NCT06790680Completed
GITMO AML/MDS-Relapse Registry Study
Managment of Acute Myeloid Leukemia and Myelodysplastic Patients Relapsing After Allogenic Stem Cell Transplantation: Results of the GITMO AML/MDS-relapse Registry Study
Source: ClinicalTrials.gov · Last updated 28 Jan 2025
Brief summary (registry, in English)
The proposal arises from the increasingly pressing need to have a program of therapy for the prevention of relapse after allogeneic transplantation in patients with acute myeloid leukemia or myelodysplasia, especially if they undergo transplantation with positive minimal residual disease. These therapeutic approaches include molecular target drugs (for example, FLT-3 inhibitors when this gene lesion is present) or apoptosis inducers in combination with hypomethylating agents (for example, the combination of venetoclax and azacitidine or decitabine) or adoptive immunotherapy (for example, with infusion of donor lymphocytes). To date, most of these therapeutic approaches are used in the phase of hematological relapse of the disease; less often they are used in the phase of persistence of minimal residual disease at the molecular level or in the phase of loss of molecular chimerism on CD34+ cells, also due to the prescribing constraints of the competent authorities (AIFA). It is believed that the collection of the Italian experience can provide important information on the use of different therapeutic platforms, in different settings. This information could be the starting point for the design of prospective and multicenter studies to be proposed in the near future.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 859 (actual)
- First submitted
- 3 Jan 2025
- Start date
- 15 Dec 2022
- Primary completion date
- 11 Aug 2023
- Lead sponsor
- Gruppo Italiano Trapianto di Midollo Osseo
- NCT number
- NCT06790680
What you commit to
- Study type: Observational
- Participants enrolled: 859
- From 15 Dec 2022 to the primary completion date, 11 Aug 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patients with a diagnosis other than AML and MDS transplanted in the same period.
Who the study is looking for
- All patients with AML and MDS who underwent allo-SCT from 2015 to 2021, who relapsed and received salvage therapy for the relapse.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GITMO Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.