Measurable 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 Project
Project aim and objectives
The RESOLVE Consortium leverages 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 is achieved through 1) development of a real-world patient registry and data platform (RESOLVE registry); 2) establishment of standardized, decentralized MRD analysis across Europe; and 3) a randomized, controlled pragmatic trial (RESOLVE 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.
Objectives
Aim: Affordable and standardized residual disease diagnostics for hematologic malignancies across Europe for improved patient outcomes
Objective 1
Data platform and MRD-registry
Objective 2
MRD standardization & analysis
Objective 3
Participatory research pipeline
Objective 4: Randomized pragmatic clinical trial
Arm A: MRD negative intermediate risk AML: alloHCT vs chemo
Arm B: MRD negative CLL treated with fixed duration regimen: continue vs stop
Objective 5
Dissemination, exploitation, communication
Objective 6
Coordination and project management