Conditions: Acute Myelogenous Leukemia Myelodysplastic Syndrome
Keywords: Acute Myelogenous Leukemia Myelodysplastic Syndrome Dacogen Decitabine
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 10
Healthy volunteers: no

Brief summary:
The purpose of this study is to provide decitabine to patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) who have completed participation per protocol in the DACO-018 study.

Detailed description:
The objectives of this trial are:

* To generate additional information about the overall safety profile,
* To generate safety information of hepatically or renally impaired patients, as appropriate, and
* To generate safety information when patients are also taking concomitant medications and/or therapies without trial restrictions when decitabine is administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks in patients with MDS or AML (≥ 30% blasts).

The purpose of this open-label, expanded-access trial is to provide decitabine to patients with AML or MDS who have completed participation per protocol in the DACO-018 study and for whom continuation of treatment with decitabine is indicated, per the opinion of the investigator. In order to continue treatment with decitabine, at a minimum, there must be no disease progression while the patient was participating in the DACO-018 trial and during the period after the patient discontinued from the DACO-018 study and before entering this trial. Patients must enroll in this trial within 8 weeks of discontinuing from the DACO-018 study and not have received any other chemotherapy for their disease during this interim period.

Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.

Arms:
arm 1: Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.

Interventions: intervention 1: Decitabine
Intervention descriptions: intervention 1: Decitabine is administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML; ≥ 30% blasts).

Protocol document: