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NCT Number: NCT05413018

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Leukemia, Myeloid, Acute Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Neoplasms Neoplasms by Histologic Type

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution - 0031, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CC-486

Drug

Specified dose on specified days

Other names: Azacitidine, Onureg

Placebo

Other

Specified dose on specified days

Primary outcomes

  1. Relapse-free survival (RFS)

    Time frame: Up to 30 months

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 42 months

  2. Time to relapse

    Time frame: Up to approximately 30 months

  3. Time to discontinuation of treatment

    Time frame: Up to approximately 42 months

  4. Number of participants with adverse events (AEs)

    Time frame: Up to approximately 42 months

  5. Number of participants with physical examination abnormalities

    Time frame: Up to approximately 42 months

  6. Number of participants with vital sign abnormalities

    Time frame: Up to approximately 42 months

  7. Number of participants with clinical laboratory abnormalities

    Time frame: 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))

    Time frame: Up to 8 weeks

  9. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 8 weeks

  10. Time of maximum observed concentration (Tmax)

    Time frame: Up to 8 weeks

  11. Terminal elimination half-life (T1/2)

    Time frame: Up to 8 weeks

  12. Minimal/measurable residual disease (MRD) assessment by flow cytometric analysis of hematopoietic cell immunophenotypes

    Time frame: Up to approximately 30 months

  13. Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale

    Time frame: Up to approximately 30 months

  14. EQ-5D-5L scale

    Time frame: Up to approximately 30 months

  15. Visual analog scale (VAS)

    Time frame: Up to approximately 30 months

  16. Healthcare Resource Utilization (HRU): Rate of Hospital Events Per Year

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jun 9, 2022
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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