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

NCT ID: NCT04469985

Last Updated: 2021-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2061 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Allogeneic Stem Cell Transplantation in Elderly Patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof Domenico Russo

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michele Malagola, MD

Role: PRINCIPAL_INVESTIGATOR

Bone Marrow Transplant Unit, University of Brescia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chair of Hematology and Bone marrow Transplant Unit

Brescia, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34818581 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GITMO-AlloElderly

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Co-transplantation of MSC in the Setting of Allo-HSCT
NCT04247945 RECRUITING PHASE2/PHASE3