Phase-II-Project – Description

Phase I/II Working Group

Objective of the Phase I/II working group is the interdisciplinary conception, initiation and coordination of phase I/II studies. The European MCL Network has proven to be a well-structured interdisciplinary Intergroup study group for the development of translational therapeutic strategies. The consortium not only conducts investigator initiated i.e. academic studies to optimise therapeutic regimes, but also represents a suitable portal to communicate and coordinate studies initiated by pharmaceutical companies.
Of the available molecular agents, the radioimmunological therapeutics Ibritumomab and Tiuxetan, the proteasome inhibitors (Bortezomib), mTOR-antagonists of the 2nd generation ( RAD001) and IMIDS (Lenalidomide) are currently being tested in clinical trials of the European MCL Network.Further promising agents are the Cdk-inhibitors (Flavopiridol), bcl-2-antisense (Oblimersen) and PKCbeta-inhibitors (Enzastaurin).
To coordinate the extensive biological supporting programme an interdisciplinary network has been formed, which consists of 5 national coordinators and 2 representatives of the national study groups (one clinician and one molecular geneticist). This coordinating network mediates collaboration with the participating national institutions as well as conducting negotiations with interested pharmaceutical companies. Although the focus of the study group is on the development of academic, investigator initiated trials, pharmaceutically sponsored studies are also conducted as long as clinicians are involved in the design of the study protocols. Due to the participation of a multitude of experienced European study centres, simultaneous recruitment of several trials is feasible. On the basis of such a structured portal, the European MCL network is an important and attractive organisation for the development and implementation of early (phase I/II) clinical trials on Mantle Cell Lymphoma.

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