Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) (STIMULUS-MDS2) | Aplastic Anemia & MDS International Foundation
Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) (STIMULUS-MDS2)

Clinical Trial: NCT04266301

For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

This is a Phase III multi-center, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to azacitidine in adult subjects with intermediate, high or very high risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) who have an indication for treatment with azacitidine in first-line setting and are not eligible for intensive chemotherapy or hematopoietic stem cell transplantation (HSCT) according to medical judgment by the investigator.

Status: 
Not yet recruiting
Study Date: 
Wed, 05/20/2020 to Thu, 03/02/2023
Bone Marrow Disease(s): 
  • myelodysplastic syndromes (MDS)
Intervention: 
Experimental: MBG453 + Azacitidine Participants will receive MBG453 plus Azacitidine Drug: MBG453 A dose of MBG453 800 mg will be administered intravenously (IV) every 4 weeks (Q4W). Drug: Azacitidine A dose of Azacitidine 75 mg/m2 will be administered IV or subcutaneously (SC) on Day 1-7, or Day 1-5, 8 and 9. Placebo Comparator: Placebo + Azacitidine Participants will receive Placebo plus Azacitidine Drug: MBG453 A dose of MBG453 800 mg will be administered intravenously (IV) every 4 weeks (Q4W). Drug: Azacitidine A dose of Azacitidine 75 mg/m2 will be administered IV or subcutaneously (SC) on Day 1-7, or Day 1-5, 8 and 9. Drug: Placebo A dose of Placebo 800 mg will be administered intravenously every 4 weeks (Q4W).