<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/NCT03259230</url>
  </required_header>
  <id_info>
    <org_study_id>NI-0501-07</org_study_id>
    <secondary_id>PA16-0129</secondary_id>
    <nct_id>NCT03259230</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Interferon Gamma (IFNγ) and Other Inflammatory Mediators in Patients With Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH)</brief_title>
  <official_title>An Observational, Multicenter Study to Evaluate Interferon Gamma (IFNγ) and Other Inflammatory Mediators in Patients With Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Light Chain Bioscience - Novimmune SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Light Chain Bioscience - Novimmune SA</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This observational study is designed to provide a better understanding of the potential use&#xD;
      of IFNγ and IFNγ-inducible chemokines as markers of HLH disease activity and prognosis, and&#xD;
      of the potential of IFNγ as a therapeutic target in M-HLH.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a non-interventional observational study designed to determine the levels of&#xD;
      inflammatory markers in patients diagnosed with M-HLH and to assess the relationship between&#xD;
      the biomarkers and disease activity in these patients during the M-HLH course. Inflammatory&#xD;
      markers will also be measured in a group of control patients diagnosed with hematological&#xD;
      malignancy but without HLH. Inflammatory markers include IFNγ and IFNγ-induced chemokines&#xD;
      CXCL9 and CXCL10.&#xD;
&#xD;
      In addition to the blood samples for the biomarker analysis, relevant information gathered by&#xD;
      the treating physician will be collected in a data collection form. Whenever possible,&#xD;
      collection of serum samples for biomarker analysis and relevant information should occur at&#xD;
      M-HLH diagnosis, at regular time intervals during the treatment course as well as at&#xD;
      resolution or reactivation of the disease.&#xD;
&#xD;
      Blood samples will also be sent to the study sponsor (NovImmune S.A.) for cytokine testing.&#xD;
      Before participant's samples are sent to the sponsor for testing, participant's name and any&#xD;
      personal identifying information will be coded to protect participant's privacy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 13, 2016</start_date>
  <completion_date type="Actual">January 29, 2020</completion_date>
  <primary_completion_date type="Actual">January 29, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Levels of Inflammatory Markers in Participants Diagnosed with Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH)</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Relationship of Levels of Inflammatory Markers in Participants Diagnosed with Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH) and Disease Activity</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Relationship Between Genetic Variants of Genes Causing HLH and M-HLH and Associated Inflammatory Markers</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">32</enrollment>
  <condition>Hemophagocytic Lymphohistiocytosis</condition>
  <arm_group>
    <arm_group_label>Malignancy-Associated Hemophagocytic Lymphohistiocytosis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Absence of HLH in patients diagnosed with malignancy</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood Draws</intervention_name>
    <arm_group_label>Absence of HLH in patients diagnosed with malignancy</arm_group_label>
    <arm_group_label>Malignancy-Associated Hemophagocytic Lymphohistiocytosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data Collection</intervention_name>
    <arm_group_label>Absence of HLH in patients diagnosed with malignancy</arm_group_label>
    <arm_group_label>Malignancy-Associated Hemophagocytic Lymphohistiocytosis</arm_group_label>
  </intervention>
  <biospec_descr>
    <textblock>
      Approximate volume of 500 µl - 1 ml of serum or plasma required per time point. Minimum of 1&#xD;
      ml of whole blood collected for genetic characterization.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Male and female (adult and children) patients who are diagnosed with M-HLH and that meet&#xD;
        the inclusion criteria. In addition, patients with a diagnosis of hematological malignancy&#xD;
        in the absence of HLH will be included as a control group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients diagnosed with HLH in the context of a malignancy. The diagnosis of M-HLH&#xD;
             will be established by the treating physician.&#xD;
&#xD;
          2. The patient or patient's legal representative (in case the patient is &lt; 18 years old)&#xD;
             must have consented to the use of their clinical data for research purposes at the&#xD;
             site.&#xD;
&#xD;
          3. For the control group, patients with a diagnosis of hematological malignancy and never&#xD;
             diagnosed with HLH or no suspicion of HLH&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        N/A&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naval Daver, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>March 16, 2020</last_update_submitted>
  <last_update_submitted_qc>March 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hemophagocytic Lymphohistiocytosis</keyword>
  <keyword>Malignancy-Associated Hemophagocytic Lymphohistiocytosis</keyword>
  <keyword>M-HLH</keyword>
  <keyword>Patients with known diagnosis of malignancy without HLH</keyword>
  <keyword>Interferon Gamma</keyword>
  <keyword>IFNγ</keyword>
  <keyword>Biomarkers</keyword>
  <keyword>Inflammatory Markers</keyword>
  <keyword>Blood draws</keyword>
  <keyword>Data collection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Lymphohistiocytosis, Hemophagocytic</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>August 24, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03259230
org study id: NI-0501-07
secondary id: PA16-0129
nct id: NCT03259230
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This observational study is designed to provide a better understanding of the potential use
      of IFNγ and IFNγ-inducible chemokines as markers of HLH disease activity and prognosis, and
      of the potential of IFNγ as a therapeutic target in M-HLH.
This is a non-interventional observational study designed to determine the levels of
      inflammatory markers in patients diagnosed with M-HLH and to assess the relationship between
      the biomarkers and disease activity in these patients during the M-HLH course. Inflammatory
      markers will also be measured in a group of control patients diagnosed with hematological
      malignancy but without HLH. Inflammatory markers include IFNγ and IFNγ-induced chemokines
      CXCL9 and CXCL10.

      In addition to the blood samples for the biomarker analysis, relevant information gathered by
      the treating physician will be collected in a data collection form. Whenever possible,
      collection of serum samples for biomarker analysis and relevant information should occur at
      M-HLH diagnosis, at regular time intervals during the treatment course as well as at
      resolution or reactivation of the disease.

      Blood samples will also be sent to the study sponsor (NovImmune S.A.) for cytokine testing.
      Before participant's samples are sent to the sponsor for testing, participant's name and any
      personal identifying information will be coded to protect participant's privacy.
observational model: Case-Control
time perspective: Other
measure: Levels of Inflammatory Markers in Participants Diagnosed with Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH)
time frame: 6 months
measure: Relationship of Levels of Inflammatory Markers in Participants Diagnosed with Malignancy-Associated Hemophagocytic Lymphohistiocytosis (M-HLH) and Disease Activity
time frame: 6 months
measure: Relationship Between Genetic Variants of Genes Causing HLH and M-HLH and Associated Inflammatory Markers
time frame: 6 months
arm group label: Malignancy-Associated Hemophagocytic Lymphohistiocytosis
arm group label: Absence of HLH in patients diagnosed with malignancy
intervention type: Other
intervention name: Blood Draws
arm group label: Absence of HLH in patients diagnosed with malignancy
arm group label: Malignancy-Associated Hemophagocytic Lymphohistiocytosis
intervention type: Other
intervention name: Data Collection
arm group label: Absence of HLH in patients diagnosed with malignancy
arm group label: Malignancy-Associated Hemophagocytic Lymphohistiocytosis
Approximate volume of 500 µl - 1 ml of serum or plasma required per time point. Minimum of 1
      ml of whole blood collected for genetic characterization.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Naval Daver, MD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Lymphohistiocytosis, Hemophagocytic
submitted: August 24, 2023