<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/NCT02194439</url>
  </required_header>
  <id_info>
    <org_study_id>1405976232</org_study_id>
    <secondary_id>1R01HD074587-01</secondary_id>
    <nct_id>NCT02194439</nct_id>
  </id_info>
  <brief_title>Bridging Pediatric and Adult Biomarkers in Graft-Versus-Host Disease</brief_title>
  <official_title>Bridging Pediatric and Adult Biomarkers in Graft-Versus-Host Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to collect longitudinal biological samples from patients after&#xD;
      hematopoietic cell transplantation (HCT) cared for at multiple bone marrow transplant centers&#xD;
      to validate biomarkers of both acute and chronic GVHD as well as for use in future&#xD;
      unspecified research. The centers include Dana-Farber Cancer Institute and Boston's&#xD;
      Children's Hospital, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Fred Hutchinson&#xD;
      Cancer Research Center, Texas Children's Hospital, Children's National Medical Center, and&#xD;
      Indiana University Simon Cancer Center.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After informed consent is signed, this study will involve 1) collection of basic HCT data and&#xD;
      clinical data available in the medical record and 2) providing blood (and saliva in&#xD;
      occasional cases) samples for processing, storage, DNA extraction, and analysis (including a&#xD;
      seven biomarker protein panel as well as future unspecified research purposes).&#xD;
&#xD;
      Pediatric and adult patients will be included (all adult patients will be from the Fred&#xD;
      Hutchinson Cancer Research Center, the Johns Hopkins Sidney Kimmel Comprehensive Cancer&#xD;
      Center, and the Indiana University Simon Cancer Center).&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
      1. To confirm that ST2 alone or the seven-biomarker panel measured at initiation of GVHD&#xD;
      therapy predict a) D180 post-therapy non-relapse mortality; b) D28 post-therapy non-response,&#xD;
      and c) GVHD grade 1-4 onset D180 post-therapy non-relapse mortality.&#xD;
&#xD;
      Secondary Objective:&#xD;
&#xD;
        1. To demonstrate that ST2 alone or the seven-biomarker panel measured at day 14 or day 21&#xD;
           post-HCT (or a combination of these time points) predicts D180 post-HCT non-relapse&#xD;
           mortality.&#xD;
&#xD;
        2. To demonstrate that ST2 alone or the seven-biomarker panel measured at initiation of&#xD;
           GVHD symptoms/therapy diagnose acute GVHD as compared to other complications presenting&#xD;
           with similar symptoms (drug rash, CMV, Clostridium enteritis).&#xD;
&#xD;
        3. To demonstrate that ST2 alone or the seven-biomarker panel measured at initiation of&#xD;
           GVHD symptoms/therapy diagnose the severity of acute GVHD at onset and maximum.&#xD;
&#xD;
        4. To develop a repository of biospecimens linked to clinical data for future unspecified&#xD;
           research.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2014</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Non Relapse Mortality (NRM) by Age and ST2 at 12 Months Post-HCT</measure>
    <time_frame>1 year</time_frame>
    <description>To measure stimulation-2 (ST2) pre-HCT by number of participants at 12 months post-HCT for non-relapse mortality according to ST2 values and age less than or equal to 10 and greater than 10 using landmark analyses.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">415</enrollment>
  <condition>Graft-Versus-Host Disease</condition>
  <arm_group>
    <arm_group_label>hematopoietic stem cell transplant</arm_group_label>
    <description>procedure</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole Blood, Plasma, Peripheral Blood Mononuclear Cells (PBMC), Saliva, Bronchoalveolar&#xD;
      lavage (BAL)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        patients receiving an allogeneic hematopoietic stem cell transplant, cord blood transplant,&#xD;
        bone marrow transplant, T cell depleted marrow, donor lymphocyte infusion (DLI), or donor&#xD;
        cellular infusion (DCI) from Dana-Farber Cancer Institute and Boston Children's Hospital,&#xD;
        Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Fred Hutchinson Cancer Research&#xD;
        Center, Texas Children's Hospital, Children's National Medical Center, and Indiana&#xD;
        University Simon Cancer Center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: - All patients receiving an allogeneic hematopoietic stem cell&#xD;
        transplant, cord blood transplant, bone marrow transplant, T cell depleted marrow, donor&#xD;
        lymphocyte infusion (DLI), or donor cellular infusion (DCI) can be included.&#xD;
&#xD;
        Exclusion Criteria: - patients not receiving an allogeneic hematopoietic stem cell&#xD;
        transplant, cord blood transplant, bone marrow transplant, T cell depleted marrow, donor&#xD;
        lymphocyte infusion (DLI), or donor cellular infusion (DCI) will be excluded.&#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>Sophie Paczesny, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indiana Unversity Melvin and Bren Simon Cancer Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <results_first_submitted>February 6, 2020</results_first_submitted>
  <results_first_submitted_qc>February 9, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 26, 2021</results_first_posted>
  <last_update_submitted>February 9, 2021</last_update_submitted>
  <last_update_submitted_qc>February 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Sophie Paczesny</investigator_full_name>
    <investigator_title>Professor of Pediatrics and Immunology</investigator_title>
  </responsible_party>
  <keyword>Acute Graft Versus Host Disease</keyword>
  <keyword>Affect</keyword>
  <keyword>Anti-inflammatory</keyword>
  <keyword>Anti-inflammatory Agents</keyword>
  <keyword>Antigen-Presenting Cells</keyword>
  <keyword>Alloantigen</keyword>
  <keyword>Allogeneic</keyword>
  <keyword>Allograft rejection</keyword>
  <keyword>Allograft Tolerance</keyword>
  <keyword>Antigens</keyword>
  <keyword>Autoimmunity</keyword>
  <keyword>Biomarkers</keyword>
