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Pill could help control Low-Risk bone marrow cancer

NCT ID NCT05469737

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests an oral medication called azacitidine (ONUREG) for people with a low- or intermediate-risk form of myelodysplastic syndrome (MDS), a bone marrow disorder. About 230 participants will receive either the drug or a placebo, along with standard supportive care. The goal is to see if the drug improves remission rates and is safe to take.

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 (ONUREG)
What this could lead to
If successful, this could provide a convenient oral treatment option to control MDS and improve remission rates without the need for injections.
What could go wrong
This is an early-to-mid-stage trial with only 230 participants, so results may not confirm benefit. Side effects from azacitidine are possible, and the drug may not work better than placebo.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 230 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Jul 2028

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

18 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: • Participant has a documented diagnosis of MDS according to WHO 2016 classification that meets International Prognostic Scoring System Revised (IPSS-R) classification of low- or intermediate-risk disease (IPSS-R score between 1.5 and 4.5). MDS diagnosis, WHO classification, and IPSS-R risk classification will be prospectively determined by independent central pathology and cytogenetics review, and applicable central laboratory results. • Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Exclusion Criteria: * Participants with prior malignancies must have an expected median life expectancy of at least 12 months at the time of inclusion and no active treatment of any sort for at least 24 weeks prior to randomization (including but not limited to immunotherapy or targeted therapy) * Hypoplastic Myelodysplastic Syndrome (MDS) with a marrow cellularity of ≤ 10% * Participants diagnosed with MDS with excess blasts-2 (MDS-EB2) * Prior treatment with azacitidine (any formulation), decitabine, or other hypomethylating agent Other protocol-defined inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

anemia myelodysplastic syndrome Myelodysplastic Syndromes thrombocytopenia

As listed by the trial registrant

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

Myelodysplastic syndromes

Contacts and locations

Locations

  • Local Institution - 0003

    Melbourne, 3004, Australia

  • Local Institution - 0004

    Melbourne, Victoria, 3065, Australia

  • Local Institution - 0006

    Clayton, Victoria, 3168, Australia

  • Local Institution - 0007

    Hamburg, 22081, Germany

  • Local Institution - 0008

    Toronto, Ontario, M4N 3M5, Canada

  • Local Institution - 0012

    Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

  • Local Institution - 0014

    Houston, Texas, 77030, United States

  • Local Institution - 0015

    Toronto, Ontario, M5G 2M9, Canada

  • Local Institution - 0016

    Buenos Aires, 1425, Argentina

  • Local Institution - 0018

    Melbourne, Victoria, 3000, Australia

  • Local Institution - 0022

    Buenos Aires, 1431, Argentina

  • Local Institution - 0024

    Tours, Indre-et-Loire, 37032, France

  • Local Institution - 0028

    Mutlangen, 73557, Germany

  • Local Institution - 0036

    Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea

  • Local Institution - 0037

    Dresden, 01307, Germany

  • Local Institution - 0039

    ABB, Buenos Aires F.D., C1199ABB, Argentina

  • Local Institution - 0048

    Seoul, Seoul Teugbyeolsi, 06591, South Korea

  • Local Institution - 0050

    Buenos Aires, CP1280AEB, Argentina

  • Local Institution - 0051

    Junggu, Taegu-Kwangyǒkshi, 41944, South Korea

  • Local Institution - 0052

    Rozzano, Milano, 20089, Italy

  • Local Institution - 0055

    Leipzig, Saxony, 04103, Germany

  • Local Institution - 0056

    Lille, Nord, 59000, France

  • Local Institution - 0058

    Hwasun Gun, Jeonranamdo, 58128, South Korea

  • Local Institution - 0060

    Hradec Králové, 500 05, Czechia

  • Local Institution - 0061

    Rome, Lazio, 00133, Italy

  • Local Institution - 0063

    Pessac, Aquitaine, 33600, France

  • Local Institution - 0070

    Pilar, Buenos Aires, 1629, Argentina

  • Local Institution - 0073

    Pittsburgh, Pennsylvania, 15224, United States

  • Local Institution - 0075

    Florence, Tuscany, 50134, Italy

  • Local Institution - 0081

    Duisburg, North Rhine-Westphalia, 47166, Germany

  • Local Institution - 0082

    Paris, 75010, France

  • Local Institution - 0085

    Villejuif, Val-de-Marne, 94805, France

  • Local Institution - 0086

    Houston, Texas, 77030, United States

  • Local Institution - 0090

    Montreal, Quebec, H4A 3J1, Canada

  • Local Institution - 0094

    Angers, Maine-et-Loire, 49933, France

  • Local Institution - 0097

    Olsztyn, Warmian-Masurian Voivodeship, 10-228, Poland

  • Local Institution - 0101

    Bologna, 40138, Italy

  • Local Institution - 0107

    Granada, 18012, Spain

  • Local Institution - 0108

    Salamanca, 37007, Spain

  • Local Institution - 0109

    Valencia, Valenciana, Comunitat, 46010, Spain

  • Local Institution - 0110

    Oviedo, 33011, Spain

  • Local Institution - 0111

    Madrid, 28006, Spain

  • Local Institution - 0112

    Ourense, 32005, Spain

  • Local Institution - 0115

    Aarhus, Central Jutland, 8200, Denmark

  • Local Institution - 0116

    Aalborg, North Denmark, 9000, Denmark

  • Local Institution - 0118

    Stockholm, Stockholms Län [se-01], 141 86, Sweden

  • Local Institution - 0119

    Örebro, Örebro Län [se-18], 701 85, Sweden

  • Local Institution - 0123

    Fairfax, Virginia, 22031, United States

  • Local Institution - 0124

    Osaka, 545-8586, Japan

  • Local Institution - 0125

    Chaïdári, Attikí, 12462, Greece

  • Local Institution - 0127

    Alexandroupoli, 08100, Greece

  • Local Institution - 0128

    Düsseldorf, North Rhine-Westphalia, 40479, Germany

  • Local Institution - 0129

    Thessaloniki, Thessaloníki, 570 10, Greece

  • Local Institution - 0130

    Sagamihara, Kanagawa, 252-0375, Japan

  • Local Institution - 0132

    East Syracuse, New York, 13057, United States

  • Local Institution - 0135

    Sendai, Miyagi, 980-8574, Japan

  • Local Institution - 0136

    Kitakyushu-shi, Fukuoka, 8068501, Japan

  • Local Institution - 0137

    Miami, Florida, 33136, United States

  • Local Institution - 0147

    Tamarac, Florida, 33321, United States

  • Local Institution - 0150

    Shinagawa-ku, Tokyo, 141-8625, Japan

  • Local Institution - 0153

    Amagasaki, Hyōgo, 660-8550, Japan

  • Local Institution - 0154

    Sapporo, Hokkaido, 064-0804, Japan

  • Local Institution - 0156

    Wuhan, Hubei, 430030, China

  • Local Institution - 0178

    Hksar, 0, Hong Kong

  • Local Institution - 0180

    Shatin, NT, Hong Kong

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