An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myeloid Leukemia in Complete Remission
NCT ID: NCT05413018
Last Updated: 2025-12-08
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
34 participants
INTERVENTIONAL
2022-08-19
2026-03-01
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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CC-486/Oral Azacitidine Administration
CC-486
Specified dose on specified days
Placebo Administration
Placebo
Specified dose on specified days
Interventions
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CC-486
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern cooperative oncology group performance status of 0, 1, or 2
* Has undergone induction therapy with intensive chemotherapy with or without consolidation therapy
* Must have achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) status within 6 months (+/- 7 days) prior to starting study therapy
Exclusion Criteria
* Candidate for allogeneic bone marrow or stem cell transplant at screening
* Have achieved CR/CRi following therapy with hypomethylating agents
* AML associated with inv(16), t(8;21), t(16;16), t(15;17), or t(9;22) karyotypes or molecular evidence of such translocations
* Proven central nervous system leukemia
* Prior bone marrow or stem cell transplantation
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 - 0031
Hefei, Anhui, China
Local Institution - 0013
Beijing, BJ, China
Local Institution - 0027
Beijing, BJ, China
Local Institution - 0028
Chongqing, CQ, China
Local Institution - 0003
Guangzhou, GD, China
Local Institution - 0008
Guangzhou, GD, China
Local Institution - 0010
Shenzhen, GD, China
Local Institution - 0002
Shijiazhuang, HE, China
Local Institution - 0022
Xuzhou, Jiangsu, China
Local Institution - 0005
Shenyang, Liaoning, China
Local Institution - 0020
Shenyang, LN, China
Local Institution - 0016
Chengdu, SC, China
Local Institution - 0006
Shanghai, SH, China
Local Institution - 0030
Xi'an, SN, China
Local Institution - 0033
Taiyuan, SX, China
Local Institution - 0001
Tianjin, TJ, China
Local Institution - 0009
Ürümqi, Xinjiang, China
Local Institution - 0007
Wenzhou, ZJ, China
Local Institution - 0017
Changchun, , China
Local Institution - 0019
Changsha, , China
Local Institution - 0015
Changsha, , China
Local Institution - 0035
Ganzhou, , China
Local Institution - 0012
Guangzhou, , China
Local Institution - 0014
Hangzhou, , China
Local Institution - 0032
Harbin, , China
Local Institution - 0011
Jinan, , China
Local Institution - 0024
Kunming, , China
Local Institution - 0026
Lanzhou, , China
Local Institution - 0018
Nanchang, , China
Local Institution - 0029
Nanjing, , China
Local Institution - 0021
Suzhou, , China
Local Institution - 0023
Tianjin, , China
Local Institution - 0034
Zhangzhou, , China
Local Institution - 0004
Zhengzhou, , China
Countries
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Related Links
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BMS Clinical Trial Information
Other Identifiers
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CA055-006
Identifier Type: -
Identifier Source: org_study_id
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