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
NCT ID: NCT05197426
Last Updated: 2025-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
19 participants
INTERVENTIONAL
2022-01-17
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Oral Azacitidine
Oral Azacitidine
Specified dose on specified days
Placebo
Placebo
Specified dose of specified days
Interventions
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Oral Azacitidine
Specified dose on specified days
Placebo
Specified dose of specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
55 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA055-005
Identifier Type: -
Identifier Source: org_study_id
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