<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/NCT04494061</url>
  </required_header>
  <id_info>
    <org_study_id>NI-0501-13</org_study_id>
    <nct_id>NCT04494061</nct_id>
  </id_info>
  <brief_title>A Clinical Study to Investigate Interferon Gamma (IFNɣ) Signature in Patients Post HSCT and in Patients With Impaired HSC Proliferation Pre-transplant</brief_title>
  <official_title>A Clinical Study to Investigate Interferon Gamma (IFNɣ) Signature in Patients Post HSCT and in Patients With Impaired HSC Proliferation Pre-transplant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swedish Orphan Biovitrum</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PRA Health Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cytel Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>BioMérieux</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Swedish Orphan Biovitrum</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>
      Clinical study designed to collect blood for research purposes in patients after&#xD;
      hematopoietic stem cell transplantation (HSCT) or in patients with a medical condition where&#xD;
      the blood cells production is impaired. The blood samples will be used to study the role of&#xD;
      Interferon gamma (IFNɣ) in graft failure or impairment of hematopoietic stem cell&#xD;
      proliferation. The IFNɣ signature will be assessed by measuring primarily IFNɣ and C-X-C&#xD;
      Motif Chemokine Ligand 9 (CXCL9).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical study is designed to investigate IFNγ activity in two cohorts of patients.&#xD;
&#xD;
        -  First group will include patients post HSCT at risk of graft failure (GF) based on their&#xD;
           underlying diseases and on the transplant procedure.&#xD;
&#xD;
        -  Second group will contain patients with conditions where HSC proliferation is impaired&#xD;
           (e.g. aplastic anemia) and with matched controls (healthy volunteers (HV) samples&#xD;
           collected outside this clinical protocol).&#xD;
&#xD;
      IFNɣ activity will be assessed by measuring IFNγ and CXCL9 in serum.&#xD;
&#xD;
      For HSCT cohort, the following sampling time points are required: on day -7, pre HSCT on day&#xD;
      0, 1, 3, 5, 9, 13, 17, 21, 28, 31, 38 and one additional sample at the time when primary or&#xD;
      secondary GF is suspected if not on the planned schedule. In addition, the following time&#xD;
      points are recommended: day 7, 11, 15, 19, 24, 35, 42. It is also suggested to collect a&#xD;
      sample when Graft vs Host Disease (GVHD) is diagnosed during any visit that the patients will&#xD;
      attend as part of his/her standard treatment during the first 100 days post-transplant. The&#xD;
      patient will be followed up until around day 100 post-transplant. This follow up will consist&#xD;
      of capturing HSCT outcome information from patient hospital records around day 100.&#xD;
&#xD;
      For IHSCP cohort pre-transplant, it is recommended that, one sample per patient at the time&#xD;
      of diagnosis (if possible not more than 1 week from the date of diagnosis) is collected.&#xD;
      Age/sex matched control samples should be collected from healthy volunteers or patients with&#xD;
      malignant disease outside of this protocol after appropriate consent.&#xD;
&#xD;
      Different sets of data will be collected for the HSCT and IHSCP cohorts respectively as&#xD;
      described below:&#xD;
&#xD;
      Data collected for both cohorts&#xD;
&#xD;
        -  Age and sex&#xD;
&#xD;
        -  Inflammatory markers&#xD;
&#xD;
        -  IFNɣ&#xD;
&#xD;
        -  CXCL9&#xD;
&#xD;
        -  Other potential relevant exploratory biomarkers&#xD;
&#xD;
        -  Diagnosis&#xD;
&#xD;
        -  Date of disease diagnosis&#xD;
&#xD;
        -  Relevant medical history&#xD;
&#xD;
        -  Date and time of sample collection&#xD;
&#xD;
      Data collected for HSCT cohort only&#xD;
&#xD;
        -  Laboratory parameters assessed at the site laboratory on the date of sample collection&#xD;
           and between collection dates when available:&#xD;
&#xD;
        -  Absolute neutrophile count (ANC) and Platelets will be measured as per the schedule of&#xD;
           assessment, if possible when routine monitoring of patient health is conducted&#xD;
&#xD;
        -  Ferritin and Chimerism data will be collected when available (if measured as per site&#xD;
           routine practice)&#xD;
&#xD;
        -  Concomitant medications at the time of sample collection and between collection dates&#xD;
&#xD;
        -  Presence of infection at the time of sample collection with the date of onset&#xD;
&#xD;
        -  Presence of donor specific antibodies (DSA)&#xD;
&#xD;
        -  Transplant information&#xD;
&#xD;
        -  Date of start of conditioning&#xD;
&#xD;
        -  Type of conditioning (Reduced Intensity Conditioning (RIC) / Myeloablative Conditioning&#xD;
           (MAC) / Non-myeloablative Conditioning (NMAC) and medications&#xD;
&#xD;
        -  Transplant details (donor type, degree of match, transplant manipulation, stem cell&#xD;
           source)&#xD;
&#xD;
        -  Date of transplant&#xD;
