The European Leukemia Net CML Registry - Objectives, Achievements and First Results.

In 2004/2005, the European Chronic Myeloid Leukemia (CML) Registry was established within the European Leukemia Net (ELN) which is funded by the EU. The purpose is to collect prospectively baseline, follow-up and outcome data of CML patients treated with imatinib or with more recent tyrosine kinase inhibitors in a standardized format. Among the objectives are the development and validation of prognostic scores, the analysis of various prespecified subgroups, e.g. of patients with imatinib failure or of patients who discontinued imatinib after complete cytogenetic remission and to support the design and analysis of future clinical trials. At present individual patient data of about 1460 bcr/abl positive CML patients from France, Germany, Italy, Poland, Romania and Spain are in the data bank. Patients were treated either with 400 or 800 mg imatinib/day as mono or combination treatment. About 40% of the patients are female. Using the New CML Score the proportion of low risk patients varies between 35% – 89% (high risk: 0% – 13%) among the participating countries. First analyses of outcome data, here the proportion of cytogenetic remissions at month 12, indicate that the results of the IRIS trial can be reproduced. With more countries participating and longer observation times the European CML Registry promises to provide highly interesting data.