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New hope for leukemia patients too sick for chemo?

NCT ID NCT04150029

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested a new drug called sabatolimab combined with two other drugs (azacitidine and venetoclax) in 90 adults with acute myeloid leukemia who were not healthy enough for intensive chemotherapy. The goal was to see if the combination could help patients achieve remission. However, the study was terminated early, so the full results are not available.

What this could mean

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

Active substance
Sabatolimab (MBG453) plus azacitidine and venetoclax
What this could lead to
If successful, this combination could offer a new treatment option for AML patients who cannot tolerate standard chemotherapy.
What could go wrong
The trial was terminated early, so results are limited. It is a phase 2 study, and the combination may cause serious side effects or not improve outcomes.

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

90 people

The number who actually took part.

Started

Sep 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 (ICF) * Newly diagnosed with AML based on 2016 WHO classification (Arber et al 2016) and not suitable for intensive chemotherapy defined as: age ≥75, ECOG performance Status 2 or 3, or any of the following comomorbitities: severe cardiac comorbities (including congestive heart failure, LVEF ≤ 50%, chronic stable Angina) , pulmonary comorbidity (DLCO ≤ 65% or FEVI ≤ 65%). moderate hepatic impairment (with total Bilirubin \>1.5 to 3x ULN) , renal impairment (eGFR≥ 30 ml/min/1.73m\^2 to \<45 ml/min/1.73m\^2), or other comorbidity incompatible with intensive chemotherapy per Investigator assessement and approved by the Novartis Medical monitor) * Not planned for hematopoietic stem-cell transplantation (HSCT) * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 , 2 or 3 Exclusion Criteria: * Prior exposure to TIM-3 directed therapy * History of severe hypersensitivity reactions to any ingredient of study drug(s) (azacitidine, venetoclax or MGB453) or monoclonal antibodies (mAbs) and/or their excipients * Current use or use within 14 days prior to randomization of systemic, steroid therapy (\> 10 mg/day prednisone or equivalent) or any immunosuppressive therapy. Topical, inhaled, nasal, ophthalmic steroids are allowed. Replacement therapy, steroids given in the context of a transfusion are allowed and not considered a form of systemic treatment. * Previous treatment at any time, with any of the following antineoplastic agents, approved or investigational; checkpoint inhibitors, venetoclax and hypomethylating agents (HMAs) such as decitabine or azacitidine. * Active autoimmune disease requiring systemic therapy (e.g.corticosteroids). * Live vaccine administered within 30 Days prior to randomization

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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

  • 25Uni of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • Chattanooga Onc And Hem Assoc PC

    Chattanooga, Tennessee, 37404, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke Univ Medical Center

    Durham, North Carolina, 27710, United States

  • Huntsman Cancer Institute Univ of Utah

    Salt Lake City, Utah, 84112 0550, United States

  • Levine Cancer Insitute Carolinas Healthcare System

    Charlotte, North Carolina, 28204, United States

  • MD Anderson Cancer Center University of Texas

    Houston, Texas, 77030, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering

    New York, New York, 10017, United States

  • Novartis Investigative Site

    Clayton, Victoria, 3168, Australia

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2M9, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H3T 1E2, Canada

  • Novartis Investigative Site

    Paris, 75475, France

  • Novartis Investigative Site

    Toulouse, 31059, France

  • Novartis Investigative Site

    Leipzig, Saxony, 04103, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Milan, MI, 20162, Italy

  • Novartis Investigative Site

    Roma, RM, 00133, Italy

  • Novartis Investigative Site

    Fukushima, Fukushima, 960 1295, Japan

  • Novartis Investigative Site

    Yamagata, Yamagata, 990 9585, Japan

  • Novartis Investigative Site

    Seoul, Seocho gu, 06591, South Korea

  • Novartis Investigative Site

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Kaohsiung City, 83301, Taiwan

  • Uni Of Iowa Hospitals And Clinics

    Iowa City, Iowa, 52242, 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

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