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A Study Evaluating Venetoclax in Combination With Azacitidine Compared With Azacitidine Alone in Participants With Previously Untreated Higher-Risk Myelodysplastic Syndromes (MDS)
||A Randomized Phase 2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of Venetoclax in Combination with Azacitidine Compared with Azacitidine Alone in Subjects with Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)
||Kellie Sprague, MD
||Elizabeth Kendricken, RN
This is a Phase 2, open-label, 3-arm randomized, multicenter study designed to determine the safety, pharmacokinetics, and efficacy of venetoclax when administered with azacitidine, compared to azacitidine alone, in subjects with treatment-naïve higher-risk MDS.
Approximately 90 subjects, from approximately 50 sites, will be enrolled with approximately 30 subjects to be randomized to each arm.
- Must have newly disgnosed MDS
- Must have adequate organ function, as determined by lab values
- Must agree to use birth control during treatment and up to 90 days after treatment
- Must not have received prior therapy for MDS
- Must not have had a previous allogeneic gematopoietic stem cell transplantation or solid organ transplantation.
- Must not be pregnant or breast feeding
Depending on which arm a subject is randomized to, they will be asked to provide an additional 1.5 teaspoons of blood for total of16 tablespoons throughout the course of the study. Bone marrow biopsies will be performed several times through out the study and subject’s will be asked to provide an additional 0.5 to 1.5 teaspoons of bone marrow aspirate.During cycle 1, subjects will be required to come to clinic on day 1 through 4, day 7, day 15, and day 22. Cycle 2 and beyond subjects will have to come to clinic on day 1, day 4, day 7, and day 28