Acute myeloid leukemia (AML) is the most common acute leukemia in adults and is diagnosed in 22,600 people per year in the EU, with increasing incidence over time. It is the most aggressive leukemia subtype, with a 5-year overall survival (OS) of only 28% overall and certain subgroups (such as ages 65 and older) having even poorer outcomes. A metric that effectively predicts patients’ risk of relapse or progression after initial treatment could allow personalized medical decision-making that would spare patients the side effects, costs, and QoL concerns associated with intensive consolidation therapy for patients who are unlikely to experience future disease or where effective salvage treatments are available.

Tailoring treatment for individuals by using effective, targeted treatment options and sophisticated risk classification at diagnosis has already improved clinical responses in many hematologic malignancies, resulting in the majority of patients reaching a complete remission (CR, as assessed by imaging and light microscopy), even in AML. However, a relatively large proportion of AML patients still suffer from disease relapse or progression (40-50% and 45%, respectively), meaning CR is insufficient to identify patients with a high risk of relapse. Current treatment guidelines for acute leukemias therefore recommend quantification of residual disease (measurable residual disease, or MRD) using the sensitive technique of multi-color flow cytometry (MFC) or qPCR to better predict prognosis. While MRD is widely utilized in leukemia diagnosis and subtype differentiation, as well as therapeutic decision-making for some leukemia subtypes, there is still clinical debate about how MRD results can be used to guide treatment decisions in patients with AML. Mounting evidence suggests that MRD-negative AML patients – those with residual disease below a certain detection limit following initial treatment – may be at a lower risk for relapse, even without intensive or prolonged consolidation therapy. To uniformly and reproducibly identify MRD-negative AML patients across Europe, we will use our expert network, ELN-DAVID, to implement harmonized MRD assessment practices across Europe, building off of existing MRD testing infrastructure in place in many countries for other leukemias. We will collaborate with colleagues from the European Research Initiative on CLL (ERIC) to exchange and harmonize MRD assessment between AML and CLL laboratories.

The principal aim of the workshop is a scientific exchange to build closer collaborations in the future and co-ordinate harmozined MRD assessment across Europe.

• 08:30 – 09:00 | Arrival and coffee
   
• 09:00 – 10:00 | Design of a clinical trial protocol for MRD guided clinical trials in AML (Michael Heuser, All)
   
• 10:00 – 10:15 | Coffee break
   
• 10:15 – 11:15 | Design of a clinical trial protocol for MRD guided clinical trials in CLL (Paolo Ghia, Lydia Scarfó, All)
   
• 11:15 – 12:00 | Statistical design of MRD guided clinical trials (Axel Benner, Georgios Karakatsoulis)
   
• 12:00 – 13:00 | Lunch break
   
• 13:00 – 15:00 |
  AML-MRD group: Find agreement on standardized Flow-MRD assessment and analysis in AML (Jacqueline Cloos, Francesco Buccisano)
  
  Co-design workshop on PROMs, FROMS, ECOMS (Annemarie Braamse, Patrizio Armeni)
   
• 15:00 – 15:30 | Coffee break
   
• 15:30 – 16:50 |
  Develop the framework for data sharing in a European MRD registr (Jacqueline Cloos, John Jacobs)
  
  Define the data dictionary for a European MRD registry (Michael Heuser, Jacqueline Cloos, Annemarie Braamse, Patrizio Armeni)
   
• 16:50 | Summary (Michael Heuser)
   
• 17:00 | End of meeting

ARMENI, PATRIZIO | Health Economics and HTA, CERGAS | SDA Bocconi School of Management, Milano, Italy 

BENNER, AXEL | Division of Biostatistics, Deutsches Krebsforschungszentrum Heidelberg, Germany

BRAAMSE, ANNEMARIE | Dept. of Medical Psychology, University Medical Center Amsterdam, The Netherlands

BUCCISANO, FRANCESCO | Dept. of Biomedicine and Prevention, Universitá di Roma di Tor Vergata Rome, Italy

CLOOS, JACQUELINE | Dept. of Hematology, VU University Medical Center Amsterdam, Netherlands

HEUSER, MICHAEL | Dept. of Hematology, Oncology, Hanover Medical School Hanover, Germany

JACOBS, JOHN | Clinical Care & Research (CCR), ORTEC Zoetermeer, The Netherlands

GHIA, PAOLO | ERIC | European Research Initiative on CL, Università Vita-Salute San Raffaele, Cologne, Germany | Milano, Italy

SCARFÓ, LYDIA | ERIC | European Research Initiative on CLL, Università Vita-Salute San Raffaele, Cologne, Germany | Milano, Italy

KARAKATSOULIS, GEORGIOS | INAB | Institute of Applied Biosciences, CERTH | Centre for Research and Technology Hellas, Thessaloniki, Greece

Wissenschaftliche Leitung
Michael Heuser
Dept. of Hematology, Hemostatis,
Oncology and Stem Cell Transplant.,
Hanover Medical School, Germany

Jacqueline Cloos
Dept. of Hematology, VU
University Medical Center
Amsterdam, Netherlands

Organisation
GWT-TUD GmbH
Freiberger Str. 33, 01067 Dresden, Germany | www.g-wt.de 

Die Anmeldung für diesen Workshop ist erforderlich und ab sofort möglich:
E-Mail: heuser.michael@mh-hannover.de   

Ihre Teilnahme ist kostenlos, Reise- und Übernachtungskosten werden erstattet (günstigster verfügbarer Tarif, Economy Class).

Hilton Frankfurt Airport
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