Study of Decitabine for Treatment of Older Patients With Acute Myeloid Leukemia (AML)

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to estimate the rate of complete remission, as well as overall survival, in older patients with Acute Myeloid Leukemia (AML).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

1. A diagnosis of AML or transformed from myelodysplastic syndrome (MDS) within 2 weeks of study enrollment.

2. Ineligible to receive intensive chemotherapy for their disease.

3. Have not received any chemotherapy within 4 weeks of study enrollment and must have recovered from any treatment-related toxicities.

Exclusion Criteria:

1. Received previous treatment for AML.

2. Previously received Vidaza.

3. Received any other investigational agents within 30 days of first dose of study drug.

4. Uncontrolled intercurrent illness.

5. Had radiotherapy within 14 days prior to study enrollment.