A Randomized, Double-blind, Placebo-controlled Phase III Multi-center Study of Azacitidine With or Without MBG453 for the Treatment of Patients With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)
Latest Information Update: 22 Apr 2025
At a glance
- Drugs Sabatolimab (Primary) ; Azacitidine; Azacitidine
- Indications Chronic myelomonocytic leukaemia; Myelodysplastic syndromes
- Focus Registrational; Therapeutic Use
- Acronyms STIMULUS-MDS2
- Sponsors Novartis; Novartis Healthcare; Novartis Pharmaceuticals
Most Recent Events
- 25 Mar 2025 Status changed from active, no longer recruiting to discontinued. ( Despite positive trends identified post unblinding after Overall Survival primary analysis, the study did not show statistical significance in its primary endpoint, overall survival. No new safety findings were detected.)
- 22 Aug 2024 Planned End Date changed from 17 Sep 2024 to 3 Oct 2024.
- 22 Aug 2024 Planned primary completion date changed from 17 Sep 2024 to 3 Oct 2024.