Clinical Trials

Leukemia Protocols

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.

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.