5-azacytidine Treatment Versus 5-azacytidine Followed by Allogeneic Stem Cell Transplantation in Elderly Patients With Myelodysplastic Syndrome (MDS)

Exclusion Criteria

• •Blasts \> 30 % in bone marrow at time of diagnosis
• •Central nervous involvement
• •Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
• •Total bilirubin, SGPT or SGOT ≥ 3 times upper the normal level
• •Left ventricular ejection fraction \< 30 %
• •Creatinine clearance \< 30 ml/min
• •DLCO \< 35 % and/or receiving supplementary continuous oxygen
• •Pregnant or breastfeeding female subject
• •Patients with a life-expectancy of less than six months because of another debilitating disease
• •Serious psychiatric or psychological disorders
• •Uncontrolled invasive fungal infection at time of registration
• •Known positive for HIV or acute infectious hepatitis, type A, B or C
• •Participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment until the end of the study