An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myeloid Leukemia in Complete Remission

Last updated: December 2, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Not Recruiting

Phase

2

Condition

Leukemia

Treatment

CC-486

Placebo

Clinical Study ID

NCT05413018
CA055-006
  • Ages > 55
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of Oral Azacitidine (CC-486) in Chinese participants with acute myeloid leukemia in complete remission.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Newly diagnosed, histologically confirmed de novo acute myeloid leukemia (AML) orAML secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (CMML)

  • Eastern cooperative oncology group performance status of 0, 1, or 2

  • Has undergone induction therapy with intensive chemotherapy with or withoutconsolidation therapy

  • Must have achieved first complete remission (CR) or complete remission withincomplete blood count recovery (CRi) status within 6 months (+/- 7 days) prior tostarting study therapy

Exclusion

Exclusion Criteria:

  • Suspected or proven acute promyelocytic leukemia or acute myeloid leukemia withprevious hematologic disorder such as chronic myeloid leukemia or myeloproliferativeneoplasms, excluding myelodysplastic syndromes and chronic myelomonocytic leukemia

  • 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 ormolecular evidence of such translocations

  • Proven central nervous system leukemia

  • Prior bone marrow or stem cell transplantation

Other protocol-defined inclusion/exclusion criteria apply

Study Design

Total Participants: 34
Treatment Group(s): 2
Primary Treatment: CC-486
Phase: 2
Study Start date:
August 19, 2022
Estimated Completion Date:
March 01, 2026

