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New pill aims to keep AML in remission for older japanese patients

NCT ID NCT05197426

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether taking an oral chemotherapy drug (azacitidine) as maintenance therapy can help keep acute myeloid leukemia (AML) from returning in Japanese patients aged 55 and older who are already in remission. Participants will receive either the drug or a placebo, along with best supportive care. The goal is to see if the drug extends the time before relapse or death.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

19 people

The number who actually took part.

Started

Jan 2022

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia

Contacts and locations

Locations

  • Local Institution - 0001

    Maebashi, Gunma, 3710821, Japan

  • Local Institution - 0002

    Shinagawa, Tokyo, 141-8625, Japan

  • Local Institution - 0003

    Kashiwa-shi, Chiba, 2778577, Japan

  • Local Institution - 0004

    Sapporo, Hokkaido, 0640804, Japan

  • Local Institution - 0005

    Kamogawa, Chiba, 2968602, Japan

  • Local Institution - 0006

    Sagamihara-shi, Kanagawa, 2520375, Japan

  • Local Institution - 0007

    Yamagata, 990-9585, Japan

  • Local Institution - 0008

    Nagasaki, 8528511, Japan

  • Local Institution - 0009

    Toyoake, Aichi-ken, 470-1192, Japan

  • Local Institution - 0010

    Matsuyama, Ehime, 7900826, Japan

  • Local Institution - 0011

    Huntsville, Alabama, 35801, United States

  • Local Institution - 0012

    Isehara, Kanagawa, 2591193, Japan

  • Local Institution - 0013

    Yokohama, Kanagawa, 236-0004, Japan

  • Local Institution - 0014

    Ōgaki, Gifu, 503-8502, Japan

  • Local Institution - 0015

    Sendai, Miyagi, 9808574, Japan

  • Local Institution - 0016

    Fukuoka, Fukuoka, 810-8539, Japan

  • Local Institution - 0017

    Nagoya, Aichi-ken, 453-8511, Japan

  • Local Institution - 0018

    Fukuoka, 810-8563, Japan

  • Local Institution - 0019

    Kanazawa, Ishikawa-ken, 9208641, Japan

  • Local Institution - 0020

    Yoshida Gun, Fukui, 9101193, Japan

  • Local Institution - 0021

    Ōsaka-sayama, Osaka, 5898511, Japan

  • Local Institution - 0022

    Aomori, Aomori, 0308553, Japan

  • Local Institution - 0023

    Nagoya, Aichi-ken, 4668560, Japan

  • Local Institution - 0025

    Okayama, 7000914, Japan

  • Local Institution - 0026

    Osaka, Osaka, 5300012, Japan

  • Local Institution - 0027

    Fukuoka, 8120033, Japan

  • Local Institution - 0028

    Saitama, 330-8503, Japan

  • Local Institution - 0029

    Sumida Ku, Tokyo, 1308575, Japan

  • Local Institution - 0030

    Shinjuku-ku, Tokyo, 1600023, Japan

  • Local Institution - 0031

    Shimotsuke, Tochigi, 329-0498, Japan

  • Local Institution - 0032

    Bunkyo Ku, Tokyo, 1138677, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.