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A Phase 2, 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 Japanese Subjects With Acute Myeloid Leukemia in Complete Remission
Description
The purpose of this study is to assess the efficacy and safety of oral azacitidine plus best supportive care versus best supportive care as maintenance therapy in a cohort of Japanese participants ≥ 55 years of age with Acute Myeloid Leukemia (AML) and in complete remission/complete remission with incomplete blood count recovery after conventional induction chemotherapy with or without consolidation chemotherapy.
Trial Eligibility
Inclusion Criteria: * ≥ 55 years of age inclusive at the time of signing the informed consent * Newly diagnosed, histologically confirmed de novo Acute Myeloid Leukemia (AML) or AML secondary to prior myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) * Should have undergone induction therapy with intensive chemotherapy with or without consolidation therapy as recommended in appropriate guideline(s) or equivalent regimen according to institutional standard: having achieved first complete remission (CR)/complete remission with incomplete blood count recovery (CRi) status within 4 months prior to starting study therapy Exclusion Criteria: * Suspected or proven acute promyelocytic leukemia; or AML with previous hematologic disorder such as chronic myeloid leukemia or myeloproliferative neoplasms, excluding MDS and CMML * Prior bone marrow or stem cell transplantation * Received therapy with hypomethylating agents for MDS and went on to develop AML within four months of discontinuing the therapy with hypomethylating agents * Have achieved CR/CRi following therapy with hypomethylating agents Other protocol-defined inclusion/exclusion criteria apply
Study Info
Organization
Bristol-Myers Squibb
Primary Outcome
Relapse-free Survival (RFS)
Interventions
Locations Recruiting
Local Institution - 0011
United States, Alabama, Huntsville
Local Institution - 0017
Japan, Aichi, Nagoya
Local Institution - 0009
Japan, Aichi, Toyoake
Local Institution - 0005
Japan, Chiba, Kamogawa
Local Institution - 0003
Japan, Chiba, Kashiwa-shi
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