasolone
other name: Di-Adreson-F
other name: Dontisolon D
other name: Estilsona
other name: Fisopred
other name: Frisolona
other name: Gupisone
other name: Hostacortin H
other name: Hydeltra
other name: Hydeltrasol
other name: Klismacort
other name: Kuhlprednon
other name: Lenisolone
other name: Lepi-Cortinolo
other name: Linola-H N
other name: Linola-H-Fett N
other name: Longiprednil
other name: Metacortandralone
other name: Meti Derm
other name: Meticortelone
other name: Opredsone
other name: Panafcortelone
other name: Precortisyl
other name: Pred-Clysma
other name: Predeltilone
other name: Predni-Coelin
other name: Predni-Helvacort
other name: Prednicortelone
other name: Prednisolonum
other name: Prelone
other name: Prenilone
other name: Sterane
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Arm A (imatinib mesylate, EsPhALL chemotherapy)
arm group label: Arm B (imatinib mesylate, COG/BFM chemotherapy)
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
intervention type: Drug
intervention name: Therapeutic Hydrocortisone
description: Given IT
arm group label: Arm A (imatinib mesylate, EsPhALL chemotherapy)
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
other name: Aeroseb-HC
other name: Barseb HC
other name: Barseb-HC
other name: Cetacort
other name: Cort-Dome
other name: Cortef
other name: Cortenema
other name: Cortifan
other name: Cortisol
other name: Cortispray
other name: Cortril
other name: Dermacort
other name: Domolene
other name: Eldecort
other name: Hautosone
other name: Heb-Cort
other name: Hydrocortisone
other name: Hydrocortone
other name: Hytone
other name: Komed-HC
other name: Nutracort
other name: Proctocort
other name: Rectoid
intervention type: Drug
intervention name: Thioguanine
description: Given PO
arm group label: Arm A (imatinib mesylate, EsPhALL chemotherapy)
arm group label: Arm B (imatinib mesylate, COG/BFM chemotherapy)
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
other name: 2-Amino 6MP
other name: 2-Amino-1,7-dihydro-6H-purine-6-thione
other name: 2-Amino-6-mercaptopurine
other name: 2-Amino-6-purinethiol
other name: 2-Aminopurin-6-thiol
other name: 2-Aminopurine-6(1H)-thione
other name: 2-Aminopurine-6-thiol
other name: 2-Aminopurine-6-thiol Hemihydrate
other name: 2-Mercapto-6-aminopurine
other name: 6-Amino-2-mercaptopurine
other name: 6-Mercapto-2-aminopurine
other name: 6-Mercaptoguanine
other name: 6-TG
other name: 6H-Purine-6-thione, 2-amino-1,7-dihydro- (9CI)
other name: BW 5071
other name: Lanvis
other name: Tabloid
other name: Thioguanine Hemihydrate
other name: Thioguanine Hydrate
other name: Tioguanin
other name: Tioguanine
other name: Wellcome U3B
other name: WR-1141
other name: X 27
intervention type: Drug
intervention name: Vincristine Sulfate
description: Given IV
arm group label: Arm A (imatinib mesylate, EsPhALL chemotherapy)
arm group label: Arm B (imatinib mesylate, COG/BFM chemotherapy)
arm group label: Arm C (imatinib mesylate, EsPhALL chemotherapy, HSCT)
other name: Kyocristine
other name: Leurocristine Sulfate
other name: Leurocristine, sulfate
other name: Oncovin
other name: Vincasar
other name: Vincosid
other name: Vincrex
other name: Vincristine, sulfate
criteria: 
gender: All
minimum age: 1 Year
maximum age: 21 Years
healthy volunteers: No
last name: Lewis B Silverman, MD
role: Principal Investigator
affiliation: Children's Oncology Group
last name: Prof Andrea Biondi
role: Principal Investigator
affiliation: EsPhALL network I-BFM Study Group
facility: 
status: Recruiting
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status: Withdrawn
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status: Active, not recruiting
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status: Recruiting
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status: Recruiting
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status: Suspended
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Active, not recruiting
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status: Suspended
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contact: 
country: Australia
country: Austria
country: Belgium
country: Canada
country: Chile
country: Czechia
country: Finland
country: France
country: Germany
country: Hong Kong
country: Israel
country: Italy
country: Netherlands
country: New Zealand
country: Puerto Rico
country: Saudi Arabia
country: Sweden
country: Switzerland
country: United States
country: China
country: United Kingdom
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphoid
mesh term: Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Philadelphia Chromosome
mesh term: Calcium, Dietary
mesh term: Leucovorin
mesh term: Folic Acid
mesh term: Cytarabine
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: Methylprednisolone
mesh term: Methylprednisolone Acetate
mesh term: Methylprednisolone Hemisuccinate
mesh term: Prednisolone
mesh term: Prednisolone acetate
mesh term: Hydrocortisone
mesh term: Hydrocortisone 17-butyrate 21-propionate
mesh term: Hydrocortisone acetate
mesh term: Hydrocortisone hemisuccinate
mesh term: Cyclophosphamide
mesh term: Ifosfamide
mesh term: Isophosphamide mustard
mesh term: Doxorubicin
mesh term: Liposomal doxorubicin
mesh term: Methotrexate
mesh term: Etoposide
mesh term: Vincristine
mesh term: Etoposide phosphate
mesh term: Imatinib Mesylate
mesh term: Daunorubicin
mesh term: Asparaginase
mesh term: Mercaptopurine
mesh term: Podophyllotoxin
mesh term: Pegaspargase
mesh term: Thioguanine
mesh term: Dexrazoxane
mesh term: Razoxane
mesh term: Azathioprine
mesh term: Lenograstim
mesh term: Prednisolone hemisuccinate
mesh term: Prednisolone phosphate
mesh term: BB 1101
mesh term: Calcium
mesh term: 2-Aminopurine
mesh term: Levoleucovorin