Treatment Study for Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia
This is a phase III study to evaluate the effectiveness and safety of guadecitabine in subjects with MDS or CMML whose disease is resistant to treatment or relapsed after treatment with azacitidine, decitabine, or both. Subjects will be randomly assigned in a 2:1 ratio to either guadecitabine or treatment choice. There are three treatment choices: low-dose cytarabine, standard intensive chemotherapy, or best supportive care. If assigned to the Treatment Choice arm, the subject and study doctor will decide on the best treatment option.
In order to participate you must meet the following criteria:
- Are 18 years of age or older and are able to understand and comply with study procedures.
- Have a confirmed diagnosis of MDS or CMML.
- Have MDS or CMML that was previously treated with azacitidine and/or decitabine for intermediate or high risk MDS or CMML.
You will be excluded from the study if any of the following criteria apply to you:
- Have been diagnosed as having acute myeloid leukemia with peripheral blood or bone marrow blasts of greater than or equal to 20%.
- Are sensitive to repeated treatment with decitabine or azacitidine. For example, subjects who had a response to prior decitabine or azacitidine treatment, but relapsed more than 6 months after stopping treatment with these agents.
- Have had prior treatment with guadecitabine.
- Have hypersensitivity to decitabine, guadecitabine, or any of their ingredients.
This is only a partial list of inclusion and exclusion criteria.