Decitabine-cytarabine chemotherapy in elderly AML and high risk MDS patients (> 65 years) with high early mortality risk

This is a phase 1-2 study to determine feasiblity and safety of decitabine-cytarabine chemotherapy in patients > 65 years with AML or high risk MDS, who have a high risk for day 30 mortality during standard treatment with intensive chemotherapy bcause of the presence of co-morbidity (HCT-CI >=2).

In this study we explore the feasibility of combined decitabine and cytarabine chemotherapy in AML and high risk MDS patients with a high risk of early mortality (day 30 mortality) during standard induction chemotherapy (HCT-CI co-morbidity index >=2). With the decitabine-cytarabine chemotherapy we hope to achieve a low incidence of early mortality. At the same time we hope to achieve complete remissions in the majority of patients.

1. Day 30 after start of decitabine-cytarabine chemotherapy

2. Four weeks after discharge from the second cycle of decitabine-cytarabine (end of study)

Patients will receive decitabine one time daily 20 mg/m2 during 5 days, directly followed by cytarabine 100 mg/m2 per day as continuous infusion during 5 days. At day 28-35 after the start of chemotherapy, remission status will be determined. In case of CR, CRi or morphologic leukemia-free state, patients will receive a second cycle of decitabine-cytarabine.