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

NCT05197426 · tracked via the Priya Life Science USA tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 2

Started

2022-01-17

Last updated

2026-02-11

Condition(s) studied

Acute Myeloid Leukemia

Investigational drug(s) / intervention(s)

Oral Azacitidine →Placebo

Oral Azacitidine: Specified dose on specified days

Placebo: Specified dose of specified days

Study 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.

Eligibility

Sex

ALL

Min age

55 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Recurrence Free Survival (RFS) — Approximately 17.7 months
The time from randomization to the date of documented relapse after CR or CRi per central review, or death from any cause, whichever occurs first. Participants who are still alive without documented relapse after CR or CRi, or who were lost to follow-up without documented relapse, will be censored at the date of their last response assessment.

Trial sites (31)

Facility	City	Region
Local Institution - 0011	Huntsville	Alabama
Local Institution - 0017	Nagoya	Aichi-ken
Local Institution - 0023	Nagoya	Aichi-ken
Local Institution - 0009	Toyoake	Aichi-ken
Local Institution - 0022	Aomori	Aomori
Local Institution - 0005	Kamogawa	Chiba
Local Institution - 0003	Kashiwa-shi	Chiba
Local Institution - 0010	Matsuyama	Ehime
Local Institution - 0020	Yoshida Gun	Fukui
Local Institution - 0016	Fukuoka	Fukuoka
Local Institution - 0014	Ōgaki	Gifu
Local Institution - 0001	Maebashi	Gunma
Local Institution - 0004	Sapporo	Hokkaido
Local Institution - 0019	Kanazawa	Ishikawa-ken
Local Institution - 0012	Isehara	Kanagawa
Local Institution - 0006	Sagamihara-shi	Kanagawa
Local Institution - 0013	Yokohama	Kanagawa
Local Institution - 0015	Sendai	Miyagi
Local Institution - 0026	Osaka	Osaka
Local Institution - 0021	Ōsaka-sayama	Osaka
Local Institution - 0031	Shimotsuke	Tochigi
Local Institution - 0032	Bunkyo Ku	Tokyo
Local Institution - 0002	Shinagawa	Tokyo
Local Institution - 0030	Shinjuku-ku	Tokyo
Local Institution - 0029	Sumida Ku	Tokyo
Local Institution - 0018	Fukuoka	Japan
Local Institution - 0027	Fukuoka	Japan
Local Institution - 0008	Nagasaki	Japan
Local Institution - 0025	Okayama	Japan
Local Institution - 0028	Saitama	Japan
Local Institution - 0007	Yamagata	Japan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05197426 on ClinicalTrials.gov ↗ ← All trials in the USA