GITMO AML/MDS-Relapse Registry Study

NCT06790680 | Completed

• 1 other identifier: GITMO AML/MDS-Relapse
• Study Type: observational
• Target: 859
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Myeloid Leukaemia; Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  Complete remission rate after salvage treatment

  Through study completion, an avarage 1 year

Secondary Outcomes (1)

• Overall survival

  Through study completion, an avarage 1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with acute myeloid leukemia and myelodysplasia relapsed after allotransplantation and who received salvage therapy.

You may qualify if:

• All patients with AML and MDS who underwent allo-SCT from 2015 to 2021, who relapsed and received salvage therapy for the relapse.

You may not qualify if:

• Patients with a diagnosis other than AML and MDS transplanted in the same period.

Sponsors & Collaborators

• Gruppo Italiano Trapianto di Midollo Osseo: lead

Study Sites (1)

GITMO

Bologna, Italy, 40124, Italy

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 24, 2025
• Study Start: December 15, 2022
• Primary Completion: August 11, 2023
• Study Completion: May 9, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

IT (1)