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Clinical Trials

Leukemia Protocols

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 (Procrit). We want to find out which is better. Epoetin alfa (Procrit) 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 (Procrit) and other red blood cell hormones. This study is being done to determine if the combination of treatment with epoetin alfa (Procrit) 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 (Procrit). 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 (Procrit).

2.  E1912:  A Randomized Phase III Study of Ibrutinib (PCI-32765)-Based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)

The purpose of this study is to compare the effects, good and/or bad, of two different therapies that include combinations of the drugs rituximab, fludarabine, cyclophosphamide and Ibrutinib have on you and your CLL. The first three of these drugs are standard treatments for CLL. Fludarabine and cyclophosphamide have been approved by the Food and Drug Administration (FDA) for the treatment of CLL. Rituximab is approved for the treatment of CLL when given in combination with fludarabine and cyclophosphamide and is also approved for treatment of non-Hodgkin lymphoma and rheumatoid arthritis. Ibrutinib has been previously studied in patients with CLL, and has been approved by the FDA for use in previously treated CLL patients. In this study, ibrutinib is investigational because it will be given to previously untreated CLL patients and administered in combination with rituximab.

3.  A041202:  A Randomized Phase III Study of Bendamustine + Rituximab vs. Ibrutinib + Rituximab vs. Ibrutinib Alone in Untreated Older Patients (>/=65yrs.) with Chronic Lymphocytic Leukemia

The purpose of this study is to compare the effects, good and/or bad, of the drug ibrutinib, either alone or in combination with the drug rituximab, with the standard treatment for this disease. The standard treatment is chemotherapy with the drug bendamustine in combination with the drug rituximab. The effects on you and your leukemia will be looked at to find out which treatment is better. Both bendamustine and rituximab are approved by the FDA to treat chronic lymphocytic leukemia (your leukemia type). Ibrutinib is FDA approved for patients who have received previous treatment for CLL. For this study, ibrutinib is considered investigational, since you have never been treated before for CLL. The combination of the drugs ibrutinib and rituximab (Arm 3) is also considered investigational. In this study, you will get either the drug ibrutinib alone or ibrutinib with rituximab, or bendamustine with rituximab. If you are in the group that receives bendamustine with rituximab and your disease returns, you will have the option to receive ibrutinib.

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.

Orange Regional Medical Center
707 East Main Street
Middletown, NY 10940
845-333-1000

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Orange Regional Medical Pavilion
75 Crystal Run Road
Middletown, NY 10940
845-695-5800

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