<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/NCT04401267</url>
  </required_header>
  <id_info>
    <org_study_id>HYPERION</org_study_id>
    <secondary_id>1K08CA250418</secondary_id>
    <secondary_id>NCI-2020-03603</secondary_id>
    <nct_id>NCT04401267</nct_id>
  </id_info>
  <brief_title>Hypertension Intervention to Reduce Osteonecrosis in Children With Acute Lymphoblastic Leukemia/Lymphoma</brief_title>
  <official_title>Hypertension Intervention to Reduce Osteonecrosis in Children With Acute Lymphoblastic Leukemia/Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Jude Children's Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Jude Children's Research Hospital</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 is a randomized unblinded Phase II clinical trial evaluating the impact of intensive&#xD;
      antihypertensive control (targeted to the 50-75th percentile for age, sex, and height)&#xD;
      compared to conventional antihypertensive control (targeted to the 90-95th percentile for&#xD;
      age, sex, and height) on the incidence of radiographically extensive osteonecrosis in&#xD;
      children and young adults receiving treatment for newly diagnosed acute lymphoblastic&#xD;
      leukemia/lymphoma (ALL).&#xD;
&#xD;
      Primary Objective&#xD;
&#xD;
        -  Compare the frequency of radiographically extensive osteonecrosis in patients receiving&#xD;
           intensive compared to conventional antihypertensive therapy.&#xD;
&#xD;
      Secondary Objectives&#xD;
&#xD;
        -  Evaluate the efficacy of intensive antihypertensive control compared to conventional&#xD;
           antihypertensive control in the prevention of clinically significant (CTCAE Grade 2 or&#xD;
           higher) and radiologically extensive osteonecrosis, overall and stratified by joints.&#xD;
&#xD;
        -  Compare the frequency of clinically significant and radiographically extensive&#xD;
           osteonecrosis in patients receiving antihypertensive therapy and historical controls.&#xD;
&#xD;
        -  Compare blood pressures achieved in intensive and conventional arms using both pressures&#xD;
           obtained as part of routine patient care and ambulatory blood pressure monitoring.&#xD;
&#xD;
        -  Compare levels of vascular dysfunction as measured physiologically, radiographically,&#xD;
           and in blood samples in patients receiving intensive compared to standard&#xD;
           antihypertensive therapy.&#xD;
&#xD;
      Exploratory Objectives&#xD;
&#xD;
        -  Identify predictive patterns of blood biomarkers which identify patients at high- risk&#xD;
           of developing clinically significant osteonecrosis.&#xD;
&#xD;
        -  Identify MRI findings during late induction which correlate with osteonecrosis lesions&#xD;
           seen during reinduction.&#xD;
&#xD;
        -  Identify patterns of diurnal blood pressure variation as measured by ambulatory blood&#xD;
           pressure monitoring associated with the later development of osteonecrosis.&#xD;
&#xD;
        -  Compare induction blood pressure control and intervention arm to echocardiographic&#xD;
           changes at reinduction II.&#xD;
&#xD;
        -  Evaluate patient-reported, health-related quality of life in patients during induction&#xD;
           and after 1.5 years of therapy when many experience the symptoms of osteonecrosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patient randomization will be stratified based on patient's location (Memphis vs. other), use&#xD;
      of antihypertensives prior to randomization, and factors known to influence osteonecrosis&#xD;
      risk, specifically sex and self-declared race (non-Hispanic white vs. other). A target&#xD;
      systolic blood pressure range will be chosen for each participant based on their&#xD;
      randomization arm, age, sex, and height.&#xD;
&#xD;
      Patients will be randomized on day 4 of induction therapy to either conventional or intensive&#xD;
      blood pressure goals. Patients will be treated with antihypertensive therapy to achieve blood&#xD;
      pressure control as indicated by their randomized arm. Therapy will be adjusted every 3-4&#xD;
      days as needed to achieve targeted control based on the mean of blood pressures obtained in&#xD;
      that period. Treatment of hypertension to the target will continue until the completion of&#xD;
      reinduction II therapy. Patients will be evaluated for osteonecrosis as indicated in their&#xD;
      primary therapeutic protocol using MRI during reinduction II.&#xD;
&#xD;
      Patients will be asked to complete a symptom survey and a semi-structured interview.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 15, 2020</start_date>
  <completion_date type="Anticipated">March 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">March 30, 2024</primary_completion_date>
  <phase>Phase 2</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>Single (Outcomes Assessor)</masking>
    <masking_description>Evaluation of the MRIs defining the primary endpoint will be performed by a blinded radiologist.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Extensive radiographic osteonecrosis</measure>
    <time_frame>during reinduction II therapy, approximately 9 months into therapy.</time_frame>
    <description>Involvement of &gt;=30% of the epiphyseal surface of either the hip or knee by prospective MRI during reinduction II</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of clinically significant osteonecrosis</measure>
    <time_frame>any time during leukemia therapy, approximately 2.5 years</time_frame>
    <description>CTCAE grade 2 or high osteonecrosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of clinically significant osteonecrosis vs. historical control</measure>
    <time_frame>any time during leukemia therapy, approximately 2.5 years</time_frame>
    <description>CTCAE grade 2 or high osteonecrosis vs. Total 16 matched controls</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure control on trial</measure>
    <time_frame>first 9 months of therapy</time_frame>
    <description>Comparison of repeated systolic and diastolic blood pressure measures between randomized treatment arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarkers of vascular dysfunction - eNO synthetase (pg/mL)</measure>
    <time_frame>3 weeks and 9 months into therapy</time_frame>
    <description>Comparison between randomized treatment arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarker of vascular dysfunction - Von Willebrand Factor (%)</measure>
    <time_frame>3 weeks and 9 months into therapy</time_frame>
    <description>Comparison between randomized treatment arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarker of vascular dysfunction - TNF-alpha (pg/mL)</measure>
    <time_frame>3 weeks and 9 months into therapy</time_frame>
    <description>Comparison between randomized treatment arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarker of vascular dysfunction - D-dimer (µg/mL)</measure>
    <time_frame>3 weeks and 9 months into therapy</time_frame>
