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| Name | Class |
|---|---|
| Gruppo Italiano Trapianto di Midollo Osseo | OTHER |
| Associazione Italiana per la Ricerca sul Cancro | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observations on Relapsed AML Allogeneic Transplanted patients | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | The probability of disease-free survival will be calculated from the transplant infusion time to the date of death, last follow-up and / or disease recurrence / progression. | From date of transplant infusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 years |
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Inclusion Criteria:
Exclusion Criteria:
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The cohort of this study will be composed of adult patients with Acute Myeloid Leukemia, who will relapse after allogeneic transplantation from either familial or unrelated donor, regardless of the cellular source of the transplant (bone marrow, mobilized peripheral stem cells or cord blood).
The samples of interest are those taken at the time of post-transplant recurrence at the same time as routine investigations and may be of both medullary blood and peripheral blood, as long as the samples have a percentage of pathological cells equal to at least 5% of cellularity.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabio Ciceri, MD | Contact | +39 02-2643-3093 | ciceri.clinicaltrials@hsr.it | |
| Stefania Trinca | Contact | +39 02-2643-4289 | regolatorio.scp@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Fabio Ciceri, MD | IRCCS Ospedale San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale San Raffaele | Recruiting | Milan | Milano | 20132 | Italy |
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Peripheral and bone marrow blood, withdrawn during clinical practice
|
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007154 | Immune System Diseases |
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