As of July 24, 2012 - protocols do open and close daily.
Please check with your physician for additional protocols and/or information.
1. E2905: Randomized Phase III Trial Comparing the Frequency of Major Erythroid Alfa in Subjects with Low or Intermediate 1 Risk MDS and Symptomatic Anemia
The purpose of this study is to compare how a drug called lenalidomide affects (good or bad) you and your condition when given alone compared with when given with another drug called epoetin alfa. We want to find out which is better. Epoetin alfa boosts the production of red blood cells. Lenalidomide makes early red blood cells more likely to be affected by the growth promoting effects of epoetin alfa and other red blood cell hormones. This study is being done to determine if the combination of treatment with epoetin alfa and lenalidomide is better than lenalidomide alone in improving red blood cell production and in relieving the need for red blood cell transfusions in patients with MDS (myelodysplastic syndrome). In this study, you will get either lenalidomide or lenalidomide and epoetin alfa. If you get lenalidomide alone and it does not have a very good effect on you after 4 cycles, then you will be offered lenalidomide and epoetin alfa.
Lenalidomide is approved by the FDA for the treatment of red cell transfusion-dependent MDS patients with a specific chromosome abnormality called deletion 5q. Lenalidomide has been shown to reduce transfusion dependence. Epoetin alfa has been FDA approved for the treatment of chemotherapy related anemia. However, the combination of epoetin alfa and lenalidomide is experimental.
2. S1117: A Randomized Phase II Study of Azactitdine in Combination with Lenadlidomide vs. Azactidine Alone vs. Azactitdine in Combination with Vorinostat for Higher-Risk Myelodysplatic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)
The purpose of this study is to compare the effects, good and/or bad on your and your MDS or CMML, of adding either the drug lenalidomide or the drug vorinostat to the regular treatment drug azacitidine. In this study, you will be on one of the following treatment arms: azacitidine alone, azacitidine and lenalidomide or azacitidine and vorinostat. You will only get one of these treatments.
For more information on these protocols or any other research, please contact your physician or our clinical research coordinator, Jessica Gerlach, CCRP at 845-333-1133.