Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CC-486/Oral Azacitidine Administration | Experimental |
| |
| Placebo Administration | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-486 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free survival (RFS) | Up to 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Up to approximately 42 months | |
| Time to relapse | Up to approximately 30 months | |
| Time to discontinuation of treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0031 | Hefei | Anhui | 230001 | China | ||
| Local Institution - 0013 |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
Not provided
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
See Plan Description
See Plan Description
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Specified dose on specified days |
|
| Up to approximately 42 months |
| Number of participants with adverse events (AEs) | Up to approximately 42 months |
| Number of participants with physical examination abnormalities | Up to approximately 42 months |
| Number of participants with vital sign abnormalities | Up to approximately 42 months |
| Number of participants with clinical laboratory abnormalities | 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)) | Up to 8 weeks |
| Maximum observed plasma concentration (Cmax) | Up to 8 weeks |
| Time of maximum observed concentration (Tmax) | Up to 8 weeks |
| Terminal elimination half-life (T1/2) | Up to 8 weeks |
| Minimal/measurable residual disease (MRD) assessment by flow cytometric analysis of hematopoietic cell immunophenotypes | Up to approximately 30 months |
| Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale | Up to approximately 30 months |
| EQ-5D-5L scale | Up to approximately 30 months |
| Visual analog scale (VAS) | 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. | 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. | 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. | 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. | 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. | Up to approximately 30 months |
| Beijing |
| BJ |
| 100044 |
| China |
| Local Institution - 0027 | Beijing | BJ | 100191 | China |
| Local Institution - 0028 | Chongqing | CQ | 400000 | China |
| Local Institution - 0003 | Guangzhou | GD | 510080 | China |
| Local Institution - 0008 | Guangzhou | GD | 510080 | China |
| Local Institution - 0010 | Shenzhen | GD | 518055 | China |
| Local Institution - 0002 | Shijiazhuang | HE | 050000 | China |
| Local Institution - 0022 | Xuzhou | Jiangsu | 221000 | China |
| Local Institution - 0005 | Shenyang | Liaoning | 110001 | China |
| Local Institution - 0020 | Shenyang | LN | 110022 | China |
| Local Institution - 0016 | Chengdu | SC | 610041 | China |
| Local Institution - 0006 | Shanghai | SH | 200025 | China |
| Local Institution - 0030 | Xi'an | SN | 710100 | China |
| Local Institution - 0033 | Taiyuan | SX | 030013 | China |
| Local Institution - 0001 | Tianjin | TJ | 300020 | China |
| Local Institution - 0009 | Ürümqi | Xinjiang | 830011 | China |
| Local Institution - 0007 | Wenzhou | ZJ | 325015 | China |
| Local Institution - 0017 | Changchun | 130021 | China |
| Local Institution - 0019 | Changsha | 410008 | China |
| Local Institution - 0015 | Changsha | 410013 | China |
| Local Institution - 0035 | Ganzhou | 341000 | China |
| Local Institution - 0012 | Guangzhou | 510060 | China |
| Local Institution - 0014 | Hangzhou | 310009 | China |
| Local Institution - 0032 | Harbin | 150086 | China |
| Local Institution - 0011 | Jinan | 250012 | China |
| Local Institution - 0024 | Kunming | 650032 | China |
| Local Institution - 0026 | Lanzhou | 730030 | China |
| Local Institution - 0018 | Nanchang | 330006 | China |
| Local Institution - 0029 | Nanjing | 210029 | China |
| Local Institution - 0021 | Suzhou | 215006 | China |
| Local Institution - 0023 | Tianjin | 300052 | China |
| Local Institution - 0034 | Zhangzhou | 363000 | China |
| Local Institution - 0004 | Zhengzhou | 450008 | China |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000709231 | cc-486 |
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
Not provided
Not provided