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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05413018




Registration number
NCT05413018
Ethics application status
Date submitted
25/05/2022
Date registered
9/06/2022
Date last updated
1/10/2024

Titles & IDs
Public title
An Efficacy and Safety Study of Oral Azacitidine (CC-486) as Maintenance Therapy in Chinese Participants With Acute Myeloid Leukemia in Complete Remission
Scientific 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
Secondary ID [1] 0 0
CA055-006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia, Myeloid, Acute 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CC-486
Other interventions - Placebo

Experimental: CC-486/Oral Azacitidine Administration -

Placebo comparator: Placebo Administration -


Treatment: Drugs: CC-486
Specified dose on specified days

Other interventions: Placebo
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Relapse-free survival (RFS)
Timepoint [1] 0 0
Up to 30 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 42 months
Secondary outcome [2] 0 0
Time to relapse
Timepoint [2] 0 0
Up to approximately 30 months
Secondary outcome [3] 0 0
Time to discontinuation of treatment
Timepoint [3] 0 0
Up to approximately 42 months
Secondary outcome [4] 0 0
Number of participants with adverse events (AEs)
Timepoint [4] 0 0
Up to approximately 42 months
Secondary outcome [5] 0 0
Number of participants with physical examination abnormalities
Timepoint [5] 0 0
Up to approximately 42 months
Secondary outcome [6] 0 0
Number of participants with vital sign abnormalities
Timepoint [6] 0 0
Up to approximately 42 months
Secondary outcome [7] 0 0
Number of participants with clinical laboratory abnormalities
Timepoint [7] 0 0
Up to approximately 42 months
Secondary outcome [8] 0 0
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-t))
Timepoint [8] 0 0
Up to 8 weeks
Secondary outcome [9] 0 0
Maximum observed plasma concentration (Cmax)
Timepoint [9] 0 0
Up to 8 weeks
Secondary outcome [10] 0 0
Time of maximum observed concentration (Tmax)
Timepoint [10] 0 0
Up to 8 weeks
Secondary outcome [11] 0 0
Terminal elimination half-life (T1/2)
Timepoint [11] 0 0
Up to 8 weeks
Secondary outcome [12] 0 0
Minimal/measurable residual disease (MRD) assessment by flow cytometric analysis of hematopoietic cell immunophenotypes
Timepoint [12] 0 0
Up to approximately 30 months
Secondary outcome [13] 0 0
Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
Timepoint [13] 0 0
Up to approximately 30 months
Secondary outcome [14] 0 0
EQ-5D-5L scale
Timepoint [14] 0 0
Up to approximately 30 months
Secondary outcome [15] 0 0
Visual analog scale (VAS)
Timepoint [15] 0 0
Up to approximately 30 months
Secondary outcome [16] 0 0
Healthcare Resource Utilization (HRU): Rate of Hospital Events Per Year
Timepoint [16] 0 0
Up to approximately 30 months
Secondary outcome [17] 0 0
Healthcare Resource Utilization (HRU): Number of Medications
Timepoint [17] 0 0
Up to approximately 30 months
Secondary outcome [18] 0 0
Healthcare Resource Utilization (HRU): Rate of Clinic Visits Per Year
Timepoint [18] 0 0
Up to approximately 30 months
Secondary outcome [19] 0 0
Healthcare Resource Utilization (HRU): Rate of Medical/Diagnostic Events Per Year
Timepoint [19] 0 0
Up to approximately 30 months
Secondary outcome [20] 0 0
Healthcare Resource Utilization (HRU): Number of Treatments for AEs Per Year
Timepoint [20] 0 0
Up to approximately 30 months

Eligibility
Key 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
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2026
Actual
Sample size
Target
78
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Anhui
Country [2] 0 0
China
State/province [2] 0 0
Beijing
Country [3] 0 0
China
State/province [3] 0 0
CQ
Country [4] 0 0
China
State/province [4] 0 0
Guangdong
Country [5] 0 0
China
State/province [5] 0 0
Hebei
Country [6] 0 0
China
State/province [6] 0 0
Jiangsu
Country [7] 0 0
China
State/province [7] 0 0
Liaoning
Country [8] 0 0
China
State/province [8] 0 0
Shanghai
Country [9] 0 0
China
State/province [9] 0 0
Shanxi
Country [10] 0 0
China
State/province [10] 0 0
Sichuan
Country [11] 0 0
China
State/province [11] 0 0
SN
Country [12] 0 0
China
State/province [12] 0 0
Tianjin
Country [13] 0 0
China
State/province [13] 0 0
Xinjiang
Country [14] 0 0
China
State/province [14] 0 0
Zhejiang
Country [15] 0 0
China
State/province [15] 0 0
Changchun
Country [16] 0 0
China
State/province [16] 0 0
Changsha
Country [17] 0 0
China
State/province [17] 0 0
Ganzhou
Country [18] 0 0
China
State/province [18] 0 0
Guangzhou
Country [19] 0 0
China
State/province [19] 0 0
Hangzhou
Country [20] 0 0
China
State/province [20] 0 0
Harbin
Country [21] 0 0
China
State/province [21] 0 0
Jinan
Country [22] 0 0
China
State/province [22] 0 0
Kunming
Country [23] 0 0
China
State/province [23] 0 0
Lanzhou
Country [24] 0 0
China
State/province [24] 0 0
Nanchang
Country [25] 0 0
China
State/province [25] 0 0
Nanjing
Country [26] 0 0
China
State/province [26] 0 0
Soochow
Country [27] 0 0
China
State/province [27] 0 0
Zhangzhou City
Country [28] 0 0
China
State/province [28] 0 0
Zhengzhou

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05413018
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05413018