    <description>Comparison between randomized treatment arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarker of vascular dysfunction - PAI-1 (AU/mL)</measure>
    <time_frame>3 weeks and 9 months into therapy</time_frame>
    <description>Comparison between randomized treatment arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarker of vascular dysfunction - E-selectin (ng/mL)</measure>
    <time_frame>3 weeks and 9 months into therapy</time_frame>
    <description>Comparison between randomized treatment arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarker of vascular dysfunction - ICAM-1 (ng/mL)</measure>
    <time_frame>3 weeks and 9 months into therapy</time_frame>
    <description>Comparison between randomized treatment arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarker of vascular dysfunction - Arterial elasticity (ml/mmHg)</measure>
    <time_frame>3 weeks and 3 months into therapy</time_frame>
    <description>Comparison between randomized treatment arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarker of vascular dysfunction - Pulse Wave Velocity (m/sec)</measure>
    <time_frame>3 weeks and 3 months into therapy</time_frame>
    <description>Comparison between randomized treatment arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Magnetic resonance imaging (MRI) of hip and knee</measure>
    <time_frame>3 weeks and 9 months into therapy</time_frame>
    <description>Comparison between randomized treatment arms</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Hypertension</condition>
  <condition>Osteonecrosis</condition>
  <condition>Osteonecrosis Due to Drug</condition>
  <arm_group>
    <arm_group_label>Intensive Antihypertensive Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will begin Intensive antihypertensive therapy to achieve the targeted blood pressure (targeted to the 50-75th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Antihypertensive Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will begin Conventional antihypertensive therapy to achieve the targeted blood pressure (targeted to the 90-95th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intensive Antihypertensive Therapy</intervention_name>
    <description>Receives intensive antihypertensive therapy</description>
    <arm_group_label>Intensive Antihypertensive Therapy</arm_group_label>
    <other_name>Hypotensive Therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Conventional Antihypertensive Therapy</intervention_name>
    <description>Receives conventional antihypertensive therapy</description>
    <arm_group_label>Conventional Antihypertensive Therapy</arm_group_label>
    <other_name>Hypotensive Therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Symptom Survey</intervention_name>
    <description>The symptom survey is comprised of the PROMIS Ped 25 profile, PROMIS pain interference 8a, PROMIS physical activity 8a, and PROMIS mobility 8a during induction (day 23-28), during week 17 of continuation (+/- 2 weeks), and continuation week 49 (+/- 3 weeks).</description>
    <arm_group_label>Conventional Antihypertensive Therapy</arm_group_label>
    <arm_group_label>Intensive Antihypertensive Therapy</arm_group_label>
    <other_name>Survey</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Semi-structured interview</intervention_name>
    <description>Patients will be interviewed by a trained examiner about their treatment and symptom burden on Week 49 of TOT17 Continuation Therapy. The interview will be recorded and will take about 30-45 minutes.</description>
    <arm_group_label>Conventional Antihypertensive Therapy</arm_group_label>
    <arm_group_label>Intensive Antihypertensive Therapy</arm_group_label>
    <other_name>Interview</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is being treated for newly diagnosed acute lymphoblastic leukemia or lymphoma&#xD;
             (ALL) on the TOT17 protocol. Patients do not need to be hypertensive to enroll.&#xD;
&#xD;
          -  Patient is 10 years of age or older at the time of enrollment on TOT17.&#xD;
&#xD;
          -  Patient has completed ≤ 4 days of protocol therapy (patients are eligible on Day 4 of&#xD;
             TOT17 therapy).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Moderate-severe renal dysfunction (glomerular filtration rate &lt;45 ml/min/1.73m2).&#xD;
&#xD;
          -  Down's syndrome (germline Trisomy 21) or other syndrome resulting in growth delay or&#xD;
             alterations in stature.&#xD;
&#xD;
          -  Chronic inability to ambulate. Patients with limitations in movement due to acute&#xD;
             complications of leukemia/lymphoma are not excluded.&#xD;
&#xD;
          -  Permanent contraindication to MRI evaluation.&#xD;
&#xD;
          -  Participants who are pregnant or lactating. Males or females of reproductive potential&#xD;
             must agree to use effective contraception for the duration of study participation.&#xD;
&#xD;
          -  Inability or unwillingness of research participant or legal guardian/representative to&#xD;
             give written informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seth E. Karol, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Jude Children's Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Jude Affiliate Clinic - Novant Health Hemby Children's Hospital</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Jude Children's Research Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.stjude.org</url>
    <description>St. Jude Children's Research Hospital</description>
  </link>
  <link>
    <url>http://www.stjude.org/protocols</url>
    <description>ClinicalTrials Open at St. Jude</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>June 8, 2023</last_update_submitted>
  <last_update_submitted_qc>June 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute Lymphoblastic Leukemia</keyword>
  <keyword>Children</keyword>
  <keyword>Hypertension</keyword>
  <keyword>Osteonecrosis</keyword>
  <keyword>Osteonecrosis Due to Drug</keyword>
  <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>Osteonecrosis</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antihypertensive Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data will be made available at the time of article publication.</ipd_time_frame>
    <ipd_access_criteria>Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 1, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT04401267/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04401267
org study id: HYPERION
secondary id: 1K08CA250418
secondary id: NCI-2020-03603
nct id: NCT04401267
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized unblinded Phase II clinical trial evaluating the impact of intensive
      antihypertensive control (targeted to the 50-75th percentile for age, sex, and height)
      compared to conventional antihypertensive control (targeted to the 90-95th percentile for
      age, sex, and height) on the incidence of radiographically extensive osteonecrosis in
      children and young adults receiving treatment for newly diagnosed acute lymphoblastic
      leukemia/lymphoma (ALL).

      Primary Objective

        -  Compare the frequency of radiographically extensive osteonecrosis in patients receiving
           intensive compared to conventional antihypertensive therapy.

      Secondary Objectives

        -  Evaluate the efficacy of intensive antihypertensive control compared to conventional
           antihypertensive control in the prevention of clinically significant (CTCAE Grade 2 or
           higher) and radiologically extensive osteonecrosis, overall and stratified by joints.

        -  Compare the frequency of clinically significant and radiographically extensive
           osteonecrosis in patients receiving antihypertensive therapy and historical controls.

        -  Compare blood pressures achieved in intensive and conventional arms using both pressures
           obtained as part of routine patient care and ambulatory blood pressure monitoring.

        -  Compare levels of vascular dysfunction as measured physiologically, radiographically,
           and in blood samples in patients receiving intensive compared to standard
           antihypertensive therapy.

      Exploratory Objectives

        -  Identify predictive patterns of blood biomarkers which identify patients at high- risk
           of developing clinically significant osteonecrosis.

        -  Identify MRI findings during late induction which correlate with osteonecrosis lesions
           seen during reinduction.

        -  Identify patterns of diurnal blood pressure variation as measured by ambulatory blood
           pressure monitoring associated with the later development of osteonecrosis.

        -  Compare induction blood pressure control and intervention arm to echocardiographic
           changes at reinduction II.

        -  Evaluate patient-reported, health-related quality of life in patients during induction
           and after 1.5 years of therapy when many experience the symptoms of osteonecrosis.
Patient randomization will be stratified based on patient's location (Memphis vs. other), use
      of antihypertensives prior to randomization, and factors known to influence osteonecrosis
      risk, specifically sex and self-declared race (non-Hispanic white vs. other). A target
      systolic blood pressure range will be chosen for each participant based on their
      randomization arm, age, sex, and height.

      Patients will be randomized on day 4 of induction therapy to either conventional or intensive
      blood pressure goals. Patients will be treated with antihypertensive therapy to achieve blood
      pressure control as indicated by their randomized arm. Therapy will be adjusted every 3-4
      days as needed to achieve targeted control based on the mean of blood pressures obtained in
      that period. Treatment of hypertension to the target will continue until the completion of
      reinduction II therapy. Patients will be evaluated for osteonecrosis as indicated in their
      primary therapeutic protocol using MRI during reinduction II.

