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Brief Title: A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Participants With Acute Myeloid Leukemia (AML) in Complete Remission
Official Title: 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
Study ID: NCT05197426
Brief Summary: 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.
Detailed Description:
Minimum Age: 55 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Local Institution - 0011, Huntsville, Alabama, United States
Local Institution - 0017, Nagoya, Aichi, Japan
Local Institution - 0009, Toyoake, Aichi, Japan
Local Institution - 0005, Kamogawa, Chiba, Japan
Local Institution - 0003, Kashiwa-shi, Chiba, Japan
Local Institution - 0010, Matsuyama, Ehime, Japan
Local Institution - 0020, Yoshida gun, Fukui, Japan
Local Institution - 0016, Fukuoka-shi, Fukuoka, Japan
Local Institution - 0014, Ogaki, Gifu, Japan
Local Institution - 0001, Maebashi, Gunma, Japan
Local Institution - 0004, Sapporo, Hokkaido, Japan
Local Institution - 0019, Kanazawa, Ishikawa, Japan
Local Institution - 0012, Isehara, Kanagawa, Japan
Local Institution - 0006, Sagamihara, Kanagawa, Japan
Local Institution - 0013, Yokohama, Kanagawa, Japan
Local Institution - 0015, Sendai-shi, Miyagi, Japan
Local Institution - 0021, Osaka Sayama, Osaka, Japan
Local Institution - 0028, Saitama shi, Saitama, Japan
Local Institution - 0031, Shimotsuke, Tochigi, Japan
Local Institution - 0032, Bunkyo Ku, Tokyo, Japan
Local Institution - 0002, Shinagawa ku, Tokyo, Japan
Local Institution - 0030, Shinjyuku Ku, Tokyo, Japan
Local Institution - 0029, Sumida ku, Tokyo, Japan
Local Institution - 0022, Aomori, , Japan
Local Institution - 0018, Fukuoka, , Japan
Local Institution - 0027, Fukuoka, , Japan
Local Institution - 0008, Nagasaki, , Japan
Local Institution - 0023, Nagoya-shi, , Japan
Local Institution - 0025, Okayama, , Japan
Local Institution - 0026, Osaka, , Japan
Local Institution - 0007, Yamagata, , Japan
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR