Status: Open
Specialty: Haematology
Date Opened: 11/10/2021
Planned Close Date:
Sponsor: Radboud university medical Centre
Principal Investigator: Dr Macheta
A prospective, multicentre European Registry for newly diagnosed patients with Myelodysplastic Syndromes (MDS), including acute myeloid leukaemia with 20-<30 percent marrow blasts (former RAEB-t), and Chronic Myelomonocytic Leukaemia (CMML).
Age > 18 years
• Newly diagnosed patient (within 100 days from the date of the diagnostic BM aspirate)
• MDS classified according to current WHO criteria (both 2008 [10] and 2016 [12] will be recorded)3
▪ All sub groups of MDS
▪ Therapy-related MDS
▪ MDS with Fibrosis (MDS-F)
▪ AML with 20-<30 percent marrow blasts (former RAEB-t)
▪ CMML and other forms of mixed MDS/MPD
• IPSS and IPSS-R Risk group classification (mandatory)4
• Able and willing to provide the written informed consent
Age <18 years
• Patient unwilling or unable to give consent
• AML with ≥30 percent marrow blasts according to WHO
• Patients with inv(16), t(15;17) and t(8;21) are considered AML and therefore not eligible
• Patients with higher risk MDS progressed from a previously diagnosed lower risk MDS that was not registered within 100 days after first diagnosis of (lower risk) MDS
Link to EDGE