A Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Japanese Participants With Acute Myeloid Leukemia (AML) in Complete Remission

  • STATUS
    Recruiting
  • End date
    Apr 11, 2026
  • participants needed
    66
  • sponsor
    Bristol-Myers Squibb
Updated on 6 June 2022
remission
chronic myelomonocytic leukemia
induction chemotherapy
consolidation therapy
azacitidine
consolidation chemotherapies

Summary

The purpose of this study is to assess the efficacy and safety of oral azacitidine plus best supportive care versus best supportive care as maintenance therapy in a cohort of Japanese participants ≥ 55 years of age with Acute Myeloid Leukemia (AML) and in complete remission/complete remission with incomplete blood count recovery after conventional induction chemotherapy with or without consolidation chemotherapy.

Details
Condition Acute Myeloid Leukemia
Treatment Placebo, Oral Azacitidine
Clinical Study IdentifierNCT05197426
SponsorBristol-Myers Squibb
Last Modified on6 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

≥ 55 years of age inclusive at the time of signing the informed consent
Newly diagnosed, histologically confirmed de novo Acute Myeloid Leukemia (AML) or AML secondary to prior myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML)
Should have undergone induction therapy with intensive chemotherapy with or without consolidation therapy as recommended in appropriate guideline(s) or equivalent regimen according to institutional standard: having achieved first complete remission (CR)/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 AML with previous hematologic disorder such as chronic myeloid leukemia or myeloproliferative neoplasms, excluding MDS and CMML
Prior bone marrow or stem cell transplantation
Received therapy with hypomethylating agents for MDS and went on to develop AML within four months of discontinuing the therapy with hypomethylating agents
Have achieved CR/CRi following therapy with hypomethylating agents
Other protocol-defined inclusion/exclusion criteria apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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