STIMULUS MDS-US : Sabatolimab Added to HMA in Higher Risk MDS
Public ClinicalTrials.gov record NCT04878432. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Single-arm, Open Label, Phase II Study of MBG453 (Sabatolimab) Added to FDA Approved Hypomethylating Agents of Investigator's Choice (IV/SC/Oral) for Patients With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R Criteria (US Multi-center) (STIMULUS MDS-US)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main objective of this study was to assess the safety profile of MBG453 (sabatolimab) in combination with FDA approved hypomethylating agents (HMAs) of investigator's choice (IV Decitabine or Azacitidine /SC Azacitidine /Oral Decitabine (cedazuridine combination (INQOVI))).
Study identification
- NCT ID
- NCT04878432
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 39 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 17, 2022 (Actual)
- Primary completion
- Oct 26, 2023 (Actual)
- Completion
- Sep 1, 2024 (Actual)
- Last update posted
- Oct 16, 2025
2022 – 2024
United States locations
- U.S. sites
- 15
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | — |
| Arizona Oncology Associates | Tucson | Arizona | 85745 | — |
| SCRI-Colorado Blood Cancer Institute | Denver | Colorado | 80218 | — |
| Yale University School Of Medicine | New Haven | Connecticut | 06520 | — |
| Advent Health Orlando | Orlando | Florida | 32803 | — |
| Uni of Massachusetts Medical Center | Worcester | Massachusetts | 01655 | — |
| University Of Michigan | Ann Arbor | Michigan | 48109 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Tisch Hospital NYU Langone | New York | New York | 10016 | — |
| Mount Sinai Medical Center | New York | New York | 10029-6574 | — |
| Duke Cancer Institute | Durham | North Carolina | 27710 | — |
| University Hospitals Of Cleveland | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Uni Of TX MD Anderson Cancer Cntr | Houston | Texas | 77030 | — |
| Texas Oncology San Antonio USO | San Antonio | Texas | 78240 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04878432, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 16, 2025 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04878432 live on ClinicalTrials.gov.