&#xD;
        -  Date of primary / secondary GF or of confirmed engraftment&#xD;
&#xD;
        -  GVHD with the date of onset&#xD;
&#xD;
        -  Post-transplant treatment and date (Donor Lymphocyte Infusion (DLI), Stem Cell (SC)&#xD;
           boost, growth factor, GVHD prophylaxis, second HSCT procedure)&#xD;
&#xD;
      Data collected for IHSCP cohort only&#xD;
&#xD;
        -  Disease severity&#xD;
&#xD;
        -  In addition, the following data will be recorded for pediatric patients up to 18 years&#xD;
           old, if available:&#xD;
&#xD;
        -  PNH clones&#xD;
&#xD;
        -  History of hepatitis&#xD;
&#xD;
        -  Karyotype&#xD;
&#xD;
      Study duration:&#xD;
&#xD;
      The study will be conducted, until the required number of patients is recruited.&#xD;
&#xD;
        -  HSCT cohort: At patient level, the study will last about 100 days from pre-transplant&#xD;
           blood collection to last follow up data collection around day 100 post HSCT, matching&#xD;
           the standard HSCT patient care&#xD;
&#xD;
        -  IHSCP cohort: At patient level the study will last 1 day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Decision related to Business Priorities, Assessment of Development Options&#xD;
  </why_stopped>
  <start_date type="Actual">November 16, 2020</start_date>
  <completion_date type="Actual">August 31, 2022</completion_date>
  <primary_completion_date type="Actual">August 31, 2022</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>HSCT cohort: IFNγ signature pre-and post-transplant</measure>
    <time_frame>Day (-7) to day 100</time_frame>
    <description>IFNγ, CXCL-9 and exploratory biomarkers in serum samples</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HSCT cohort: Relationship between IFNγ and the risk of graft failure</measure>
    <time_frame>Day (-7) to day 100</time_frame>
    <description>IFNγ and CXCL-9 in serum samples</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HSCT cohort: Relationship between IFNγ and the occurrence of GVHD</measure>
    <time_frame>Day (-7) to day 100</time_frame>
    <description>IFNγ and CXCL-9 in serum samples</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IHSCP cohort: IFNγ signature pre-transplant</measure>
    <time_frame>Day 1</time_frame>
    <description>IFNγ, CXCL-9 and exploratory biomarkers in serum samples</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">101</enrollment>
  <condition>Graft Failure</condition>
  <arm_group>
    <arm_group_label>HSCT - Hematopoetic Stem Cell Proliferation</arm_group_label>
    <description>Patients who received hematopoietic stem cell transplant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IHSCP - Impaired HSC proliferation</arm_group_label>
    <description>Patients with impaired hematopoietic stem cell proliferation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>blood collection</intervention_name>
    <description>Blood samples will be collected as per protocol defined schedule. There is no investigation drug in this study.</description>
    <arm_group_label>HSCT - Hematopoetic Stem Cell Proliferation</arm_group_label>
    <arm_group_label>IHSCP - Impaired HSC proliferation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        -  Patients post HSCT at risk of graft failure based on their underlying diseases and on&#xD;
             the transplant procedure.&#xD;
&#xD;
          -  Patients with conditions where HSC proliferation is impaired (e.g. aplastic anemia)&#xD;
             and with respective controls (healthy volunteers (HV)).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient must have consented to the use of their clinical data and biological&#xD;
             samples for research investigations.&#xD;
&#xD;
          -  In HSCT cohort:&#xD;
&#xD;
               -  Patients with underlying:&#xD;
&#xD;
                  i. non-malignant hematological disease (e.g. autoimmune and metabolic disorders,&#xD;
                  aplastic anemia, Sickle cell anemia, Fanconi anemia, Diamond-blackfan anemia,&#xD;
                  thalassemia, osteopetrosis, Wiskott-Aldrich syndrome, severe combined&#xD;
                  immunodeficiency) or ii. malignant disease with higher risk of GF, i.e. Acute&#xD;
                  Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL) with primary&#xD;
                  induction failure, second partial remission or relapse; Chronic Myeloid Leukemia&#xD;
                  (CML) in blastic phase (circulating blast or blast above 5% in biopsy); Non&#xD;
                  Hodgkin and Hodgkin Lymphoma and multiple myeloma with primary induction failure,&#xD;
                  second partial remission or relapse, myelodysplastic syndromes (MDS) and&#xD;
                  myeloproliferative disorders (MPD) with splenomegaly, myelofibrosis with portal&#xD;
                  hypertension pre-transplant, MDS/MPD overlap syndromes&#xD;
&#xD;
               -  and who received allogeneic HSCT and are at higher risk of graft failure based on&#xD;
                  at least one of the following criteria: i. Having received reduced intensity&#xD;
                  conditioning (RIC) or non myeloablative conditioning (NMA) combined with a&#xD;
