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Published in Blood, a top-tier peer-reviewed medical journal published by the American Society of Hematology, ‘Impact-AML: A European Master Framework for Cohort Studies and Pragmatic Clinical Trials in Relapse or Refractory Acute Myeloid Leukemia‘ and presented at international Symposium ACUTE LEUKEMIAS XIX (ISALXIX) in Munich the IMPACT-AML work is recognized by this very high Impact factor journal First author of the paper is Giovanni Marconi, Associate Professor at the University of Bologna and Hematologist at Ospedale Santa Maria delle Croci of Ravenna, member of the coordination team of the IMPACT-AML project. The scientific article describes STREAM, an inclusive, prospective, master framework for the design and conduction of pragmatic trials in refractory acute myeloid leukemia (R/R AML).

STREAM was developed to address the gap by supporting clinical trial design, real-world evidence collection, and streamlined data sharing across multiple centers and to find a standardized approach for relapsed or refractory acute myeloid leukemia (R/R AML), which still has limited treatment options, high relapse rates, and poor survival rates. STREAM aims to create a comprehensive framework for R/R AML patients, facilitating the comparison of treatment regimens, and establishing a large accrual network via a platform approach. Through standardized data collection and cross-country collaboration, STREAM seeks to optimize treatment strategies for neglected AML populations and improve treatment accessibility and outcomes.

Funded by the European Union under Mission Cancer (IMPACT-AML project), STREAM will engage institutions across the world, integrating patient registration via an online platform. SPIDER pseudonymization is applied to avoid duplicate entries and allows cross-border management of patients.  Data collection is based on rare disease domains established by European Reference Networks, and aligns with the European Leukemia Network guidelines, ensuring interoperability and minimal data entry requirements. Biobanking and minimal disease testing procedures were developed to allow a local – yet standardized – adherence to sample storage for research purposes.

Up to now, STREAM is being activated in about 40 centers in 7 EU countries and includes further sites in several EU and extra-EU, with the aim to reaching worldwide participation. STREAM offers a novel platform for integrating personalized medicine approaches within R/R AML research, optimizing both patient care and resource allocation. Its framework supports flexible, adaptive trial designs, bridging gaps in AML research and addressing heterogeneity in treatment practices across Europe. This structure will provide critical evidence for developing affordable, accessible treatments for R/R AML and lay the foundation for sustainable, patient-centered research models.

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