Allogeneic Stem Cell Transplantation in Elderly PatientsNCT04469985
Allogeneic Stem Cell Transplantation (ALLO-SCT) in Elderly: 17-years Retrospective GITMO Survey
An observational study of Allogeneic Stem Cell Transplantation in Elderly Patients, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Allogeneic Stem Cell Transplantation in Elderly Patients
- How many people
- 2,061 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
This study will enrol patients older than 60 years who received hematopoietic stem cell transplantation (HSCT) between 1st January 2000 and 31st December 2017.
Trial locations and contacts
1 site in 1 country.
About this study
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall Survival
Measured: 1 year
Disease Free Survival
Disease Free Survival
Measured: 1 year
Transplant Related Mortality
Transplant Related Mortality
Measured: 1 year
Acute Graft Versus Host Disease Incidence
Acute Graft Versus Host Disease Incidence
Measured: 100 days
Chronic Graft Versus Host Disease Incidence
Chronic Graft Versus Host Disease Incidence
Measured: 1 year
Relapse Incidence
Relapse Incidence
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start1 Feb 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allogeneic Stem Cell Transplantation in Elderly PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,061 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Domenico Russo, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Investigators
- Michele Malagola, MD, Principal investigator, Bone Marrow Transplant Unit, University of Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469985
- Sponsor's protocol ID
- GITMO-AlloElderly
- Status last verified
- Jul 2021
- First submitted
- 9 Jul 2020
- Last updated
- 22 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34818581
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Stem Cell Transplantation (ALLO-SCT) in Elderly: 17-years Retrospective GITMO Survey
- ClinicalTrials.gov ID
- NCT04469985
- Acronym / sponsor ID
- GITMO-AlloElderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,061 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival
Time frame: 1 year
Overall Survival
Disease Free Survival
Time frame: 1 year
Disease Free Survival
Transplant Related Mortality
Time frame: 1 year
Transplant Related Mortality
Acute Graft Versus Host Disease Incidence
Time frame: 100 days
Acute Graft Versus Host Disease Incidence
Chronic Graft Versus Host Disease Incidence
Time frame: 1 year
Chronic Graft Versus Host Disease Incidence
Relapse Incidence
Time frame: 1 year
Relapse Incidence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Derived from this study: PubMed 34818581Malagola 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Malagola, MD principal investigator
Bone Marrow Transplant Unit, University of Brescia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allogeneic Stem Cell Transplantation in Elderly Patients, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04469985, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.