                  non-malignant disease or having received graft from Bone Marrow (BM) ii. Ex vivo&#xD;
                  T cell depleted graft iii. Graft from mismatched unrelated donor or&#xD;
                  haploidentical donor iv. Graft from Umbilical Cord Blood (UCB)&#xD;
&#xD;
          -  In the IHSCP cohort:&#xD;
&#xD;
               -  Patients with IHSCP pre-transplant (e.g. aplastic anemia)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HLH patients&#xD;
&#xD;
          -  Body weight &lt; 10kg&#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>Regis Peffault de Latour, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Saint Louis Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Algemeen Ziekenhuis Delta - Campus Rumbeke</name>
      <address>
        <city>Roeselare</city>
        <state>West-Vlaanderen</state>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires Saint-Luc</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Côte De Nacre</name>
      <address>
        <city>Caen cedex 9</city>
        <state>Basse-Normandie</state>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Pontchaillou</name>
      <address>
        <city>Rennes cedex 9</city>
        <state>Bretagne</state>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz</name>
      <address>
        <city>Besançon Cedex</city>
        <state>Franche-Comte</state>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint-Louis</name>
      <address>
        <city>Paris</city>
        <state>Ile De France</state>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Universitaire Robert-Debré</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux de Brabois</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <state>Lorraine</state>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hosptitalier Universitaire d'Angers</name>
      <address>
        <city>Angers Cedex 9</city>
        <state>Maine Et Loire</state>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Haut-Lévêque</name>
      <address>
        <city>Pessac</city>
        <state>Nouvelle Aquitaine</state>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint-Eloi</name>
      <address>
        <city>Montpellier Cedex 5</city>
        <state>Provence Alpes Cote d'Azur</state>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Arnaud de Villeneuve</name>
      <address>
        <city>Montpellier</city>
        <state>Provence Alpes Cote d'Azur</state>
        <zip>34090</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Grenoble Alpes</name>
      <address>
        <city>La Tronche</city>
        <state>Rhone-Alpes</state>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Estaing</name>
      <address>
        <city>Clermont-Ferrand</city>
        <state>Rhône</state>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Tübingen</name>
      <address>
        <city>Tübingen</city>
        <state>Baden-Württemberg</state>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Pediatrico Bambino Gesù - Roma - Gianicolo</name>
      <address>
        <city>Roma</city>
        <state>Lombardia</state>
        <zip>00165</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera San Giuseppe Moscati</name>
      <address>
        <city>Avellino</city>
        <zip>83100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Giannina Gaslini</name>
      <address>
        <city>Genova</city>
        <zip>16147</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Raffaele</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Policlinico San Matteo</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Regina Margherita</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prinses Maxima Centrum Kinderoncologie</name>
      <address>
        <city>Utrecht</city>
        <zip>3584 CS</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiff and Vale University Health Board</name>
      <address>
        <city>Cardiff</city>
        <state>Wales</state>
        <zip>CF14 4XW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Marsden Hospital - London</name>
      <address>
        <city>London</city>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imperial College Healthcare NHS Trust NHS Trust</name>
      <address>
        <city>London</city>
        <zip>W12 0HS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>October 19, 2022</last_update_submitted>
  <last_update_submitted_qc>October 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04494061
org study id: NI-0501-13
nct id: NCT04494061
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Clinical study designed to collect blood for research purposes in patients after
      hematopoietic stem cell transplantation (HSCT) or in patients with a medical condition where
      the blood cells production is impaired. The blood samples will be used to study the role of
      Interferon gamma (IFNɣ) in graft failure or impairment of hematopoietic stem cell
      proliferation. The IFNɣ signature will be assessed by measuring primarily IFNɣ and C-X-C
      Motif Chemokine Ligand 9 (CXCL9).
This clinical study is designed to investigate IFNγ activity in two cohorts of patients.

