A Randomized, Multicentre, Open-label, Phase 2 Study Evaluating the Efficacy and Safety of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Subjects With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly (>= 65 Years) Acute Myeloid Leukemia (AML) Subjects Not Eligible for Hematopoietic Stem Cell Transplantation (HSCT)
This is a Phase 2, multicentre, randomized, parallel-group, open-label study consisting of 3
phases: Screening, Treatment, and Follow-up.
To confirm the safety, ie, the absence of overlapping toxicities of the combination
treatment regimen, an early safety monitoring will be performed based on approximately the
first 12 subjects randomized.
A total of approximately 72 subjects will be included in the Myelodysplastic syndromes (MDS)
cohort and approximately 110 subjects in the Acute Myeloid Leukemia (AML) cohort.
View this trial on ClinicalTrials.gov
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