Mid-term report 2013 - The European LeukemiaNet

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European LeukemiaNet Midterm Report, 08-RNP-071 Other topics • Further progress and experience in the field of molecular markers and new drugs targets have been achieved. A major goal is still the implementation of minimal residual disease measurements in clinical trials improving the risk stratification in AML and the integrated risk-score. A cooperation between HOVON (the Haemato Oncology Foundation for Adults in the Netherlands), SAKK (schweizerische Arbeitsgemeinschaft für klinische Studien in der Krebsforschung), and the German AML-Cooperative Group on joint trials and analyses was started first results were published • Registry: Good progress was made in the European APL registry. A total of xx patients are registered so far. In addition in Germany several registry are running to collect data outside of clinical studies. • A web based scoring system for older AML patients was developed on the basis of meta-analysis (Krug et al Lancet 2010). • Multiple approaches and experiences were reported on the field of allogeneic SCT 2.1.6. WP6 (ALL): The successful national European study groups for ALL, (EWALL) aim to combine their efforts in order to create a world-wide leading research group for adult ALL. Integrating activities are of major importance and include the development of standardized laboratory procedures for diagnostic confirmation, an overview on prognostic factors and on ongoing European studies in ALL within a study registry. Phase I-III intergroup studies and the combination and standardization of methods, definitions and clinical application of MRD are jointly executed research activities. Recommendations: The EWALL has recently published the value of pre-autologous SCT MRD in Ph+ and Phnegative ALL patients (S. Giebel, Eur J Cancer. 2012) Studies: Different national ALL study groups of the EWALL (European Working group on ALL) are leading in the exploration of new antibodies in the treatment of adult ALL with antibody studies on Blinatumomab and Inotuzumab. There are several studies on Ph+ ALL going on, focusing on elderly patients and Nilotinib and Imatinib in rotation. There are various pilot studies with new substances going on in the EWALL. New studies with the application of Peg-asparaginase have been presented for the different national EWALL study groups . New joined retrospective analyses within the EWALL are planned: • T-ALL risk factors: • Value of pre-allogeneic SCT MRD level in Ph-negative ALL patients: • Retrospective analysis the value of pre-allogeneic SCT MRD. • Pre-allogeneic SCT molecular status in Ph+ ALL patients • Value of monosomal karyotypes in adult ALL patients • CNS prophylaxis in patients receiving SCT • CNS relapse incidence and management in Ph+ ALL patients • Secondary malignancies after ALL therapy in adult 2.1.7. WP7 (CLL ERIC): The European Research Initiative on CLL (ERIC) has fostered scientific credibility, competence and excellence of ERIC as a European non-profit organization. Furthermore, it connects the European LeukemiaNet and EHA as interacting European promoters of competence in hematology and leukemia. Now there are 366 members from 36 countries 6
European LeukemiaNet Midterm Report, 08-RNP-071 involved in ERIC. Molecular studies: The accreditation programme for IGHV gene analysis: focus was on external quality assessment in diagnostic laboratories and how to provide certificates Clinical Studies • ERIC Phase IV trial on Ofatumumab in CLL therapy. international CLL registry for spontaneous regression in CLL. The aims of the project were shown such as to facilitate studies in ERIC. Completed and on-going projects are shared on the website www.ericll.org. 2.1.8. WP8 (MDS): WP 8 is now integrated into the Working group of the European Hematology association, EHA MDS Working group. The results provided by the WP8 of the ELN have major impact on new diagnostic strategies in MDS. This is of particular importance since new drugs are emerging in both lower and higher risk MDS. In addition, the Working Group may provide evidence that flow cytometry may add in new prognostic scoring systems. To this end the Pavia Meeting in 2011 and Amsterdam meeting in 2012 focused on designing prospective multicenter studies to emphasize diagnostics and prognostics in MDS which might be included in the new WHO classification of hematopoietic neoplasms in [anticipated] 2015. A major goal of WP8 is to set up an international MDS clinical trial platform to standardize methodology of diagnosis (flow cytometry), therapy (Vidaza, Lenalinomide) and follow up in MDS and to allow better comparison of results. The platform is now active EMSCO (European Leukemia Net Myelodysplastic Syndromes Studies Coordination Office) Recommendations: • Therapeutic guidelines on treatment of MDS can be found on the website: http://mds.haematologica.org • In addition, in the almost finalized diagnostic and therapeutic guidelines in MDS as provided by WP8, flow cytometric assessment is now recognized as one of the recommended approached in the diagnostic work-up (Leukemia, 2012; Leukemia & Lymphoma, 2013) Studies: Prospective multicenter studies to emphasize diagnostics and prognostics in MDS were initiated. Registry: Another project is the successful registry for MDS (EUMDS) a collaboration between WP8 and Novartis. In total 1000 patients in 14 countries were registered, first results were presented at ASH 2011 and 2012 (de Witte et al.). Other topics: Collaborations with the MDS Foundation were initiated Finally, as can be depicted from the reference list below, the working group is successful in translating the workgroup conferences into published documents on behalf of ELN. 1) Progress studies in EU‐MDS Registry General overview of EU‐MDS registry: Currently more than 1,457 patients have been reported in the registry. Serbia and Croatia have joined the Registry and it will start reporting patients in a few months. Several manuscripts are in preparation, including the general 7
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