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

Leukemia, Myeloid, Acute Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05413018
• Other study ID #: CA055-006
• Status: Recruiting
• Phase: Phase 2
• Start date: August 19, 2022
• Est. completion date: March 1, 2026

Study information

• Verified date: June 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: March 1, 2026
• Est. primary completion date: January 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• CC-486
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
China	Local Institution - 0013	Beijing	Beijing
China	Local Institution - 0027	Beijing	Beijing
China	Local Institution - 0017	Changchun
China	Local Institution - 0015	Changsha
China	Local Institution - 0019	Changsha
China	Local Institution - 0016	Chengdu	Sichuan
China	Local Institution - 0028	Chongqing	CQ
China	First Affiliated Hospital of Gannan Medical University	Ganzhou
China	Local Institution - 0003	Guangzhou	Guangdong
China	Local Institution - 0008	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou
China	Local Institution - 0014	Hangzhou
China	Local Institution - 0032	Harbin
China	Local Institution - 0031	Hefei	Anhui
China	Qilu Hospital of Shandong University	Jinan
China	Local Institution - 0024	Kunming
China	Local Institution - 0026	Lanzhou
China	The First Affiliated Hospital of Nanchang University - Donghu District	Nanchang
China	Local Institution - 0029	Nanjing
China	Local Institution - 0006	Shanghai	Shanghai
China	Local Institution - 0005	Shenyang	Liaoning
China	Local Institution - 0020	Shenyang	Liaoning
China	Local Institution - 0025	Shenzhen	Guangdong
China	Shenzhen University General Hospital	Shenzhen	Guangdong
China	Local Institution - 0002	Shijiazhuang	Hebei
China	Local Institution - 0021	Soochow
China	Local Institution - 0033	Taiyuan	Shanxi
China	Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences	Tianjin	Tianjin
China	Local Institution - 0023	Tianjin
China	Local Institution - 0009	Urumqi	Xinjiang Uygur Autonomous Region
China	Local Institution - 0007	Wenzhou City	Zhejiang
China	Local Institution - 0030	Xian	SN
China	Local Institution - 0022	Xuzhou	Jiangsu
China	Zhangzhou Municipal Hospital of Fujian Province	Zhangzhou City
China	Local Institution - 0004	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse-free survival (RFS)		Up to 30 months
Secondary	Overall Survival (OS)		Up to approximately 42 months
Secondary	Time to relapse		Up to approximately 30 months
Secondary	Time to discontinuation of treatment		Up to approximately 42 months
Secondary	Number of participants with adverse events (AEs)		Up to approximately 42 months
Secondary	Number of participants with physical examination abnormalities		Up to approximately 42 months
Secondary	Number of participants with vital sign abnormalities		Up to approximately 42 months
Secondary	Number of participants with clinical laboratory abnormalities		Up to approximately 42 months
Secondary	Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-t))		Up to 8 weeks
Secondary	Maximum observed plasma concentration (Cmax)		Up to 8 weeks
Secondary	Time of maximum observed concentration (Tmax)		Up to 8 weeks
Secondary	Terminal elimination half-life (T1/2)		Up to 8 weeks
Secondary	Minimal/measurable residual disease (MRD) assessment by flow cytometric analysis of hematopoietic cell immunophenotypes		Up to approximately 30 months
Secondary	Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale		Up to approximately 30 months
Secondary	EQ-5D-5L scale		Up to approximately 30 months
Secondary	Visual analog scale (VAS)		Up to approximately 30 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   BMS Clinical Trial Information