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

Inclusion Criteria:

* Patients with proven de novo or therapy-related MDS / CMML (WBC \<13 GPT/l)according to FAB and risk profile according to IPSS: intermediate II- risk or high-risk or intermediate I with high-risk cytogenetic (according to IPSS, taking into account that IPSS, however, was not validated for t- MDS), patients with secondary AML (according to WHO) and blasts ≤ 30 % (= RAEB-t according to FAB)
* Previously untreated or maximal 1 cycle of 5-azacytidine (Vidaza®)
* Male or Female; Age 55 - 70 years
* Understand and voluntarily sign an informed consent form
* ECOG performance status of ≤ 2 at study entry
* Adequate renal and liver function: creatinine and bilirubin \< 3 x the upper limit of normal
* Sufficient cardiac function (ejection fraction \> 30 %)

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