Trial of Decitabine in Patients With Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient's choice with the physician's advice of either cytarabine or supportive care medication.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Inc.
• Treatments: Azacitidine; Cytarabine; Decitabine

Criteria

Inclusion Criteria:

1. Must have diagnosed acute myeloid leukemia.

2. Must have a life expectancy of at least 12 weeks.

3. Must sign informed consent.

Exclusion Criteria:

1. Must not have acute promyelocytic leukemia (M3 classification)

2. Must not have any other active systemic malignancies.

3. Must not have inaspirable bone marrow.

4. Must not have received previous chemotherapy (except hydroxyurea) for any myeloid disorder.

5. Must not have chronic respiratory disease that requires continuous oxygen use.

6. Must not have received any experimental drug within 4 weeks before randomization.

7. Must not be a candidate for a bone marrow or stem cell transplant within 12 weeks after randomization.

8. Must not have known HIV.