Trial Information

A Prospective, Multicenter European Registry for Newly Diagnosed Patients With Myelodysplastic Syndromes of IPSS Low and Intermediate-1 Subtypes

Methodology:

Data on patients with low or intermediate-1 risk MDS will be collected prospectively at
diagnosis and at 6-months intervals after diagnosis. The data will be gathered by eleven
existing national MDS Registries that are represented within the LeukemiaNet MDS Working
Party and will be combined in one central European Database. Data analyses will be conducted
by the Data Management Centre after every 400 patients included in the European Registry and
at the end of the follow-up period.

Number of Patients & Centres Eleven hematology centres in eleven different countries
(Austria, Czech Republic, France, Germany, Greece, Italy, Netherlands, Rumania, Spain,
Sweden and United Kingdom) will participate as referral centres in this Registry. The
recruitment target is 1000.

Population:

The study population will consist of newly diagnosed patients with IPSS low- or
intermediate-1 risk myelodysplastic syndrome.

Study Duration:

The enrollment time i scheduled to be 12 months. Patients will be followed during 4 years.