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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
Sponsor: Bristol-Myers Squibb
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.
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
Key Details
Gender
All
Age Range
55 Years - Any
Study Type
INTERVENTIONAL
Enrollment
19
Start Date
2022-01-17
Completion Date
2026-04-30
Last Updated
2026-02-11
Healthy Volunteers
No
Conditions
Interventions
Oral Azacitidine
Specified dose on specified days
Placebo
Specified dose of specified days
Locations (31)
Local Institution - 0011
Huntsville, Alabama, United States
Local Institution - 0017
Nagoya, Aichi-ken, Japan
Local Institution - 0023
Nagoya, Aichi-ken, Japan
Local Institution - 0009
Toyoake, Aichi-ken, Japan
Local Institution - 0022
Aomori, Aomori, 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, Fukuoka, Japan
Local Institution - 0014
Ōgaki, Gifu, Japan
Local Institution - 0001
Maebashi, Gunma, Japan
Local Institution - 0004
Sapporo, Hokkaido, Japan
Local Institution - 0019
Kanazawa, Ishikawa-ken, Japan
Local Institution - 0012
Isehara, Kanagawa, Japan
Local Institution - 0006
Sagamihara-shi, Kanagawa, Japan
Local Institution - 0013
Yokohama, Kanagawa, Japan
Local Institution - 0015
Sendai, Miyagi, Japan
Local Institution - 0026
Osaka, Osaka, Japan
Local Institution - 0021
Ōsaka-sayama, Osaka, Japan
Local Institution - 0031
Shimotsuke, Tochigi, Japan
Local Institution - 0032
Bunkyo Ku, Tokyo, Japan
Local Institution - 0002
Shinagawa, Tokyo, Japan
Local Institution - 0030
Shinjuku-ku, Tokyo, Japan
Local Institution - 0029
Sumida Ku, Tokyo, Japan
Local Institution - 0018
Fukuoka, Japan
Local Institution - 0027
Fukuoka, Japan
Local Institution - 0008
Nagasaki, Japan
Local Institution - 0025
Okayama, Japan
Local Institution - 0028
Saitama, Japan
Local Institution - 0007
Yamagata, Japan