<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/NCT03016130</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201700581</org_study_id>
    <secondary_id>UF-BMT-LDND-101</secondary_id>
    <secondary_id>OCR15632</secondary_id>
    <nct_id>NCT03016130</nct_id>
  </id_info>
  <brief_title>Comparing Two Diets in Patients Undergoing HSCT or Remission Induction Chemo for Acute Leukemia and MDS (UF-BMT-LDND-101)</brief_title>
  <official_title>A Phase III, Randomized, Clinical Trial Comparing Two Diets in Patients Undergoing Hematopoietic Stem Cell Transplant (HSCT) or Remission Induction Chemotherapy for Acute Leukemia and Myelodysplastic Syndrome (UF-BMT-LDND-101)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, two-arm, phase III non-inferiority trial to evaluate the safety of a&#xD;
      liberalized hospital diet inclusive of fresh fruits and vegetables to a neutropenic diet in&#xD;
      patients with prolonged neutropenia. Both cohorts and diets will adhere to the hygiene and&#xD;
      common sense advice listed in the FDA-endorsed food safety guidelines.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 18, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2024</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of major infections</measure>
    <time_frame>1 year</time_frame>
    <description>The primary objective of the trial is to compare the incidence of major infections in subjects undergoing HSCT or receiving induction chemotherapy for acute leukemia with prolonged neutropenia (less than or equal to 7 days) who are receiving either Diet A or Diet B.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of infections in each diet group</measure>
    <time_frame>1 year</time_frame>
    <description>This secondary objective of the trial is to compare the impact of diet on severe infections including: septic shock, bloodstream infection, invasive fungal infection, upper respiratory infection, infectious &amp; non-infectious pneumonia, C. difficile infection, Vancomycin-resistant &amp; -sensitive enterococcal colonization, Vancomycin-resistant &amp; -sensitive enterococcal infections, febrile neutropenia, typhlitis, lower tract respiratory viral infections, infection-related mortality, and admission to the ICU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Admission frequency</measure>
    <time_frame>1 year</time_frame>
    <description>This secondary objective of the trial will examine the admission frequency to the intensive care unit (ICU).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance</measure>
    <time_frame>1 year</time_frame>
    <description>This secondary objective of the trial will evaluate the degree of compliance to each diet from the time of initiation of the diet intervention until either the Absolute Neutrophil Count (ANC) is equal to or less than 500/mm3, the subject is discharged from the hospital, the subject is transferred from the unit, or after 30 days of ANC less than 500/mm3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Generated Subjective Global Assessment (PG-SGA)</measure>
    <time_frame>1 year</time_frame>
    <description>This secondary objective of the trial will evaluate the impact of each diet on nutritional status as assessed by PG-SGA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of mucositis</measure>
    <time_frame>1 year</time_frame>
    <description>This secondary objective of the trial will evaluate the impact of mucositis on dietary intake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom incidence</measure>
    <time_frame>1 year</time_frame>
    <description>This secondary objective of the trial is to compare symptoms between diets using the MDASI tool.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QoL)</measure>
    <time_frame>1 year</time_frame>
    <description>This secondary objective of the trial is to compare the QoL between diets as assessed by FACT-G.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>1 year</time_frame>
    <description>This secondary objective of the trial is to evaluate OS from 1 year following randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS)</measure>
    <time_frame>1 year</time_frame>
    <description>This secondary objective of the trial is to evaluate PFS from 1 year following randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of graft vs.host disease (GVHD)</measure>
    <time_frame>1 year</time_frame>
    <description>This secondary objective of the trial is to evaluate the incidence of GVHD in allogeneic HSCT subjects only.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">217</enrollment>
  <condition>Leukemia</condition>
  <condition>Myelodysplastic Syndromes</condition>
  <arm_group>
    <arm_group_label>Liberalized Hospital Diet (Diet A)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Diet A would include fresh fruits and/or fresh vegetables in a liberalized hospital diet, and subjects will be encouraged to eat at least one daily serving of fresh fruits and/or vegetables.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neutropenic Diet (Diet B)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Diet B is the hospital neutropenic diet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diet</intervention_name>
    <description>Diet Intervention: Subjects will undergo stratified randomization to account for the heterogeneous population, to receive one of the two diets: liberalized hospital diet (Diet A) or a neutropenic diet (Diet B).</description>
    <arm_group_label>Liberalized Hospital Diet (Diet A)</arm_group_label>
    <arm_group_label>Neutropenic Diet (Diet B)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Undergoing treatment for hematologic malignancies or HSCT as outlined below:&#xD;
&#xD;
          -  Underlying diagnosis for non-HSCT patients:&#xD;
&#xD;
          -  Acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) receiving induction or&#xD;
             reinduction chemotherapy; OR&#xD;
&#xD;
          -  Acute lymphoblastic leukemia (ALL) receiving an intensive induction chemotherapy&#xD;
             (e.g., HyperCVAD±R, CALGB9251, Larsons protocol) with an expected duration of&#xD;
             neutropenia of ≥7 days; OR&#xD;
&#xD;
