Phase-II-Project – Description
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.