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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05413018
Collaborator
(none)
78
Enrollment
32
Locations
2
Arms
42.4
Anticipated Duration (Months)
2.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of CC-486 in Chinese participants with acute myeloid leukemia in complete remission.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jun 4, 2022
Anticipated Primary Completion Date :
Dec 2, 2024
Anticipated Study Completion Date :
Dec 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: CC-486 Administration

Drug: CC-486
Specified dose on specified days
Other Names:
  • Azacitidine

    		•
    Placebo Comparator: Placebo Administration

    Other: Placebo
    Specified dose on specified days

    Outcome Measures

    Primary Outcome Measures

    1. Relapse-free survival (RFS) [Up to 30 months]

    Secondary Outcome Measures

    1. Overall Survival (OS) [Up to approximately 42 months]

    2. Time to relapse [Up to approximately 30 months]

    3. Time to discontinuation of treatment [Up to approximately 42 months]

    4. Number of participants with adverse events (AEs) [Up to approximately 42 months]

    5. Number of participants with physical examination abnormalities [Up to approximately 42 months]

    6. Number of participants with vital sign abnormalities [Up to approximately 42 months]

    7. Number of participants with clinical laboratory abnormalities [Up to approximately 42 months]

    8. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-t)) [Up to 8 weeks]

    9. Maximum observed plasma concentration (Cmax) [Up to 8 weeks]

    10. Time of maximum observed concentration (Tmax) [Up to 8 weeks]

    11. Terminal elimination half-life (T1/2) [Up to 8 weeks]

    12. Minimal/measurable residual disease (MRD) assessment by flow cytometric analysis of hematopoietic cell immunophenotypes [Up to approximately 30 months]

    13. Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale [Up to approximately 30 months]

    14. EQ-5D-5L scale [Up to approximately 30 months]

    15. Visual analog scale (VAS) [Up to approximately 30 months]

    16. 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.

    17. 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.

    18. 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.

    19. 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.

    20. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Hefei Anhui China 230001
    2 Local Institution Beijing Beijing China 100044
    3 Local Institution Beijing Beijing China 100191
    4 Local Institution Chongqing Chongqing China 400038
    5 Local Institution Lanzhou Gansu China 730030
    6 Local Institution Guangdong Guangdong China 510080
    7 Local Institution Guangzhou Guangdong China 510030
    8 Local Institution Guangzhou Guangdong China 510060
    9 Local Institution Shenzhen Guangdong China 518055
    10 Local Institution Shenzhen Guangdong China 518116
    11 Local Institution Changsha Hainan China 410008
    12 Local Institution Changsha Hainan China 410013
    13 Local Institution Shijiazhuang Hebei China 050004
    14 Local Institution Haerbin Heilongjiang China 150001
    15 Local Institution Zhengzhou Henan China 450008
    16 Local Institution Nanjing Jiangsu China 210029
    17 Local Institution Suzhou Jiangsu China 215006
    18 Local Institution Xuzhou Jiangsu China 221002
    19 Local Institution Nanchang Jiangxi China 330019
    20 Local Institution Changchun Jilin China 130021
    21 Local Institution Shenyang Liaoning China 110001
    22 Local Institution Shenyang Liaoning China 110022
    23 Local Institution Urumqi Shan1xi China 830054
    24 Local Institution Xi'an Shan3xi China 710038
    25 Local Institution Jinan Shandong China 250012
    26 Local Institution Shanghai Shanghai China 200025
    27 Local Institution Chengdu Sichuan China 610041
    28 Local Institution Tianjin Tianjin China 300041
    29 Local Institution Tianjin Tianjin China 300052
    30 Local Institution Kunming Yunnan China 650032
    31 Local Institution Hangzhou Zhejiang China 310009
    32 Local Institution Wenzhou Zhejiang China 325000

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT05413018
    Other Study ID Numbers:
    • CA055-006
    First Posted:
    Jun 9, 2022
    Last Update Posted:
    Jun 9, 2022
    Last Verified:
    Jun 1, 2022
    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
    Keywords provided by Bristol-Myers Squibb
    Azacitidine
    CC-486
    Acute Myeloid Leukemia
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute
    Azacitidine
    Cc-486

    Study Results

    No Results Posted as of Jun 9, 2022