      Patients will be asked to complete a symptom survey and a semi-structured interview.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Evaluation of the MRIs defining the primary endpoint will be performed by a blinded radiologist.
measure: Extensive radiographic osteonecrosis
time frame: during reinduction II therapy, approximately 9 months into therapy.
description: Involvement of >=30% of the epiphyseal surface of either the hip or knee by prospective MRI during reinduction II
measure: Rate of clinically significant osteonecrosis
time frame: any time during leukemia therapy, approximately 2.5 years
description: CTCAE grade 2 or high osteonecrosis
measure: Rate of clinically significant osteonecrosis vs. historical control
time frame: any time during leukemia therapy, approximately 2.5 years
description: CTCAE grade 2 or high osteonecrosis vs. Total 16 matched controls
measure: Blood pressure control on trial
time frame: first 9 months of therapy
description: Comparison of repeated systolic and diastolic blood pressure measures between randomized treatment arms
measure: Biomarkers of vascular dysfunction - eNO synthetase (pg/mL)
time frame: 3 weeks and 9 months into therapy
description: Comparison between randomized treatment arms
measure: Biomarker of vascular dysfunction - Von Willebrand Factor (%)
time frame: 3 weeks and 9 months into therapy
description: Comparison between randomized treatment arms
measure: Biomarker of vascular dysfunction - TNF-alpha (pg/mL)
time frame: 3 weeks and 9 months into therapy
description: Comparison between randomized treatment arms
measure: Biomarker of vascular dysfunction - D-dimer (µg/mL)
time frame: 3 weeks and 9 months into therapy
description: Comparison between randomized treatment arms
measure: Biomarker of vascular dysfunction - PAI-1 (AU/mL)
time frame: 3 weeks and 9 months into therapy
description: Comparison between randomized treatment arms
measure: Biomarker of vascular dysfunction - E-selectin (ng/mL)
time frame: 3 weeks and 9 months into therapy
description: Comparison between randomized treatment arms
measure: Biomarker of vascular dysfunction - ICAM-1 (ng/mL)
time frame: 3 weeks and 9 months into therapy
description: Comparison between randomized treatment arms
measure: Biomarker of vascular dysfunction - Arterial elasticity (ml/mmHg)
time frame: 3 weeks and 3 months into therapy
description: Comparison between randomized treatment arms
measure: Biomarker of vascular dysfunction - Pulse Wave Velocity (m/sec)
time frame: 3 weeks and 3 months into therapy
description: Comparison between randomized treatment arms
measure: Magnetic resonance imaging (MRI) of hip and knee
time frame: 3 weeks and 9 months into therapy
description: Comparison between randomized treatment arms
arm group label: Intensive Antihypertensive Therapy
arm group type: Experimental
description: Patients will begin Intensive antihypertensive therapy to achieve the targeted blood pressure (targeted to the 50-75th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
arm group label: Conventional Antihypertensive Therapy
arm group type: Active Comparator
description: Patients will begin Conventional antihypertensive therapy to achieve the targeted blood pressure (targeted to the 90-95th percentile for age, sex, and height) on day 4 of Remission Induction on TOT17 and continue during steroid containing phases until the completion of reinduction II.
intervention type: Drug
intervention name: Intensive Antihypertensive Therapy
description: Receives intensive antihypertensive therapy
arm group label: Intensive Antihypertensive Therapy
other name: Hypotensive Therapy
intervention type: Drug
intervention name: Conventional Antihypertensive Therapy
description: Receives conventional antihypertensive therapy
arm group label: Conventional Antihypertensive Therapy
other name: Hypotensive Therapy
intervention type: Other
intervention name: Symptom Survey
description: The symptom survey is comprised of the PROMIS Ped 25 profile, PROMIS pain interference 8a, PROMIS physical activity 8a, and PROMIS mobility 8a during induction (day 23-28), during week 17 of continuation (+/- 2 weeks), and continuation week 49 (+/- 3 weeks).
arm group label: Conventional Antihypertensive Therapy
arm group label: Intensive Antihypertensive Therapy
other name: Survey
intervention type: Other
intervention name: Semi-structured interview
description: Patients will be interviewed by a trained examiner about their treatment and symptom burden on Week 49 of TOT17 Continuation Therapy. The interview will be recorded and will take about 30-45 minutes.
arm group label: Conventional Antihypertensive Therapy
arm group label: Intensive Antihypertensive Therapy
other name: Interview
criteria: 
gender: All
minimum age: 10 Years
maximum age: N/A
healthy volunteers: No
last name: Seth E. Karol, MD
role: Principal Investigator
affiliation: St. Jude Children's Research Hospital
facility: 
facility: 
country: United States
url: http://www.stjude.org
description: St. Jude Children's Research Hospital
url: http://www.stjude.org/protocols
description: ClinicalTrials Open at St. Jude
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphoid
mesh term: Osteonecrosis
mesh term: Hypertension
mesh term: Antihypertensive Agents
sharing ipd: Yes
ipd description: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data will be made available at the time of article publication.
ipd access criteria: Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
provided document: 