<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/NCT03821727</url>
  </required_header>
  <id_info>
    <org_study_id>PRN°0068937</org_study_id>
    <nct_id>NCT03821727</nct_id>
  </id_info>
  <brief_title>SCT in Ph Positive Acute Lymphoblastic Leukemia</brief_title>
  <official_title>Outcome of Hematopoietic Stem Cell Transplantation in Philadelphia Positive Acute Lymphoblastic Leukemia in the Era of Tyrosine Kinase Inhibitors. A Registry-based Study of the Italian Blood and Marrow Transplantation Society (GITMO)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CANDONI ANNA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gruppo Italiano Trapianto di Midollo Osseo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Udine, Italy</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 study includes a registry-based, nationwide analysis to describe the clinical outcome of&#xD;
      adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)&#xD;
      who underwent an allogeneic hematopoietic stem cell transplantation (HSCT) after a Tyrosine&#xD;
      Kinase Inhibitors (TKI)-based treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a retrospective nationwide analysis based on registry data collected by GITMO.&#xD;
      Inclusion criteria were: 1) diagnosis of Ph+ ALL; age ≥18 years at transplant; 2) patients&#xD;
      receiving first allogeneic HSCT from any donor (HLA-identical sibling donor (MSD), unrelated&#xD;
      donor (UD) or alternative donor (haploidentical or cord blood) between 2005 and 2016 in a&#xD;
      GITMO center; 3) TKI-based treatment prior to HSCT; 4) patients with available pre-transplant&#xD;
      MRD status, as well as complete clinical data and outcome. Data were extracted from the GITMO&#xD;
      Registry (PROMISE Registry).&#xD;
&#xD;
      The endpoints of the study were: OS, progression-free survival (PFS), cumulative incidence of&#xD;
      relapse (CIR), non-relapse mortality (NRM), cumulative incidence of extensive chronic graft&#xD;
      versus host disease (cGVHD), rate of minimal residual disease (MRD) negativity and the rate&#xD;
      of complete cytologic remission (CR) before and after transplant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 26, 2016</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Overall Survival (OS).</measure>
    <time_frame>5 years</time_frame>
    <description>as reported</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of complete cytologic remission (CR) before and after transplant.</measure>
    <time_frame>Baseline and 3 months after SCT</time_frame>
    <description>As reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of minimal residual disease (MRD).</measure>
    <time_frame>Baseline and 3 months post SCT</time_frame>
    <description>As reported</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of extensive chronic graft versus host disease (cGVHD).</measure>
    <time_frame>5 years</time_frame>
    <description>as reported</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Progression-free survival (PFS).</measure>
    <time_frame>5 years</time_frame>
    <description>as reported</description>
  </other_outcome>
  <other_outcome>
    <measure>Cumulative incidence of relapse (CIR).</measure>
    <time_frame>5 years</time_frame>
    <description>as reported</description>
  </other_outcome>
  <other_outcome>
    <measure>Non-relapse mortality (NRM).</measure>
    <time_frame>5 years</time_frame>
    <description>as reported</description>
  </other_outcome>
  <enrollment type="Actual">441</enrollment>
  <condition>Philadelphia Positive Acute Lymphoblastic Leukemia</condition>
  <condition>SCT</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hematopoietic Stem Cell Transplantation</intervention_name>
    <description>Hematopoietic Stem Cell Transplantation in Acute Leukemia Ph positive</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Data were extracted from the GITMO Registry (PROMISE Registry). All patients received a&#xD;
        first allogeneic HSCT from any donor.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Ph+ ALL; age ≥18 years at transplant.&#xD;
&#xD;
          -  Patients receiving first allogeneic HSCT from any donor (HLA-identical sibling donor&#xD;
             (MSD), unrelated donor (UD) or alternative donor (haploidentical or cord blood)&#xD;
             between 2005 and 2016 in a GITMO center.&#xD;
&#xD;
          -  TKI-based treatment prior to HSCT.&#xD;
&#xD;
          -  Patients with available pre-transplant MRD status, as well as complete clinical data&#xD;
             and outcome.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All cases without one or more of inclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Renato Fanin, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Udine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GITMO Centers and GITMO CLINICAL OFFICE-AOU-IRCSS San Martino-Ge</name>
