Leukemia, Myeloid, AcutePhase 2NCT05413018
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 study testing CC-486 in people with Leukemia, Myeloid, Acute, run by Bristol-Myers Squibb at 34 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Leukemia, Myeloid, Acute
- What is being tested?
- CC-486
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 34 sitesChina
- Study dates
- 19 Aug 2022to 31 Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
China34 sites
Local Institution - 0013
Beijing, BJ, 100044
Local Institution - 0027
Beijing, BJ, 100191
Local Institution - 0017
Changchun, 130021
Local Institution - 0019
Changsha, 410008
Local Institution - 0015
Changsha, 410013
Local Institution - 0016
Chengdu, SC, 610041
Local Institution - 0028
Chongqing, CQ, 400000
Local Institution - 0035
Ganzhou, 341000
Local Institution - 0003
Guangzhou, GD, 510080
Local Institution - 0008
Guangzhou, GD, 510080
Local Institution - 0012
Guangzhou, 510060
Local Institution - 0014
Hangzhou, 310009
Local Institution - 0032
Harbin, 150086
Local Institution - 0031
Hefei, Anhui, 230001
Local Institution - 0011
Jinan, 250012
Local Institution - 0024
Kunming, 650032
Local Institution - 0026
Lanzhou, 730030
Local Institution - 0018
Nanchang, 330006
Local Institution - 0029
Nanjing, 210029
Local Institution - 0006
Shanghai, SH, 200025
Local Institution - 0005
Shenyang, Liaoning, 110001
Local Institution - 0020
Shenyang, LN, 110022
Local Institution - 0010
Shenzhen, GD, 518055
Local Institution - 0002
Shijiazhuang, HE, 050000
Local Institution - 0021
Suzhou, 215006
Local Institution - 0033
Taiyuan, SX, 030013
Local Institution - 0001
Tianjin, TJ, 300020
Local Institution - 0023
Tianjin, 300052
Local Institution - 0009
Ürümqi, Xinjiang, 830011
Local Institution - 0007
Wenzhou, ZJ, 325015
Local Institution - 0030
Xi'an, SN, 710100
Local Institution - 0022
Xuzhou, Jiangsu, 221000
Local Institution - 0034
Zhangzhou, 363000
Local Institution - 0004
Zhengzhou, 450008
About this study
Official title: 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
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.
- Conditions
- Leukemia, Myeloid, Acute
- Being tested
- CC-486, Placebo
- Keywords
- Azacitidine, CC-486, Onureg, Acute Myeloid Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-486Drug
Also called Azacitidine, Onureg
Specified dose on specified days
PlaceboOther
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| CC-486/Oral Azacitidine Administration | Experimental | Not described Receives: Drug: CC-486 |
| Placebo Administration | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival (RFS)
Measured: Up to 30 months
Secondary outcomes (20)
Overall Survival (OS)
Measured: Up to approximately 42 months
Time to relapse
Measured: Up to approximately 30 months
Time to discontinuation of treatment
Measured: Up to approximately 42 months
Number of participants with adverse events (AEs)
Measured: Up to approximately 42 months
Number of participants with physical examination abnormalities
Measured: Up to approximately 42 months
Number of participants with vital sign abnormalities
Measured: Up to approximately 42 months
Number of participants with clinical laboratory abnormalities
Measured: Up to approximately 42 months
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-t))
Measured: Up to 8 weeks
Maximum observed plasma concentration (Cmax)
Measured: Up to 8 weeks
Time of maximum observed concentration (Tmax)
Measured: Up to 8 weeks
Terminal elimination half-life (T1/2)
Measured: Up to 8 weeks
Minimal/measurable residual disease (MRD) assessment by flow cytometric analysis of hematopoietic cell immunophenotypes
Measured: Up to approximately 30 months
Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
Measured: Up to approximately 30 months
EQ-5D-5L scale
Measured: Up to approximately 30 months
Visual analog scale (VAS)
Measured: Up to approximately 30 months
Healthcare Resource Utilization (HRU): Rate of Hospital Events Per Year
HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the participant. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective.
Measured: Up to approximately 30 months
Healthcare Resource Utilization (HRU): Number of Medications
HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the participant. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective.
Measured: Up to approximately 30 months
Healthcare Resource Utilization (HRU): Rate of Clinic Visits Per Year
HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the participant. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective.
Measured: Up to approximately 30 months
Healthcare Resource Utilization (HRU): Rate of Medical/Diagnostic Events Per Year
HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the participant. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective.
Measured: Up to approximately 30 months
Healthcare Resource Utilization (HRU): Number of Treatments for AEs Per Year
HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the participant. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective.
Measured: Up to approximately 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start19 Aug 2022
- Primary completion31 Oct 2025
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413018
- Sponsor's protocol ID
- CA055-006
- Status last verified
- Apr 2026
- First submitted
- 25 May 2022
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05413018
- Acronym / sponsor ID
- CA055-006
- Conditions
- Leukemia, Myeloid, Acute
- Keywords
- Azacitidine, CC-486, Onureg, Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2022 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CC-486/Oral Azacitidine Administration | Experimental | Drug: CC-486 |
| Placebo Administration | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC-486Also: Azacitidine, OnuregSpecified dose on specified days | Drug | CC-486/Oral Azacitidine Administration |
| PlaceboSpecified dose on specified days | Other | Placebo Administration |
Primary outcome
Relapse-free survival (RFS)
Time frame: Up to 30 months
20 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 42 months
Time to relapse
Time frame: Up to approximately 30 months
Time to discontinuation of treatment
Time frame: Up to approximately 42 months
Number of participants with adverse events (AEs)
Time frame: Up to approximately 42 months
Number of participants with physical examination abnormalities
Time frame: Up to approximately 42 months
Number of participants with vital sign abnormalities
Time frame: Up to approximately 42 months
Number of participants with clinical laboratory abnormalities
Time frame: Up to approximately 42 months
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-t))
Time frame: Up to 8 weeks
Maximum observed plasma concentration (Cmax)
Time frame: Up to 8 weeks
Time of maximum observed concentration (Tmax)
Time frame: Up to 8 weeks
Terminal elimination half-life (T1/2)
Time frame: Up to 8 weeks
Minimal/measurable residual disease (MRD) assessment by flow cytometric analysis of hematopoietic cell immunophenotypes
Time frame: Up to approximately 30 months
Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
Time frame: Up to approximately 30 months
EQ-5D-5L scale
Time frame: Up to approximately 30 months
Visual analog scale (VAS)
Time frame: Up to approximately 30 months
Healthcare Resource Utilization (HRU): Rate of Hospital Events Per Year
Time frame: Up to approximately 30 months
Healthcare Resource Utilization (HRU): Number of Medications
Time frame: Up to approximately 30 months
Healthcare Resource Utilization (HRU): Rate of Clinic Visits Per Year
Time frame: Up to approximately 30 months
Healthcare Resource Utilization (HRU): Rate of Medical/Diagnostic Events Per Year
Time frame: Up to approximately 30 months
Healthcare Resource Utilization (HRU): Number of Treatments for AEs Per Year
Time frame: Up to approximately 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CC-486 in people with Leukemia, Myeloid, Acute, run by Bristol-Myers Squibb at 34 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-free survival (RFS) (time frame: Up to 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.