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Allogeneic Stem Cell Transplantation (ALLO-SCT) in Elderly: 17-years Retrospective GITMO Survey

Sponsor
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Other)
Overall Status
Completed
CT.gov ID
NCT04469985
Collaborator
(none)
2,061
Enrollment
1
Location
11
Actual Duration (Months)
187.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2061 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Allogeneic Stem Cell Transplantation (ALLO-SCT) in Elderly: 17-years Retrospective GITMO Survey
    Actual Study Start Date :
    Feb 1, 2020
    Actual Primary Completion Date :
    Dec 31, 2020
    Actual Study Completion Date :
    Dec 31, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival [1 year]

      Overall Survival

    2. Disease Free Survival [1 year]

      Disease Free Survival

    3. Transplant Related Mortality [1 year]

      Transplant Related Mortality

    4. Acute Graft Versus Host Disease Incidence [100 days]

      Acute Graft Versus Host Disease Incidence

    5. Chronic Graft Versus Host Disease Incidence [1 year]

      Chronic Graft Versus Host Disease Incidence

    6. Relapse Incidence [1 year]

      Relapse Incidence

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    This study will enrol patients older than 60 years who received hematopoietic stem cell transplantation (HSCT) between 1st January 2000 and 31st December 2017.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chair of Hematology and Bone marrow Transplant Unit Brescia Italy 25123

    Sponsors and Collaborators

    • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    Investigators

    • Principal Investigator: Michele Malagola, MD, Bone Marrow Transplant Unit, University of Brescia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof Domenico Russo, PI, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
    ClinicalTrials.gov Identifier:
    NCT04469985
    Other Study ID Numbers:
    • GITMO-AlloElderly
    First Posted:
    Jul 14, 2020
    Last Update Posted:
    Jul 22, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 22, 2021