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Experimental combo for rare blood cancers hits roadblock

NCT ID NCT04266301

Disease control Sponsor: Novartis Pharmaceuticals 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 tested whether adding sabatolimab to standard chemotherapy (azacitidine) helps people with high-risk myelodysplastic syndrome (MDS) or a related leukemia (CMML-2). The trial aimed to see if the combination improved survival. However, the study was stopped early, so we don't have clear answers. About 530 adults participated, all of whom were not eligible for intensive treatment or a stem cell transplant.

What this could mean

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

Active substance
Sabatolimab (also called MBG453) and azacitidine
What this could lead to
If it had succeeded, this combination could have offered a new treatment option for people with high-risk MDS or CMML-2 who cannot have intensive chemo or a stem cell transplant.
What could go wrong
The trial was terminated early, so we don't have full results. It's unclear if sabatolimab adds benefit over azacitidine alone, and any new drug carries unknown side effects.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

530 people

The number who actually took part.

Started

Jun 2020

Finished

Oct 2024

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 to 100 years

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: * Signed informed consent must be obtained prior to participation in the study * Age ≥ 18 years at the date of signing the informed consent form * Morphologically confirmed diagnosis of myelodysplastic syndrome (MDS) based on WHO 2016 classification (Arber et al 2016) by local investigator assessment with one of the following Prognostic Risk Categories, based on the revised International Prognostic Scoring System (IPSS-R): * Very high (\> 6 points) * High (\> 4.5 - ≤ 6 points) * Intermediate (\> 3 - ≤ 4.5 points) Or Morphologically confirmed diagnosis of Chronic Myelomonocytic Leukemia -2 based on WHO 2016 classification (Arber et al 2016, including persistent monocytosis) by local investigator assessment with WBC \< 13 x 109/L at time of initial diagnosis * Indication for azacitidine treatment according to the investigator, based on local standard medical practice and institutional guidelines for treatment decisions * Not eligible at time of screening for intensive chemotherapy according to the investigator, based on local standard medical practice and institutional guidelines for treatment decisions, including assessment of individual clinical factors such as age, comorbidities and performance status * Not eligible at time of screening for hematopoietic stem cell transplantation (HSCT) according to the investigator, based on local standard medical practice and institutional guidelines for treatment decisions, including assessment of individual clinical factors such as age, comorbidities, performance status, and donor availability * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 Exclusion Criteria: * Prior exposure to TIM-3 directed therapy at any time. Prior therapy with immune checkpoint inhibitors (e.g, anti-CTLA4, anti-PD-1, anti-PD-L1, or anti-PD-L2), cancer vaccines is allowed except if the drug was administered within 4 months prior to randomization * Previous first-line treatment for intermediate, high, very high risk myelodysplastic syndromes (based on IPSS-R) or CMML with any antineoplastic agents including for example chemotherapy, lenalidomide and hypomethylating agents (HMAs) such as decitibine and azacitidine. However, previous treatment with hydroxyurea or leukopheresis to reduce WBC count is allowed prior to randomization. * Investigational treatment received within 4 weeks or 5 half-lives of this investigational treatment, whatever is longer, prior to randomization. In case of a checkpoint inhibitor: a minimal interval of 4 months prior to randomization is necessary to allow randomization. * Subjects with Myelodysplastic syndrome (MDS) based on 2016 WHO classification (Arber et al 2016) with revised International Prognostic Scoring System (IPSS-R) ≤ 3 * Diagnosis of acute myeloid leukemia (AML) including acute promyelocytic leukemia and extra-medullary acute myeloid leukemia, primary or secondary myelofibrosis based on WHO 2016 classification (Arber et al 2016) * Diagnosis of therapy related myeloid neoplasms based on WHO 2016 classification (Arber et al 2016) * History of organ or allogeneic hematopoietic stem cell transplant

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Conditions

The condition(s) this trial relates to.

chronic myelomonocytic leukemia myelodysplastic syndrome Myelodysplastic Syndromes

As listed by the trial registrant

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

Leukemia, myelomonocytic, chronic Myelodysplastic syndromes

Contacts and locations

Locations

  • Hackensack University Medical Ctr

    Hackensack, New Jersey, 07601, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Novartis Investigative Site

    Pilar, Buenos Aires, B1629AHJ, Argentina

  • Novartis Investigative Site

    Wooloongabba, Queensland, 4102, Australia

  • Novartis Investigative Site

    Clayton, Victoria, 3168, Australia

  • Novartis Investigative Site

    Perth, Western Australia, 6000, Australia

  • Novartis Investigative Site

    Innsbruck, Tyrol, 6020, Austria

  • Novartis Investigative Site

    Graz, 8036, Austria

  • Novartis Investigative Site

    Linz, 4020, Austria

  • Novartis Investigative Site

    Roeselare, West-Vlaanderen, 8800, Belgium

  • Novartis Investigative Site

    Brasschaat, 2930, Belgium

  • Novartis Investigative Site

    Florianópolis, Santa Catarina, 88020-210, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 04014-002, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 05319-000, Brazil