Connect with a study center

  • Local Institution

    Hefei, Anhui 230001
    China

    Site Not Available

  • Local Institution - 0031

    Hefei, Anhui 230001
    China

    Site Not Available

  • Local Institution - 0031

    Hefei 1808722, Anhui 1818058 230001
    China

    Site Not Available

  • Local Institution - 0013

    Beijing 1816670, BJ 100044
    China

    Site Not Available

  • Local Institution - 0027

    Beijing 1816670, BJ 100191
    China

    Site Not Available

  • Local Institution

    Beijing, Beijing 100044
    China

    Site Not Available

  • Local Institution - 0013

    Beijing, Beijing 100044
    China

    Site Not Available

  • Local Institution - 0027

    Beijing, Beijing 100191
    China

    Site Not Available

  • Local Institution - 0028

    Chongqing, CQ 400000
    China

    Site Not Available

  • Local Institution - 0028

    Chongqing 1814906, CQ 400000
    China

    Site Not Available

  • Local Institution

    Chongqing, Chongqing 400038
    China

    Site Not Available

  • Local Institution - 0003

    Guangzhou 1809858, GD 510080
    China

    Site Not Available

  • Local Institution - 0008

    Guangzhou 1809858, GD 510080
    China

    Site Not Available

  • Local Institution - 0010

    Shenzhen 1795565, GD 518055
    China

    Site Not Available

  • Local Institution

    Lanzhou, Gansu 730030
    China

    Site Not Available

  • Local Institution

    Guangzhou, Guangdong 510030
    China

    Site Not Available

  • Local Institution - 0003

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Local Institution - 0008

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Local Institution - 0010

    Shenzhen, Guangdong 518055
    China

    Site Not Available

  • Local Institution - 0025

    Shenzhen, Guangdong 518117
    China

    Site Not Available

  • Shenzhen University General Hospital

    Shenzhen, Guangdong 518055
    China

    Site Not Available

  • Local Institution - 0002

    Shijiazhuang 1795270, HE 050000
    China

    Site Not Available

  • Local Institution

    Changsha, Hainan 410008
    China

    Site Not Available

  • Local Institution

    Shijiazhuang, Hebei 050004
    China

    Site Not Available

  • Local Institution - 0002

    Shijiazhuang, Hebei 050000
    China

    Site Not Available

  • Local Institution

    Haerbin, Heilongjiang 150001
    China

    Site Not Available

  • Local Institution

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Local Institution

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • Local Institution

    Xuzhou, Jiangsu 221002
    China

    Site Not Available

  • Local Institution - 0022

    Xuzhou, Jiangsu 221000
    China

    Site Not Available

  • Local Institution - 0022

    Xuzhou 10630003, Jiangsu 1806260 221000
    China

    Site Not Available

  • Local Institution

    Changchun, Jilin 130021
    China

    Site Not Available

  • Local Institution - 0020

    Shenyang 2034937, LN 110022
    China

    Site Not Available

  • Local Institution

    Shenyang, Liaoning 110001
    China

    Site Not Available

  • Local Institution - 0005

    Shenyang, Liaoning 110001
    China

    Site Not Available

  • Local Institution - 0020

    Shenyang, Liaoning 110022
    China

    Site Not Available

  • Local Institution - 0005

    Shenyang 2034937, Liaoning 2036115 110001
    China

    Site Not Available

  • Local Institution - 0016

    Chengdu 1815286, SC 610041
    China

    Site Not Available

  • Local Institution - 0006

    Shanghai 1796236, SH 200025
    China

    Site Not Available

  • Local Institution - 0030

    Xi'an 1790630, SN 710100
    China

    Site Not Available

  • Local Institution - 0030

    Xian, SN 710100
    China

    Site Not Available

  • Local Institution - 0033

    Taiyuan 1793511, SX 030013
    China

    Site Not Available

  • Local Institution

    Shanghai, Shanghai 200025
    China

    Site Not Available

  • Local Institution - 0006

    Shanghai, Shanghai 200025
    China

    Site Not Available

  • Local Institution - 0033

    Taiyuan, Shanxi 030013
    China

    Site Not Available

  • Local Institution

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Local Institution - 0016

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Local Institution - 0001

    Tianjin 1792947, TJ 300020
    China

    Site Not Available

  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

    Tianjin, Tianjin 300020
    China

    Site Not Available

  • Local Institution

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • Local Institution - 0001

    Tianjin, Tianjin 300020
    China

    Site Not Available

  • Local Institution - 0009

    Urumqi, Xinjiang 830011
    China

    Site Not Available

  • Local Institution - 0009

    Ürümqi 1529102, Xinjiang 1529047 830011
    China

    Site Not Available

  • Local Institution

    Kunming, Yunnan 650032
    China

    Site Not Available

  • Local Institution - 0007

    Wenzhou 1791388, ZJ 325015
    China

    Site Not Available

  • Local Institution

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

  • Local Institution

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

  • Local Institution - 0007

    Wenzhou City, Zhejiang 325015
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou City, Zhejiang 325015
    China

    Site Not Available

  • Local Institution - 0017

    Changchun, 130021
    China

    Site Not Available

  • Local Institution - 0017

    Changchun 2038180, 130021
    China

    Site Not Available

  • Local Institution - 0015

    Changsha, 410013
    China

    Site Not Available

  • Local Institution - 0019

    Changsha, 410008
    China

    Site Not Available

  • Local Institution - 0015

    Changsha 1815577, 410013
    China

    Site Not Available

  • Local Institution - 0019

    Changsha 1815577, 410008
    China

    Site Not Available

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, 341000
    China

    Site Not Available

  • Local Institution - 0035

    Ganzhou, 341000
    China

    Site Not Available

  • Local Institution - 0035

    Ganzhou 1810638, 341000
    China

    Site Not Available

  • Local Institution - 0003

    Guangdong, 510080
    China

    Site Not Available

  • Local Institution - 0012

    Guangzhou, 510060
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center

    Guangzhou, 510060
    China

    Site Not Available

  • Local Institution - 0012

    Guangzhou 1809858, 510060
    China

    Site Not Available

  • Local Institution - 0014

    Hangzhou, 310009
    China

    Site Not Available

  • Local Institution - 0014

    Hangzhou 1808926, 310009
    China

    Site Not Available

  • Local Institution - 0032

    Harbin, 150086
    China

    Site Not Available

  • Local Institution - 0032

    Harbin 2037013, 150086
    China

    Site Not Available

  • Local Institution - 0011

    Jinan, 250012
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, 250012
    China

    Site Not Available

  • Local Institution - 0011

    Jinan 1805753, 250012
    China

    Site Not Available

  • Local Institution - 0024

    Kunming, 650032
    China

    Site Not Available

  • Local Institution - 0024

    Kunming 1804651, 650032
    China

    Site Not Available

  • Local Institution - 0026

    Lanzhou, 730030
    China

    Site Not Available

  • Local Institution - 0026

    Lanzhou 1804430, 730030
    China

    Site Not Available

  • Local Institution - 0018

    Nanchang, 330006
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University - Donghu District

    Nanchang, 330006
    China

    Site Not Available

  • Local Institution - 0018

    Nanchang 1800163, 330006
    China

    Site Not Available

  • Local Institution - 0029

    Nanjing, 210029
    China

    Site Not Available

  • Local Institution - 0029

    Nanjing 1799962, 210029
    China

    Site Not Available

  • Local Institution - 0021

    Soochow, 215006
    China

    Site Not Available

  • Local Institution - 0021

    Suzhou 1886760, 215006
    China

    Site Not Available

  • Local Institution - 0023

    Tianjin, 300052
    China

    Site Not Available

  • Local Institution - 0023

    Tianjin 1792947, 300052
    China

    Site Not Available

  • Local Institution - 0009

    Wulumuqi, 830054
    China

    Site Not Available

  • Local Institution - 0030

    Xi'an, 710038
    China

    Site Not Available

  • Local Institution - 0034

    Zhangzhou 1785018, 363000
    China

    Site Not Available

  • Local Institution - 0034

    Zhangzhou City, 363000
    China

    Site Not Available

  • Zhangzhou Municipal Hospital of Fujian Province

    Zhangzhou City, 363000
    China

    Site Not Available

  • Local Institution - 0004

    Zhengzhou, 450008
    China

    Site Not Available

  • Local Institution - 0004

    Zhengzhou 1784658, 450008
    China

    Site Not Available

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