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IMPACT- AML

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Master Framework and Pragmatic Clinical Trial for Relapse or Refractory Acute My...

Master Framework and Pragmatic Clinical Trial for Relapse or Refractory Acute Myeloid Leukemia 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 met... see more

31/03/2028

IRST

6M€

Project Budget: 6M€

Project leader

ISTITUTO ROMAGNOLO PER LO STUDIO DEI TUMORI D... No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

PARTICIPATION DEPralty Sin fecha límite de participación.

Financing granted El organismo HORIZON EUROPE notifico la concesión del proyecto The day 2023-04-01

HORIZON-MISS-2022-CANCER-01-03: Pragmatic clinical trials to optimi... Expected Outcome:While cancer research and innovation have generated novel treatment options, cancer...

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characteristics of the participant

Este proyecto no cuenta con búsquedas de partenariado abiertas en este momento.

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IRST

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Project duration: 59 months Date Start: 2023-04-01
End date: 2028-03-31

Project leader

ISTITUTO ROMAGNOLO PER LO STUDIO DEI TUMORI D... No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Project Budget 6M€

participation deadline Sin fecha límite de participación.

Project description 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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