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Pill may keep leukemia at bay: new trial tests oral azacitidine as maintenance therapy

NCT ID NCT05413018

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether an oral chemotherapy drug called azacitidine (CC-486) can help prevent acute myeloid leukemia from coming back in Chinese patients who are already in complete remission after initial treatment. About 34 participants will receive either the drug or a placebo, along with best supportive care. The study aims to see if the drug extends the time before relapse and improves overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oral azacitidine (CC-486, Onureg)
What this could lead to
If successful, this could provide a convenient oral maintenance option to help keep acute myeloid leukemia in remission longer for Chinese patients.
What could go wrong
This is a small, early-phase (phase 2) study with only 34 participants, so results may not apply broadly. The drug may cause side effects and might not improve survival or prevent relapse.

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

34 people

The number who actually took part.

Started

Aug 2022

Expected to finish

Oct 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: * 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

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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.

Leukemia, myeloid, acute

Contacts and locations

Locations

  • Local Institution - 0001

    Tianjin, TJ, 300020, China

  • Local Institution - 0002

    Shijiazhuang, HE, 050000, China

  • Local Institution - 0003

    Guangzhou, GD, 510080, China

  • Local Institution - 0004

    Zhengzhou, 450008, China

  • Local Institution - 0005

    Shenyang, Liaoning, 110001, China

  • Local Institution - 0006

    Shanghai, SH, 200025, China

  • Local Institution - 0007

    Wenzhou, ZJ, 325015, China

  • Local Institution - 0008

    Guangzhou, GD, 510080, China

  • Local Institution - 0009

    Ürümqi, Xinjiang, 830011, China

  • Local Institution - 0010

    Shenzhen, GD, 518055, China

  • Local Institution - 0011

    Jinan, 250012, China

  • Local Institution - 0012

    Guangzhou, 510060, China

  • Local Institution - 0013

    Beijing, BJ, 100044, China

  • Local Institution - 0014

    Hangzhou, 310009, China

  • Local Institution - 0015

    Changsha, 410013, China

  • Local Institution - 0016

    Chengdu, SC, 610041, China

  • Local Institution - 0017

    Changchun, 130021, China

  • Local Institution - 0018

    Nanchang, 330006, China

  • Local Institution - 0019

    Changsha, 410008, China

  • Local Institution - 0020

    Shenyang, LN, 110022, China

  • Local Institution - 0021

    Suzhou, 215006, China

  • Local Institution - 0022

    Xuzhou, Jiangsu, 221000, China

  • Local Institution - 0023

    Tianjin, 300052, China

  • Local Institution - 0024

    Kunming, 650032, China

  • Local Institution - 0026

    Lanzhou, 730030, China

  • Local Institution - 0027

    Beijing, BJ, 100191, China

  • Local Institution - 0028

    Chongqing, CQ, 400000, China

  • Local Institution - 0029

    Nanjing, 210029, China

  • Local Institution - 0030

    Xi'an, SN, 710100, China

  • Local Institution - 0031

    Hefei, Anhui, 230001, China

  • Local Institution - 0032

    Harbin, 150086, China

  • Local Institution - 0033

    Taiyuan, SX, 030013, China

  • Local Institution - 0034

    Zhangzhou, 363000, China

  • Local Institution - 0035

    Ganzhou, 341000, China

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