Back to resultsAn Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myeloid Leukemia in Complete Remission
Primary Purpose
Leukemia, Myeloid, Acute
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CC-486
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Myeloid, Acute focused on measuring Azacitidine, CC-486, Onureg, Acute Myeloid Leukemia
Eligibility Criteria
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 4 months 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
Sites / Locations
- Local Institution - 0031
- Local Institution - 0027
- Local Institution - 0028
- Local Institution - 0003
- Local Institution - 0008
- Local Institution - 0010Recruiting
- Local Institution - 0025
- Local Institution - 0002
- Local Institution - 0022
- Local Institution - 0005
- Local Institution - 0020
- Local Institution - 0006
- Local Institution - 0033
- Local Institution - 0016
- Local Institution - 0030Recruiting
- Local Institution - 0001Recruiting
- Local Institution - 0007
- Local Institution - 0013
- Local Institution - 0017
- Local Institution - 0019
- Local Institution - 0015Recruiting
- Local Institution - 0035
- Local Institution - 0012Recruiting
- Local Institution - 0014
- Local Institution - 0032
- Local Institution - 0011Recruiting
- Local Institution - 0024
- Local Institution - 0026
- Local Institution - 0018Recruiting
- Local Institution - 0029
- Local Institution - 0021
- Local Institution - 0023
- Local Institution - 0009
- Local Institution - 0034
- Local Institution - 0004
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CC-486/Oral Azacitidine Administration
Placebo Administration
Arm Description
Outcomes
Primary Outcome Measures
Relapse-free survival (RFS)
Secondary Outcome Measures
Overall Survival (OS)
Time to relapse
Time to discontinuation of treatment
Number of participants with adverse events (AEs)
Number of participants with physical examination abnormalities
Number of participants with vital sign abnormalities
Number of participants with clinical laboratory abnormalities
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-t))
Maximum observed plasma concentration (Cmax)
Time of maximum observed concentration (Tmax)
Terminal elimination half-life (T1/2)
Minimal/measurable residual disease (MRD) assessment by flow cytometric analysis of hematopoietic cell immunophenotypes
Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
EQ-5D-5L scale
Visual analog scale (VAS)
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05413018
Brief Title
An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myeloid Leukemia in Complete Remission
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 19, 2022 (Actual)
Primary Completion Date
January 3, 2025 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Acute
Keywords
Azacitidine, CC-486, Onureg, Acute Myeloid Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CC-486/Oral Azacitidine Administration
Arm Type
Experimental
Arm Title
Placebo Administration
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CC-486
Other Intervention Name(s)
Azacitidine, Onureg
Intervention Description
Specified dose on specified days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Relapse-free survival (RFS)
Time Frame
Up to 30 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
Up to approximately 42 months
Title
Time to relapse
Time Frame
Up to approximately 30 months
Title
Time to discontinuation of treatment
Time Frame
Up to approximately 42 months
Title
Number of participants with adverse events (AEs)
Time Frame
Up to approximately 42 months
Title
Number of participants with physical examination abnormalities
Time Frame
Up to approximately 42 months
Title
Number of participants with vital sign abnormalities
Time Frame
Up to approximately 42 months
Title
Number of participants with clinical laboratory abnormalities
Time Frame
Up to approximately 42 months
Title
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
Title
Maximum observed plasma concentration (Cmax)
Time Frame
Up to 8 weeks
Title
Time of maximum observed concentration (Tmax)
Time Frame
Up to 8 weeks
Title
Terminal elimination half-life (T1/2)
Time Frame
Up to 8 weeks
Title
Minimal/measurable residual disease (MRD) assessment by flow cytometric analysis of hematopoietic cell immunophenotypes
Time Frame
Up to approximately 30 months
Title
Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
Time Frame
Up to approximately 30 months
Title
EQ-5D-5L scale
Time Frame
Up to approximately 30 months
Title
Visual analog scale (VAS)
Time Frame
Up to approximately 30 months
Title
Healthcare Resource Utilization (HRU): Rate of Hospital Events Per Year
Description
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 Frame
Up to approximately 30 months
Title
Healthcare Resource Utilization (HRU): Number of Medications
Description
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 Frame
Up to approximately 30 months
Title
Healthcare Resource Utilization (HRU): Rate of Clinic Visits Per Year
Description
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 Frame
Up to approximately 30 months
Title
Healthcare Resource Utilization (HRU): Rate of Medical/Diagnostic Events Per Year
Description
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 Frame
Up to approximately 30 months
Title
Healthcare Resource Utilization (HRU): Number of Treatments for AEs Per Year
Description
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 Frame
Up to approximately 30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0031
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0031
Facility Name
Local Institution - 0027
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0027
Facility Name
Local Institution - 0028
City
Chongqing
State/Province
CQ
ZIP/Postal Code
400000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0028
Facility Name
Local Institution - 0003
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0003
Facility Name
Local Institution - 0008
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0008
Facility Name
Local Institution - 0010
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518055
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0010
Facility Name
Local Institution - 0025
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518117
Country
China
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0002
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0002
Facility Name
Local Institution - 0022
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0022
Facility Name
Local Institution - 0005
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0005
Facility Name
Local Institution - 0020
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110022
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0020
Facility Name
Local Institution - 0006
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0006
Facility Name
Local Institution - 0033
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030013
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0033
Facility Name
Local Institution - 0016
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0016
Facility Name
Local Institution - 0030
City
Xian
State/Province
SN
ZIP/Postal Code
710100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0030
Facility Name
Local Institution - 0001
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0001
Facility Name
Local Institution - 0007
City
Wenzhou City
State/Province
Zhejiang
ZIP/Postal Code
325015
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0007
Facility Name
Local Institution - 0013
City
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0013
Facility Name
Local Institution - 0017
City
Changchun
ZIP/Postal Code
130021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0017
Facility Name
Local Institution - 0019
City
Changsha
ZIP/Postal Code
410008
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0019
Facility Name
Local Institution - 0015
City
Changsha
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0015
Facility Name
Local Institution - 0035
City
Ganzhou
ZIP/Postal Code
341000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0035
Facility Name
Local Institution - 0012
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0012
Facility Name
Local Institution - 0014
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0014
Facility Name
Local Institution - 0032
City
Harbin
ZIP/Postal Code
150001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0032
Facility Name
Local Institution - 0011
City
Jinan
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0011
Facility Name
Local Institution - 0024
City
Kunming
ZIP/Postal Code
650032
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0024
Facility Name
Local Institution - 0026
City
Lanzhou
ZIP/Postal Code
730030
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0026
Facility Name
Local Institution - 0018
City
Nanchang
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0018
Facility Name
Local Institution - 0029
City
Nanjing
ZIP/Postal Code
210029
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0029
Facility Name
Local Institution - 0021
City
Soochow
ZIP/Postal Code
215006
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0021
Facility Name
Local Institution - 0023
City
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0023
Facility Name
Local Institution - 0009
City
Wulumuqi
ZIP/Postal Code
830054
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0009
Facility Name
Local Institution - 0034
City
Zhangzhou City
ZIP/Postal Code
363000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0034
Facility Name
Local Institution - 0004
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Individual Site Status
Withdrawn
12. IPD Sharing Statement
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myeloid Leukemia in Complete Remission
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