| Project Detail |
"MeMeasurable residual disease (MRD) detected by multiparameter flow cytometry (MFC) has strong prognostic value in patients with the most frequent acute and chronic leukemias, acute myeloid (AML) and chronic lymphocytic leukemia (CLL), but it has not yet been confirmed as a treatment-guiding biomarker. The RESOLVE Consortium will leverage numerous existing expert networks and patient advocacy partnerships to establish the predictive value of MRD in AML/CLL patients, with the expectation that this affordable, minimally-invasive biomarker can be imminently used to guide the intensity of consolidation therapy, improve quality of life (QoL), and reduce costs. This will be achieved through 1) development of a real-world patient registry and data platform; 2) establishment of standardized, decentralized MRD analysis across Europe; and 3) a randomized, controlled multi-national pragmatic trial based on the hypothesis that treatment intensity can be safely reduced in MRD negative AML/CLL patients, to provide evidence for the clinical, personal and societal impact of MRD-guided therapy. These efforts will be supported by RESOLVE’s participatory research pipeline, which will incorporate input from patients, caregivers, and experts in social sciences and health economics. The real-world nature of the study ensures broadly applicable results for all patients regardless of location, socioeconomic status, gender, sex, disability or ethnicity. The findings will then be effectively communicated and disseminated following open science principles through the medical community for uptake in routine clinical practice. The laboratory, clinical, and patient advocacy infrastructures already in place will support rapid adoption of MFC-based MRD assessment to aid in clinical decision-making. The Consortium’s widespread member organizations will work with policymakers and authorities across the EU to provide access to the test in the national health care systems for all AML and CLL patients. |
