Collecting Real World Evidence to improve outcomes of Acute Myeloid Leukemia patients in Europe
Acute myeloid leukemia (AML) is a genetically heterogeneous disease with outcomes that strongly depend on molecular features. Since 2017, the introduction of novel targeted therapies and less intensive regimens has transformed the AML treatment landscape, improving survival for specific subgroups and patients unfit for intensive chemotherapy. Despite these advances, relapse and resistance remain major challenges, particularly in patients with high-risk mutations.
We are launching a Call for Data Partners to collect and harmonize real-world data from AML patients treated with standard-of-care chemotherapies combined with targeted therapies.
The overall goal of this data collection is to extend the centralized, harmonized, and curated HARMONY AML repository so that it can be used as historical control for:
- Novel therapy approaches in a first-line setting, mainly building on triple therapies, both in combination with intensive and less-intensive therapies, and
- The increasing number of novel approaches in the relapse/refractory setting.
Specific objectives of the call include making data available to researchers to assess the real-world impact of novel first-line therapies and salvage treatments—particularly targeted approaches, whose effects remain insufficiently defined—and to refine current treatment guidelines, risk classification schemes, and related frameworks.
Join us as a Data Partner: send your Expression of Interest
If you manage a registry, database, or have access to real-world data of patients with AML, we want to hear from you! Together, we can generate the evidence needed to transform care for this difficult-to-treat population.
Benefits for Data Partners
- Access to the resulting database.
- Possibility to submit research questions using data on the HARMONY Platform.
- Access to dashboards to facilitate data visualization.
- Authorship rights in any publication resulting from the use of your data.
- Networking opportunities.
- Potential funding opportunities.
Fill out this form if you want to collaborate and receive further information
Why this matters
Despite these advances, relapse and resistance remain major challenges, particularly in patients with high-risk mutations such as TP53. Current guidelines, such as the updated ELN classifications, are adapting to this evolution, yet therapeutic decisions are increasingly complex as new treatment modalities—including menin inhibitors, FLT3 inhibitors, and venetoclax-based combinations—continue to emerge. These rapid developments underscore the need for comprehensive, up-to-date datasets that capture the real-world impact of these evolving approaches across diverse patient populations.
The HARMONY Alliance has already established one of the largest international AML datasets, integrating genetic and clinical information from patients treated primarily with conventional intensive therapies prior to the approval of targeted agents. While this provides an invaluable foundation, significant data gaps remain, particularly regarding patients treated with current standards of care, those receiving targeted or immune-based therapies, and those with relapsed or refractory disease. Expanding the dataset to include these contemporary treatment modalities and patient subgroups is crucial for understanding therapy responses, resistance mechanisms, and long-term outcomes. Such enriched data will be essential to refine risk classification, guide personalized treatment strategies, and ensure that emerging evidence is effectively translated into updated clinical practice guidelines.
Background
The HARMONY Alliance Foundation is a globally focused non-profit organization, established in Spain and built upon the achievements of two EU-funded IHI initiatives of HARMONY and HARMONY PLUS. The strategic focus of the foundation lies in using multi-source data and advanced analytics to speed up the development of therapies for patients with haematological malignancies.
For more than 8 years, the HARMONY Platform has powered high-impact research by providing structured, secure access to real-world data — supporting collaboration, insight generation, and better outcomes. We are now expanding our datasets and would like to invite you to share data reflecting recent treatments. If you are interested in contributing your data to the largest GDPR compliant data repository in haematological malignancies in the EU, and being part of a collaborative effort to move the field in the shortest time possible, please send your Expression of Interest.
Do you have any questions or suggestions?
Contact us and help shape the future of treatments for patients with AML.