      <address>
        <city>Genova</city>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital, Udine</name>
      <address>
        <city>Udine</city>
        <zip>33100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 19, 2019</study_first_submitted>
  <study_first_submitted_qc>January 26, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 26, 2019</last_update_submitted>
  <last_update_submitted_qc>January 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Udine, Italy</investigator_affiliation>
    <investigator_full_name>CANDONI ANNA</investigator_full_name>
    <investigator_title>Principal Investigator, Clinical Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data were extracted from the GITMO Registry (PROMISE Registry). All patients included in the registry signed an informed consent form. The study was conducted in compliance with current national and European legislation on clinical trials, in accordance with the Helsinki Declaration and the principles of good clinical practice (GCP). This study was approved by the GITMO board and by the institutional review board of the coordinating center (Hematology-University of Udine) and from institutional review boards of all participating centers.</ipd_description>
  </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/NCT03821727
org study id: PRN°0068937
nct id: NCT03821727
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study includes a registry-based, nationwide analysis to describe the clinical outcome of
      adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)
      who underwent an allogeneic hematopoietic stem cell transplantation (HSCT) after a Tyrosine
      Kinase Inhibitors (TKI)-based treatment.
This was a retrospective nationwide analysis based on registry data collected by GITMO.
      Inclusion criteria were: 1) diagnosis of Ph+ ALL; age ≥18 years at transplant; 2) patients
      receiving first allogeneic HSCT from any donor (HLA-identical sibling donor (MSD), unrelated
      donor (UD) or alternative donor (haploidentical or cord blood) between 2005 and 2016 in a
      GITMO center; 3) TKI-based treatment prior to HSCT; 4) patients with available pre-transplant
      MRD status, as well as complete clinical data and outcome. Data were extracted from the GITMO
      Registry (PROMISE Registry).

      The endpoints of the study were: OS, progression-free survival (PFS), cumulative incidence of
      relapse (CIR), non-relapse mortality (NRM), cumulative incidence of extensive chronic graft
      versus host disease (cGVHD), rate of minimal residual disease (MRD) negativity and the rate
      of complete cytologic remission (CR) before and after transplant.
observational model: Case-Only
time perspective: Other
measure: Overall Survival (OS).
time frame: 5 years
description: as reported
measure: Rate of complete cytologic remission (CR) before and after transplant.
time frame: Baseline and 3 months after SCT
description: As reported
measure: Rate of minimal residual disease (MRD).
time frame: Baseline and 3 months post SCT
description: As reported
measure: Cumulative incidence of extensive chronic graft versus host disease (cGVHD).
time frame: 5 years
description: as reported
measure: Progression-free survival (PFS).
time frame: 5 years
description: as reported
measure: Cumulative incidence of relapse (CIR).
time frame: 5 years
description: as reported
measure: Non-relapse mortality (NRM).
time frame: 5 years
description: as reported
intervention type: Procedure
intervention name: Hematopoietic Stem Cell Transplantation
description: Hematopoietic Stem Cell Transplantation in Acute Leukemia Ph positive
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Renato Fanin, Professor
role: Principal Investigator
affiliation: University of Udine
facility: 
facility: 
country: Italy
responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital, Udine, Italy
investigator full name: CANDONI ANNA
investigator title: Principal Investigator, Clinical Professor
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphoid
sharing ipd: No
ipd description: Data were extracted from the GITMO Registry (PROMISE Registry). All patients included in the registry signed an informed consent form. The study was conducted in compliance with current national and European legislation on clinical trials, in accordance with the Helsinki Declaration and the principles of good clinical practice (GCP). This study was approved by the GITMO board and by the institutional review board of the coordinating center (Hematology-University of Udine) and from institutional review boards of all participating centers.