<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/NCT04469985</url>
  </required_header>
  <id_info>
    <org_study_id>GITMO-AlloElderly</org_study_id>
    <nct_id>NCT04469985</nct_id>
  </id_info>
  <brief_title>Allogeneic Stem Cell Transplantation (ALLO-SCT) in Elderly: 17-years Retrospective GITMO Survey</brief_title>
  <official_title>Allogeneic Stem Cell Transplantation (ALLO-SCT) in Elderly: 17-years Retrospective GITMO Survey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The age of patients' population is increasing every year, as the life expectancy. Thus, the&#xD;
      incidence and prevalence of hematological cancers is increasing. In particular, acute&#xD;
      leukemias and myelodisplastic syndromes are the most frequent diseases of the hematopoietic&#xD;
      system. Allogeneic stem cell transplantation (allo-SCT) is the main therapeutic options for&#xD;
      these diseases, and the number of allo-SCTs in the elderly is currently in progressive&#xD;
      growth. This is partially due to the improvement of the allo-SCT procedure over the years,&#xD;
      with the amelioration of donor selection, HLA typing, graft versus host disease (GVHD) and&#xD;
      infections prophylaxis and treatment.&#xD;
&#xD;
      Nevertheless, there is still an unmet clinical need, represented by the lack of extensively&#xD;
      and detailed outcome analysis of elderly patients addressed to allo-SCT. With this aim, we&#xD;
      planned this retrospective analysis of allo-SCTs in patients older than 60 years, within the&#xD;
      GITMO transplant activity of the last 17 years. This study will help us in designing future&#xD;
      prospective trials, including a comprehensive geriatric assessment of frailty, in order to&#xD;
      address to allo-SCT those elderly who have the highest probability to achieve the best long&#xD;
      term outcome with the lowest transplant-related mortality and morbidity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>1 year</time_frame>
    <description>Overall Survival</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease Free Survival</measure>
    <time_frame>1 year</time_frame>
    <description>Disease Free Survival</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Transplant Related Mortality</measure>
    <time_frame>1 year</time_frame>
    <description>Transplant Related Mortality</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute Graft Versus Host Disease Incidence</measure>
    <time_frame>100 days</time_frame>
    <description>Acute Graft Versus Host Disease Incidence</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chronic Graft Versus Host Disease Incidence</measure>
    <time_frame>1 year</time_frame>
    <description>Chronic Graft Versus Host Disease Incidence</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relapse Incidence</measure>
    <time_frame>1 year</time_frame>
    <description>Relapse Incidence</description>
  </primary_outcome>
  <enrollment type="Actual">2061</enrollment>
  <condition>Allogeneic Stem Cell Transplantation in Elderly Patients</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This study will enrol patients older than 60 years who received hematopoietic stem cell&#xD;
        transplantation (HSCT) between 1st January 2000 and 31st December 2017.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        This study will enrol patients older than 60 years who received hematopoietic stem cell&#xD;
        transplantation (HSCT) between 1st January 2000 and 31st December 2017.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michele Malagola, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bone Marrow Transplant Unit, University of Brescia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chair of Hematology and Bone marrow Transplant Unit</name>
      <address>
        <city>Brescia</city>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 21, 2021</last_update_submitted>
  <last_update_submitted_qc>July 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia</investigator_affiliation>
    <investigator_full_name>Prof Domenico Russo</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </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/NCT04469985
org study id: GITMO-AlloElderly
nct id: NCT04469985
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The age of patients' population is increasing every year, as the life expectancy. Thus, the
      incidence and prevalence of hematological cancers is increasing. In particular, acute
      leukemias and myelodisplastic syndromes are the most frequent diseases of the hematopoietic
      system. Allogeneic stem cell transplantation (allo-SCT) is the main therapeutic options for
      these diseases, and the number of allo-SCTs in the elderly is currently in progressive
      growth. This is partially due to the improvement of the allo-SCT procedure over the years,
      with the amelioration of donor selection, HLA typing, graft versus host disease (GVHD) and
      infections prophylaxis and treatment.

      Nevertheless, there is still an unmet clinical need, represented by the lack of extensively
      and detailed outcome analysis of elderly patients addressed to allo-SCT. With this aim, we
      planned this retrospective analysis of allo-SCTs in patients older than 60 years, within the
      GITMO transplant activity of the last 17 years. This study will help us in designing future
      prospective trials, including a comprehensive geriatric assessment of frailty, in order to
      address to allo-SCT those elderly who have the highest probability to achieve the best long
      term outcome with the lowest transplant-related mortality and morbidity.
observational model: Other
time perspective: Retrospective
measure: Overall Survival
time frame: 1 year
description: Overall Survival
measure: Disease Free Survival
time frame: 1 year
description: Disease Free Survival
measure: Transplant Related Mortality
time frame: 1 year
description: Transplant Related Mortality
measure: Acute Graft Versus Host Disease Incidence
time frame: 100 days
description: Acute Graft Versus Host Disease Incidence
measure: Chronic Graft Versus Host Disease Incidence
time frame: 1 year
description: Chronic Graft Versus Host Disease Incidence
measure: Relapse Incidence
time frame: 1 year
description: Relapse Incidence
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Michele Malagola, MD
role: Principal Investigator
affiliation: Bone Marrow Transplant Unit, University of Brescia
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
investigator full name: Prof Domenico Russo
investigator title: PI