Clinical trial NCT04469985: Allogeneic Stem Cell Transplantation (ALLO-SCT) in Elderly: 17-years Retrospective GITMO Survey
Official title: Allogeneic Stem Cell Transplantation (ALLO-SCT) in Elderly: 17-years Retrospective GITMO Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allogeneic Stem Cell Transplantation in Elderly Patients
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 2061
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enrol patients older than 60 years who received hematopoietic stem cell transplantation (HSCT) between 1st January 2000 and 31st December 2017.

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.


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

Primary outcomes:
measure: Overall Survival
timeFrame: 1 year
measure: Disease Free Survival
timeFrame: 1 year
measure: Transplant Related Mortality
timeFrame: 1 year
measure: Acute Graft Versus Host Disease Incidence
timeFrame: 100 days
measure: Chronic Graft Versus Host Disease Incidence
timeFrame: 1 year
measure: Relapse Incidence
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Chair of Hematology and Bone marrow Transplant Unit
Study officials:
affiliation: Bone Marrow Transplant Unit, University of Brescia
name: Michele Malagola, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Malagola M, Polverelli N, Rubini V, Martino M, Patriarca F, Bruno B, Giaccone L, Grillo G, Bramanti S, Bernasconi P, De Gobbi M, Natale A, Terruzzi E, Olivieri A, Chiusolo P, Carella AM, Casini M, Nozzoli C, Mazza P, Bassi S, Onida F, Vacca A, Falcioni S, Luppi M, Iori AP, Pavone V, Skert C, Carluccio P, Borghero C, Proia A, Selleri C, Sacchi N, Mammoliti S, Oldani E, Ciceri F, Russo D, Bonifazi F. GITMO Registry Study on Allogeneic Transplantation in Patients Aged >/=60 Years from 2000 to 2017: Improvements and Criticisms. Transplant Cell Ther. 2022 Feb;28(2):96.e1-96.e11. doi: 10.1016/j.jtct.2021.11.006. Epub 2021 Nov 21.