Termination of the trial ASTIMS
Last November, the ASTIMS steering committee met in Florence, Italy to review the activity, interim results, toxicity profile and accrual trend of the trial. According to the Principal Investigator, Prof. Gianluigi Mancardi, given the relevant problems in the accrual of new patients, the lack of funds and the impossibility to organize an efficient monitoring of all the involved centers, the long period that passed from the design of the study (2003) and the current medical situation of MS (new drugs such as monoclonal antibodies that for more than 2 years have been on the market and new oral therapies that will be available in 2010), the best solution was to close the study and to collect the available data.
However with the 21 patients who were enrolled, ASTIMS will be able to give relevant information on the activity of AHSCT on MRI and it will be certainly very useful for the design of new studies that will evaluate AHSCT in severe cases of MS.
There was a general consensus that the trial should not be prolonged in part due to the slow accrual of ASTIMS and that, in the interest of the procedure - considered by all the members of the Steering Committee to be a powerful therapy – it was best to terminate the study, collect the available data and in the meantime to contribute, with other interested physicians in this field, to the design of a new study, that will consider the current situation of the various therapies for MS.
All the members of the ASTIMS Steering Committee who were present: G.L.Mancardi, Genoa, Italy; A.Fassas, Tessaloniki, Greece; R. Saccardi, Florence, Italy;. A.Tyndall, Basel, Switzerland; J Snowden, Sheffield, UK; T Kozak, Prague, Czech Republic; P Muraro, London, UK, Eva Krasulova (on behalf of Eva Havrdova), Prague, Czech Republic; and Dominique Farge, Paris, France; voted and unanimously agreed to terminate the ASTIMS Study.