Study of Low-Dose Intravenous Decitabine in Patients Aged > 60 Years With Acute Myeloid Leukemia
Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
Participant gender:
Summary
This study is an open-label phase II trial to investigate the efficacy and toxicity of
low-dose decitabine (5-aza-2'-deoxycytidine) in elderly patients with acute myeloid leukemia
(AML) not eligible for aggressive induction chemotherapy. AML patients above the age of 60
years (no upper age limit) who have not previously received and are not eligible for,
standard induction treatment of their disease will be eligible for this trial. Decitabine
will be administered as a 3 hour infusion at 15 mg/m2 three times daily on three consecutive
days (total dose 135 mg/m2). In all patients with > 20000 WBC/µl, this treatment will be
repeated 1 week later. In patients with white blood cells exceeding 50 000/μl, decitabine
treatment will be preceded by cytoreductive doses of hydroxyurea.