S1117 A Randomized Phase II Study of Azacitidine in Combination with Lenalidomide vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)
This research is being done to compare the effects, good and/or bad on myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML), of adding either the drug lenalidomide or the drug vorinostat to the standard treatment drug azacitidine.
18 years or older, Myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML), Have not received lenalidomide, azacitidine, vorinostat, or decitabine, Have not received radiation therapy, chemotherapy, or cytotoxic therapy for other reasons in the previous year, Have not had a stem cell or bone marrow transplantation, Females may not be pregnant or become pregnant, Adequate imaging and blood results.
Eligible subjects will be randomly assigned, like drawing a number from a hat, to one of three study regimens. Subject will either receive azacitidine, azacitidine and lenalidomide, or azacitidine and vorinostat. Subjects will continue to receive the study regimen as long as they are doing well. All subjects will be followed for 5 years.
12/19/2013 04:02 AM