Therapy of Chronic Lymphocytic Leukemia With Dasatinib (BMS-354825)
Dasatinib is designed to interfere with a type of protein that appears to be important for
the survival of CLL cells.
If you are found to be eligible to take part in this study, you will take dasatinib by mouth
twice a day. You will be instructed to take dasatinib in the morning and in the evening.
You will have an electrocardiogram (ECG—a test of the electrical activity of your heart) and
a physical exam once every 3 months while on study. Blood (about 2-3 teaspoons) will be
drawn for routine tests once a week for 1 month and then once a month for the rest of your
treatment on this study. A bone marrow biopsy and aspiration will be performed, as needed,
to check the status of the disease. To collect a bone marrow aspirate and biopsy, an area
of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow and
bone is withdrawn through a large needle.
Dasatinib will be given for as long as you are responding. You will be taken off study if
the disease gets worse or intolerable side effects occur.
This is an investigational study. Dasatinib is not FDA-approved for CLL, and it has been
authorized for use in research only. Up to 25 patients will take part in this multicenter
study. Up to 25 will be enrolled at M. D. Anderson.
Optional Procedures: If you agree, blood samples (about 2 tablespoons each time) will be
collected before therapy starts, at 3-4 hours after the first dose, and at 3 months on
therapy. These blood draws will be done when other routine tests are done. No additional
needle sticks will be needed. The blood will be used to see how the disease is responding
to the drug.
You do not have to agree to take part in the optional procedures in order to receive
treatment on this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate
Number of participants with a response (Complete Response or Partial Response) out of total participants. Responses evaluated every 3 months +/- 1 week by each component and overall by NCI criteria.
4 week treatment cycle
Susan O'Brien, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|UT MD Anderson Cancer Center||Houston, Texas 77030|