Allogeneic Stem Cell Transplantation in Elderly Patients Clinical Trial
Official title:
Allogeneic Stem Cell Transplantation (ALLO-SCT) in Elderly: 17-years Retrospective GITMO Survey
| Verified date | July 2021 |
| Source | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 2061 |
| Est. completion date | December 31, 2020 |
| Est. primary completion date | December 31, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 60 Years and older |
| Eligibility | This study will enrol patients older than 60 years who received hematopoietic stem cell transplantation (HSCT) between 1st January 2000 and 31st December 2017. |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Chair of Hematology and Bone marrow Transplant Unit | Brescia |
| Lead Sponsor | Collaborator |
|---|---|
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival | Overall Survival | 1 year | |
| Primary | Disease Free Survival | Disease Free Survival | 1 year | |
| Primary | Transplant Related Mortality | Transplant Related Mortality | 1 year | |
| Primary | Acute Graft Versus Host Disease Incidence | Acute Graft Versus Host Disease Incidence | 100 days | |
| Primary | Chronic Graft Versus Host Disease Incidence | Chronic Graft Versus Host Disease Incidence | 1 year | |
| Primary | Relapse Incidence | Relapse Incidence | 1 year |