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Completed

NCT Number: NCT04469985

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

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.

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Key information

Conditions

Allogeneic Stem Cell Transplantation in Elderly Patients

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chair of Hematology and Bone marrow Transplant Unit

Brescia, 25123, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall Survival

    Time frame: 1 year

    Overall Survival

  2. Disease Free Survival

    Time frame: 1 year

    Disease Free Survival

  3. Transplant Related Mortality

    Time frame: 1 year

    Transplant Related Mortality

  4. Acute Graft Versus Host Disease Incidence

    Time frame: 100 days

    Acute Graft Versus Host Disease Incidence

  5. Chronic Graft Versus Host Disease Incidence

    Time frame: 1 year

    Chronic Graft Versus Host Disease Incidence

  6. Relapse Incidence

    Time frame: 1 year

    Relapse Incidence

Sponsors and collaborators

Lead sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 14, 2020
Registry last updated
Jul 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.