          -  Allogeneic or autologous HSCT for any indication. For patients undergoing reduced&#xD;
             intensity conditioning, only those regimens in which the expected neutropenia is ≥ 7&#xD;
             days are permitted and the patient must reside in the hospital&#xD;
&#xD;
          -  Expected duration of neutropenia of ≥ 7 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of anti infectives for treatment of active systemic infections within 7 days prior&#xD;
             to initiation of study diet&#xD;
&#xD;
          -  Untreated major infection at presentation&#xD;
&#xD;
          -  Patients with uncontrolled invasive fungal infection (defined as those who have not&#xD;
             completed at least 6 weeks of treatment; or who are symptomatic with two CT scans, at&#xD;
             least 1 week apart showing uncontrolled disease at the time of initiation of study&#xD;
             diet)&#xD;
&#xD;
          -  Uncontrolled HIV, Hepatitis B and C infection&#xD;
&#xD;
          -  Receipt of nutrition via enteral tube or total parenteral nutrition at the time of&#xD;
             enrollment&#xD;
&#xD;
          -  Patients unwilling to eat fresh fruit and/or vegetables&#xD;
&#xD;
          -  Planned management of neutropenia in the outpatient setting&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zeina A Al-Mansour, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UF Health Cancer Center</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>August 25, 2023</last_update_submitted>
  <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>leukemia</keyword>
  <keyword>myelodysplastic</keyword>
  <keyword>myeloid</keyword>
  <keyword>lymphoblastic</keyword>
  <keyword>diet</keyword>
  <keyword>infection</keyword>
  <keyword>hematopoietic</keyword>
  <keyword>stem cell</keyword>
  <keyword>transplant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Preleukemia</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_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/NCT03016130
org study id: IRB201700581
secondary id: UF-BMT-LDND-101
secondary id: OCR15632
nct id: NCT03016130
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is an open-label, two-arm, phase III non-inferiority trial to evaluate the safety of a
      liberalized hospital diet inclusive of fresh fruits and vegetables to a neutropenic diet in
      patients with prolonged neutropenia. Both cohorts and diets will adhere to the hygiene and
      common sense advice listed in the FDA-endorsed food safety guidelines.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Incidence of major infections
time frame: 1 year
description: The primary objective of the trial is to compare the incidence of major infections in subjects undergoing HSCT or receiving induction chemotherapy for acute leukemia with prolonged neutropenia (less than or equal to 7 days) who are receiving either Diet A or Diet B.
measure: Incidence of infections in each diet group
time frame: 1 year
description: This secondary objective of the trial is to compare the impact of diet on severe infections including: septic shock, bloodstream infection, invasive fungal infection, upper respiratory infection, infectious & non-infectious pneumonia, C. difficile infection, Vancomycin-resistant & -sensitive enterococcal colonization, Vancomycin-resistant & -sensitive enterococcal infections, febrile neutropenia, typhlitis, lower tract respiratory viral infections, infection-related mortality, and admission to the ICU.
measure: Admission frequency
time frame: 1 year
description: This secondary objective of the trial will examine the admission frequency to the intensive care unit (ICU).
measure: Compliance
time frame: 1 year
description: This secondary objective of the trial will evaluate the degree of compliance to each diet from the time of initiation of the diet intervention until either the Absolute Neutrophil Count (ANC) is equal to or less than 500/mm3, the subject is discharged from the hospital, the subject is transferred from the unit, or after 30 days of ANC less than 500/mm3.
measure: Patient-Generated Subjective Global Assessment (PG-SGA)
time frame: 1 year
description: This secondary objective of the trial will evaluate the impact of each diet on nutritional status as assessed by PG-SGA.
measure: Incidence of mucositis
time frame: 1 year
description: This secondary objective of the trial will evaluate the impact of mucositis on dietary intake.
measure: Symptom incidence
time frame: 1 year
description: This secondary objective of the trial is to compare symptoms between diets using the MDASI tool.
measure: Quality of life (QoL)
time frame: 1 year
description: This secondary objective of the trial is to compare the QoL between diets as assessed by FACT-G.
measure: Overall survival (OS)
time frame: 1 year
description: This secondary objective of the trial is to evaluate OS from 1 year following randomization
measure: Progression free survival (PFS)
time frame: 1 year
description: This secondary objective of the trial is to evaluate PFS from 1 year following randomization
measure: Incidence of graft vs.host disease (GVHD)
time frame: 1 year
description: This secondary objective of the trial is to evaluate the incidence of GVHD in allogeneic HSCT subjects only.
arm group label: Liberalized Hospital Diet (Diet A)
arm group type: Active Comparator
description: Diet A would include fresh fruits and/or fresh vegetables in a liberalized hospital diet, and subjects will be encouraged to eat at least one daily serving of fresh fruits and/or vegetables.
arm group label: Neutropenic Diet (Diet B)
arm group type: Active Comparator
description: Diet B is the hospital neutropenic diet.
intervention type: Other
intervention name: Diet
description: Diet Intervention: Subjects will undergo stratified randomization to account for the heterogeneous population, to receive one of the two diets: liberalized hospital diet (Diet A) or a neutropenic diet (Diet B).
arm group label: Liberalized Hospital Diet (Diet A)
arm group label: Neutropenic Diet (Diet B)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zeina A Al-Mansour, MD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Preleukemia
mesh term: Myelodysplastic Syndromes
mesh term: Syndrome