  <keyword>Biospecimen Repository</keyword>
  <keyword>BMT</keyword>
  <keyword>Bone Marrow Transplantation</keyword>
  <keyword>Cell Transplantation</keyword>
  <keyword>Cells</keyword>
  <keyword>Clonal Expansion</keyword>
  <keyword>Complex</keyword>
  <keyword>Cytokine</keyword>
  <keyword>Data</keyword>
  <keyword>Development</keyword>
  <keyword>Environment</keyword>
  <keyword>Failure (biologic function)</keyword>
  <keyword>Genomics</keyword>
  <keyword>Graft-vs-Host Disease</keyword>
  <keyword>Graft-vs-Leukemia</keyword>
  <keyword>GVHD</keyword>
  <keyword>GVL</keyword>
  <keyword>Hematopoietic</keyword>
  <keyword>Hematopoietic Stem Cell Transplantation</keyword>
  <keyword>HCT</keyword>
  <keyword>HSCT</keyword>
  <keyword>IL-33 Receptor</keyword>
  <keyword>Immune Reconstitution</keyword>
  <keyword>Immune Response</keyword>
  <keyword>Inflammatory</keyword>
  <keyword>Modeling</keyword>
  <keyword>Novel</keyword>
  <keyword>Novel therapeutics</keyword>
  <keyword>Outcome</keyword>
  <keyword>Pathway interactions</keyword>
  <keyword>Peptides</keyword>
  <keyword>Prevent</keyword>
  <keyword>Process</keyword>
  <keyword>Production</keyword>
  <keyword>Proteomics</keyword>
  <keyword>Regulatory T-Lymphocyte</keyword>
  <keyword>Response</keyword>
  <keyword>Role</keyword>
  <keyword>Signal</keyword>
  <keyword>ST2</keyword>
  <keyword>Transduction</keyword>
  <keyword>T-cell response</keyword>
  <keyword>T-cell Activation</keyword>
  <keyword>T-Lymphocytes</keyword>
  <keyword>Tissues</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Graft vs Host Disease</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT02194439/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 12, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT02194439/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Hematopoietic Stem Cell Transplant</title>
          <description>4 plasma biomarkers were assessed pre-HCT and at days +7, +14 and +21 post-HCT.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="415"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="415"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Patients who performed biomarker collection.</population>
      <group_list>
        <group group_id="B1">
          <title>Hematopoietic Stem Cell Transplant</title>
          <description>4 plasma biomarkers were assessed pre-HCT and at days +7, +14 and +21 post-HCT.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="415"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age &lt;10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age &gt;10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="245"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="187"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="228"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="351"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="293"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="415"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Non Relapse Mortality (NRM) by Age and ST2 at 12 Months Post-HCT</title>
        <description>To measure stimulation-2 (ST2) pre-HCT by number of participants at 12 months post-HCT for non-relapse mortality according to ST2 values and age less than or equal to 10 and greater than 10 using landmark analyses.</description>
        <time_frame>1 year</time_frame>
        <population>Participants who had all four biomarkers and four timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Hematopoietic Stem Cell Transplant</title>
            <description>4 plasma biomarkers were assessed pre-HCT and at days +7, +14 and +21 post-HCT.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Non Relapse Mortality (NRM) by Age and ST2 at 12 Months Post-HCT</title>
          <description>To measure stimulation-2 (ST2) pre-HCT by number of participants at 12 months post-HCT for non-relapse mortality according to ST2 values and age less than or equal to 10 and greater than 10 using landmark analyses.</description>
          <population>Participants who had all four biomarkers and four timepoints.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="415"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Age &lt;10 high Pre-HCT ST2 &gt;26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age &lt;10 low pre-HCT ST2 &lt;26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age &gt;10 high Pre-HCT ST2 &gt;26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age &gt;10 low Pre-HCT ST2 &lt;26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>up to 3 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Hematopoietic Stem Cell Transplant</title>
          <description>4 plasma biomarkers were assessed pre-HCT and at days +7, +14 and +21 post-HCT.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="415"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="415"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="415"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Sophie Paczesny</name_or_title>
      <organization>IndianaU</organization>
      <phone>317-278-5487</phone>
      <email>sophpacz@iu.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02194439
org study id: 1405976232
secondary id: 1R01HD074587-01
nct id: NCT02194439
lead sponsor: 
collaborator: 
has dmc: Yes
This study is designed to collect longitudinal biological samples from patients after
      hematopoietic cell transplantation (HCT) cared for at multiple bone marrow transplant centers
      to validate biomarkers of both acute and chronic GVHD as well as for use in future
      unspecified research. The centers include Dana-Farber Cancer Institute and Boston's
      Children's Hospital, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Fred Hutchinson
      Cancer Research Center, Texas Children's Hospital, Children's National Medical Center, and
      Indiana University Simon Cancer Center.
After informed consent is signed, this study will involve 1) collection of basic HCT data and
      clinical data available in the medical record and 2) providing blood (and saliva in
      occasional cases) samples for processing, storage, DNA extraction, and analysis (including a
      seven biomarker protein panel as well as future unspecified research purposes).

