A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best-supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission
The purpose of this study is to determine the effect of oral Azacitidine on Acute Myeloid Leukemia (AML). The study also aims to learn more about the safety and effectiveness of the study drug.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Placebo
- drug : 300 mg Oral Azacitidine
Phase: Phase 3
Ages Eligible For Study:
1. Male or female subjects ? 55 years of age 2. Newly diagnosed, histologically confirmed de novo AML or AML secondary to prior myelodysplastic disease or CMML (Chronic myelomonocytic leukemia) 3. First Complete remission (CR)/ Complete remission with incomplete blood count recovery (CRi) with induction therapy + consolidation therapy within 4 months (+/- 7 days of achieving CR or CRi) 4. Eastern Cooperative Oncology Group (ECOG) performance status - 0, 1, 2, 3