Periodic Reporting for period 1 - RESOLVE (Residual disease assessment in hematologic malignancies to improve patient-relevant outcomes across Europe (RESOLVE))
Periodo di rendicontazione: 2024-04-01 al 2025-09-30
Measurable residual disease (MRD) detected by multiparameter flow cytometry (MFC) is a strong prognostic marker in acute myeloid (AML) and chronic lymphocytic leukaemia (CLL), but its value as a treatment-guiding biomarker remains unconfirmed. The EU-funded RESOLVE project aims to validate the predictive utility of MRD and enable its routine clinical use. RESOLVE brings together expert networks and patient advocacy groups to assess whether therapy intensity can be safely reduced in MRD-negative patients, improving quality of life while lowering costs.
The project integrates three components: a real-world patient registry and data platform, standardized decentralized MRD testing across Europe, and a multinational pragmatic trial evaluating MRD-guided consolidation therapy. A participatory research pipeline will incorporate input from patients, caregivers and experts in social sciences and health economics, ensuring broad applicability across demographic and socioeconomic groups.
RESOLVE follows open-science dissemination principles and will provide clinical, personal and societal evidence for adopting MRD as an affordable, minimally invasive tool in national health systems. Supported by established laboratory, clinical and advocacy infrastructures, the consortium is well positioned to drive EU-wide implementation. The initiative directly contributes to the Cancer Mission’s Diagnostics and Treatment cluster and advances precision medicine in AML and CLL.
The project integrates three components: a real-world patient registry and data platform, standardized decentralized MRD testing across Europe, and a multinational pragmatic trial evaluating MRD-guided consolidation therapy. A participatory research pipeline will incorporate input from patients, caregivers and experts in social sciences and health economics, ensuring broad applicability across demographic and socioeconomic groups.
RESOLVE follows open-science dissemination principles and will provide clinical, personal and societal evidence for adopting MRD as an affordable, minimally invasive tool in national health systems. Supported by established laboratory, clinical and advocacy infrastructures, the consortium is well positioned to drive EU-wide implementation. The initiative directly contributes to the Cancer Mission’s Diagnostics and Treatment cluster and advances precision medicine in AML and CLL.
The RESOLVE project has achieved significant progress across its six objectives in the first 18 months. A data dictionary covering all clinical and MRD data has been agreed, and two eCRFs—one for MRD data, one for clinical data from the registry and RCPT—have been designed, forming the project’s data platform. MRD assessment has been standardized across six countries, and participating laboratories trained. Patient- and family-reported outcome measures and a socio-economic questionnaire have been developed, selected, and translated into all required languages. Preparations for the randomized controlled trial in AML and CLL are advancing: the study protocol is finalized, regulatory approval obtained for Israel and France, and submissions are underway for Germany, Italy, Greece, and Poland. Dissemination and communication are active through the project homepage, conference presentations, and press releases. Strong project management and an extensive legal framework ensure all deliverables are achieved on schedule.
Standardization of MRD assessment across Europe is supported by a centralized platform for expertise exchange and laboratory training, enabling decentralized, reproducible, rapid, and cost-effective MRD testing. All outcome measures for evaluating social impacts of MRD-guided treatments via a multidisciplinary participatory research pipeline are ready, enabling data collection during recruitment and treatment to assess emotional, social, societal, and economic impacts.
The MRD-guided RCPT and associated cohort studies in AML and CLL are ready to start in Israel and France. These core studies are crucial for collecting accurate, efficient data to inform clinicians and policymakers on practice changes, infrastructure, and funding. They will also guide patient and caregiver discussions on risks and benefits of standard versus reduced-intensity therapy when MRD tests indicate low recurrence risk.
