A Phase 3, Multicentre, Randomized, Open-Label Study of Guadecitabine (SGI-110) Versus Treatment Choice in Adults With Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML) Previously Treated With Hypomethylating Agents
A Phase 3, randomized, open-label, parallel-group, multicentre 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 centres 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.
View this trial on ClinicalTrials.gov
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