An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myeloid Leukemia in Complete Remission
- Conditions
- Leukemia, Myeloid, Acute
- Interventions
- Other: Placebo
- Registration Number
- NCT05413018
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 78
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Administration Placebo - CC-486/Oral Azacitidine Administration CC-486 -
- Primary Outcome Measures
Name Time Method Relapse-free survival (RFS) Up to 30 months
- Secondary Outcome Measures
Name Time Method Number of participants with clinical laboratory abnormalities Up to approximately 42 months Healthcare Resource Utilization (HRU): Rate of Clinic Visits Per Year Up to approximately 30 months 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.
Time of maximum observed concentration (Tmax) 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 Visual analog scale (VAS) Up to approximately 30 months Healthcare Resource Utilization (HRU): Rate of Hospital Events Per Year Up to approximately 30 months 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.
Healthcare Resource Utilization (HRU): Rate of Medical/Diagnostic Events Per Year Up to approximately 30 months 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.
Time to discontinuation of treatment Up to approximately 42 months Number of participants with physical examination 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 Terminal elimination half-life (T1/2) Up to 8 weeks Healthcare Resource Utilization (HRU): Number of Medications Up to approximately 30 months 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.
EQ-5D-5L scale Up to approximately 30 months Healthcare Resource Utilization (HRU): Number of Treatments for AEs Per Year Up to approximately 30 months 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.
Overall Survival (OS) Up to approximately 42 months Time to relapse Up to approximately 30 months Number of participants with adverse events (AEs) Up to approximately 42 months Number of participants with vital sign abnormalities Up to approximately 42 months Maximum observed plasma concentration (Cmax) Up to 8 weeks
Trial Locations
- Locations (34)
Local Institution - 0010
🇨🇳Shenzhen, Guangdong, China
Local Institution - 0001
🇨🇳Tianjin, Tianjin, China
Local Institution - 0007
🇨🇳Wenzhou City, Zhejiang, China
Local Institution - 0035
🇨🇳Ganzhou, China
Local Institution - 0012
🇨🇳Guangzhou, China
Local Institution - 0011
🇨🇳Jinan, China
Local Institution - 0018
🇨🇳Nanchang, China
Local Institution - 0034
🇨🇳Zhangzhou City, China
Local Institution - 0031
🇨🇳Hefei, Anhui, China
Local Institution - 0013
🇨🇳Beijing, Beijing, China
Local Institution - 0027
🇨🇳Beijing, Beijing, China
Local Institution - 0028
🇨🇳Chongqing, CQ, China
Local Institution - 0003
🇨🇳Guangzhou, Guangdong, China
Local Institution - 0008
🇨🇳Guangzhou, Guangdong, China
Local Institution - 0002
🇨🇳Shijiazhuang, Hebei, China
Local Institution - 0022
🇨🇳Xuzhou, Jiangsu, China
Local Institution - 0005
🇨🇳Shenyang, Liaoning, China
Local Institution - 0020
🇨🇳Shenyang, Liaoning, China
Local Institution - 0006
🇨🇳Shanghai, Shanghai, China
Local Institution - 0033
🇨🇳Taiyuan, Shanxi, China
Local Institution - 0016
🇨🇳Chengdu, Sichuan, China
Local Institution - 0030
🇨🇳Xian, SN, China
Local Institution - 0009
🇨🇳Urumqi, Xinjiang, China
Local Institution - 0017
🇨🇳Changchun, China
Local Institution - 0019
🇨🇳Changsha, China
Local Institution - 0015
🇨🇳Changsha, China
Local Institution - 0014
🇨🇳Hangzhou, China
Local Institution - 0032
🇨🇳Harbin, China
Local Institution - 0024
🇨🇳Kunming, China
Local Institution - 0026
🇨🇳Lanzhou, China
Local Institution - 0029
🇨🇳Nanjing, China
Local Institution - 0021
🇨🇳Soochow, China
Local Institution - 0023
🇨🇳Tianjin, China
Local Institution - 0004
🇨🇳Zhengzhou, China