      Pediatric and adult patients will be included (all adult patients will be from the Fred
      Hutchinson Cancer Research Center, the Johns Hopkins Sidney Kimmel Comprehensive Cancer
      Center, and the Indiana University Simon Cancer Center).

      Primary Objective:

      1. To confirm that ST2 alone or the seven-biomarker panel measured at initiation of GVHD
      therapy predict a) D180 post-therapy non-relapse mortality; b) D28 post-therapy non-response,
      and c) GVHD grade 1-4 onset D180 post-therapy non-relapse mortality.

      Secondary Objective:

        1. To demonstrate that ST2 alone or the seven-biomarker panel measured at day 14 or day 21
           post-HCT (or a combination of these time points) predicts D180 post-HCT non-relapse
           mortality.

        2. To demonstrate that ST2 alone or the seven-biomarker panel measured at initiation of
           GVHD symptoms/therapy diagnose acute GVHD as compared to other complications presenting
           with similar symptoms (drug rash, CMV, Clostridium enteritis).

        3. To demonstrate that ST2 alone or the seven-biomarker panel measured at initiation of
           GVHD symptoms/therapy diagnose the severity of acute GVHD at onset and maximum.

        4. To develop a repository of biospecimens linked to clinical data for future unspecified
           research.
observational model: Cohort
time perspective: Prospective
measure: Number of Participants With Non Relapse Mortality (NRM) by Age and ST2 at 12 Months Post-HCT
time frame: 1 year
description: To measure stimulation-2 (ST2) pre-HCT by number of participants at 12 months post-HCT for non-relapse mortality according to ST2 values and age less than or equal to 10 and greater than 10 using landmark analyses.
arm group label: hematopoietic stem cell transplant
description: procedure
Whole Blood, Plasma, Peripheral Blood Mononuclear Cells (PBMC), Saliva, Bronchoalveolar
      lavage (BAL)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Sophie Paczesny, MD, PhD
role: Study Chair
affiliation: Indiana University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Sophie Paczesny
investigator title: Professor of Pediatrics and Immunology
mesh term: Graft vs Host Disease
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 