Information about Project 4: Chronic myeloid leukemia (CML)
The main objective of this workpackage is to integrate the leading European national trial groups in CML to form a cooperative network for advancements in CML related research and health care. A clinical trials platform was created to promote the performance of clinical trials with new drugs and/or treatment strategies across Europe. Standardization of diagnostic and therapeutic procedures allows to compare outcome across Europe. On the basis of uniform common data sets a registry of newly diagnosed CML patients within trials was set up. Standardized molecular and advanced genomic technology to analyze biological prognostic factors, MRD, resistance to therapy and progressive disease across Europe was applied to CML.
On the basis of randomized clinical trials metaanalyses will be performed. Metaanalyses, consensus reports and expert reviews will be used to develop guidelines on a European scale. Spread of excellence will be achieved by regular meetings, training courses, exchange of researchers and information through the internet and printed media.
Description of work
- The first step will be the establishment of common communication, information and management structures of the CML subnetwork. This will be accomplished by the set up of a web page in close cooperation with WP 3 (CICS) and information on ongoing trials, researchers and centers participating in the trials, on number of recruited patients, and on perspectives for future trials. The web page will increase transparency and visibility of ongoing and future work of the CML trial platform thereby attracting users and new participants.
- On the basis of ongoing trials and common uniform data sets CML patients will be reported to a central registry enabling the analysis of critical questions in the future such as
- recognition of prognostic subgroups,
- association of environmental influences on defined genomic subtypes,
- gender aspects,
- demographic and geographical variations etc.
- Standardizations of diagnostics and therapeutic procedures will further strengthen integration. The thereby achieved comparability of outcome will facilitate recognition of interstudy differences and of rare, better defined subtypes.
- Clinical trials and their results will be the basis for preparing metaanalyses and guidelines. Guidelines, WP and network meetings as well as training courses and exchange of researchers will spread excellence and raise standards of research and of patient care across Europe. The CML network and its activities provide the critical mass for added value and European leadership.