NCT05413018Active, not recruitingPhase 2
An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myeloid Leukemia in Complete Remission
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Compare Efficacy and Safety of Oral Azacitidine (CC-486) Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Chinese Patients With Acute Myeloid Leukemia in Complete Remission
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 25 May 2022
- Start date
- 19 Aug 2022
- Primary completion date
- 31 Oct 2025
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT05413018
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 34
- From 19 Aug 2022 to the primary completion date, 31 Oct 2025
- 34 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Prior bone marrow or stem cell transplantation
- Other protocol-defined inclusion/exclusion criteria apply
Other
- 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
Who the study is looking for
- 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
Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers
Sites (34)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 0013 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution - 0027 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution - 0017 Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Local Institution - 0019 Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Local Institution - 0015 Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Local Institution - 0016 Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Local Institution - 0028 Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Local Institution - 0035 Coordinator of this site? Confirm its status | Ganzhou | China | Unknown status |
| Local Institution - 0008 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Local Institution - 0003 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Local Institution - 0012 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Local Institution - 0014 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Local Institution - 0032 Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Local Institution - 0031 Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Local Institution - 0011 Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Local Institution - 0024 Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| Local Institution - 0026 Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
| Local Institution - 0018 Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Local Institution - 0029 Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Local Institution - 0006 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Local Institution - 0005 Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Local Institution - 0020 Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Local Institution - 0010 Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Local Institution - 0002 Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
| Local Institution - 0021 Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Local Institution - 0033 Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Local Institution - 0001 Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Local Institution - 0023 Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Local Institution - 0009 Coordinator of this site? Confirm its status | Ürümqi | China | Unknown status |
| Local Institution - 0007 Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Local Institution - 0030 Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Local Institution - 0022 Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| Local Institution - 0034 Coordinator of this site? Confirm its status | Zhangzhou | China | Unknown status |
| Local Institution - 0004 Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.