        -  First group will include patients post HSCT at risk of graft failure (GF) based on their
           underlying diseases and on the transplant procedure.

        -  Second group will contain patients with conditions where HSC proliferation is impaired
           (e.g. aplastic anemia) and with matched controls (healthy volunteers (HV) samples
           collected outside this clinical protocol).

      IFNɣ activity will be assessed by measuring IFNγ and CXCL9 in serum.

      For HSCT cohort, the following sampling time points are required: on day -7, pre HSCT on day
      0, 1, 3, 5, 9, 13, 17, 21, 28, 31, 38 and one additional sample at the time when primary or
      secondary GF is suspected if not on the planned schedule. In addition, the following time
      points are recommended: day 7, 11, 15, 19, 24, 35, 42. It is also suggested to collect a
      sample when Graft vs Host Disease (GVHD) is diagnosed during any visit that the patients will
      attend as part of his/her standard treatment during the first 100 days post-transplant. The
      patient will be followed up until around day 100 post-transplant. This follow up will consist
      of capturing HSCT outcome information from patient hospital records around day 100.

      For IHSCP cohort pre-transplant, it is recommended that, one sample per patient at the time
      of diagnosis (if possible not more than 1 week from the date of diagnosis) is collected.
      Age/sex matched control samples should be collected from healthy volunteers or patients with
      malignant disease outside of this protocol after appropriate consent.

      Different sets of data will be collected for the HSCT and IHSCP cohorts respectively as
      described below:

      Data collected for both cohorts

        -  Age and sex

        -  Inflammatory markers

        -  IFNɣ

        -  CXCL9

        -  Other potential relevant exploratory biomarkers

        -  Diagnosis

        -  Date of disease diagnosis

        -  Relevant medical history

        -  Date and time of sample collection

      Data collected for HSCT cohort only

        -  Laboratory parameters assessed at the site laboratory on the date of sample collection
           and between collection dates when available:

        -  Absolute neutrophile count (ANC) and Platelets will be measured as per the schedule of
           assessment, if possible when routine monitoring of patient health is conducted

        -  Ferritin and Chimerism data will be collected when available (if measured as per site
           routine practice)

        -  Concomitant medications at the time of sample collection and between collection dates

        -  Presence of infection at the time of sample collection with the date of onset

        -  Presence of donor specific antibodies (DSA)

        -  Transplant information

        -  Date of start of conditioning

        -  Type of conditioning (Reduced Intensity Conditioning (RIC) / Myeloablative Conditioning
           (MAC) / Non-myeloablative Conditioning (NMAC) and medications

        -  Transplant details (donor type, degree of match, transplant manipulation, stem cell
           source)

        -  Date of transplant

        -  Date of primary / secondary GF or of confirmed engraftment

        -  GVHD with the date of onset

        -  Post-transplant treatment and date (Donor Lymphocyte Infusion (DLI), Stem Cell (SC)
           boost, growth factor, GVHD prophylaxis, second HSCT procedure)

      Data collected for IHSCP cohort only

        -  Disease severity

        -  In addition, the following data will be recorded for pediatric patients up to 18 years
           old, if available:

        -  PNH clones

        -  History of hepatitis

        -  Karyotype

      Study duration:

      The study will be conducted, until the required number of patients is recruited.

        -  HSCT cohort: At patient level, the study will last about 100 days from pre-transplant
           blood collection to last follow up data collection around day 100 post HSCT, matching
           the standard HSCT patient care

        -  IHSCP cohort: At patient level the study will last 1 day.
observational model: Cohort
time perspective: Prospective
measure: HSCT cohort: IFNγ signature pre-and post-transplant
time frame: Day (-7) to day 100
description: IFNγ, CXCL-9 and exploratory biomarkers in serum samples
measure: HSCT cohort: Relationship between IFNγ and the risk of graft failure
time frame: Day (-7) to day 100
description: IFNγ and CXCL-9 in serum samples
measure: HSCT cohort: Relationship between IFNγ and the occurrence of GVHD
time frame: Day (-7) to day 100
description: IFNγ and CXCL-9 in serum samples
measure: IHSCP cohort: IFNγ signature pre-transplant
time frame: Day 1
description: IFNγ, CXCL-9 and exploratory biomarkers in serum samples
arm group label: HSCT - Hematopoetic Stem Cell Proliferation
description: Patients who received hematopoietic stem cell transplant
arm group label: IHSCP - Impaired HSC proliferation
description: Patients with impaired hematopoietic stem cell proliferation
intervention type: Procedure
intervention name: blood collection
description: Blood samples will be collected as per protocol defined schedule. There is no investigation drug in this study.
arm group label: HSCT - Hematopoetic Stem Cell Proliferation
arm group label: IHSCP - Impaired HSC proliferation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Regis Peffault de Latour, MD
role: Principal Investigator
affiliation: Hôpital Saint Louis Paris
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country: Belgium
country: France
country: Germany
country: Italy
country: Netherlands
country: United Kingdom
responsible party type: Sponsor