  • Novartis Investigative Site

    Calgary, Alberta, T2N 4N2, Canada

  • Novartis Investigative Site

    Toronto, Ontario, M4N 3M5, Canada

  • Novartis Investigative Site

    Viña del Mar, Valparaiso, 2540364, Chile

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510080, China

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510515, China

  • Novartis Investigative Site

    Shenzhen, Guangdong, 518037, China

  • Novartis Investigative Site

    Wuhan, Hubei, 430022, China

  • Novartis Investigative Site

    Wuhan, Hubei, 430030, China

  • Novartis Investigative Site

    Suzhou, Jiangsu, 215004, China

  • Novartis Investigative Site

    Changchun, Jilin, 130021, China

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310003, China

  • Novartis Investigative Site

    Beijing, 100029, China

  • Novartis Investigative Site

    Beijing, 100730, China

  • Novartis Investigative Site

    Jinan, 250012, China

  • Novartis Investigative Site

    Shanghai, 200025, China

  • Novartis Investigative Site

    Shanghai, 200233, China

  • Novartis Investigative Site

    Tianjin, 300020, China

  • Novartis Investigative Site

    Tianjin, 300052, China

  • Novartis Investigative Site

    Rionegro, Antioquia, 054047, Colombia

  • Novartis Investigative Site

    Bogotá, 110231, Colombia

  • Novartis Investigative Site

    Brno, 625 00, Czechia

  • Novartis Investigative Site

    Hradec Králové, 500 05, Czechia

  • Novartis Investigative Site

    Prague, 128 00, Czechia

  • Novartis Investigative Site

    Prague, 128 08, Czechia

  • Novartis Investigative Site

    Helsinki, FIN 00290, Finland

  • Novartis Investigative Site

    Kuopio, 70211, Finland

  • Novartis Investigative Site

    Grenoble, 38043, France

  • Novartis Investigative Site

    Lille, 59037, France

  • Novartis Investigative Site

    Paris, 75475, France

  • Novartis Investigative Site

    Toulouse, 31059, France

  • Novartis Investigative Site

    Tours, 37044, France

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy, 54511, France

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60590, Germany

  • Novartis Investigative Site

    Velbert, North Rhine-Westphalia, 42551, Germany

  • Novartis Investigative Site

    Dresden, Saxony, 01307, Germany

  • Novartis Investigative Site

    Jena, Thuringia, 07740, Germany

  • Novartis Investigative Site

    Augsburg, 86179, Germany

  • Novartis Investigative Site

    Düsseldorf, 40479, Germany

  • Novartis Investigative Site

    Greifswald, 17475, Germany

  • Novartis Investigative Site

    Kiel, 24116, Germany

  • Novartis Investigative Site

    Ulm, 89081, Germany

  • Novartis Investigative Site

    Alexandroupoli, 681 00, Greece

  • Novartis Investigative Site

    Pátrai, 265 04, Greece

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380009, India

  • Novartis Investigative Site

    Faridabad, Haryana, 121 001, India

  • Novartis Investigative Site

    Madurai, Tamil Nadu, 625107, India

  • Novartis Investigative Site

    Kolkata, West Bengal, 700014, India

  • Novartis Investigative Site

    Kolkata, West Bengal, 700160, India

  • Novartis Investigative Site

    Delhi, 110085, India

  • Novartis Investigative Site

    Afula, 1834111, Israel

  • Novartis Investigative Site

    Tel Aviv, 6423906, Israel

  • Novartis Investigative Site

    Bologna, BO, 40138, Italy

  • Novartis Investigative Site

    Catania, CT, 95123, Italy

  • Novartis Investigative Site

    Florence, FI, 50134, Italy

  • Novartis Investigative Site

    Genova, GE, 16132, Italy

  • Novartis Investigative Site

    Milan, MI, 20162, Italy

  • Novartis Investigative Site

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    Reggio Calabria, RC, 89124, Italy

  • Novartis Investigative Site

    Roma, RM, 00133, Italy

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 464 8681, Japan

  • Novartis Investigative Site

    Kashiwa, Chiba, 277 8577, Japan

  • Novartis Investigative Site

    Fukuoka, Fukuoka, 812-8582, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 064 0804, Japan

