Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs
Status:
Completed
Trial end date:
2020-11-30
Target enrollment:
Participant gender:
Summary
A Phase 3, randomized, open-label, parallel-group, multicenter study designed to evaluate the
efficacy and safety of guadecitabine in subjects with MDS or CMML who failed or relapsed
after adequate prior treatment with azacitidine, decitabine, or both. This global study will
be conducted in approximately 15 countries. Approximately 408 subjects from approximately 100
study centers will be randomly assigned in a 2:1 ratio to either guadecitabine (approximately
272 subjects) or Treatment Choice (approximately 136 subjects). The study consists of a
14-day screening period, a treatment period, a safety follow-up visit, and a long-term
follow-up period. The study is expected to last more than 2 years, and the duration of
individual subject participation will vary. Subjects may continue to receive treatment for as
long as they continue to benefit.