Experimental MDS combo trial halted early – what we know

NCT ID NCT04878432

Terminated Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

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

Summary

This phase 2 study tested adding sabatolimab, an experimental immunotherapy, to standard chemotherapy drugs (azacitidine, decitabine, or oral decitabine) in 39 adults with intermediate to very high risk myelodysplastic syndrome (MDS). The main goal was to check safety, and the trial also looked at how many patients achieved complete remission within 12 months. The study was terminated early, so the full picture is limited, but the data collected helps understand the combination's safety and potential effectiveness.

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 a hypomethylating agent (azacitidine, decitabine, or oral decitabine/cedazuridine)
What this could lead to: If successful, this combination could offer a new treatment option for people with higher-risk myelodysplastic syndrome (MDS) by improving remission rates.
What could go wrong: The trial was terminated early with only 39 participants, so results are limited. It is unclear if sabatolimab adds meaningful benefit over standard therapy, and side effects are possible.

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

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Conditions

The condition(s) this trial relates to.

myelodysplastic syndrome Myelodysplastic Syndromes

As listed by the trial registrant

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

MYELODYSPLASTIC SYNDROME (MDS)

Contacts and locations

Locations

Advent Health Orlando

Orlando, Florida, 32803, United States
Arizona Oncology Associates

Tucson, Arizona, 85745, United States
Cleveland Clinic

Cleveland, Ohio, 44195, United States
Duke Cancer Institute

Durham, North Carolina, 27710, United States
Karmanos Cancer Institute

Detroit, Michigan, 48201, United States
Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States
Mount Sinai Medical Center

New York, New York, 10029-6574, United States
SCRI-Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States
Texas Oncology San Antonio USO

San Antonio, Texas, 78240, United States
Tisch Hospital NYU Langone

New York, New York, 10016, United States
Uni Of TX MD Anderson Cancer Cntr

Houston, Texas, 77030, United States
Uni of Massachusetts Medical Center

Worcester, Massachusetts, 01655, United States
University Hospitals Of Cleveland

Cleveland, Ohio, 44106, United States
University Of Michigan

Ann Arbor, Michigan, 48109, United States
Yale University School Of Medicine

New Haven, Connecticut, 06520, United States

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