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

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.

Study Overview

• Status: Completed
• Conditions: Myelodysplastic Syndrome; Acute Myeloid Leukaemia

• Study Type: Observational
• Enrollment (Actual): 859

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40124
    • GITMO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome	Complete remission rate after salvage treatment	Through study completion, an avarage 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Secondary Outcome	Through study completion, an avarage 1 year

Collaborators and Investigators

• Sponsor: Gruppo Italiano Trapianto di Midollo Osseo

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Actual): August 11, 2023
• Study Completion (Actual): May 9, 2024

Study Registration Dates

• First Submitted: January 3, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Bone Marrow Diseases; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes
• Other Study ID Numbers: GITMO AML/MDS-Relapse

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No