The Project

Project aim and objectives

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 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

The Study

The study is a multicenter randomized controlled pragmatic trial of standard intensity versus reduced intensity consolidation treatment in MRD-negative patients with AML or CLL (RESOLVE) EU CT: 2024 – 512503 – 39 – 00. 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 study will be conducted in France, Germany, Greece, Israel, Italy, and Poland.

The Study

The study is a multicenter randomized controlled pragmatic trial of standard intensity versus reduced intensity consolidation treatment in MRD-negative patients with AML or CLL (RESOLVE) EU CT: 2024-512503-39-00. 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 study will be conducted in France, Germany, Greece, Israel, Italy, and Poland.