Objectives

STREAM is a master framework for patient data collection, for patients for relapsed or refractory acute myeloid leukemia (AML) across Europe. STREAM aims at mapping demographics, diagnosis methods, genetic data, patient survival status and treatments at the EU level in line with EU data protection and interoperability standards with the following major objectives:

1. Create an innovative framework: in which every R/R AML patient can be enrolled, without neglecting population due to ethnicity, country of origin, previous lines of therapy, subcategorization due to personalized medicine, or rare mutations. STREAM will collect the largest real-life R/R AML set prospectively by the implementation of a dedicated AML module in the European Rare Blood Disorders Platform (ENROL), as the ERN-EuroBloodNet platform for patients registries on rare hematological diseases. Patients will be included at any stage of the disease, for any cancer subtype, in any age group, or part of society.
2. Retrieve high-quality data to address treatment interventions: for patients with refractory cancers. Particularly, low-intensity vs standard chemotherapy rescue will be evaluated in the RPCT with a predefined accrual calculation, with the primary objective to demonstrate a survival advantage with one strategy. The primary endpoint of the pragmatic trial will be overall survival, while secondary endpoints will be event-free survival, response rate and quality of response, bridge to SCT, patient-reported outcomes, and quality of life issues considered important by and for cancer patients and their caregivers.

STREAM Data Collection

STREAM is a platform used for the registration of R/R AML patients and it is aligned with the European Rare Blood Disorders Platform (ENROL). Patient data collected through STREAM will include demographics, assessment of diagnosis methods, genetic data, treatments, and patient survival status.

The STREAM platform design and collected data will align with the EU data protection and interoperability standards and the FAIR principles, as also promoted by ENROL.