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


Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

This is an international, multicenter, placebo-controlled, phase 3 study with a double-blind, randomized, parallel-group design with de novo AML (Acute Myeloid Leukemia) or AML secondary to prior diagnosis of Myelodysplastic Syndromes (MDS).

Who is eligible to participate?

Inclusion Criteria: 1. Male or female subjects ≥ 55 years of age 2. Newly diagnosed, confirmed de novo AML or AML Secondary to prior MDS 3. First CR/CRi with induction therapy ± consolidation therapy within 90 days of achieving CR 4. Eastern Cooperative Oncology Group (ECOG) performance status - 0, 1, 2, 3 Exclusion Criteria: 1. AML with inv(16), t(8;21), t(16;16), t(15;17), or t(9;22) or molecular evidence of such translocations 2. Prior bone marrow or stem cell transplantation 3. Candidate for allogeneic bone marrow or stem cell transplant 4. Have achieved CR/CRi following therapy with hypomethylating agents 5. Diagnosis of malignant disease within the previous 12 months 6. Proven Central Nervous System (CNS) leukemia

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