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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)

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Trial Profile

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)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 22 Apr 2025

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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.

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