drugset / Trial / NCT04812548

A Study of Sabatolimab in Combination With Azacitidine and Venetoclax in High or Very High Risk MDS Participants

NCT04812548 ↗

Phase 2 Terminated 20 enrolled Novartis Pharmaceuticals
NaSequentialOpen-labelTreatment

Summary

The purpose of the study was to find out if the new drug sabatolimab when given in combination with azacitidine and venetoclax, was safe and had beneficial effects in participants with high or very high risk myelodysplastic syndrome (MDS) who were not suitable for treatment with intensive chemotherapy or a stem-cell transplant (HSCT).

Timeline

Start
2021-05-31
Primary completion
2023-05-08
Completion
2023-05-08

Outcome

Outcome not reported

Stopped (Business): “Study was stopped following a strategic decision from the Sponsor. It was not based on any safety findings or safety concerns with sabatolimab.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Sabatolimab Monoclonal antibody — Intravenous
Background Azacitidine Other / unclassified — Subcutaneous
Background Venetoclax Small molecule 400 mg Oral