Analysis of the Immunobiology of Acute Myeloid Leukemia Relapses After Allogeneic Hematopoietic Stem Cell Transplant (HSCT) for the Generation of Guidelines and Personalized Therapeutic Pathways

NCT ID: NCT05124288

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-18
• Study Completion Date: 2027-06-20

Brief Summary

This is a retrospective and prospective non-interventional multicenter observational study. Neither diagnostic approaches nor experimental drugs/procedure will be applied and the samples will take place at the same time as the samples will be taken during routinary clinical practice.

The aim of this study is to analyze the immunobiology of Acute Myeloid Leukemia (AML) relapses after allogeneic HSCT for the generation of guidelines and personalized therapeutic pathways.

Detailed Description

Background: The identification of leukemic relapses characterized by the "Human Leukocyte Antigens loss" event or by changes in the expression levels of genes involved in antigen presentation and lymphocyte co-stimulation demonstrate how a complete characterization of disease recurrence is necessary to ensure the patient a treatment that is as personalized and targeted as possible, avoiding the choice of sub-optimal or, sometimes, harmful therapies. Unfortunately, the identification of the post-transplant relapse mechanism is now far from being part of an established clinical routine, mainly due to the lack of quick and easy-to-access diagnostic tools and multicentre studies demonstrating the efficacy of a type of personalized therapeutic approach.

The main objective of the study is to favor, exploiting the consolidated collaboration between the Italian transplant centers belonging to the Italian Group of Bone Marrow Transplantation, Hematopoietic Stem Cells and Cell Therapies (GITMO), the implementation in clinical practice of an in-depth biological study of relapses of leukemia in order to allow an increasingly targeted and effective planning of the therapeutic strategies to be implemented, ensuring better patient survival.

The study is divided into two parts:

• data collection, from clinical standard practice, of patients with relapse of the disease which will allow to standardize the therapeutic management process and will allow us to promote innovative clinical studies on acute myeloid leukemia post allogeneic HSCT, with the ultimate aim of improving the survival of these patients;
• biological substudy that will allow to define the role of the tumor microenvironment in promoting or counteracting the phenomenon of relapse by identifying its specific alterations in the various forms of disease relapse.

Conditions

Acute Myeloid Leukemia, in Relapse

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Acute Myeloid Leukemia relapsed patients

Adult patients (\< 18 years old), with Acute Myeloid Leukemia, who relapse after allogeneic transplantation from either family or unrelated donors, regardless of the cellular source of the transplant (bone marrow, mobilized peripheral stem cells or cord blood).

Observations on Relapsed AML Allogeneic Transplanted patients

Intervention Type: OTHER

This is not an interventional clinical study. This is a retrospective/prospective observational study on Relapsed AML Allogenic Transplanted patients. Additional samples will be collected during the standard practice.

Interventions

Observations on Relapsed AML Allogeneic Transplanted patients

This is not an interventional clinical study. This is a retrospective/prospective observational study on Relapsed AML Allogenic Transplanted patients. Additional samples will be collected during the standard practice.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patients with Acute Myeloid Leukemia, who relapse after allogeneic transplantation from either family or unrelated donors, regardless of the cellular source of the transplant (bone marrow, mobilized peripheral stem cells or cord blood), who have signed the informed consent of the study;
• For the coordinating center, all patients who have previously signed informed consent to the "Hematological Neoplasms Biobank" and for which samples, stored in the Biobank are available.
• For the other centers, all patients who have previously signed an informed consent, aimed at the prior authorization for the storage of samples in the biobank of the aforementioned center, according to centers own practice, and for which samples, stored in a Biobank, are available.

Exclusion Criteria

• Participation in clinical protocols that expressly exclude the possibility of participating in other studies.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gruppo Italiano Trapianto di Midollo Osseo

OTHER

Sponsor Role: collaborator

Associazione Italiana per la Ricerca sul Cancro

OTHER

Sponsor Role: collaborator

Ciceri Fabio

OTHER

Sponsor Role: lead

Responsible Party

Ciceri Fabio

Principal Investigator, Professor and Head of Hematology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Fabio Ciceri, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Ospedale San Raffaele

Locations

IRCCS Ospedale San Raffaele

Milan, Milano, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Fabio Ciceri, MD

Role: CONTACT

ciceri.clinicaltrials@hsr.it

+39 02-2643-3093

Stefania Trinca

Role: CONTACT

regolatorio.scp@hsr.it

+39 02-2643-4289

Facility Contacts

Fabio Ciceri, MD

Role: primary

ciceri.clinicaltrials@hsr.it

+39 02-2643-3093

Stefania Trinca

Role: backup

regolatorio.scp@hsr.it

+39 02-2643-4289

Other Identifiers

GITMO-RELAPSE

Identifier Type: -

Identifier Source: org_study_id