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

NCT05413018 · tracked via the Priya Life Science China tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 2

Started

2022-08-19

Last updated

2026-04-28

Condition(s) studied

Leukemia, Myeloid, Acute

Investigational drug(s) / intervention(s)

CC-486Placebo

CC-486: Specified dose on specified days

Placebo: Specified dose on specified days

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

Sex

ALL

Min age

55 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Newly diagnosed, histologically confirmed de novo acute myeloid leukemia (AML) or AML 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 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: * Suspected or proven acute promyelocytic leukemia or acute myeloid leukemia with previous hematologic disorder such as chronic myeloid leukemia or myeloproliferative neoplasms, 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 or molecular evidence of such translocations * Proven central nervous system leukemia * Prior bone marrow or stem cell transplantation Other protocol-defined inclusion/exclusion criteria apply

Primary outcome measure(s)

Relapse-free survival (RFS) — Up to 30 months

Trial sites (34)

Facility	City	Region
Local Institution - 0031	Hefei	Anhui
Local Institution - 0013	Beijing	BJ
Local Institution - 0027	Beijing	BJ
Local Institution - 0028	Chongqing	CQ
Local Institution - 0003	Guangzhou	GD
Local Institution - 0008	Guangzhou	GD
Local Institution - 0010	Shenzhen	GD
Local Institution - 0002	Shijiazhuang	HE
Local Institution - 0022	Xuzhou	Jiangsu
Local Institution - 0005	Shenyang	Liaoning
Local Institution - 0020	Shenyang	LN
Local Institution - 0016	Chengdu	SC
Local Institution - 0006	Shanghai	SH
Local Institution - 0030	Xi'an	SN
Local Institution - 0033	Taiyuan	SX
Local Institution - 0001	Tianjin	TJ
Local Institution - 0009	Ürümqi	Xinjiang
Local Institution - 0007	Wenzhou	ZJ
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05413018 on ClinicalTrials.gov ↗ ← All trials in China