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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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:

Keywords

Eligibility

Minimum Age: 55 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Bristol-Myers Squibb

Affiliation: Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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