- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Brescia, Italy, 25123
- Chair of Hematology and Bone marrow Transplant Unit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: 1 year
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Overall Survival
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1 year
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Disease Free Survival
Time Frame: 1 year
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Disease Free Survival
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1 year
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Transplant Related Mortality
Time Frame: 1 year
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Transplant Related Mortality
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1 year
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Acute Graft Versus Host Disease Incidence
Time Frame: 100 days
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Acute Graft Versus Host Disease Incidence
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100 days
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Chronic Graft Versus Host Disease Incidence
Time Frame: 1 year
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Chronic Graft Versus Host Disease Incidence
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1 year
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Relapse Incidence
Time Frame: 1 year
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Relapse Incidence
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1 year
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Collaborators and Investigators
Investigators
- Principal Investigator: Michele Malagola, MD, Bone Marrow Transplant Unit, University of Brescia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- GITMO-AlloElderly
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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