<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/NCT03802773</url>
  </required_header>
  <id_info>
    <org_study_id>2382</org_study_id>
    <nct_id>NCT03802773</nct_id>
  </id_info>
  <brief_title>Cord Blood Transplantation With Myeloablative Conditioning and Post-transplant Cyclophosphamide (COmPACt Study)</brief_title>
  <acronym>COmPACt</acronym>
  <official_title>Cord Blood Transplantation With Myeloablative Conditioning and Post-transplant Cyclophosphamide in Patients With Hematological Malignancies (The COmPACt Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</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>
      Despite anti-thymocyte globulin has a mainstay role in preventing GvHD (and non-relapse&#xD;
      mortality) in CB transplantation, it also induces delayed immune recovery, increased risk of&#xD;
      cytomegalovirus and Epstein-Barr virus reactivation, post-transplant lymphoproliferative&#xD;
      diseases, overall accounting for increased transplant-related mortality and/or increased&#xD;
      relapse incidence. All these findings support the use of alternative approaches for in vivo T&#xD;
      cell depletion in the setting of CB transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study objectives. The primary objective is to evaluate neutrophil and platelet engraftment&#xD;
      and day +100 CD4+ cell count in patients receiving matched CB unit transplant with a&#xD;
      myeloablative conditioning regimen and a GVHD prophylaxis including post-transplant&#xD;
      cyclophosphamide. Secondary objective is to estimate the incidence and severity of acute and&#xD;
      chronic GVHD. Study endpoints. Primary endpoints are hematopoietic engraftment and day +100&#xD;
      CD4+ cell count. Secondary endpoints are acute and chronic GVHD&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 14, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Actual">January 26, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>hematopoietic reconstitution</measure>
    <time_frame>first post-transplant 1 day with neutrophil &gt; 0.5x10^9/L and platelet &gt; 20x10^9/L</time_frame>
    <description>number of days for neutrophil (&gt; 0.5x10^9/L) and platelet (&gt; 20x10^9/L) engraftment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>immune reconstitution</measure>
    <time_frame>day 100 from transplant</time_frame>
    <description>number of CD4+cells at day 100</description>
  </secondary_outcome>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Cord Blood Transplantation</condition>
  <condition>Hematological Malignancies</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CB transplantation</intervention_name>
    <description>Myeloablative conditioning with post-transplant cyclophosphamide in patients receiving a matched CB transplant for hematological malignancies.</description>
    <other_name>Myeloablative conditioning and post-transplant cyclophosphamide</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with no matched (&lt;7/8 HLA loci) sibling or unrelated donor, candidate to receive a&#xD;
        transplant of a matched CB unit (TNC&gt; 2,0 x10^7/kg and &gt; 4/6 loci HLA)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: ≥ 18 ≤ 75 years old&#xD;
&#xD;
          -  CB unit transplantation (TNC&gt; 2,0 x10^7/kg and &gt; 4/6 loci HLA matched)&#xD;
&#xD;
          -  Myeloablative conditioning regimen consisting of either Thiotepa/ Busulfan/&#xD;
             Fludarabine or TBI/ Fludarabine&#xD;
&#xD;
          -  GVHD prophylaxis including PT-Cy (30 mg/kg or more on days + 3and +5) CSA and MMF&#xD;
&#xD;
          -  Diagnosis of 1 of the following hematological malignancies: Acute Myeloid Leukemia&#xD;
             (AML), Myelodysplastic Syndrome, high risk Acute Lymphoblastic Leukemia (ALL), Bi&#xD;
             phenotypic/undifferentiated leukemia, Chronic Myeloid Leukemia resistant to TK&#xD;
             inhibitors, Ph-neg Myeloproliferative Neoplasms, resistant/relapsing Non-Hodgkin's&#xD;
             lymphoma ineligible for an autologous transplant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Positive serologic markers for human immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Acute hepatitis B virus (HBV) or acute hepatitis C virus (HCV) infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrizia Chiusolo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondazione Policlinico Universitario A. Gemelli, IRCCS</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andrea Bacigalupo, Prof.</last_name>
    <phone>0630154180</phone>
    <email>andrea.bacigalupo@unicatt.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Patrizia Chiusolo, MD</last_name>
    <phone>0630156244</phone>
    <email>patrizia.chiusolo@unicatt.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario A. Gemelli IRCCS</name>
      <address>
        <city>Roma</city>
        <state>RM</state>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Bacigalupo, Prof.</last_name>
      <phone>0630154180</phone>
      <email>andrea.bacigalupo@unicatt.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>February 8, 2023</last_update_submitted>
  <last_update_submitted_qc>February 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Hematologic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclophosphamide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03802773
org study id: 2382
nct id: NCT03802773
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Despite anti-thymocyte globulin has a mainstay role in preventing GvHD (and non-relapse
      mortality) in CB transplantation, it also induces delayed immune recovery, increased risk of
      cytomegalovirus and Epstein-Barr virus reactivation, post-transplant lymphoproliferative
      diseases, overall accounting for increased transplant-related mortality and/or increased
      relapse incidence. All these findings support the use of alternative approaches for in vivo T
      cell depletion in the setting of CB transplantation.
Study objectives. The primary objective is to evaluate neutrophil and platelet engraftment
      and day +100 CD4+ cell count in patients receiving matched CB unit transplant with a
      myeloablative conditioning regimen and a GVHD prophylaxis including post-transplant
      cyclophosphamide. Secondary objective is to estimate the incidence and severity of acute and
      chronic GVHD. Study endpoints. Primary endpoints are hematopoietic engraftment and day +100
      CD4+ cell count. Secondary endpoints are acute and chronic GVHD
observational model: Case-Only
time perspective: Prospective
measure: hematopoietic reconstitution
time frame: first post-transplant 1 day with neutrophil > 0.5x10^9/L and platelet > 20x10^9/L
description: number of days for neutrophil (> 0.5x10^9/L) and platelet (> 20x10^9/L) engraftment
measure: immune reconstitution
time frame: day 100 from transplant
description: number of CD4+cells at day 100
intervention type: Procedure
intervention name: CB transplantation
description: Myeloablative conditioning with post-transplant cyclophosphamide in patients receiving a matched CB transplant for hematological malignancies.
other name: Myeloablative conditioning and post-transplant cyclophosphamide
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Patrizia Chiusolo, MD
role: Principal Investigator
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
last name: Andrea Bacigalupo, Prof.
phone: 0630154180
email: andrea.bacigalupo@unicatt.it
last name: Patrizia Chiusolo, MD
phone: 0630156244
email: patrizia.chiusolo@unicatt.it
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Hematologic Neoplasms
mesh term: Cyclophosphamide
sharing ipd: No