ASTIStrial News

 

latest news (May 2007)

The ASTIS Trial (Autologous Stem cell Transplantation International Scleroderma Trial) is an international multicenter and investigator-driven trial conducted under the auspices of the European organization for Bone Marrow Transplantation (EBMT) and European League Against Rheumatism (EULAR). The protocol of the ASTIS Trial has been approved by Ethics Committees in centers from Australia, Austria, France, Germany, Greece, Italy, The Netherlands, Slovak Republic, Switzerland, and United Kingdom (see participating centers). 

At the time of this writing (May 11, 2007) 91 patients have been randomized in 20 centers, and allocated to either high dose immunoablation followed by autologous stem cell transplantation (43 patients) or pulse-therapy cyclophosphamide i.v (48 patients). All patients were enrolled because of severe systemic sclerosis with extensive skin thickening and involvement of heart, lung or kidneys. No treatment-related mortality has yet occurred in either arm. 

Following the encouraging results from the safety-interim analysis on the first group of 20 patients, an Independent Data Monitoring Committee (Dr. F. Wolheim, Sweden , Dr. Furst, USA , Dr. J. Apperley, UK ) has approved an amendment of the protocol to allow inclusion of patients with early diffuse scleroderma at risk of premature morbidity and mortality. The encouraging results from the second interim-safety analysis on 60 patients, randomized between December 2002 and November 2005 were presented at the EULAR 2006-meeting in Amsterdam .

A grant was awarded by the European League Against Rheumatism at its annual meeting in Vienna (June 2005) to sponsor local data management in participating centers, and an extension of the grant was secured recently to complete the trial.

If you have any queries, please contact any of the study-chairpersons or the study administration office (administrative details listed on the first page of the protocol).

The third ASTIS trial investigators meeting is scheduled for 2007.


If you have any queries, please contact any of the study-chairpersons or the study administration office.

Kind regards,

 

Jaap van Laar                            Dominique Farge                         Alan Tyndall

 

 

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Last change: 27 June 2007