Coordination and management: Early RESOLVE activities focused on establishing internal governance, the legal framework, and preparing the RCPT. The project combines top-down coordination with bottom-up implementation to ensure partner engagement and quality execution. Project Coordinator M. Heuser (MLU) supervises all work packages and management bodies, liaising with the European Commission and ensuring compliance with the Grant and Consortium Agreements. He is supported by Deputy Coordinators J. Cloos (VUMC) and P. Ghia (ERIC), and a Project Manager handling administrative, financial, and communication tasks. Decision-making is led by the Project Steering Committee (PSC) of partner representatives, while the Clinical Trial Steering Committee (CTSC) oversees trial organization, accrual, and database management. Communication relies on regular meetings, a shared cloud repository, mailing lists, and open-science practices. All activities follow Gender, Equity, Diversity, and Inclusion (GEDI) principles across teams, patient recruitment, and leadership.
The coordination team manages daily operational, financial, and administrative tasks, supporting startup activities, reporting, and partner engagement. Establishing the contractual and organizational framework required extensive effort. The EU signed the Grant Agreement with 22 partners, and the Consortium Agreement governs collaboration, resource sharing, quality standards, and GDPR-compliant data protection. Additional agreements were made between the Sponsor and National Study Group Coordinators (NSGCs), NSGCs and clinical sites, and, where applicable, with MRD laboratories and monitoring CROs, ensuring governance and compliance across all operational levels.
Standardization of MRD assessment across Europe is supported by a centralized platform for expertise exchange and laboratory training, enabling decentralized, reproducible, rapid, and cost-effective MRD testing. All outcome measures for evaluating social impacts of MRD-guided treatments via a multidisciplinary participatory research pipeline are ready, enabling data collection during recruitment and treatment to assess emotional, social, societal, and economic impacts.
The MRD-guided RCPT and associated cohort studies in AML and CLL are ready to start in Israel and France. These core studies are crucial for collecting accurate, efficient data to inform clinicians and policymakers on practice changes, infrastructure, and funding. They will also guide patient and caregiver discussions on risks and benefits of standard versus reduced-intensity therapy when MRD tests indicate low recurrence risk.
Coordination and management: Early RESOLVE activities focused on establishing internal governance, the legal framework, and preparing the RCPT. The project combines top-down coordination with bottom-up implementation to ensure partner engagement and quality execution. Project Coordinator M. Heuser (MLU) supervises all work packages and management bodies, liaising with the European Commission and ensuring compliance with the Grant and Consortium Agreements. He is supported by Deputy Coordinators J. Cloos (VUMC) and P. Ghia (ERIC), and a Project Manager handling administrative, financial, and communication tasks. Decision-making is led by the Project Steering Committee (PSC) of partner representatives, while the Clinical Trial Steering Committee (CTSC) oversees trial organization, accrual, and database management. Communication relies on regular meetings, a shared cloud repository, mailing lists, and open-science practices. All activities follow Gender, Equity, Diversity, and Inclusion (GEDI) principles across teams, patient recruitment, and leadership.
The coordination team manages daily operational, financial, and administrative tasks, supporting startup activities, reporting, and partner engagement. Establishing the contractual and organizational framework required extensive effort. The EU signed the Grant Agreement with 22 partners, and the Consortium Agreement governs collaboration, resource sharing, quality standards, and GDPR-compliant data protection. Additional agreements were made between the Sponsor and National Study Group Coordinators (NSGCs), NSGCs and clinical sites, and, where applicable, with MRD laboratories and monitoring CROs, ensuring governance and compliance across all operational levels.
Overall, RESOLVE has already established a sustainable framework for harmonized MRD diagnostics across Europe and strengthened collaboration between clinical and research networks. A trial management infrastructure has been established that will allow us to recruit the projected patient numbers efficiently. By educating the hematologic community MRD is considered a key prognostic factor and the necessity of a prospective trial for the predictive use of MRD has been fully accepted by the community. The updated MRD guidelines of ELN-DAVID will further standardize MRD in AML and promote its use in real world treatment of AML patients. By combining scientific excellence, and patient participation, RESOLVE reinforced the European research ecosystem and laid the foundation for long-term improvements in leukemia care, patient empowerment, and healthcare system efficiency.