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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT05197426

Run by

Bristol-Myers Squibb

People needed

19

Starts

2022-01-17

Expected to finish

2026-04-30

Last updated by the study team

2026-02-11

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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

Where it is running

• Local Institution - 0011 — Huntsville, Alabama, United States
• Local Institution - 0017 — Nagoya, Aichi-ken, Japan
• Local Institution - 0023 — Nagoya, Aichi-ken, Japan
• Local Institution - 0009 — Toyoake, Aichi-ken, Japan
• Local Institution - 0022 — Aomori, Aomori, Japan
• Local Institution - 0005 — Kamogawa, Chiba, Japan
• Local Institution - 0003 — Kashiwa-shi, Chiba, Japan
• Local Institution - 0010 — Matsuyama, Ehime, Japan
• Local Institution - 0020 — Yoshida Gun, Fukui, Japan
• Local Institution - 0016 — Fukuoka, Fukuoka, Japan
• Local Institution - 0014 — Ōgaki, Gifu, Japan
• Local Institution - 0001 — Maebashi, Gunma, Japan
• Local Institution - 0004 — Sapporo, Hokkaido, Japan
• Local Institution - 0019 — Kanazawa, Ishikawa-ken, Japan
• Local Institution - 0012 — Isehara, Kanagawa, Japan
• Local Institution - 0006 — Sagamihara-shi, Kanagawa, Japan
• Local Institution - 0013 — Yokohama, Kanagawa, Japan
• Local Institution - 0015 — Sendai, Miyagi, Japan
• Local Institution - 0026 — Osaka, Osaka, Japan
• Local Institution - 0021 — Ōsaka-sayama, Osaka, Japan
• Local Institution - 0031 — Shimotsuke, Tochigi, Japan
• Local Institution - 0032 — Bunkyo Ku, Tokyo, Japan
• Local Institution - 0002 — Shinagawa, Tokyo, Japan
• Local Institution - 0030 — Shinjuku-ku, Tokyo, Japan
• Local Institution - 0029 — Sumida Ku, Tokyo, Japan

Full record on ClinicalTrials.gov

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