  • Novartis Investigative Site

    Isehara, Kanagawa, 259-1193, Japan

  • Novartis Investigative Site

    Sendai, Miyagi, 980 8574, Japan

  • Novartis Investigative Site

    Nagasaki, Nagasaki, 852-8501, Japan

  • Novartis Investigative Site

    Sakai, Osaka, 590-0197, Japan

  • Novartis Investigative Site

    Bunkyo-ku, Tokyo, 113-8603, Japan

  • Novartis Investigative Site

    Yamagata, Yamagata, 990 9585, Japan

  • Novartis Investigative Site

    Osaka, 545-8586, Japan

  • Novartis Investigative Site

    Beirut, 113-0236, Lebanon

  • Novartis Investigative Site

    Vilnius, LT-08406, Lithuania

  • Novartis Investigative Site

    George Town, Pulau Pinang, 10450, Malaysia

  • Novartis Investigative Site

    Kuching, Sarawak, 93586, Malaysia

  • Novartis Investigative Site

    Kuala Lumpur, 59100, Malaysia

  • Novartis Investigative Site

    Kuala Selangor, 68000, Malaysia

  • Novartis Investigative Site

    Satélite, Edo Mexico, 53100, Mexico

  • Novartis Investigative Site

    Mexico City, Mexico City, 06720, Mexico

  • Novartis Investigative Site

    Morelia, Michoacán, 58260, Mexico

  • Novartis Investigative Site

    Estado de México, 52787, Mexico

  • Novartis Investigative Site

    Groningen, Provincie Groningen, 9713 GZ, Netherlands

  • Novartis Investigative Site

    Khoudh, 123, Oman

  • Novartis Investigative Site

    Lisbon, 1099-023, Portugal

  • Novartis Investigative Site

    Porto, 4200-072, Portugal

  • Novartis Investigative Site

    Saint Petersburg, 191024, Russia

  • Novartis Investigative Site

    Saint Petersburg, 197022, Russia

  • Novartis Investigative Site

    Riyadh, 11211, Saudi Arabia

  • Novartis Investigative Site

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    Singapore, 169608, Singapore

  • Novartis Investigative Site

    Seoul, Korea, 03080, South Korea

  • Novartis Investigative Site

    Seoul, Seoul, 06351, South Korea

  • Novartis Investigative Site

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    Seoul, 05505, South Korea

  • Novartis Investigative Site

    Seoul, 06591, South Korea

  • Novartis Investigative Site

    Badalona, Barcelona, 08916, Spain

  • Novartis Investigative Site

    Salamanca, Castille and León, 37007, Spain

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035, Spain

  • Novartis Investigative Site

    Oviedo, Principality of Asturias, 33011, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Seville, 41013, Spain

  • Novartis Investigative Site

    Valencia, 46010, Spain

  • Novartis Investigative Site

    Valencia, 46026, Spain

  • Novartis Investigative Site

    Bern, 3010, Switzerland

  • Novartis Investigative Site

    Zurich, 8091, Switzerland

  • Novartis Investigative Site

    Hualien City, 970, Taiwan

  • Novartis Investigative Site

    Kaohsiung City, 83301, Taiwan

  • Novartis Investigative Site

    Liouying Township, 736005, Taiwan

  • Novartis Investigative Site

    Taichung, 40447, Taiwan

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Taoyuan, 33305, Taiwan

  • Novartis Investigative Site

    Songkhla, Hat Yai, 90110, Thailand

  • Novartis Investigative Site

    Khon Kaen, THA, 40002, Thailand

  • Novartis Investigative Site

    Bangkok, 10330, Thailand

  • Novartis Investigative Site

    Bangkok, 10400, Thailand

  • Novartis Investigative Site

    Bangkok, 10700, Thailand

  • Novartis Investigative Site

    Chiang Mai, 50200, Thailand

  • Novartis Investigative Site

    Samsun, Atakum, 55200, Turkey (Türkiye)

  • Novartis Investigative Site

    Edirne, Merkez, 22030, Turkey (Türkiye)

  • Novartis Investigative Site

    Istanbul, Pendik, 34899, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, 06230, Turkey (Türkiye)

  • Novartis Investigative Site

    Izmir, 35100, Turkey (Türkiye)

  • Novartis Investigative Site

    Portsmouth, Hants, PO6 3LY, United Kingdom

  • Novartis Investigative Site

    Edinburgh, Scotland, EH4 2XU, United Kingdom

  • Novartis Investigative Site

    Manchester, M20 2BX, United Kingdom

  • Novartis Investigative Site

    Nottingham, NG5 1PB, United Kingdom

  • University Of Miami

    Miami, Florida, 33136, United States

  • University of California LA

    Los Angeles, California, 90095, United States

  • University of Rochester Medical Ctr

    Rochester, New York, 14642, United States

  • University of Virginia

    Charlottesville, Virginia, 22903, United States

  • Weill Cornell Medicine NY-Presb

    New York, New York, 10021, United States

  • Yale University School Of Medicine

    New Haven, Connecticut, 06520, United States

  • Yuma Regional Cancer Center

    Yuma, Arizona, 85364, United States

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