Objective
In IMPACT-AML, a multidisciplinar R/R AML represents a model of high-impact disease, in which no standard of care exists, and where we have an urgent need for new evidence on possible therapies; AML offers the setting in which methodological innovation will combine powerful instruments of clinical trials with personalized medicine through academic efforts. Hereby, we propose to create an inclusive master framework for relapsed or refractory acute myeloid leukemia (STREAM) to include patients with R/R AML across Europe proficiently acquire an unselected population for clinical trials and monitor outcomes including neglected cohorts. Thereafter we will conduct a prospective randomized pragmatic clinical trial (RPCT) that will compare the classical “high intensity” rescue chemotherapy with biology-driven, “low intensity” rescue to obtain “real world” data on the benefit of one of the two different strategies in term of survival also considering patients and caregivers preferences, patient-reported outcomes (PRO), accessibility, affordability, and social cost.
RPCT will aim to evaluate the effectiveness of real-world clinical alternatives in routine care. In addition to retaining the high internal validity of traditional randomized trials, it will maximize external validity, i. e. generalizability of results to many settings. In this context, the inclusion of an RPCT in the master framework will allow a dynamic inclusion and the collection of the excluded population as an instrument to predict the real-life applicability of clinical trial results. We will offer Europe results from an ambitious project, that will go beyond the state of the art in R/R AML demonstrating the superiority of a strategy in a first-of-his-kind clinical trial, providing strong data that will be delivered to national health care providers, policymakers, and health authorities data on optimized and affordable treatment for R/R AML and promoting the implementation of the selected better option. This action is part of the Cancer Mission cluster of projects on ‘Diagnosis and treatment’.
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Keywords
Programme(s)
- HORIZON.2.1 - Health Main Programme
Funding Scheme
HORIZON-RIA - HORIZON Research and Innovation ActionsCoordinator
47014 Meldola
Italy
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Participants (16)
08035 Barcelona
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2371 AGIOS DOMETIOS
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00182 Roma
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69469 Weinheim
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46026 Valencia
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00165 Roma
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04289 Leipzig
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625 00 Brno
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
10117 Berlin
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42002 Soria
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1000 Bruxelles / Brussel
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
40126 Bologna
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30625 Hannover
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10115 Berlin
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53100 Siena
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50161 KAUNAS
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